Medicine information helpline after hospitalization–a randomized trial: Impact on patient satisfaction, patient concerns about medicines and clinical outcome on patient safety

Karianne Wilhelmsen Fjære; Tim Emil Vejborg; Lene Colberg; Cecilia Strøjer Ulrich; Lars Pedersen; Ann Kathrin Demény; Joo Hanne Poulsen; Helle Byg Armandi; Marianne Hald Clemmensen

doi:10.1371/journal.pone.0293523

. 2023 Oct 26;18(10):e0293523. doi: 10.1371/journal.pone.0293523

Medicine information helpline after hospitalization–a randomized trial: Impact on patient satisfaction, patient concerns about medicines and clinical outcome on patient safety

Karianne Wilhelmsen Fjære ^1,^#, Tim Emil Vejborg ^1,^#, Lene Colberg ^1,^#, Cecilia Strøjer Ulrich ^1,^‡, Lars Pedersen ^2,^‡, Ann Kathrin Demény ^3,^‡, Joo Hanne Poulsen ^1,^‡, Helle Byg Armandi ^1,^‡, Marianne Hald Clemmensen ^1,^*,^#

Editor: Vineet Gupta⁴

PMCID: PMC10602279 PMID: 37883413

Abstract

Background and aim

Hospitalization often leads to changes in patients’ medicine which challenges a safe medication use after discharge. Medicine information helplines (MIHs) can be valuable for patients in overcoming these challenges. This study evaluates patient satisfaction with a newly established Danish hospital-based MIH for discharged patients. The MIH is operated by experienced pharmacists and a pharmacy technician, and the study explores how the service affects the patient’s concerns and perception of safety in relation to their medication, followed by an assessment of the clinical impact of MIH on patient safety.

Method

A randomized controlled study design was used in the present study. The study was registered at clinicaltrials.gov with the identification number NCT03829995. Participants were randomized 1:4 (50:200) into a control- and intervention group. Participants in the control group were offered standard care and those in the intervention group were offered access to the MIH. A telephone interview performed 2–4 weeks after discharge assessed patient satisfaction with the helpline and patient’s feeling of safety in relation to medicine use (primary outcome). Data were analyzed using a Mann-Whitney U test. After case handling of each enquiry to the MIH, the cases were assessed with regard to medication-related problems (MRPs) and clinical impact of the MIH service was assessed (primary outcome).

Results

A total of 250 participants were included in the study and 152 participated in the telephone interviews (33 control and 119 intervention). Thirty-seven questions were enquired by 26 participants to the MIH. Of these, 8 were requested before the telephone interviews and these patients all expressed a high satisfaction with the MIH (score 4.57 +/- 0.73 on a 5-point scale). Most patients offered access to the MIH expressed that it increased the sense of safety in relation to their medicines (79%). However, comparing the control- and intervention group with regard to patient concerns and feeling of safety in relation to medicine use no differences were found. Evaluation of the enquiries revealed at least one MRP per enquiry, and in most cases the advice given were assessed to have a high- or moderate clinical significance.

Conclusion

The MIH was appreciated by the participants, indicating that the MIH could be a valuable service for discharged patients in improving the sense of safety in relation to medication and alleviating MRPs. Providing easy access for patients to medicine information may contribute to patient safe medicine use after discharge.

Introduction

Healthcare systems are becoming more and more complex, and patients must navigate between hospitals and the primary sector. Transition from hospitals to private homes is known to challenge patient safety [1–3]. Recent studies highlight that adverse events related to cross-sectorial care are increasing of which many can be attributed to errors in the medication process [1–3]. During hospitalization patients often experience changes in their medication, which can lead to confusion and insecurity about the new or changed medicine after discharge [1,3]. Further, patients report that they did not receive important information about their medication upon hospital discharge [2,4,5]. It is estimated that up to 65% of patients discharged from a hospital subsequently experience medication-related problems (MRPs) defined as events or circumstances related to a patient’s medication that can adversely affect patients’ health status [3].

Importantly, it has been shown that patient education and counseling can reduce the risk of medicine related adverse events and rehospitalization, and patients have been identified as a key resource in improving medicines safety in cross-sector situations [1,2,4]. Thus, there is a need to ensure that patients receive the relevant support, information and education related to their medicine.

Medicine Information Helplines (MIH) can play an important role in supporting patients in a safe medication after hospitalization [1,2]. Several studies have shown that patients in general express a high satisfaction with MIH services and the information they have received about their medicine [1,5–8]. In the UK, MIH services were established in the early 1990s enabling patients discharged from the hospital direct access to communication with a pharmacy professional to improve the medication safety and to reduce medication errors [6]. Similar services have been established in countries like Norway, Sweden and Germany [9–11]. MIH could also support a better medication adherence by empowering the patients through provision of knowledge and information about their use of medicines [1,6,7,12,13].

Up until 2018, discharged patients in Denmark had no access to a MIH. Patients may contact the general practitioners, community pharmacies or the respective hospital ward with medicine-related questions [9]. However, this is not always suitable, as the new medicine may be used in hospitals only, the general practitioners may be unavailable, the community pharmacy does not have access to the discharge summary from the hospital or the hospital staff might be busy taking care of admitted patients. Therefore, the Danish hospital-based service, MIH, was established in 2018 for discharged patients in the Capital Region of Denmark [14]. This study is to our knowledge the first to explore if addition of MIH affects patient’s concerns and perception of safety about medicines use as compared to standard care with limited medicine information support after discharge. Furthermore, the aim was to evaluate patient satisfaction with the new MIH followed by an assessment of the clinical significance of MIH on patient safety.

Method

Setting

The MIH was operated by experienced pharmacists and a pharmacy technician from the Medicine Information Centre (MIC) at the Hospital Pharmacy at Bispebjerg Hospital in the Capital Region of Denmark. Staff was trained in clinical pharmacy and drug information activities. The MIH team consists of 12 medicine information pharmacists and a pharmacy technician, who have been providing medicine information between 5–25 years in the MIC. The helpline is accessible on all weekdays from 8 am to 3.30 pm.

An acute care setting and a non-acute inpatient setting were purposively chosen to obtain possible variations in the clinical impact related to the MIH, and the impact on patient satisfaction, concerns and perception of safety in relation to their medicine after discharge. Thus, the Emergency Department and the Department of Respiratory Medicine at Bispebjerg Hospital were selected. Bispebjerg Hospital is one of the hospitals in the Capital Region of Denmark. The hospital serves as a community hospital for approximately 400,000 citizens. The Emergency Department has around 40 beds while the Department of Respiratory Medicine has 38 beds [15].

Enrollment of participants

A total of 250 patients were enrolled in the study from July 2018 to May 2019. The patients were enrolled from the two selected hospital wards by the first three authors from the MIC. All admitted patients at the two wards were assessed and eligible participants were subsequently approached for enrollment. Eligible participants were 18 years or older, spoke and understood Danish, and were scheduled for discharge to their private homes within a few days after enrollment. Exclusion criteria included severe dementia diagnosis, terminally illness, isolation precautions, aphasia, suicidal or patients in custody. Length of stay and whether the patient used medicines or not were not exclusion criteria.

Participation in the study was voluntary and all patients were given oral and written information about the study, publication plans and his or her right to withdraw from the study at any time without further consequences. All participants signed a consent form and patients’ participation was documented in their hospital files by the clinical pharmacists.

Study design

A randomized controlled study design was used to explore the study objective [16]. The included participants were randomized 1:4 (50:200) into a control and an intervention group with parallel assignment using the randomization online system (randomization.com) by the Pharmacy’s Clinical Trials Department; see the Data Analysis section for more details. The randomization was blinded and divided into block sizes of 5/10/15/20/25 with consecutive numbered, opaque sealed envelopes, that were subsequently distributed to the included participants. Patients were recruited in the hospital wards by the first three authors from MIC who were blinded to the allocation until the envelope was opened.

The control group (50 participants) received no intervention beyond standard care which does not include access to any information services post discharge. The intervention group (200 participants) were offered standard care and the opportunity to contact the MIH on all business days, should any medicine-related questions arise after hospital discharge. Upon enrollment, patients in the intervention group received a card with contact information for the MIH. All enquiries to the MIH were answered orally and/or in writing by either a pharmacist or a pharmacy technician from the MIC. All enquiries and the case handling were documented in the MIC’s database and categorized into predefined types of categories, such as adverse effects, choice of therapy, dosage/administration, drug interactions and product information.

Telephone interviews

A primary outcome of the present study was to evaluate whether the offer to contact the MIH influenced patient’s concerns and perception of safety in relation to their medicines (S1 Appendix question 9–14) as compared to standard care. Further, patient satisfaction with the new MIH was included as a primary outcome (S1 Appendix, question 25). The primary outcomes were investigated through telephone interviews with the included participants, lasting on average between 20–30 minutes.

An interview guide was developed to assess patient satisfaction with the medicine information obtained during hospitalization, at discharge and given by the MIH. In order to investigate patients concerns and perception of safety in relation to medicines use, already validated questions from the Beliefs About Medicine Questionnaire proposed by Horne et al. [17] and from a study by Badiani et al. [6] were included in the interview guide. Further questions were developed by author one and nine and were included according to the study objectives and contextual setting; see S1 Appendix for the complete questionnaire. The guide was divided into three overall sections directed towards the participants in the control group, the intervention group and those who contacted the MIH. The interview guide was structured and contained both closed- and open-ended questions or statements the participants would rate using a five-point scale (1 = not at all and 5 = to a very great extent); see S1 Appendix. If a patient was not in any medical treatment prior to, during admission or after discharge, the patient was not able to provide an answer to all questions from the interview guide. Hence, the total number of respondents to each question may vary. Further, not all patients answered all questions, but the responses given were included in the study. The number of answers given to each specific question will be represented by “n”, and the calculated percentages are based on the fraction of “n”.

