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. 2023 Aug 29;18(8):e0290733. doi: 10.1371/journal.pone.0290733

Implementation of a care-pathway at the emergency department for older people presenting with nonspecific complaints; a protocol for a multicenter parallel cohort study

M G A M van der Velde 1,2,*, M A C Jansen 3, M A C de Jongh 3, M N T Kremers 1,4, H R Haak 2,5
Editor: Antony Bayer6
PMCID: PMC10464958  PMID: 37643185

Abstract

Background

Older adults frequently attend the Emergency Department (ED) with poorly defined symptoms, often called nonspecific complaints (NSC). NSC such as ‘weakness’ and ‘not feeling well’, often lead to an extensive differential diagnosis. Patients with NSC experience a prolonged length of stay at the ED and are prone to adverse outcomes. Currently, a care pathway for patients with NSC does not exist. A special structured care pathway for patients with NSC was designed to improve the efficiency and quality of care at the ED.

Method

A multicenter parallel cohort study, organized in different hospitals in the Noord-Brabant area, the Netherlands, in which general practitioners (GP), elderly care physicians (ECP), Emergency Physicians (EP), geriatricians and internists will collaborate. Patients ≥ 70 years presenting with NSC and in need of ED admission as indicated by their own GP or ECP are eligible for inclusion. Before implementation each hospital will retrospectively include their own control-group. After implementation, patients will prospectively be included. The care-pathway exists of risk stratification by the APOP-screener, in-depth history taking, i.e. limited comprehensive geriatric assessment (CGA) and a standard set of diagnostics, and a dedicated ED-nurse (if possible) present to ensure the care-pathway is followed. The primary outcome is length of stay at the ED (LOS-ED) and perceived quality of care. Secondary outcomes are hospital length of stay, revisits, readmissions and mortality at 30- and 90-day follow-up.

Discussion

This study proposes a structured care pathway for older patients presenting at the ED with NSCs and considering effectiveness and perceived quality this may improve acute care for these patients.

Trial registration

Dutch Trial register, number NL8960.

Background

Older adults frequently attend the Emergency Department (ED) with poorly defined symptoms, often called nonspecific complaints (NSC) [1, 2]. The concept of NSC is defined as all complaints that are not part of the set of specific complaints or signs, or where an initial working diagnosis cannot be definitely established [3]. NSC, such as ‘not feeling well’, ‘being tired’, unexplainable falling or simply being unable to cope with usual daily activities lead to a variety of differential diagnosis, ranging from social problems to life threatening conditions [3, 4]. Furthermore, 50% of the patients experience an acute medical problem at the time of presentation with a NSC [3, 5].

Studies have shown that patients with NSC have different characteristics compared to patients with specific complaints (SC) [6]. Patients with NSC have more comorbidities and polypharmacy than patients with SC. These factors combined with problems in functional status or communication lead to an increased complexity of the diagnostic process and under-triage, resulting in a high proportion of incorrect diagnoses and a great variety of discharge diagnosis in this population [3, 7, 8]. Consequently, patients with NSC are more frequently discharged with unrecognized and untreated health problems, have a longer length of stay at the ED (LOS-ED), higher admission rates and are more prone to adverse outcomes, such as mortality [9–12].

Treating older patients with NSC is challenging, due to the complexity of NSC and lack of a structured protocol evaluating these complaints. Several interventions in organization of care for this group have been tested, for example geriatric screening at the ED, geriatric EDs or passing the ED straight to the geriatric ward, but identifying patients at the highest risk is challenging and therefore rarely used in practice [13]. The development of the Acutely Presenting Older Patient (APOP)-screener, provides a way to identify older patients at the ED with a high risk of short and long-term poor outcomes[13, 14]. However, risk stratification should be the first step and a structured approach in managing patients with NSC is needed. Therefore, we aim to implement an integrated care pathway which will structure and streamline the acute care for patients with NSC from arrival at the ED until discharge.

We hypothesize that the NSC-care pathway will primarily improve patient satisfaction and reduce the LOS-ED. Reduced hospital length of stay, decreased 30-day mortality, a reduction of (re-)admission rates for older adults with NSC and reduced costs of care for this patient population might follow as a result of implementing this care pathway. Our study can be used to guide a management protocol for older patients with NSC at the ED to further improve the quality of care.

Methods

Objective

The aim of this study is to implement and evaluate a care pathway for older adults presenting at the ED with NSC. The secondary aim of our study is to evaluate the standardization and need of the included diagnostic tests in the care-pathway.

