Using an electronic medical record patient portal for warfarin self-management: Empowering children and parents

Abstract

Background

Many children taking warfarin perform their international normalized ratio (INR) at home, with results phoned to a clinician who instructs warfarin dosing. Data suggest that parents can be supported to make warfarin dosing decisions themselves, a process known as patient self-management (PSM).

Objectives

This study aimed to determine the suitability and acceptability of warfarin PSM in children using the Epic Patient Portal.

Methods

Children currently performing INR patient self-testing were eligible. Participation involved an individualized education session, adherence to the PSM program, and participation in phone interviews. Clinical outcomes (INR time in therapeutic range and safety outcomes), patient portal functionality, and family experience were assessed. The hospital human research ethics committee approved the study and consent was obtained from parents/guardians.

Results

Twenty-four families undertook PSM. The median age of children was 11 years and all children had congenital heart disease. A median of 13 INRs was uploaded to the portal per family (range, 8-47) across a 10-month period. Before PSM, the mean time the INR was in therapeutic range was 71%; this increased to 79.9% during PSM (difference: P < .001). No adverse events were encountered. Eight families participated in a phone interview. The major theme identified was empowerment; minor themes that emerged included “gaining knowledge,” “trust and responsibility builds confidence,” “saving time,” and “resources as a safety net.”

Conclusion

This study demonstrates that communication via the Epic Patient Portal is satisfactory to families and offers a suitable option for PSM for children. Importantly, PSM empowers and builds confidence in families to facilitate management of their child’s health.

Essentials

• •Evidence suggests that families can be taught to dose-adjust to their child’s warfarin.
• •A patient self-management (PSM) program was established using a patient portal.
• •The mean time the international normalized ratio was in range during PSM was 79.9%.
• •PSM via the Epic Patient Portal empowered parents and streamlined communication.

1. Introduction

Warfarin has been used in clinical practice for the treatment and prevention of thrombosis since the 1950s. Despite the advent of several direct oral anticoagulants across the last decade, warfarin remains the only oral anticoagulant with data available on safety and efficacy for long-term (years) use for thromboprophylaxis [1]. The majority of children (80%) requiring warfarin have an underlying cardiac defect, for which they require primary thromboprophylaxis [2,3]. The remaining 20% of children require warfarin for the management of thromboembolic disease (eg, stroke or deep vein thrombosis) or other thrombosis-potentiating indications, such as a need for long-term central venous access device placement [1].

Warfarin has a narrow therapeutic index and requires regular blood test monitoring using the international normalized ratio (INR). INR results that are below the lower limit of the therapeutic range confer an increased risk of thrombosis in patients, whereas INR results above the upper therapeutic limit confer an increased risk of bleeding events. Many families of children on warfarin have been supported to perform INR self-testing on a point-of care (POC) device, following the completion of a comprehensive training program [[4], [5], [6]]. Home patient self-testing (PST) programs have been evaluated and demonstrated to provide safe, efficacious warfarin management and improve the quality of life for both children and families [[4], [5], [6], [7], [8]].

International evidence has emerged that families can be taught to make dose-adjustments to their child’s warfarin therapy based on INR results determined at home without detrimental effects on treatment safety or efficacy [9,10]. These studies suggest that participation in patient self-management (PSM) of their child’s warfarin therapy is preferred by some parents [9,10]. However, studies to date have been underpowered to confirm equivalent safety and efficacy outcomes between PST and PSM programs and have targeted older children [9,10]. Furthermore, previous studies were performed prior to the implementation of electronic medical records (EMRs) in most major pediatric hospitals. A pediatric warfarin PSM program has not been explored using a digital patient portal within an EMR as a tool to support communication between families and clinicians.

This study aimed to determine the suitability and acceptability of warfarin PSM in children using the Epic Patient Portal at a pediatric hospital. To achieve this aim, the study included the development and establishment of necessary digital infrastructure and education to support the implementation of a warfarin PSM program for children. Under the existing PST program, families must leave a message on an answering machine regarding the INR result obtained at home. A member of the hematology team calls the family back with ongoing management advice. This process entails transcription of data into the RCH electronic medical record (Epic), multiple phone calls, and frequent need of repeat attempts to contact families. Furthermore, it does not acknowledge the significant knowledge level many families have regarding their child’s specific warfarin responsiveness, and maintains their dependence upon hematology rather than fostering positive self-management practices. Engaging adolescents with chronic illness, especially those who require lifelong oral warfarin therapy, in PSM activities can enhance knowledge acquisition and aid in their preparation for transition to adult services [11].