The questions in the interview guide were pilottested by 12 patients and 5 healthcare professionals, and the wording of some of the questions was subsequently optimized accordingly. All eligible participants were interviewed by telephone within 2–4 weeks after discharge to ensure that the patients remembered details about their hospital stay. The telephone interviews were performed by author one, two and three.

Participants were rated as non-responders if they declined to be interviewed or if they did not answer the phone within five attempts on five different days over a two-week period. In addition, participants were also rated as a non-responder if they showed cognitive or/and communicative problems during the interview, making it difficult to complete the interview, or if the patient was readmitted or deceased.

Clinical impact assessment

Another primary outcome of the present study was the clinical impact of MIH on patient safety. To assess the clinical impact, all enquiries were analyzed and categorized for MRPs and pharmacy interventions according to the Westerlund System; see Table 1 [18,19]. Furthermore, the impact on patient safety was assessed using the DOCUMENT system, where the clinical significance of each enquiry from the intervention group was determined individually by two clinical pharmacists each with approximately 10 years of experience within clinical pharmacy and medicine information (the first and fourth author) [20]. Any discrepancies were discussed in order to determine a concluding assessment of the clinical significance; see Table 1.

Table 1. Clinical impact assessment of MRPs and the pharmacy intervention.

MRPs classified using the Westerlund System [18,19]

Uncertainty about aim of the medicine; adverse reaction; interaction; therapy failure; problem of administration; inappropriate time for the medication intake/wrong dosage interval; over-/underuse of the medicine, medicine duplication; inappropriate storage of the medicine; difficulty opening the medicine; other MRPs.

Clinical significance of the pharmacy intervention described by the DOCUMENT system [20]

Nil: No consequence to the patient

Low: Consequences to the patient are related to costs or information only

Mild: Consequences to the patient are that they have improved compliance or improved or prevented a minor symptom. The sign or symptom should not require a doctor’s visit to treat

Moderate: When, if the intervention did not occur, it was likely that the patient would have had to visit the doctor because of the consequences. Also covers the situation where the pharmacist needs to refer the patient to the doctor because of the seriousness of the situation

High: When, if the intervention did not occur, it was likely that the patient would have
• had to go to a hospital because of the consequences. Also covers the situation where the pharmacist needs to refer the patient to a hospital because of the seriousness of the situation
• required assistance from a regular nurse visit, or would have required placement into residential care

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Data analysis

No similar studies are available from which a sample size can be calculated.

This study used a randomized controlled study design, and it was set to detect a 10% improvement on a 5-point scale measuring patient satisfaction with medicine information and patient concerns about medicine. From the literature, a mean score of 3.5 ± 0.5 is anticipated [2,21–23]. The 10% was set by the authors as this was assessed to allow for detection of any relevant changes in the scores.

Power was set by the authors to 90% and p-values less than 0.05 were considered statistically significant. Thus, a sample size of 43 patients was calculated [24], but to adjust for dropouts, the sample size was set to 50 patients. It was estimated by the authors that approximately 20% of the patients in the intervention group would contact the MIH thus resulting in a (50:200) (control:intervention) allocation.

Quantitative data from the patient interviews were analyzed in Microsoft Excel (for Office 365 MSO) and IBM SPSS (Version 25) with descriptive statistics and simple parametric statistics. Mann-Whitney U test were used for analysis of ordinal variables (five-point scale) and Chi-Square test were used for nominal variables (gender, yes/no). Data are displayed as the mean of rating ± SD (Standard Deviation) unless otherwise specified. A confidence interval (CI) was calculated using the Clopper-Pearson method for the primary outcome data using nominal variables. An independent t-test was used to test for difference in age and number of medications by admission and discharge. Test for normality was done using Shapiro-Wilk test. If data did not show a normality distribution a Wilcoxon rank sum test was used to test for difference. Free text comments were not analyzed explicitly but were solely used to support the interpretation of the patient interview.

Results

Participants

A total of 946 patients were assessed for eligibility at the two hospital wards. Of these, 319 patients failed to meet the inclusion criteria and 377 patients either declined the invitation to participate, were asleep, discharged or transferred to another ward at the time of inclusion.

Thus, 250 participants were included in the study and randomized into a control group (n = 50) and an intervention group (n = 200). In the follow-up period, 98 participants (17 in the control group and 81 in the intervention group) were considered as non-responders. Finally, 33 participants were interviewed in the control group and 119 participants in the intervention group; see Fig 1.

The participants were included equally from the Emergency Department and from the Department of Respiratory Medicine, and their characteristics are presented in Table 2. No significant differences were found between control and intervention groups regarding gender, age or number of medications at admission or discharge respectively; see Table 2.

Table 2. Characteristics of enrolled participants.

Characteristics	Control group (n = 33)	Intervention group (n = 119)	All participants (n = 152)	P Value
Gender, No. (%)^a Male Female	13 (39) 20 (61)	55 (46) 64 (54)	68 (45) 84 (55)	0.540
Age, median (IQR)	71 (57–78)	67 (51–74)	68 (54–75.5)	0.143^C
Hospital ward, No. (%)^a Acute medical ward Department of respiratory medicine	12 (36) 21 (64)	60 (50) 59 (50)	72 (47) 80 (53)	0.152
No. of medications by admission, median (IQR)^b	7 (5–12.5)	8 (4–13)	7,5 (4–12.5)	0.766^C
No. of medications by discharge, median (IQR)^b	9 (5.5–14.5)	9 (5–14)	9 (5–14)	0.881^C

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IQR: Interquartile range.

^aPercentages of total number.

^bIncluding all registered medicines in the hospital files at admission and discharge.

^CWilcoxon rank sum test.

Medicine information during hospitalization and after discharge

A total of 152 participants were interviewed by telephone and the interview guide in S1 Appendix was followed. For nominal data, participants answering either”yes”,”no”,”do not know” were included in the analysis, whereas ordinal data only included answers containing ratings from 1–5. Not all participants answered all the questions. Thus, in the following, the number of answers given to each specific question is represented by “n”, and the results are provided with the calculated percentage based on the fraction of “n”.

In the control group 55% of the participants (18/33) reported a change in their medication during hospitalization, see S2 Appendix. A similar level of change in medication was reported by participants in the intervention group (58%, 68/118), see S2 Appendix. Further, the participants expressed a high level of satisfaction (score >3) with the medicine information provided during hospitalization and at discharge, see Fig 2. No significant differences were seen between the control- and intervention group with regard to satisfaction with the medicine information provided during hospitalization or at discharge, see Fig 2.

Fig 2 — Patients scored satisfaction with medicine information provided during hospitalization and at discharge on a 5-point scale where score 1 = not at all and score 5 = to a very great extent. Results are shown as mean of rating ± SD. No significant difference was found between the control- and intervention group with regard to satisfaction with medicine information provided during hospitalization (Mann-Whitney U test, p = 0.337) or at discharge (Mann-Whitney U test, p = 0.580).

Approximately half of the participants (48%, 73/141) preferred receiving their medicine information both written and orally at discharge, and 2/3 of these expressed that this combination gave them the opportunity to validate and repeat the obtained information when settled at home. Of the participants in the control and intervention group, 21% (7/33) and 29% (34/118) respectively did not recall that they received a medication-status-list at discharge. There was no significant difference between the groups (p = 0.377).

Of all participants, 26% (39/150) responded that they had questions regarding their medication after discharge (18% (6/33) in the control group and 28% (33/117) in the intervention group). The percentage of patients that had a question regarding their medication were higher in both control- and intervention group when looking at patients who reported a change in their medication (22% and 39,7% respectively). Among all patients who reported they had a question regarding their medicine a total of 67% in both the control group (4/6) and intervention group (22/33) found an answer to their question by searching the internet or contacting their general practitioner, pharmacy, hospital, relatives or visiting nurses, see S2 Appendix. In total, 8 patients from the intervention group contacted the MIH before the telephone interview and 100% (8/8) of those received an answer to their question. Of these 8 patients 6 patients reported a change in their medication (75%).

Patient satisfaction with MIH

One of the primary outcomes was patient satisfaction with MIH. Participants in the intervention group were asked if the opportunity to contact the MIH affected the feeling of safety in relation to their medication, which the majority of the participants acknowledged (72%, 79/110, CI [0.67–0.84[). Patients who contacted the MIH before the telephone interview (n = 8) reported a slightly lower score on the questions regarding feeling of safety with regard to their medication and they felt to a higher degree that their medicines were a mystery to them (see S2 Appendix). Importantly, these patients expressed that the feeling of security increased after contacting the MIH, as they found the information reassuring and brought clarity to potential worries, such as side effects, dosage regimens etc. In addition, the patients reported that the helpline provided practical advice on how to administer the medication.

Only patients in contact with the MIH before the telephone interview were asked about their satisfaction with the service (n = 8). The participants contacted the MIH by phone and received an answer by phone. The participants found the answers provided by the MIH timely, easy to understand and relevant. Furthermore, they reported that the answers to a great extent affected their use of medicine in a positive manner, just as they were satisfied with the answers to a very great extent (4.71 ± 0.45 on a 5-point scale). Generally, the participants were satisfied with the service (4.57 ± 0.73 on a 5-point scale), they would use it again (100% answered yes, n = 8), and they believed the helpline should be a permanent service for discharged patients in the Capital Region of Denmark (93% answered yes, n = 126).