Trial design

This study is a longitudinal multicenter parallel cohort trial. The study will be organized in hospitals in the Noord-Brabant area, the Netherlands, in which general practitioners (GPs), elderly care physicians (ECPs), Emergency Physicians (EPs), geriatricians and internists will collaborate. Participating hospitals can be general or teaching hospitals.

Eligibility criteria

Older patients (≥ 70 years) with NSC referred to the ED by the GP or ECP will be screened for inclusion. Patients who are referred by their known GP or ECP within working-hours (8:00–17:00 on weekdays) are eligible, due to the accessibility of the patients personal GP-office to retrieve further medical or social data when needed and the different organization of acute care out-of-hours [15]. Subsequent presentation at the ED is possible between 8:00 and 20:00, taking logistic difficulties as transport into account. Patients can also enter the care pathway if triage at the ED indicates NSC. In order to be eligible to participate in this study, patients have to meet the following criteria; 1) indicated for admission to the ED, and 2) age ≥ 70 years, and 3) a nonspecific complaint at presentation. NSC are divided into five referral categories: 1) somatic problems, such as weakness, not feeling well, change in nutritional status or unexplained weight loss; 2) an increased demand of care, such as loss of independency, a necessity for change in the living situation or 24–7 care, not indicated previously; 3) cognitive problems, such as disorientation, changes in behavior, abrupt cognitive decline; 4) a decline in functional status, such as loss of mobility; and 5) unexplained falls, not related to extrinsic factors.

Patient recruitment, randomization and collection of data

This study is a parallel cohort study with a baseline period. Before implementing the care pathway each hospital will include their own control group using a graphic user interface data mining tool with text-mining features (CTcue, version 3.0; Amsterdam, the Netherlands) [16]. Ctcue is a search engine in which unstructured data from an Electronic Health Record (EHR) can be easily found using specific queries. Data will be retrieved according to our defined in- and exclusion criteria, study parameters and endpoints anonymously, therefore a waiver for informed consent has been obtained. When Ctcue is not available, the control group will be included prospectively. The ED physician will save the data of eligible patients in the care pathway (before it is implemented). The specialist in charge of the patient is allowed to use patient data for research without consent, when data is pseudonymized. The specialist may grant this right to a third party, in this case the research team. Exchange of data has to be approved by the involved departments, i.e. Internal Medicine, Geriatrics and the Emergency Department (Fig 1). Given the unprecedented strain on acute care services, we decided not to perform a randomized trial as we estimated this as non-feasible. Therefore, we start the intervention period conform convenience, sequentially following the capacity of participating hospitals to implement the pathway (Fig 2). Hence, we will not include a transition period [17]. Control patients will be included retrospectively after the start date of implementation, to prevent information bias.

Fig 1. Schedule of enrolment, interventions, and assessments.

Fig 1

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Fig 2. A parallel cohort study with baseline period.

Fig 2

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NA: Not applicable. Light blue: Control. Dark blue: Intervention.

Intervention patients will receive written patient information and will subsequently be asked for informed consent at the end of the ED-visit. If a patient has impaired cognitive function at the time of presentation at the ED, the caregiver or relative may grant their permission for inclusion. Patients are asked to fill out a questionnaire regarding patient satisfaction, when given informed consent. Patient satisfaction will be measured by the PRM-acute care (S1 File) [18]. This is a valid instrument to measure the perceived quality of healthcare in an acute setting in five domains: relief of symptoms, understanding the diagnosis, presence and understanding of the diagnostic and/or therapeutic plan, reassurance and patient experiences. We added two questions to the validated questionnaire, for further evaluation of the care pathway. These questions involve the patient experience of their complaints being treated (question 3) and the experience of needing further examination (question 8). When a patient is unable to fill out the questionnaire, for instance due to impaired cognitive function, he/she can still participate in the study but the patient questionnaire cannot be used and will be considered missing data. Data of ED-revisits, readmissions and mortality will be gathered at 30 and 90 days after the ED-visit.

Ethics

The study will be conducted according to the principles of the Declaration of Helsinki (version 2004, May 22, 2007; www.wma.net) in accordance with the Medical Research Involving Human Subjects Act (WMO). This study is approved by the ethics committee at the Máxima Medical Centre in Veldhoven (ref. no N19.034) and by participating hospitals. The ethics committee judged the pathway as standard care, therefore patients eligible for the pathway will be included and are asked for informed consent at the end of the ED-visit. Data handling will be done pseudonymized. Informed consent forms will be stored locally. Data will be collected in a digital research platform (Research Manager, version 6.8, Deventer, The Netherlands), and in accordance with guidelines of the Dutch Federation of University Medical Centers (NFU) the data will be kept for 20 years [19]. The protocol is registered in the Dutch Trial Register, number NL8960. The authors received no specific funding for this word and declared that no conflict of interest exists. We expect to publish the results of the care pathway in a peer reviewed journal.