This project has 4 key objectives: First, to determine the suitability of PSM in a cohort of children requiring long-term warfarin; second, to determine the level of family adherence to the nomogram guiding decision-making regarding warfarin PSM by parents; third, to establish a world-first integration between the Epic Anticoagulation Tracker and the Epic Patient Portal for the purpose of sharing data between families and clinicians regarding warfarin management; and finally, to explore patient and family confidence and competence with warfarin PSM using the Epic Patient Portal.

2. Materials and Methods

This was an observational study of a new model of anticoagulation care; a warfarin PSM program.

In order to offer a PSM program, an evidence-informed warfarin dosing nomogram for parents was developed to guide their decision-making regarding warfarin dosing and re-testing. An education program to support families commencing warfarin PSM was designed based on previously validated education materials used by the service [6,12]. Integration between the Epic Patient Portal (MyChart, known locally as My RCH Portal) and the Epic Anticoagulation Tracker was achieved to enable direct entry of the INR result, warfarin dosing plans, and comments relating to factors that may be impacting warfarin responsiveness.

Potential participants of the study were pediatric patients currently being treated by the Clinical Haematology Department at the Royal Children’s Hospital, Melbourne, for warfarin management. Families of children on warfarin who were less than 18 years of age were currently performing home INR ST, had been on warfarin for a minimum of 6 months, and were expected to remain on warfarin for a duration of more than 12 months were eligible to participate in the program. Children and families who had not been adherent to recommended plans for INR testing or warfarin dosing and/or had infrequent contact with the Clinical Haematology Department or those who only required warfarin dosing for less than 12 months were excluded.

The hospital human research ethics committee approved the study (HREC# 40951) and consent was obtained from parents/guardians. Children meeting the inclusion criteria were invited to participate in the study via letter. Parents and children could volunteer to participate in a phone interview exploring their confidence and competence in self-management, but this was not mandatory for inclusion into the study.

2.1. Warfarin PSM education program

Families were required to attend an appointment with the Anticoagulation clinical nurse consultant (CNC) for individualized warfarin PSM education. Only 1 parent of each patient and children aged >8 years were required to attend the appointment at the Royal Children’s Hospital. The education appointment encompassed the following:

• •Revision of warfarin action, indication, and confounders to stable therapy.
• •Individual therapeutic target range and dose revision.
• •Dosing warfarin using a nomogram and rationales for dosing decisions.
• •Deciding when to perform the next INR test.
• •When to call Clinical Haematology Department in response to changes in the child’s health status.
• •Management of a high INR at home (>5.0).
• •Where applicable, if bridging anticoagulation was required, discussion of the threshold for the administration of low-molecular-weight heparin for subtherapeutic INR.

Prior to attendance at the education appointment, parents and children were requested to complete a warfarin knowledge questionnaire to assess their current level of warfarin knowledge [6]. This enabled the Anticoagulation CNC to tailor the education to each family’s individual needs and ensure that the family was well equipped to make informed warfarin dosing decisions. This questionnaire has been validated as part of the RCH’s established home INR monitoring program [12].

2.2. Pediatric warfarin nomogram

A novel pediatric warfarin nomogram was developed to support the program. The new warfarin nomogram was assessed and reported in a separate study [13]. There was a different version of the nomogram for each target therapeutic INR range, which provides dose recommendation and factors to consider that may have influenced INR results and recommends a time to retest the INR. The nomogram was to be used in combination with guidance documents that detail the impact of known factors on warfarin dose requirements and INR results. Families were requested to consider the trend of their child’s INRs by looking at previous results and the stability of the INR over time. Families were encouraged to problem-solve based on child’s individual dose requirements and clinical status, rather following a prescriptive dosing regimen merely based on the INR result that day.