Concerns and perception of safety in relation to medication

The other primary outcome focused on patients’ concerns and perception of safety in relation to their medication. Both the control- and the intervention group responded that they felt safe to a great extent regarding their medication after discharge, which equals to a rating 4 or more on a 5-point Likert scale. There was no significant difference between the groups (p = 0.59). Both groups expressed that their current health to some extent or to a great extent was dependent on medication (no group difference, p = 0.33). However, they did not worry about taking their medicine (no group difference, p = 0.969), nor did they experience their medication as a mystery (no group difference, p = 0.507), and they expressed that the medication only disrupted their lives to a small extent (no group difference, p = 0.844) (see Fig 3).

Fig 3 — Patients scored on a 5-point scale with 1 = not at all and 5 = to a very great extent. Results are shown as mean of rating ± SD. No significant difference was found between control- and intervention group for any of the questions (Mann-Whitney U test, p>0.05 for all questions).

Enquiries to the MIH service

During the study period, the participants from the intervention group were offered the possibility to contact the MIH if they had any questions regarding their medication after discharge.

In all, 26 participants raised a total of 37 enquiries to the MIH pre-, post- or during the telephone interviews (S3 File). These enquiries were categorized into predefined types of categories. The majority of enquiries were related to dosage/administration and product information (effect and usage), see Table 3.

Table 3. Categorization of enquiries to MIH from July 2018 through May 2019 (n = 37).

Category	Enquiries before telephone interview	Enquiries during telephone interview	Enquiries after telephone interview
Adverse effects, No. (%)	1 (2.7)	2 (5.4)	3 (8.1)
Choice of therapy, No. (%)	1 (2.7)	0 (0.0)	1 (2.7)
Dosage & administration, No. (%)	3 (8.1)	5 (13.5)	3 (8.1)
Interactions, No. (%)	1 (2.7)	0 (0.0)	3 (8.1)
Product information, effect and usage, No. (%)	4 (10.8)	6 (16.3)	1 (2.7)
Other, No. (%)	0 (0.0)	1 (2.7)	2 (5.4)
Total number	10 (27%)	14 (38%)	13 (35%)

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MIH: Medicines Information Helpline. “Other” include enquiries about patients’ control/treatment at the hospital and the need to speak with either a hospital- or general physician.

Clinical impact of MIH on patient safety

MRPs and the clinical impact of the helpline responses were assessed by two clinical pharmacists working at the MIC. All enquiries were included in the assessment regardless of when the patient asked the question relatively to the telephone interview, i.e., pre-, post- or during the telephone interviews. From the 37 enquiries, a total of 43 MRPs were identified according to the Westerlund system (Fig 4). The most frequent MRP was “uncertainty about the aim of the medicine”, e.g., uncertainty on how to take insulin or whether two prescribed medications during hospitalization were the same and should be administered similarly. Further, concerns about adverse reactions, interactions between medicines and therapy failure were identified MRPs in more than 10% of the enquiries (see Fig 4).

Fig 4 — The 43 MRPs extracted from the 37 enquiries to the MIH. Other MRPs included enquiries about vitamins and the need to speak with either a hospital- or general physician.

The pharmacy interventions for each MRP were also identified using the Westerlund system. One MRP may trigger several pharmaceutical interventions, and a total of 77 were identified. Of these, the pharmaceutical intervention medicine counseling was performed for all the 43 MRPs extracted from the 37 enquiries to the MIH. Further, the pharmaceutical interventions consisted of referral to prescriber or other health-care provider (17 situations); provision of practical information (12 situations); direct contact from the pharmacy personnel with the hospital prescriber (3 situations), and provision of information to patients’ representative (2 situations), which adds up to a total of 77 pharmaceutical interventions.

Clinical significance was assessed using the DOCUMENT system [20]. However, in most cases the clinical significance could not be attributed to a single specific pharmacy intervention. Instead, it was a sum of several pharmacy interventions performed to alleviate the MRP. Thus, clinical assessment was performed at the level of each MRP. More than 50% of the MRPs resulted in pharmacy interventions assessed to have a high- or moderate clinical significance (see Table 4). Among these were: counselling on how to administer insulin; impact of concomitant treatment with ciprofloxacin and theophylline; and length of antibiotic treatment to a patient who had only received tablets for 3 days and no prescription.

Table 4. Assessment of the clinical significance of the pharmacy interventions proposed to mitigate MRPs.

Clinical significance	Number of MRPs (n (%)) (N = 43)
Nil	1 (2)
Low	8 (19)
Mild	11 (26)
Moderate	17 (39)
High	6 (14)

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Discussion

The current study showed that patients discharged from hospital in general expressed a high level of satisfaction with the standard care medicine information provided by the health care personnel at the wards during hospitalization and at discharge. Despite this, a number of patients still had questions regarding their medication after hospital discharge. As expected, the rate of patients who had a question regarding their medicines was higher in the group of patients who reported having experienced a change in their medication during hospitalization indication that changes in medicine may lead to insecurity. Patients who were offered access to contact a newly established hospital-based MIH reported an increase in their feeling of safety in relation to their medication and all patients in contact with the MIH were “to a great extent” satisfied with the MIH service. However, asking all patients about their perception of safety in relation to medicines use revealed no difference between the control and the intervention group. During the study period, a total of 37 enquiries were received and answered. Analysis of the enquiries revealed 43 MRPs of which 53% triggered interventions assessed to have a moderate to high clinical significance.

Need for medicine information after discharge

The present study shows that approximately one fourth of the participants (26%) express a needed for information about their medication after hospital discharge. Similar results have been reported by Shuen et al. who found that 26% of patients discharged from an emergency department made a call or visit to their primary medical doctor or a specialist physician post discharge [25]. In this study only 8 out of 200 patients contacted the MIH after discharge. However, performing the telephone interviews (post discharge) triggered another 18 patients to make a total of 37 enquiries. The fact that post discharge contact triggers medicine-related questions is not surprising, and several studies have explored the impact of different follow-up strategies such as post-discharge home visits by pharmacist, follow-up phone calls and text messages in order to alleviate MRPs [21,26,27]. Although the number of patients taking a non-stimulated contact to the MIH is limited in this study, it should be seen in the context that the service is newly established to patients. As the MIH becomes a well-known service, we anticipate that the number of enquiries increase over time. Indeed, it could be relevant to introduce follow-up contacts as this has been shown to be a very effective strategy in supporting patients in relation to their medication after discharge [21,26,27]. The present study did not explore barriers to contact the MIH and it could be relevant in future studies to elucidate patients’ motivation and barriers to contact the MIH.

Increased patient safety

Analysis of the patient enquiries to the MIH revealed that 53% triggered interventions assessed to have a moderate to high clinical significance, suggesting that the interventions improved the patient safety of the patient medication. It is well known that medication after discharge is indeed a major cause of rehospitalization [1–3]. Studies indicate that providing the appropriate level of medicine information after discharge may reduce medicine related rehospitalization or contact to primary medical doctor or physician [4,27,28]. In this context a MIH may not only improve the patient safety of the medication after discharge, but it may also decrease overall costs of treatment. However, further studies are needed to elucidate the cost-benefit of a MIH service to patients after discharge.

High level of patient satisfaction with MIH

This study showed a high level of satisfaction with the MIH. The participants found the answers to their enquiries comprehensible and relevant, which affected their use of medicine. Other medicine helplines have reported similar high ratings of user satisfaction where the majority of the patients report that they received sufficient information and felt reassured about their medicine [8]. In line with the current study, Badiani et al. found that 95.9% of the respondents followed the advice provided in their study [6].

In this study, the most common enquiries were related to dose, administration, effect and usage of medicines. The nature of these enquiries is similar to those found in the literature [5,6,8]. Further assessment of each enquiry revealed 43 MRPs, where the most frequent MRP was uncertainty about the aim of the medicine, which indicates that the information given during hospitalization or at discharge was insufficient. Similar results have been reported from other medicine helplines where incorrect or insufficient information about medicine is the main topic of enquiries [5,8].

Perception of safety with medicine after discharge

Patients in both groups reported that they to a high degree felt safe with their medication after discharge. Further, the current study revealed that patients with access to the MIH expressed an increase in the feeling of safety in relation to their medication; see S2 Appendix. Many patients take action and seek information from e.g., friends, family or the internet in order to prevent harm [29] and here MIHs may indeed be a relevant source of information helping the patients alleviating these worries and support and empower the patients to deal with the problems.

Relevant medical information not only enables the patients to prevent and solve MRPs, but it may also be a key factor in relation to medicine adherence [30]. In this study adherence was not directly evaluated, however, the increase in feeling of safety in relation to medication may have a positive effect on adherence. Future studies are needed to elucidate the role of MIH in relation to adherence.

Methodological considerations

The present study was using a randomized study design. The dropout rate (enrolled patients not performing the telephone interview) in the current study was higher than anticipated (39%, 17 and 81 in the control and intervention group respectively) limiting the power to identify statistically significant differences. Applicable to both groups, the high dropout rate was mainly due to patients not answering their phone or being readmitted. For future studies, a suggestion to minimize the high dropout rate could be to schedule follow-up telephone calls or to arrange a personal meeting in the patients’ private homes and enroll patients who are less prone to be readmitted.