Intervention

The structure and content of the care pathway has been established by review of literature regarding NSC at the ED, followed by a total of eight expert meetings with input from physicians, (ED-) managers, counsellors acute care and epidemiologists from different departments (i.e. emergency, internal, geriatric and general medicine).

The care pathway will comprise of special attention and focused care for the patient with NSC at the ED (Fig 3). All older adult patients presenting with a nonspecific complaint, can be referred to the NSC-care pathway at the ED by the GP or ECP. Upon referral to the ED, the GP or ECP and ED-physician review the name and address details for the patient, discuss advance care planning and review the reason for access to the NSC-care pathway following the five categories of NSC. Patients can also enter the care pathway if triage at the ED indicates NSC.

Fig 3. Schematic overview of the care-pathway nonspecific complaints (NSC).

Fig 3

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GP: General practitioner, ECP: Elderly care physician, ED: Emergency Department, APOP: Acutely Presenting Older Patient.

Upon arrival at the ED, patients will be triaged, including execution of the APOP-screener, which is integrated in the electronic health record. The APOP-screener is a validated instrument to estimate frailty for older patients (≥ 70 years old) presenting to the ED, expressed as risk for functional decline and mortality within three months and estimated cognitive impairment [13, 14]. This short questionnaire consists of questions regarding performance status, medical history, gender and age, and can be completed in only 2 minutes. The estimated risk of frailty is expressed in four outcomes: low risk, high risk at functional decline, evidence of cognitive impairment and both risk of functional decline and evidence of cognitive impairment. When a patient is admitted at the hospital and scored unfavorable in the APOP screener, a consultation for a comprehensive geriatric assessment (CGA) lead by the internist geriatric medicine or clinical geriatrician with a team of allied health care professionals, should be considered

Additional to the APOP-screener and somatic history taking, treating physicians are asked to screen various domains following the CGA, i.e. cognitive, functional and social. The estimated extra time needed for performing the APOP screener and the ‘acute’ geriatric assessment is calculated at fifteen minutes per patient. Patients will be treated by an experienced doctor, according to the hospital policy. Medical students are excluded from participation in the pathway.

Due to the broad differential diagnosis and potential underlying diseases in patients presenting with NSC, we standardized the diagnostics for patients in the care pathway. These diagnostic measurements consists of an electrocardiogram (EKG), urinalysis, chest radiography (X-thorax), bladder scan and comprehensive bloodwork including complete blood count, electrolytes (sodium, potassium, calcium), kidney function, thyroid gland function and inflammation parameters. Further diagnostics measurements can be performed according to the physicians expertise. Medication verification will be done at the ED by the pharmacists assistants or the treating physician at the ED.

After establishment of the treatment plan, patients will be discharged from the ED and either be admitted to the ward, discharged home, to a care home, a short stay facility for primary care or a geriatric rehabilitation. If possible, a dedicated ED-nurse can be assigned to each patient in the care pathway to oversee the care process, check the progress at the ED and assess the participants satisfaction of the care pathway.

Outcome measures

The primary outcome is LOS- ED and perceived quality of care on five domains. In the Netherlands the LOS-ED does not end when diagnosis is established and patients is referred to a specialty, it ends when the patient is discharged to the ward. LOS-ED is therefore associated with the number of consultations during the ED-visit, a higher number of diagnostic tests and experience of the evaluating physician [20]. By standardizing diagnostic tests and by agreeing experienced physicians will evaluate these patients, we expect to reduce the LOS-ED. To evaluate the effectiveness of the care pathway, secondary outcomes are hospital length of stay, discharge destination, frequency of revisits/readmissions, 30 and 90-day mortality, medical diagnosis (at admission versus discharge) and outcomes/appropriateness of the performed diagnostic measurements.

Statistical analysis

Sample size

We hypothesize that implementing the care pathway will reduce the mean LOS-ED with 10%. In a prospective study about the quality of acute care by M.N.T. Kremers, preliminary data showed a mean LOS-ED in the Máxima Medical Centre of three hours and twenty minutes (95% CI 3:00–3:40, SD = 1.17) for patients presenting to the ED for internal medicine between January 5 and March 12, 2020 [21]. Assuming a normal distribution, a two-sided test, power of 80% and a significance level (α) of 0.05, a minimum of 466 patients need to be included, 233 patients in both control and intervention group. We aim to include 300 patients in each group, divided over three participating hospitals, to guarantee power in case of missing data. Each hospital will gather their own control-group previous to implementation of the care-pathway. A minimum number of control- and intervention patients will be established for each participating hospital, dependent of number of annual patient-visits at the Emergency Department. Control and intervention patients will be gathered following a 1:1 ratio per hospital.

Data-analysis

All statistical analyses will be performed with SPSS 24.0 for Windows (IBM, SPSS Statistics, Chicago, IL, USA). Descriptive statistics will be used for frequencies, percentages, means and standard deviations variables with normal distribution and median and interquartile ranges for variables with non-normal distribution. Prevalence of the most frequent diagnosis (coded ICD-10) at discharge will be presented in percentages. Continuous variables will be analyzed using independent t-tests, whereas the categorical data will be analyzed by chi-square or Fisher’s exact test. Non-normally distributed categorical and metric variables of the study will be analyzed using Mann-Whitney-U-test. All tests will be performed using a significance level of alpha 0.05. A two-sided p-value <0.05 will be considered significant.

Timeline

Control patients were gathered within CTcue before implementation was started. This period covers patients presenting to the ED with NSC between December 2020 and date of implementation of the care-pathway. The first hospital implementing the care pathway started in April 2020. Currently, all participating hospitals have gathered control patients and have implemented the care-pathway in the ED. Patient inclusion is expected to be completed by December 2023. The data analysis will be conducted in 2024, and the manuscript will be completed at the end of 2024.

Discussion

In view of the ‘ever-increasing’ older population presenting to the ED with NSC, optimization of acute care for this population is of upmost importance. Every patient deserves a goal-oriented and person centered approach, however due to the complexity of NSC and lack of a structured protocol evaluating these complaints, managing patients with NSC is challenging and they subsequently experience a higher risk of adverse health outcomes. This study proposes a structured care pathway for patients presenting at the ED with NSC. The care-pathway consists of risk stratification by the APOP-screener, in-depth history taking with screening the domains following the CGA and a standard set of diagnostics, with an active ED-coach (if possible) present to ensure the care-pathway is followed. The goal of our study is to evaluate the proposed care-pathway and the standardization and need of the included diagnostic tests in the care-pathway. The results of this study will help us to establish a management protocol for patients with NSC and to make further recommendations, for example tailormade diagnostic trajectories following referral category. We hypothesize this will improve efficacy and quality of care at the ED, and reduced costs of care might follow as a result.

  • Mw. C. Schepel, director, Netwerk Acute Zorg Brabant, Tilburg

  • Mw E.T.J. du Cloo, counselor acute care, Netwerk Acute Zorg Brabant, Tilburg

  • Mw. Dr. K. Holtkamp, counselor acute care, Netwerk Acute Zorg Brabant, Tilburg

  • Mw. C. de Vries, project-leader, Zorggroep DOH, Eindhoven

  • Dhr. Drs. P. Wouda †, general practitioner, Huisartsencentrum Parklaan-Wouda, Eindhoven

  • Mw. Drs. S.L.E Lambooij, Department of Internal Medicine, Máxima MC, Eindhoven/Veldhoven

  • Mw. Drs. M. Hermans, elderly care physician, de Wever, Tilburg

  • Dhr. Drs. S. Elbouazati, Emergency Department, Bravis Hospital, Bergen op Zoom/Roosendaal

  • Mw. Drs. F. Horsten, Emergency Department, Bravis Hospital, Bergen op Zoom/Roosendaal

  • Mw. Dr. G. Buunk, Department of Internal Medicine, Amphia Hospital, Breda

  • Dhr. Drs. C.A.S. Berende, Emergency Department, Amphia Hospital, Breda

  • Mw. Dr. M. van der Velde, Department of Internal Medicine, Elisabeth Twee Steden Hospital, Tilburg

  • Mw. Dr. C.J.P.W. Keijsers, Department of Geriatrics, Jeroen Bosch Hospital, ‘s Hertogenbosch

  • Dhr. J. de Laat, Emergency Department, Jeroen Bosch Hospital, ‘s Hertogenbosch

  • Dhr. Drs. R.W. Vingerhoets, Department of Geriatrics, Elisabeth Twee Steden Hospital, Tilburg

Supporting information

S1 File. PRM acute care.