Another limitation in the current study concerns the interview guide that includes some questions that are not fully validated. However, most of the questions in the interview guide were adopted word-for-word from other studies ensuring that the majority of the questions had been tested by other researchers beforehand [6,17]. Furthermore, the final interview guide was pilot-tested, thus assuring an acceptable level of validity. The study did not include the full Beliefs About Medicine Questionnaire [17], thus not allowing a fully valid conclusion on patients concerns and the necessity of taking medicine. In this regard it should be considered if the sensitivity to measure the primary outcome regarding patients feeling of safety in relation to the medication was high enough.

The clinical impact of the helpline responses was assessed by two clinical pharmacists working at the MIC. This is a potential bias, and it would have strengthened the data analysis if an impartial party had analyzed the responses.

Another methodological consideration in the current study is the risk of respondent’s social desirability bias where respondents may respond in a way they think the investigator wants to hear and hereby present themselves in the best possible way [31]. Social desirability bias may lead to a better rating of the medicine helpline service although neutral wordings were used in the questions and most questions were answered on a scale rather than single items.

Further, there is a risk of recall bias, which is a systematic error that occurs when the participants do not recall or remember previous experiences accurately or omit details related to the topic of interest [32,33]. Since the interview in this study took place 2–4 weeks after discharge, there is a risk of recall bias, especially with regards to the medicine information during hospitalization and at discharge. However, recall bias is considered more prominent in retrospective surveys or self-reports, and the methodological approach in this study was telephone interviews where the researchers had the opportunity to probe and clarify the questions during the interviews. Thus, the extent of recall bias is considered minimal. Another limitation aspect is the fact that 39% of the included patients were lost in the follow-up and thus they were never interviewed. Although a 61% response rate is considered acceptable a high dropout rate might affect the generalizability of the study results.

Participants in the current study were included from two departments, an emergency department and a department of respiratory medicine. Thus, the present results are most probably only representative of similar clinical settings. Indeed, future studies should investigate other clinical settings.

Conclusion

MIH offers support for discharged patients to alleviate MRPs. More than 50% of the MRPs found in this study resulted in pharmacy interventions assessed to have a high- or moderate clinical significance. Although patients expressed a high satisfaction with the MIH, the access to the MIH did not significantly increase patients’ feeling of safety in relation to medicines use. This study emphasizes that patients value the service and the information provided by the MIH, and that the service might positively affect a safe medication after discharge. Changes in the medical treatment after discharge is challenging and patients should be provided with sufficient pharmaceutical support and information to overcome these struggles, ultimately ensuring a patient safe medication.

Supporting information

S1 Checklist. CONSORT 2010 checklist of information to include when reporting a randomised trial*.

(DOC)

Click here for additional data file.^{(219KB, doc)}

S1 Appendix. This is the interview guide.

(DOCX)

Click here for additional data file.^{(16.7KB, docx)}

S2 Appendix. This is the results based in the interview guide.

(DOCX)

Click here for additional data file.^{(21.9KB, docx)}

S1 File. This is the ethic committee protocol in Danish.

(DOCX)

Click here for additional data file.^{(72.6KB, docx)}

S2 File. This is the ethic committee protocol in English.

(DOCX)

Click here for additional data file.^{(60.9KB, docx)}

S3 File. This is the raw data from the case handling of request to MIH.

(DOCX)

Click here for additional data file.^{(34.9KB, docx)}

S4 File. This shows means, medians and box plots for all data given in ordinal variables.

(DOCX)

Click here for additional data file.^{(324.3KB, docx)}

Data Availability

All relevant data are within the paper and its Supporting Information files.

Funding Statement

MHCL received one grant supporting the research presented in the article. No other authors received any grants or awards. The grant was received from The Danish Research Unit for Hospital Pharmacy, Amgros I/S, Copenhagen, Denmark. https://amgros.dk/om-amgros/samarbejdspartnere/nationalt-samarbejde/ The funders did not play any role in study design, data collection and analysis, preparation of the manuscript or in the decision to publish the data. The grant only finansed a small part of the total costs of the study.

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PLoS One. doi: 10.1371/journal.pone.0293523.r001

Decision Letter 0

Johannes Stortz

6 Mar 2023

PONE-D-22-33407Medicine Information Helpline after hospitalization – a randomized trial: impact on patient satisfaction, patient belief in medicine and clinical outcome on patient safetyPLOS ONE

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Reviewer #1: Thank you for the opportunity to look at your work. I provided my individual comments at relevant sections. I didn't look at the references and conclusion. Also suggest to double check the references. Please refer to attached pdf file. Hope they are useful.

Reviewer #2: The randomized-controlled clinical trial evaluated discharged patient satisfaction with a newly established Danish hospital-based medicine information helpline (MIH) by describing the service’s effects on patient beliefs and perception of security about their medical treatment. The study also assessed the clinical impact of MIH on patient safety. The conclusions are unclear.

Major revisions:

1- Abstract: Briefly state the statistical method used from which the conclusions were drawn and provide p-values to support the statements.

2- If age is normally distributed, provide means and standard deviations as summary measures and compare groups using an independent t-test. If age is non-normally distributed, summarize with medians, first and third quartiles and compare groups using the Wilcoxon rank sum test. Use the Shapiro-Wilk test to test if the distribution of data deviates from a comparable normal distribution.

3- Apply the same approach as stated in comment 4 to the number of medications at admission and discharge.

4- Line 228: Provide statistical justification for the following statement. “No significant differences were seen between the control- and intervention group.”

5- Express p-values more precisely than p>0.05.

6- Line 254: Provide statistical justification for the following statement. “No significant difference was found between the groups.”

7- Line 272: State the statistical methods used to estimate the values of 4.17 and 0.48.

8- Figures: Determine if these variables are normally distributed. Perhaps a box plot is more appropriate if the data does not follow a normal distribution. In this case, summarize the variables using median, first and third quartiles.

9- The drop-out rate was extremely high. Discuss this limitation.

Minor revisions:

1- Line 163 contains a grammatical error.

2- Indicate the date range subjects were enrolled in the study.

Reviewer #3: This manuscript describes a randomised controlled trial of a medicines information helpline (MIH) designed to support patients recently discharged from hospital. 250 participants were randomised to have access to a MIH, or not to have access to a MIH. Patient reported outcomes on medicines information needs, beliefs about the security of medicines and helpline satisfaction were collected from 152 participants. Of the 119 of these participants randomised to MIH access, only 8 contacted the helpline before data collection.

There were no significant differences between the two randomised groups, but 72% of participants in the MIH group reported that the availability of the MIH made them feel safer. The MIH also identified and potentially resolved 43 medicines related problems (MRPs), 23 of which had moderate or high clinical significance.

MIHs are widely used in some countries, but there is limited and weak evidence of their effectiveness. A randomised study of an MIH is therefore necessary, making this study a novel contribution to the literature, which may be interesting and useful to readers of PLoS ONE.

The authors clearly faced challenges in delivering the study, as 98 participants were lost to follow up. In addition, only 8 participants had contacted the MIH before outcome data were collected, meaning the study is underpowered to detect a difference between the two groups. I think this has affected how the authors have reported their results, as the Results and Discussion sections focus on user satisfaction and MRPs from the MIH, and do not emphasise the comparison of outcomes in the two groups as would normally be expected in a RCT report. I therefore suggest the following recommendations.

Major comments:

1) State the primary and secondary outcomes more specifically. The primary outcomes are described in lines 127-130 as evaluating perceptions of security about medicines use and satisfaction. However, these constructs relate to 5 and 14 questions, respectively, in the follow up survey. So, I suggest it is clearly stated which of these questions were considered the primary outcomes.

2) Include these primary outcomes earlier in the results section, immediately after participant characteristics are described. Clearly describe them as the primary outcome and consider including an estimated effect size and 95% confidence interval for each one (as per CONSORT 2010). A description of the secondary outcomes can then follow.

3) Be clear at the start of the discussion and in the conclusion that no effect of the MIH was seen on the primary outcome, as 39% of participants were lost to follow up and there were not many calls to the helpline – both of which are major limitations. Consider discussing what the authors learned from this study that might be useful for future authors attempting a similar project.

4) In a similar way, make sure the primary outcomes are clearly stated in both the Methods and Results sub-sections of the abstract, and include numerical data in the results.

Minor comments:

Lines 111-125: as per CONSORT 2010, state who randomised the participants, as well as who recruited them.

Lines 111-125: as per CONSORT 2010 state whether the investigators and statisticians were blinded to the allocation. For clarity, state explicitly if the study was completely open label.

Line 138: the interview guide is described as ‘semi-structured’. This implies a qualitative method, with the guide used flexibly in response to what participants said – which would be inappropriate for an RCT. However, the interview guide in Appendix S2 appears to be a ‘structured’ (not semi-structured), so I would change this description.

Lines 168-169: include a reference for the type of calculation used to determine sample size.

Lines 162-176: how were ‘free text’ responses analysed?

Lines 162-176: clearly state whether or not the data were analysed on an intention to treat basis.

Lines 175-176: Differences in age and number of medications are analysed using the t-test, yet these results are summarised as the median and IQR in Table 2. This implies that they were not normally distributed, in which case the Mann-Whitney U test would be more appropriate.

Line 277: Clinical impact was assessed by pharmacists providing the MIH. This is a potential source of bias, which I suggest is discussed in the limitations section.

Figure 1: consider extending this to include how many participants called the MIH before, during and after the interviews

Figures 2&3 (and the sections of Appendix S3 that report the same data): define what values are reported for each Likert scale outcome. I assume it’s mean +/- standard deviation, but this is not stated.

There are multiple minor English language problems – I suggest a thorough proof-read by an experienced writer in English.

Reviewer #4: Thank you for a great initiative to improve the care transition concerning patients’ need for more/better medication information. I believe the approach is very appealing; however, I think your conclusion should be slightly more moderate. This includes updating the abstract. Further, I have some comments about potential sub-analyses to understand your data better, which you should include if possible. I also think you need to compare your intervention more to other similar ones and discuss how you might want to develop/modify yours. For example, only 8 patients contacted you without a reminder, maybe patients need some sort of reminder.

Titel

Medication instead of medicine? I’d recommend medications in more formal language and medicines in more lay language.

Patients’ beliefs about medicines/medications?

Abstract

Who performed the MIH service? Nurses, pharmacists?

Line:35/36 affects the patient’s belief and perception of security about their medical treatment= referring back to the title do you mean beliefs about medical treatment of only medications specifically?

43 helpline, patient belief about medicine. Add (BMQ)

43 helpline, patient belief about medicine-> patient’s beliefs

Line 44/45 Medication-related problems (MRPs) were identified and clinical impact of the MIH service was assessed. Of the person performing the service or during the telephone interviews?

47/48: thirty-seven questions were enquired by 26 participants to the MIH during the study-> please also add the percentage of how many had used the service and numbers from pre and post-trigger as well.

they all?n=26?

Line 48:Participants in the intervention group reported that the MIH increased their sense of security regarding medicine= all 119?

From line 249: Both the control- and the intervention group responded that they felt safe to a great extent regarding their medication after discharge, and there was no significant difference between groups (p=0.59).

52 Conclusion: The MIH was highly appreciated by the participants, which indicate that the MIH is a valuable service for discharged patients in improving the sense of security in relation to medication and alleviating MRPs.

Please make this statement a little more modest based on the results from line 249.

Background

58: Transition from hospitals to private homes is known to challenge (the) patient safety. Remove the, and please add a reference.

medication-related problems (MRPs), why MRPs and not DRP? How do you define the concept? You use DRPs in the conclusion.

Line 72: Medicine Information Helplines (MIH) can play an important role in supporting patients in a safe medication after hospitalization. Add a reference.

74: A pharmacy professional. Wording, pharmacist?

Do other countries use MIH or only UK?

80:Patient may enquire the general practitioners or community pharmacies with medicine-related questions [9]. not the hospital?

85: This study is to our knowledge the first to explore if addition of MIH affects patient’s beliefs and perception of security about medicines as compared to standard care with limited medicine information support after discharge. Is this totally new or only in the Danish context? Please clarify.

I lack a summary of other possible services also aiming at supporting patients after discharge in regard to medication use. What makes MIH an alternative above other possible options?

Method

Please start with the study design first.

Setting->? Description of the MIH?

Please describe the service in more in-depth. How many pharmacists offer the services, how were they trained in e.g. telephone consultations skills? Opening hours. Did some of them always carry a phone with them? Did you pilot the service first?

Also briefly describe the hospital, its size?

101: were recruited in the hospital wards-> in the two selected?

Were it some inclusion criteria regarding the length of the stay at the ward? Did they have to use medications? Did they have to have had a medication change during the stay as this probably will impact their perceived information needs?

Study design

112 A randomized controlled study design was used to explore the study objective. Reference to a method book?

The included participants were randomized 1:4 (50:200). Why this ratio? Add a reference. I see you discussed this in the analysis section, maybe refer to that section?

123 pharmacy technician from the MIC. Potential questions were documented. Only questions no actions/responses?

135. and from a study by Badiani et 135 al. (2017) [7] were included in the interview guide. Is that something different from Hornes? Please describe. Add also what Danish version you used.

136 further questions were included according to 136 the study objectives and contextual setting. Such as? Or refer to the appendix earlier.

All eligible participants were interviewed by telephone within 145 2-4 weeks after discharge. How did you decide upon the timeframe? Add an argument.

140: However, if a patient is not in any medical treatment prior to, during admission or after discharge, the patient is not able to provide an answer to each question from the interview guide.

With medical treatment? Do you then mean medication use? If yes, please perform a sub-analysis with these persons excluded as this probably impacts your user rate of the service. I.e. do you have some data on which patients had some changes in their medication use, it would be interesting to see if these people more frequently used your service. If possible add this information, if not possible include it in the method discussion.

156 enquiry from the intervention group was determined individually by two clinical pharmacists. Why didn’t you include a medical doctor as well in this assessment?

162 No similar studies are available from which a sample size can be calculated. What about the studies from UK?

Results

How long were the consultations on average?

208 Enquiries to the MIH->MIH service

Table 3

Explain the abbreviation MIH under the table.

Enquiries before

interview

Enquiries during

interview

Enquiries after

Interview

I don’t understand the categorization, do you mean during the consultation? What do you mean by after? Please add this information/categorization to your method section as well.

Enquiries during interview. Can you count this? I think you need to add these pre-post data in e.g. your abstract.

In the control group 55% of the participants (18/33) reportedly experienced a change in their medication during hospitalization, see S3 appendix. A similar level of change in medication was reported by participants in the intervention group (58%, 68/118), see S3 appendix. See previous comment. I’d like you to perform a subanalysis to see how this impacts the use of the service.

Line 233: Different formatting of the text

233 Patients scored satisfaction, with what?

228 hospitalization and at discharge (figure 2).-> Figure 2.

236 Approximately half of the participants (48 %, 73/141) preferred receiving their medicine information both written and orally. At discharge?

244:Among those, 67 % in both the control group (4/6) and intervention group (22/33) found an answer to their question by searching the internet or contacting their general practitioner, pharmacy, hospital, relatives or visiting nurses. Please refer to Appendix 3 for the distribution? N=X pharmacy.

246: in total, 8 patients from the intervention group contacted the 247 MIH and 100% (8/8). Didn’t you state: line 48: Thirty-seven questions were enquired by 26 participants to the MIH during the study,

263:Further, patients who contacted the MIH reported that the feeling of security increased after contacting the MIH, as they found the information reassuring and brought clarity to potential worries, such as side effects, dosage regimens etc. In addition, the patients informed that the helpline provided practical advice on how to administer the medication.

The patients contacting the MIH what characteristics did they have? What kind of beliefs about medicines did they have, did they differ from the others?

267 Only patients in contact with the MIH before the telephone interview were asked about their satisfaction with the service (n = 8).?? I don’t understand, please elaborate on this. Why didn’t you ask the otherones?

The pharmacy interventions? What do you mean here?

314 Despite this a considerable number of patients still had questions regarding their medication after hospital discharge. Do you refer to the Appendix 3 question. I don’t agree as if I understand right only about 20% contacted the MIH 26/119=21%

. Do you know why not more contacted your service of the 28% having questions?

Discussion.

I lack a discussion about how you would like to improve the MIH offered and a comparison to other similar services. In general, what outcomes do you think are important to assess? If someone wants to perform a similar service that would be of interest.

316/317: Patients who were offered access to the helpline reported an increase in their feeling of security in relation to their medication. Yes, but the groups did not differ regards beliefs about medicines etc. Please add this information.

323 The present study shows that patients have a need for information about their medication after discharge, more specifically, 26 % of the participants in the current study. 26/119?=21%? Or which numbers do you refer to? Is it question 6?

333 MIH is limited in this study, it should be seen in the context that the service is newly established to patients. As the MIH becomes a well-known service, we anticipate that the number of enquiries increase over time. So, you don’t think you need some more personal follow up to increase the numbers? Do you have some data from the patients on this what might make them contact MIH?

340: Studies indicate that providing the appropriate level of medicine information after discharge may reduce medicine related rehospitalization or contact to primary medical doctor or physician [1, 4, 23, 24]. In this context a MIH may not only improve the patient safety of the medication after discharge but it may also decrease overall costs of treatment. However, further studies are needed to elucidate the cost-benefit of a MIH service to patients after discharge. Do you have some data on how many also had tried to contact their doctor and you parallel?

350 with the current study, Badiani et al. found that 93% of the respondents followed the advice provided in their study [7]. How do you know this that they followed your advice?

361 Although patients in both groups reported that they to a high degree felt safe with their medication after discharge, the current study revealed that patients with access to the MIH expressed an increase in the feeling of security in relation to their medication. Do your data support this claim? Please reframe.

379: The study did not include the full Beliefs About Medicine Questionnaire [14], thus not allowing a fully valid conclusion on patients concerns and necessity of taking medicine. Why did you not include that?

383 A methodological consideration in the current study is the risk of respondent’s social desirability. Who did perform the interviews?

Other important outcomes to assess in a future study in addition to adherence?

Conclusion

405 MIH offers an important support for discharged patients to alleviate DRPs. Here you use DRPs not MRPs please be consistent and that the service positively affects a safe medication after discharge. Might impact.

Please make sure you answer your aims in the conclusion. Also add information about how many used the service pre/post prompt.

405 MIH offers an important support for discharged patients to alleviate DRPs and increase the belief and perception of security with their medicine after discharge. Can you draw that conclusion? The groups appear to have similar beliefs about medicines and level of security.

**********

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Reviewer #3: No

Reviewer #4: No

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PLoS One. 2023 Oct 26;18(10):e0293523. doi: 10.1371/journal.pone.0293523.r002

Author response to Decision Letter 0

17 Jun 2023

Journal requirements

1: Thank you for underlining the importance of the format. We have revised the manuscript according to the standards provided and hope it fulfills your requirements.

2: The authors apologize for this mistake in not registering the study before starting the inclusion of the first patients. We have added a comment as requested to the manuscript.