(DOCX)

Click here for additional data file. (23.2KB, docx)
S2 File. SPIRIT 2013 checklist.

(DOCX)

Click here for additional data file. (23.4KB, docx)
S3 File

(PDF)

Click here for additional data file. (504.3KB, pdf)

Acknowledgments

We thank the following persons for their input and expertise in formulating this protocol:

Data Availability

This paper does not report any data and the data availability policy is not applicable to this article.

Funding Statement

The authors received no specific funding for this work.

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Decision Letter 0

Antony Bayer

9 Jul 2023

PONE-D-23-17637Implementation of a care-pathway at the emergency department for older people presenting with nonspecific complaints; A protocol for a multicenter stepped wedged cohort studyPLOS ONE

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

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********** 

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

********** 

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

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

********** 

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Nice proposal and a much needed study. I was unclear as to whether or not this was a cluster deisgn, and if so why no randomisation, and if you needed to adjust the sample size for the cluster design. Also the intervention made no mention of other members of the team required to deliver CGA such as therapists. Good to see a PROM in the outcomes, but perhaps also add in function?

Reviewer #2: Thank you for inviting me to review this manuscript presenting a protocol for a stepped wedged cohort implementation study.

Non-specific complaints are beginning to be recognised as the deadliest of presenting symptoms to geriatric emergency care. I might describe an NSC as a vaguely characterised symptom set outside of traditional teaching’s disease-based medical classification, which naively assumes that people can usually localise their problem. The classification presented in the methods is very helpful.

For an international audience, I wonder if you might consider changing your first sentence from “older adults are frequently referred to the ED” to “older adults frequently attend the ED…” – outside of Belgium and the Netherlands people more commonly attend without referral, and NSC are no less serious in these cases.

I notice the authors use a term “elderly care physicians”. I am interested to know how these professionals differ from geriatricians. In the UK, “elderly” has become an ageist slur and is a word best avoided if at all possible.

It is pleasing to see a patient-reported outcome being collected and that the researchers will include people with impaired cognition but who are able to answer the items. I wonder if you might consider adding a short statement acknowledging that capacity can fluctuate and that the participant will receive opportunity to re-attempt the PRM.

Regarding the care pathway, I am not sure I understand why the diagnostics are being standardised. Does this imply that every person attending with a NSC will receive every stated test, including the controversial urinalysis? This approach would contradict my understanding of frailty risk and NSC as prompts for goal-oriented, person-centred care in which an investigation plan is tailored to the individual. I can see this ‘shotgun approach’ leading to confirmation bias in clinical decision-making. I also cannot see how analysis will differentiate the value of investigations, as for some NSCs a test e.g. chest xray will be appropriate and useful, whereas for others it will not add value.

The study is being powered to observe for reduction in LOS-ED. This for me prompts interesting reflection – in my practice, the LOS-ED is due to hospital capacity and crowding rather than patient factors, but presumably in all the research settings here the LOS-ED ends when an initial diagnosis is made and the person is referred to a specialty. In my setting, a patient outcome such as the PRM-Acute would be more meaningful than the LOS-ED.

I look forward to reading the results of the project in due course.

********** 

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Reviewer #1: Yes: Simon Conroy

Reviewer #2: Yes: James van Oppen

**********

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Attachment

Submitted filename: renamed_9141c.docx

Click here for additional data file. (21.1KB, docx)
PLoS One. 2023 Aug 29;18(8):e0290733. doi: 10.1371/journal.pone.0290733.r002

Author response to Decision Letter 0

28 Jul 2023

Dear Mr. Bayer,

We thank you and the reviewers for your effort to assess our manuscript. The feedback on the manuscript was helpful and we feel that this helped us to improve the quality of our paper. We have edited the manuscript to address the concerns. All modified parts are marked with track changes. We have outlined the major changes and provided a point to point reply to the comments.

The most important change of our article is renaming the study design as it should have been named. We agree with the reviewers that in we in fact did not meet the criteria for a stepped wedged design study. We also had to conclude that our aimed and described study design is a parallel cohort study with a baseline period. We have changed this in the title and abstract, and further elaboration on the design is added to the method section. We apologize for the inconvenience.

Regarding the mentioned publication criteria error, two of the authors are indeed part of The ORCA Acute Medicine Research Consortium, however this proposed study is not initiated by this consortium. Therefore we did not mention the consortium and have not adjusted this in our manuscript, conform the applicable agreements within ORCA.

Regarding data availability, this manuscript does not report any data and the data availability policy is not applicable to this article.