3: We have revisited the raw data of the present manuscript. The data have been anonymized, so they comply with the informed consent as well as GDPR regulations. As requested, the data have been submitted as S6 Supporting Information.

4: Captions for the supporting Information files have been included at the end of the manuscript as requested.

Reviewer 1:

Line 40: Thank you for the comment. The manuscript has been revised as suggested.

Line 52: We are unfortunately not able to give an exact number as this statement relates to more than one question – ex question 14, 22, 25 all combined to an overall evaluation about patient satisfaction from the patient-telephone interview.

Line 80: Thank you for the comment. The manuscript has been revised as suggested.

Line 92: Thank you for the comment. The manuscript has been revised as suggested.

Line 102 – see line 99, 100 and 101: Thank you for the comment. We have aligned the wording as suggested.

Line 104: We have aligned wording as suggested.

Line 130: Thank you for the comment. The manuscript has been revised as suggested.

Line 136: Than you for the comment. A clarification has been added to the manuscript.

Line 144: We have emphasized that revision after pilot testing was revision of wording.

Line 147: Thank you for the comment. We have added a clarification and revised the manuscript as suggested.

Line 150: A detailed description of the inclusion of responders are given in figure 1. We did not experience a postponement of the interview when we first got in contact with a respondent.

Line 157: Thank you for the comment. A clarification of the experience level has been added to the manuscript

Line 192: We are not sure about this comment. Please provide a clarification if further revision is deemed.

Line 206: Thank you for the comment. A clarification has been added to the manuscript.

Line 208: We are not sure what is meant by “validated separately”. All questions were received separately but some contacted the MIH more than once.

Line 211: A clarification has been added to the manuscript.

Line 214: The manuscript has been updated as suggested.

Line 223: Thank you for the comment. The manuscript has been revised as suggested.

Line 224: If there was a change in medicine, the patient stated it during the interview, but no details on change on dosage, brand etc. was requested. This was regarded as face value. All raw data are now provided as supplementary material.

Line 227: Thank you for the comment. We believe that the statement is supported by the data shown in figure 2. We have added a clarification that we make the conclusion based on a score >3.

Line 241: The manuscript has been updated as suggested by another reviewer.

Line 249: Thank you for the comment. The manuscript has been revised as suggested.

Line 250 : Thank you for the comments. The manuscript has been updated accordingly.

Line 256 + 262: We believe Safety is the correct term but that they can be used interchangeably. We have updated and aligned the wording.

Line 272: Thank you for the comments. Quantified data has been added to the manuscript as suggested.

Line 289: We understand the confusion and have suggested to delete the sentence as it does not really add any value to the current data.

Line 293 + line 295: Thank you for the comments. We have tried to clarify that all MRP included “medicine counseling” and then further detail how many other interventions that were provided for the 43 MRPs.

Line 293: We have tried to clarify that the listed interventions add adds up to a total of 77 pharmaceutical interventions.

Line 321: Thank you for the comments. We agree that the discussion may not be clear and we have updated the manuscript to specify and make it more clear to the reader.

Line 324: We thanks for the comment and have revised the manuscript as suggested.

Line 327: We thank you for this comment. We would like to emphasize that half of the patients enrolled in the current study are ED patients and we thus believe that the reference is valid in this context.

Line 350: We apologize for this mistake and have revised the manuscript as requested.

Line 360: We believe Safety is the correct term and have thus kept the wording.

Line 374: The 60 % is the number of patients that were contacted but where enrollment was not succeeded. The 39 % is the dropout rate for respondents that were actually enrolled but did not perform the – please see figure 1. We have tried to clarify this further in the manuscript.

Line 376: Thank you for the comments. We have deleted the adjective “smaller”. We believe however, that the pilot testing of the interview guide does account for a minimum level of validity.

Line 379: We agree with the reviewers point and the consideration is taken for future studies.

Line 395: A revision of the manuscript has been provided earlier and we hope that the dropout rate is now more clearly explained and discussed.

Line 398: We thank you for the comments which is taken to consideration for future studies

Reviewer 2:

Major revisions

1- Abstract: Briefly state the statistical method used from which the conclusions were drawn and provide p-values to support the statements.

We thank you for the comment. We have tried to update the abstract accordingly so both statistical method and p-values are clear from the abstract. However, one of the primary endpoints consist of four questions where we have only provided the overall statistics in the abstract.

The authors thank for the comment and has revised the manuscript accordingly.

3- Apply the same approach as stated in comment 4 to the number of medications at admission and discharge.

The authors thank for the comment and has revised the manuscript accordingly and table 2 have been updated with statistical clarification.

4- Line 228: Provide statistical justification for the following statement. “No significant differences were seen between the control- and intervention group.”

A clarification has been added to the manuscript and further statistical justification and clarification has been provided in the legends to figure 2.

5- Express p-values more precisely than p>0.05.

A full revision of the manuscript has been done and all exact p-values are now provided in the manuscript.

6- Line 254: Provide statistical justification for the following statement. “No significant difference was found between the groups.”

A clarification has been added to the manuscript and further statistical justification and clarification has been provided.

7- Line 272: State the statistical methods used to estimate the values of 4.17 and 0.48.

The values provided in line 272 are the mean of rating ± SD. A clarification has been added to the methods.

A test for normality has been applied and the statistics been adjusted accordingly where relevant. As this manuscript is not based on hard core qualitative data non-parametric tests have been applied throughout the manuscript. Levene’s test for equal varians has been applied for all ordinal variables (five-point scale) and no differences was found. We believe that showing the means gives a more honest presentation of the data. However, we do agree that box plots can add to the understanding of the raw data. Thus, box plots and medians for all questions that given in ordinal variables (five-point scale) have been included in S7 Supporting Information.

9- The drop-out rate was extremely high. Discuss this limitation.

Further clarification of the drop-out rate has been added to the manuscript and the limitation has been further discussed.

Minor revisions:

1: We apologize for the mistake and the error has been corrected.

2: The date range is already included in the study in line 100.

Reviewer 3:

1: State the primary and secondary outcomes more specifically. The primary outcomes are described in lines 127-130 as evaluating perceptions of security about medicines use and satisfaction. However, these constructs relate to 5 and 14 questions, respectively, in the follow up survey. So, I suggest it is clearly stated which of these questions were considered the primary outcomes.

Thank you for this relevant input. The questions considered as primary outcomes have been specified in the manuscript as suggested.

2: Include these primary outcomes earlier in the results section, immediately after participant characteristics are described. Clearly describe them as the primary outcome and consider including an estimated effect size and 95% confidence interval for each one (as per CONSORT 2010). A description of the secondary outcomes can then follow.

We thank the reviewer for this suggestion. After careful consideration we believe that the logic way of presenting data follow the patient journey. Thus, we start with the medicine information provided during hospitalization and at discharge. We have then rearranged the section moving to patient satisfaction with the MIH before we go to the primary outcome regarding believes and perception of safety in relation to medication. We hope that this rearrangement of the data makes the reading logic and easy to follow.

3: Be clear at the start of the discussion and in the conclusion that no effect of the MIH was seen on the primary outcome, as 39% of participants were lost to follow up and there were not many calls to the helpline – both of which are major limitations. Consider discussing what the authors learned from this study that might be useful for future authors attempting a similar project.

A clarification has been added to both the start of the discussion and the conclusion. Further discussion of the drop out rate have been added. The authors believe that another limitation could be the sensitivity of the questionnaire and a small discussion have been added on this issue,

4: In a similar way, make sure the primary outcomes are clearly stated in both the Methods and Results sub-sections of the abstract, and include numerical data in the results.

We thank for the input hand have tried to clarify throughout the manuscript when primary outcome data are described and discussed.

Minor comments:

Lines 111-125: as per CONSORT 2010, state who randomised the participants, as well as who recruited them.

We thank for the comment and have added information on who randomized the patients and who recruited them.

Lines 111-125: as per CONSORT 2010 state whether the investigators and statisticians were blinded to the allocation. For clarity, state explicitly if the study was completely open label.

A description of the blinding of the investigator has been added to the manuscript. We do not understand the relevance of the blinding of the statistician as no analyses were performed before inclusion of all data was final.

We thank for the comment and agree with the reviewer. The guide was followed as displayed in Appendix S2. We have revised the manuscript accordingly.

Lines 168-169: include a reference for the type of calculation used to determine sample size.

A reference has been provided as requested.

Lines 162-176: how were ‘free text’ responses analysed?

Free text comments were not analyzed explicitly, but were solely used to support the interpretation of the patient interview. This information has been added to the manuscript.

Lines 162-176: clearly state whether or not the data were analysed on an intention to treat basis.

The authors are not sure if this statement makes the analysis much clearer. It is clearly stated throughout the paper that patients were excluded for several reasons and thus not included in the analysis as would have been the case if an ITT approach was used.

The authours agree and have revised the statistics regarding age and number of number of medication using a non-parametric test proposed by another reviewer.

Line 277: Clinical impact was assessed by pharmacists providing the MIH. This is a potential source of bias, which I suggest is discussed in the limitations section.

The authors agree and a short discussion of this limitation have been added to the manuscript.

Figure 1: consider extending this to include how many participants called the MIH before, during and after the interviews

We believe that the data requested by the reviewer is available I table 3.

We apologize for the confusion and have provided the information as requested.

Reviewer 4:

Titel

Medication instead of medicine? I’d recommend medications in more formal language and medicines in more lay language.

Patients’ beliefs about medicines/medications?

Thank you for the comment. We have updated the title but have keept “medicines” as this is also the word used in the original title for the BMQ.

Abstract

Who performed the MIH service? Nurses, pharmacists?

The requested information has been added to the abstract.

We specifically mean medication and the abstract has been updated accordingly. We have however chosen to use medication instead of medicines in this context. We believe the two words can be used interchangeably without confusing the reader.

43 helpline, patient belief about medicine. Add (BMQ)

The abstract has been updated as suggested.

43 helpline, patient belief about medicine-> patient’s beliefs

The abstract has been updated as suggested.

Line 44/45 Medication-related problems (MRPs) were identified and clinical impact of the MIH service was assessed. Of the person performing the service or during the telephone interviews?

The assessment was done after each case handling and it was done by a person that not involved in the specific case handling. We have tried to make this more clear in the abstract as proposed.

they all?n=26?

The abstract has been updated as suggested.

Line 48: Participants in the intervention group reported that the MIH increased their sense of security regarding medicine= all 119?

All 119 reported that the MIH increased their sense of security. However, the abstract has been updated based on input from another reviewer and this sentence has been deleted.

Please make this statement a little more modest based on the results from line 249.

We have updated the abstract and added the point from line 249 as suggested. Moreover, the conclusion Has been modified to a more modest statement.

Background

58: Transition from hospitals to private homes is known to challenge (the) patient safety. Remove the, and please add a reference.

The manuscript has been updated as suggested and a reference has been added.

Medication-related problems (MRPs), why MRPs and not DRP? How do you define the concept? You use DRPs in the conclusion.

We thank you for the comment and DRP has been changed to MRP in the conclusion. We have used the definition of MRP as stated in reference 3 and have added the definition to the manuscript.

Line 72: Medicine Information Helplines (MIH) can play an important role in supporting patients in a safe medication after hospitalization. Add a reference.

References have been added as requested.

74: A pharmacy professional. Wording, pharmacist?

Do other countries use MIH or only UK?

A sentence has been added providing information about MIH in other countries.

80: Patient may enquire the general practitioners or community pharmacies with medicine-related questions [9]. not the hospital?

We agree with the point and have corrected accordingly.

To our knowledge this is totally new as not other studies have asked patients receiving standard care, thus, no control group have to our knowledge been reported.

I lack a summary of other possible services also aiming at supporting patients after discharge in regard to medication use. What makes MIH an alternative above other possible options?

We believe this has been accounted for in the manuscript: Patients may contact the general practitioners, or community pharmacies or the respective hospital ward with medicine-related questions [9]. However, this is not always suitable, as the new medicine may be used in hospitals only, the general practitioners may be unavailable, or the community pharmacy does not have access to the discharge summary from the hospital or the hospital staff might be busy taking care of admitted patients.

Method

Please start with the study design first.

Setting->? Description of the MIH?

Thank you for the comment. We believe that the setting section is more than a description of the MIH and that setting is appropriate.

The manuscript have been updated with the suggested information.

Also briefly describe the hospital, its size?

Further details of the hospital have been added to the manuscript.

101: were recruited in the hospital wards-> in the two selected?

The manuscript has been updated accordingly.

The length of stay or whether the patients used medicine or not were not exclusion criteria.

Study design

112 A randomized controlled study design was used to explore the study objective. Reference to a method book?

Reference to a method book has been added.

The included participants were randomized 1:4 (50:200). Why this ratio? Add a reference. I see you discussed this in the analysis section, maybe refer to that section?

The manuscript has been updated as suggested.

123 pharmacy technician from the MIC. Potential questions were documented. Only questions no actions/responses?

The manuscript has been updated as suggested.

135. and from a study by Badiani et 135 al. (2017) [7] were included in the interview guide. Is that something different from Hornes? Please describe. Add also what Danish version you used.

The interview guide in the current study included questions from both papers. The questions from Hornes are different from the ones form Badiani et la. We are not sure what is ment by adding the Danish version. If you find it relevant we will be happy to add the Danish version of the interview guide as supplementary information

136 further questions were included according to 136 the study objectives and contextual setting. Such as? Or refer to the appendix earlier.

All eligible participants were interviewed by telephone within 145 2-4 weeks after discharge. How did you decide upon the timeframe? Add an argument.

An argument has been added to the manuscript as suggested.

140: However, if a patient is not in any medical treatment prior to, during admission or after discharge, the patient is not able to provide an answer to each question from the interview guide.

In the current presentation of the data it has been accounted for if a patient has not been able to answer a question. Thus, for each question the number of answers are given.

With medical treatment? Do you then mean medication use? If yes, please perform a sub-analysis with these persons excluded as this probably impacts your user rate of the service.

A total of 3 patients from the intervention group were identified as not receiving no medication either at hospitalization nor at discharge. Comparison of data when removing the three patients did not result in any changes in the data shown in the manuscript.

I.e. do you have some data on which patients had some changes in their medication use, it would be interesting to see if these people more frequently used your service. If possible add this information, if not possible include it in the method discussion.

We thank the author for this comment. As shown in S3 Appendix there are two patients out the 8 patients who contacted the MIH who did not report a change in their medication. A total of 68 patients in the intervention group reported that they had a change in their medication. Of these 27 had a question regarding their medication (39,7%).

A total of 18 patients in the control group reported that they had a change in their medication. Of these 4 patients had a question regarding their medication (22%).

The data has been presented as results and discussed in the discussion.

156 enquiry from the intervention group was determined individually by two clinical pharmacists. Why didn’t you include a medical doctor as well in this assessment?

We agree that the optimal setting would have been to include an assessment by both a pharmacist and a medical doctor. Due to work load pressure it was unfortunately not feasible to get the assessment done by any of the medical doctors involved in the current study.

162 No similar studies are available from which a sample size can be calculated. What about the studies from UK?

At the time of study design the authors were not aware of other studies using similar questionnaire and including a control group. Thus, we are not aware of other studies that can indicate an effect size We have to our best tried to set a sample size that can detect an 10% improvement on a 5-point scale as described in the manuscript.

Results

How long were the consultations on average?

Information has been added to the manuscript.

208 Enquiries to the MIH->MIH service

The manuscript has been updated as suggested.

Table 3

Explain the abbreviation MIH under the table.

Enquiries before

interview

Enquiries during

interview

Enquiries after

Interview

The table has been updated as suggested.

I don’t understand the categorization, do you mean during the consultation? What do you mean by after? Please add this information/categorization to your method section as well.

Enquiries during interview. Can you count this? I think you need to add these pre-post data in e.g. your abstract.

Further explanation has been added to the manuscript.

We have added further information on how big a percentage of the patients experiencing a change in medication also have a question to their medication and how many of the patients that used the MIH experienced to have a change in their medicines.

Line 233: Different formatting of the text

The different formatting is used because it is the legends to figure 2.

233 Patients scored satisfaction, with what?

A clarification has been added to the manuscript.

228 hospitalization and at discharge (figure 2).-> Figure 2.

The manuscript has been updated as suggested.

236 Approximately half of the participants (48 %, 73/141) preferred receiving their medicine information both written and orally. At discharge?

A clarification has been added to the manuscript.

A reference to Appendix 3 has been added.

The 8 patients contacted the MIH before the telephone interview. A clarification has been added to the manuscript.

263: Further, patients who contacted the MIH reported that the feeling of security increased after contacting the MIH, as they found the information reassuring and brought clarity to potential worries, such as side effects, dosage regimens etc. In addition, the patients informed that the helpline provided practical advice on how to administer the medication.

The patients contacting the MIH what characteristics did they have? What kind of beliefs about medicines did they have, did they differ from the others?

We thank you for the comment. We believe that all the information can be found in Appendix 3. We have included more details on the group of patients.

We only executed the telephoneinterview once. This meant that all enqueries raised during or after the interview was answered after the actual telephone interview took place. In other words, patients that asked questions during or after the telephoneinterview were unable to assess satisfaction with the MIH.

The pharmacy interventions? What do you mean here?

We are not sure what this comment refers to.

Do you know why not more contacted your service of the 28% having questions?

We have modified the statement. Our point is that event the respondents express a high level of satisfaction with the medicine information received still18- 28% had questions to their medicines. As described in the manuscript the respondents found answers in different ways like the internet, GP, pharmacy, relatives or visiting nurse. We did not ask them why they did not choose the MIH as first place to search for information.

Discussion.

We believe that we already have provided a discussion on this as the literature shows that if you actively follow-up. We have on this suggestion added a clarification to the discussion.

The manuscript has been revised as suggested.

It is correct that we here refer to the total number of answers given to question 6. The numbers are clearly stated in the result section. We have however revised this part of the discussion according to input from reviewer 1. We hope the reference to the data is now more clear.

We have no data on what might make them contact the MIH. We have provided further input to the discussion regarding follow-up contact which has been proven effective in several studies.

None of the 8 patients that contacted the MIH prior to the telephone interview contacted their GP. For the remaining patients we don’t know whether they contacted parallel. Unfortunately, we did not collect these data.

350 with the current study, Badiani et al. found that 93% of the respondents followed the advice provided in their study [7]. How do you know this that they followed your advice?

The data supporting this statement are from question 21-24 – see S3 Appendix.

We believe that our data support this statement as we specifically aske patients in the intervention group on this issue – see question 14 in S3 Appendix. We have provided a reference to S3 Appendix to the statement and rephrased the sentence.

We fully agree that it would have been highly relevant to include the full BMQ. However, at the time of study design we found that the final questionnaire became too long and took away focus on the evaluation of the MIH. Furthermore at study by the University of Copenhagen (not published yet) had experience in assessing patient concerns only using part of the questions included in the BMQ. For these reasons we decided to only use selected questions from the BMQ.