We believe that the manuscript is now suitable for publication in PLOS One.

Kind regards, on behalf of all authors,

M.G.A.M. van der Velde

 

Point to point response

Reviewer #1:

Nice proposal and a much needed study.

Dear reviewer, Mr. Conway,

We thank you for your effort to assess our manuscript. The feedback on the manuscript was helpful and we feel that this helped us to improve the quality of our paper. We have edited the manuscript to address the concerns.

Comment 1.1: I was unclear as to whether or not this was a cluster design, and if so why no randomisation, and if you needed to adjust the sample size for the cluster design.

Reply 1.1: Thank you for your comment. We agree that we did not describe the study design properly and apologize for naming our study a stepped wedged design study while we do not meet criteria for this design. The aimed design of our study is a parallel cohort study with a baseline period. Due to the logistic restraints of implementing a care pathway in an acute care system that is under unprecedented strain, we did not randomize clusters. We started the intervention period conform convenience, sequentially following the capacity of participating hospitals to implement the pathway. We changed title, abstract and further elaboration on the design is given in the method section. We added a reference on parallel designs versus stepped wedged design. See page 1, line 3, page 2, line 25 , page 4, line 80 and the patient recruitment section on page 5-6.

[1] Hemming K, Haines T P, Chilton P J, Girling A J, Lilford R J. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting BMJ 2015; 350 :h391 doi:10.1136/bmj.h391

Comment 1.2: Also the intervention made no mention of other members of the team required to deliver CGA such as therapists.

Reply 1.2: We agree that we did not mention the much needed help from allied health care professionals for performing a CGA and added this to the manuscript. See page 8, lines 166-169.

Comment 1.3: Good to see a PROM in the outcomes, but perhaps also add in function?

Reply 1.3: We agree that evaluation of functional status would be of great value in this group of patients, but active measurements and follow-up of functional status was deemed not feasible in this study. Additionally, we do not expect the proposed care-pathway to primarily lead to improved functional outcomes. However, we did integrate the APOP-screener in the care-pathway. The APOP-screener expresses the risk of functional decline and we agreed that patients who are admitted and score high risk on the functional domain will receive consultation by a physical therapist during their hospital stay. Functional status is indeed an important outcome in this group of patients and for future studies we aim to implement active functional status measurements to evaluate this outcome.

Reviewer #2:

Thank you for inviting me to review this manuscript presenting a protocol for a stepped wedged cohort implementation study. Non-specific complaints are beginning to be recognised as the deadliest of presenting symptoms to geriatric emergency care. I might describe an NSC as a vaguely characterised symptom set outside of traditional teaching’s disease-based medical classification, which naively assumes that people can usually localise their problem. The classification presented in the methods is very helpful.

Dear reviewer, Mr. van Oppen,

We thank you and the reviewers for your effort to assess our manuscript. The feedback on the manuscript was helpful and we feel that this helped us to improve the quality of our paper. We have edited the manuscript to address the concerns.

Comment 2.1: For an international audience, I wonder if you might consider changing your first sentence from “older adults are frequently referred to the ED” to “older adults frequently attend the ED…” – outside of Belgium and the Netherlands people more commonly attend without referral, and NSC are no less serious in these cases.

Reply 2.1: Agreed. We changed it to older adults frequently attend the ED. See page 2, lines 19-21 and page 3, lines 42-43.

Comment 2.2: I notice the authors use a term “elderly care physicians”. I am interested to know how these professionals differ from geriatricians. In the UK, “elderly” has become an ageist slur and is a word best avoided if at all possible.

Reply 2.2: You make an excellent point about the avoidance of the word ‘elderly’, and we did avoid this term in our manuscript as much as possible. However, to our knowledge no other translation of ‘elderly care physician’ (ECP) exists. ECP’s are physicians who specializes in long-term care for older patients and work in nursing or residential homes and primary health care, and this function is unique in the world. The Dutch Association of Elderly Care Physicians is aware of the negative association with the word elderly and are currently looking for a better translation, until then the translation remains elderly care physician.

Comment 2.3: It is pleasing to see a patient-reported outcome being collected and that the researchers will include people with impaired cognition but who are able to answer the items. I wonder if you might consider adding a short statement acknowledging that capacity can fluctuate and that the participant will receive opportunity to re-attempt the PRM.

Reply 2.3: Although we think you make an excellent point about fluctuations in cognitive capacity, we are reluctant to add this statement. Although we feel reattempting the questionnaire could be of value, we can’t guarantee that all patients will have the opportunity to re-attempt due to logistic difficulties.