383 A methodological consideration in the current study is the risk of respondent’s social desirability. Who did perform the interviews?

A description of who performed the interviews is described in the Methods section. The telephoneinterviews were preformed by author 1, 2 and 3.

Other important outcomes to assess in a future study in addition to adherence?

Outcomes as patient motivation and barriers to contact an MIH has been added to the discussion.

Conclusion

The conclusion has been revised as suggested.

Please make sure you answer your aims in the conclusion. Also add information about how many used the service pre/post prompt.

We believe that the conclusion answers the aims: satisfaction with MIH, clinical significance of intervention and effect on patients feeling of safety in relation to medication.

We agree with the reviewer and have revised the conclusion.

Attachment

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PLoS One. doi: 10.1371/journal.pone.0293523.r003

Decision Letter 1

Vineet Gupta

1 Aug 2023

PONE-D-22-33407R1Medicine Information Helpline after Hospitalization - a randomzed trial: impact on patient satisfaction, patient concerns about medicines and clinical outcome on patient safetyPLOS ONE

Dear Dr. Clemmensen,

The revised manuscript addresses major concerns raised by reviewers on the prior version. Address points raised by reviewer#2 for clarity sake.

Please submit your revised manuscript by Sep 15 2023 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

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An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

We look forward to receiving your revised manuscript.

Kind regards,

Vineet Gupta, MD, FACP, SFHM

Academic Editor

PLOS ONE

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Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #2: (No Response)

Reviewer #4: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #2: Yes

Reviewer #4: Partly

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: Yes

Reviewer #4: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #2: Yes

Reviewer #4: No

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #2: Yes

Reviewer #4: Yes

**********

6. Review Comments to the Author

Reviewer #2: Minor revisions:

1- Sample size estimate: State the statistical testing method which achieves 90% power.

2- Define SD at its first appearance.

3- The Wilcoxon rank sum test is the complete name of the test.

4- Table 2: Remove repeat p-values for individual characteristics. For instance, place the p-value of 0.540 on the line for "Sex, No. (%)" rather than on the lines for Male and Female. Also relabel this characteristic "Gender".

5- Figure 2 caption: Clarify that "No significance" refers to "No significant differences".

6- In the "Data analysis" section, state the level of the p-value that has been used to define statistically significant differences. For example many publications include the following sentence: P-values less than 0.05 were considered statistically significant.

7- Patient satisfaction with MIH: The first sentence of this paragraph suffers from subject-verb disagreement. The corrected sentence reads, "One of the primary outcomes was patient satisfaction with MIH."

8- For primary outcomes reported as percentages, provide 95% confidence intervals for these percentages. State the statistical method used to estimate these confidence intervals in the "Data analysis" section of the manuscript.

9- Discussion: Subject-verb disagreement correction: "As expected, the rate of patients who had a question regarding their medicines was higher ..."

10- To assist in the review process, add line numbering to the document.

Reviewer #4: (No Response)

**********

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Reviewer #2: No

Reviewer #4: No

**********

PLoS One. 2023 Oct 26;18(10):e0293523. doi: 10.1371/journal.pone.0293523.r004

Author response to Decision Letter 1

21 Sep 2023

Thank you for giving us the opportunity to revise the manuscript. We thank you for your review which have given us a chance to further improve the manuscript.

Changes to reference list

There have been no changes to the reference list. Thus, the submitted reference list is identical to the one submitted previously.

Reviewer 2:

1- Sample size estimate: State the statistical testing method which achieves 90% power.

No statistical testing method was used to achieve a 90% power. The power was set by the authors to 90% which we consider to be a conservative choise as most studies will accept a power of 80%. A small clarification has been added to the data analysis to clarify that the level of power was set by the authors (line 193-194).

2- Define SD at its first appearance.

Thank you for the comment. We have added an explanation to “SD” when it is first introduced in the manuscript (line 202).

3- The Wilcoxon rank sum test is the complete name of the test.

The manuscript has been updated accordingly.

We thank the reviewer for the comment and has updated Table 2 as suggested.

5- Figure 2 caption: Clarify that "No significance" refers to "No significant differences".

The Figure 2 caption has been revised as suggested.

The manuscript has been updated with the suggested wording in the Data analysis section (line 193-194).

Thank you for this review. The manuscript has been updated accordingly.

The primary outcomes are reported as follows:

- Patient satisfaction with the MIH is reported as a mean score and the CI can be found in S7 Supporting Information, Question 25.

- Patients feeling of safety regarding their medication is assessed by Question 9-14. Question 9-13 is reported as mean score and the CI can be found in S7 Supporting Information. Question 14 is reported as percentage and a confidence interval has been added to the manuscript regarding question 14 (line 289). Furthermore, a sentence has been added to the method section describing the method used to calculate the CI (line 203).

- Clinical impact of MIH is reported with exact numbers (descriptive statistics) and thus a CI is not calculated.

9- Discussion: Subject-verb disagreement correction: "As expected, the rate of patients who had a question regarding their medicines was higher ..."

Thank you for the input. The manuscript has been corrected.

10- To assist in the review process, add line numbering to the document.

Line numbering has been added to the document.

Attachment

Submitted filename: Response to Reviewers.docx

Click here for additional data file.^{(27.8KB, docx)}

PLoS One. doi: 10.1371/journal.pone.0293523.r005

Decision Letter 2

Vineet Gupta

16 Oct 2023

Medicine Information Helpline after hospitalization – a randomized trial: impact on patient satisfaction, patient concerns about medicines and clinical outcome on patient safety

PONE-D-22-33407R2

Dear Dr. Clemmensen,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Vineet Gupta, MD, FACP, SFHM, CHCQM

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

PLoS One. doi: 10.1371/journal.pone.0293523.r006

Acceptance letter

Vineet Gupta

19 Oct 2023

PONE-D-22-33407R2

Medicine Information Helpline after hospitalization – a randomized trial: impact on patient satisfaction, patient concerns about medicines and clinical outcome on patient safety

Dear Dr. Clemmensen:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr Vineet Gupta

Academic Editor

PLOS ONE

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

S1 Checklist. CONSORT 2010 checklist of information to include when reporting a randomised trial*.

(DOC)

Click here for additional data file.^{(219KB, doc)}

S1 Appendix. This is the interview guide.

(DOCX)

Click here for additional data file.^{(16.7KB, docx)}

S2 Appendix. This is the results based in the interview guide.

(DOCX)

Click here for additional data file.^{(21.9KB, docx)}

S1 File. This is the ethic committee protocol in Danish.

(DOCX)

Click here for additional data file.^{(72.6KB, docx)}

S2 File. This is the ethic committee protocol in English.

(DOCX)

Click here for additional data file.^{(60.9KB, docx)}

S3 File. This is the raw data from the case handling of request to MIH.

(DOCX)

Click here for additional data file.^{(34.9KB, docx)}

S4 File. This shows means, medians and box plots for all data given in ordinal variables.

(DOCX)

Click here for additional data file.^{(324.3KB, docx)}

Attachment

Submitted filename: PONE-D-22-33407_reviewer.pdf

Click here for additional data file.^{(2.5MB, pdf)}

Attachment

Submitted filename: Response to Reviewers.docx

Click here for additional data file.^{(39.5KB, docx)}

Attachment

Submitted filename: Response to Reviewers.docx

Click here for additional data file.^{(27.8KB, docx)}

Data Availability Statement

All relevant data are within the paper and its Supporting Information files.

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PERMALINK

Medicine information helpline after hospitalization–a randomized trial: Impact on patient satisfaction, patient concerns about medicines and clinical outcome on patient safety

Karianne Wilhelmsen Fjære

Tim Emil Vejborg

Lene Colberg

Cecilia Strøjer Ulrich

Lars Pedersen

Ann Kathrin Demény

Joo Hanne Poulsen

Helle Byg Armandi

Marianne Hald Clemmensen

Roles

Abstract

Background and aim

Method

Results

Conclusion

Introduction

Method

Setting

Enrollment of participants

Study design

Telephone interviews

Clinical impact assessment

Table 1. Clinical impact assessment of MRPs and the pharmacy intervention.

Data analysis

Results

Participants

Fig 1. Consort study diagram showing the flow of invited, included, excluded and dropout patients.

Table 2. Characteristics of enrolled participants.

Medicine information during hospitalization and after discharge

Fig 2. Patient satisfaction with medicine information provided during hospitalization and after discharge.

Patient satisfaction with MIH

Concerns and perception of safety in relation to medication

Fig 3. Concerns and perception of safety about medicine.

Enquiries to the MIH service

Table 3. Categorization of enquiries to MIH from July 2018 through May 2019 (n = 37).

Clinical impact of MIH on patient safety

Fig 4. Categorization of MRPs related to the enquiry according to the Westerlund system [18,19].

Table 4. Assessment of the clinical significance of the pharmacy interventions proposed to mitigate MRPs.

Discussion

Need for medicine information after discharge

Increased patient safety

High level of patient satisfaction with MIH

Perception of safety with medicine after discharge

Methodological considerations

Conclusion

Supporting information

Data Availability

Funding Statement

References

Decision Letter 0

Johannes Stortz

Roles

Author response to Decision Letter 0

Decision Letter 1

Vineet Gupta

Roles

Author response to Decision Letter 1

Decision Letter 2

Vineet Gupta

Roles

Acceptance letter

Vineet Gupta

Roles

Associated Data

Supplementary Materials

Data Availability Statement

ACTIONS

PERMALINK

RESOURCES

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