Comment 2.4: Regarding the care pathway, I am not sure I understand why the diagnostics are being standardised. Does this imply that every person attending with a NSC will receive every stated test, including the controversial urinalysis? This approach would contradict my understanding of frailty risk and NSC as prompts for goal-oriented, person-centred care in which an investigation plan is tailored to the individual. I can see this ‘shotgun approach’ leading to confirmation bias in clinical decision-making. I also cannot see how analysis will differentiate the value of investigations, as for some NSCs a test e.g. chest xray will be appropriate and useful, whereas for others it will not add value.

Reply 2.4: We think you make an excellent point, this group of patients indeed need a goal-oriented, person-centered approach with a tailored investigation plan. However, treatment of older patients with NSC is challenging as shown by the high prevalence of adverse outcomes these patients experience. In our opinion these results show we are not yet in the place in which physicians can give these patients the best tailored care possible. The proposed set of diagnostic tests are considered standard care for the older ED-patient in a great number of Dutch ED’s. However, the advantages and possible disadvantages of standardized diagnostic screening and the different measurements is unknown. The secondary aim of our study is to evaluate standardization of diagnostic tests and the need for the different diagnostic measurements, including the controversial urine analysis. We believe this will help us guide a management protocol for patients with NSC and to make further recommendations, for example tailormade diagnostic trajectories following referral category. We added this in the objective, page 4, lines 76-77, and the discussion, page 11, lines 229-243.

Comment 2.5: The study is being powered to observe for reduction in LOS-ED. This for me prompts interesting reflection – in my practice, the LOS-ED is due to hospital capacity and crowding rather than patient factors, but presumably in all the research settings here the LOS-ED ends when an initial diagnosis is made and the person is referred to a specialty. In my setting, a patient outcome such as the PRM-Acute would be more meaningful than the LOS-ED. I look forward to reading the results of the project in due course.

Reply 2.5: Thank you for your comment. In the Netherlands the LOS-ED does not end when diagnosis is established and patients is referred to a specialty, it ends when the patient is discharged to the ward. LOS-ED is therefore associated with the number of consultations during the ED-visit, a higher number of diagnostic tests and experience of the evaluating physician. [1] By standardizing diagnostic tests and by agreeing experienced physicians will evaluate these patients, we expect to reduce the LOS-ED. However, we agree that LOS-ED is confounded by hospital capacity and crowding. We purposely did not power our study on patient reported measures, while we expect a considerable percentage of missing data due to the often high prevalence of cognitive disorders in the aimed population. However, in future projects it would be very meaningful to focus more on patient reported outcomes. We added this in the outcome measures, page 9, lines 188-196.

[1] Brouns SH, Stassen PM, Lambooij SL, Dieleman J, Vanderfeesten IT, Haak HR. Organisational Factors Induce Prolonged Emergency Department Length of Stay in Elderly Patients--A Retrospective Cohort Study. PLoS One. 2015 Aug 12;10(8):e0135066. doi: 10.1371/journal.pone.0135066. PMID: 26267794; PMCID: PMC4534295.

Reviewer 3:

Dear reviewer,

We thank you for your effort to assess our manuscript. The feedback on the manuscript was helpful and we feel that this helped us to improve the quality of our paper. We have edited the manuscript to address the concerns.

Comment 3.1: It is appreciated that the protocol suggests to use a novel research study design [The stepped wedge cluster randomised trial or cohort study which is increasingly being used in the evaluation of service delivery type interventions] with such mention in the title (A protocol for a multicenter stepped wedged cohort study), however, the actual design details are not described/given/clarified adequately. Even ‘Methods-Trial design’ section (lines 77-80, where details are expected) is very short and does not elaborate on this. It only says that “This study is a longitudinal multicenter cohort trial with a stepped wedged design. The study will be organized in hospitals in the Noord-Brabant area, the Netherlands, in which general practitioners (GPs), elderly care physicians (ECPs), Emergency Physicians (EPs), geriatricians and internists will collaborate. Participating hospitals can be general or teaching hospitals” which is not adequate. It is well recognised that design deserves as much consideration as analysis [This is pasted from one standard textbook on ‘Medical Research Methodology’] and I am sure that the authors already know this. According to my information/knowledge, this design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. A classical article on this design in BMJ by Hemming [Hemming K, Haines T P, Chilton P J, Girling A J, Lilford R J. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting BMJ 2015; 350 :h391 doi:10.1136/bmj.h391] is unfortunately (seems to had not used &) not quoted in the manuscript. This article says “In a stepped wedge study, the sample size calculation is complicated by the need to allow for the confounding effect of calendar time, and this means that the standard design effect is no longer applicable. Compared with a simple parallel study, where no such confounding occurs, the time effect tends to degrade the precision of the study and increase the sample size needed to achieve adequate power”. Even standard ‘design effect’ seems to have not been applied {or if applied is not mentioned/clarified in ‘Statistical Analysis-Sample size’ section (lines 179-191)}. If because of (due to) “crossover” cluster ‘design effect’ is not applicable, that needs to clarify and quote the reference. In fact, there is a complete absence of any reference on this design or methodology {I could not identify any such reference out 18 mentioned/listed in this manuscript}. Is not it surprising?

Reply 3.1: Thank you for your comment. We agree that we did not describe the study design properly and apologize for naming our study a stepped wedged design study while we do not meet criteria for this design. The aimed design of our study is a parallel cohort study with a baseline period. Due to the logistic restraints of implementing a care pathway in an acute care system that is under unprecedented strain, we did not randomize clusters. We started the intervention period conform convenience, sequentially following the capacity of participating hospitals to implement the pathway. We changed title, abstract and further elaboration on the design is given in the method section. We added the proposed reference on parallel designs versus stepped wedged design. See page 1, line 3, page 2, line 25 , page 4, line 80 and the patient recruitment section on page 5-6.

[1] Hemming K, Haines T P, Chilton P J, Girling A J, Lilford R J. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting BMJ 2015; 350 :h391 doi:10.1136/bmj.h391

Comment 3.2 Is article quoted as number 17 [Kremers MNT, Mols EEM, Simons YAE, van Kuijk SMJ, Holleman F, Nanayakkara PWB, et al. Quality of acute internal medicine: A patient-centered approach. Validation and usage of the Patient Reported Measure-acute care in the Netherlands. PLOS ONE. 2020;15(12):e0242603] used for required sample size estimation? Since the design used and focus of that study is entirely different {In this study, we primarily aim to assess the validity of the PRM-acute care in internal medicine patients and secondly, to gain insight into the current perceived quality of acute care, with the overarching goal to use the PRM-acute care in daily practice and improve patient-centered care in the ED}, I wonder, ‘how’ that helped? Will you please explain? [essential since it is quoted here]. Because the earlier quoted Hemming’s article on page 4 says “As yet, there is no specific adaptation of design effects, for calculating the power or sample size in a cohort stepped wedge trial, nor implementation in a statistical package for this design.”, I would like to learn (as Hemming’s article is of 2015 & you may be aware or might have used later/newer developments).

Except these minor points, the article is acceptable. Nevertheless, mind you that as pointed out in ‘important note’ above “This review pertains only to ‘statistical aspects’ of the study and so ‘clinical aspects’ should be assessed separately/independently. ‘Minor Revision’ is recommended.

Reply 3.2: We apologize, the added reference is wrong. The data used for our power analysis is preliminary data from a prospective study about the quality of acute care, by the same author as the referred article, M.N.T. Kremers. These data are submitted and we adjusted the reference. See page 9, lines 199-203.

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Decision Letter 1

Antony Bayer

13 Aug 2023

Implementation of a care-pathway at the emergency department for older people presenting with nonspecific complaints; A protocol for a multicenter parallel cohort study

PONE-D-23-17637R1

Dear Dr. van der Velde,

Thank you for your revised manuscript and for your considered attention to the reviewer comment. 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.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. 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.

Kind regards,

Antony Bayer

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #2: Yes

Reviewer #3: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #2: Yes

Reviewer #3: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable?

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #2: Yes

Reviewer #3: Yes

**********

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

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #2: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #2: My concerns have been addressed and I thank the authors for their attentiveness to my comments. Good luck with the study.

Reviewer #3: COMMENTS: All the comments are answered and positively attended [good that the study title is changed]. I recommend the acceptance because the manuscript has now achieved the acceptable level in my opinion.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #2: No

Reviewer #3: Yes: Dr. Sanjeev Sarmukaddam

**********

Acceptance letter

Antony Bayer

21 Aug 2023

PONE-D-23-17637R1

Implementation of a care-pathway at the emergency department for older people presenting with nonspecific complaints; A protocol for a multicenter parallel cohort study

Dear Dr. van der Velde:

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,

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on behalf of

Professor Antony Bayer

Academic Editor

PLOS ONE

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