2.3. Epic and My RCH Patient Portal (MyChart) interface

The priority in developing a designated warfarin PSM platform was to ensure the visibility of INR results inputted by families in the Epic Patient Portal to clinicians. Working with an expert electronic medical record analyst (J.H.), a platform was developed that allowed patient INR data entered via the Epic Patient Portal to be communicated through to the Epic Anticoagulation Tracker (used by clinicians for warfarin dosing). Upper and lower limits were set for INR TTR (individual to each patient) to trigger notification to clinical team, and a setting could be enacted to make regular notifications to clinicians about INR entries. Clinicians received notifications of breach of safety parameters via their “In basket” messages. Patients and families had to sign up to the My RCH Portal, involving an identification check, and were then given a unique login and password. At the time of the education session for PSM, a self-management flowsheet was activated by anticoagulation team for the patient in Epic, which allows the patient and family to begin inputting INR data via the patient portal.

2.4. Data collection

Data was sourced from patients’ medical records on Epic. Specific quantitative variables of interest are discussed below. Phone interviews were conducted at a mutually agreeable time for study participants and the interviewer (S.J.). Interviews were audiotaped and transcribed verbatim. Questions asked in the phone interviews with parents and children are listed in Supplementary Text. The interview questions related to family’s experience of PSM and their self-assessment of confidence and competence with PSM.

2.5. Data analysis

Descriptive statistics were performed to analyze all demographic characteristics, which included age, indication for warfarin, and target INR range. The following data were generated from collected INRs and warfarin dosing data via Epic:

• •Patients’ current time in therapeutic range on ST program and patients’ TTR for a minimum of 6 months of PSM.
• •The number of INRs performed for period of PSM.
• •Major or clinically relevant bleeding and thrombotic episodes.
• •Adherence to PSM nomogram for dosing and scheduling of tests.

Cluster analysis was used to calculate TTR through Epic [12,14]. TTR before PSM and during PSM, as continuous variables that were both normally distributed, were compared using a t-test. Adherence was assessed by describing the number of deviations from nomogram; whether the warfarin dose recorded by parents and if the time planned for the next INR to be performed matched the recommendation.

The incidence of any thrombotic or bleeding complications was reported descriptively. Bleeding is defined as major or clinically relevant bleeding, with major bleeding defined as “composite of” fatal bleeding; clinically overt bleeding associated with a fall in hemoglobin level of 20 g L or more in a 24-hour period; bleeding that is retroperitoneal, pulmonary, and intracranial or involves the central nervous system; and bleeding that requires surgical intervention in an operating suite [15]. Clinically relevant nonmajor bleeding is defined as a composite of overt bleeding requiring a blood transfusion, which “is not directly attributable to the patient’s underlying medical condition and bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite” [15]. Minor bleeding was not reported.

Warfarin dosages were individually recorded. This information was stored and analyzed in Microsoft Excel (Version 1908, 2022) and Statistical Package for Social Science (Version 27, 2020, IBM).

Transcripts of the family phone interviews were analyzed using thematic analysis. Thematic analysis was used to code data in order to develop themes inductively from within the transcripts. This method follows widely recognized qualitative content analysis processes, such as those described by Parahoo [16]. Coding of the data was cross-checked between the authors (S.J., J.L.H., and F.N.).

3. Results

An invitation to participate was sent to 92 eligible patients. Thirty-six families formally consented to participate; 26 families attended the Anticoagulation Clinic for education and training in PSM and signed up to use the Epic My RCH Portal. Ten children aged ≥8 years attended the education session with their parent(s). The education session took approximately 1 hour for each family and was conducted by one Anticoagulation CNC. The education session was followed up with email and phone correspondence with each family to ensure that they had successfully accessed the My RCH Portal and were able to upload the INR results. Ten of the 36 families who consented for the study failed to attend an education session during the study period (despite repeated attempts to organize this). Two families completed the PSM training, but despite numerous follow up phone calls, they failed to upload any INR results to the My RCH Portal during the study period and thus were excluded from the final analysis.

Data for the 24 patients who completed training, commenced PSM, and uploaded INR results during the study period are presented in Table 1. All children in the study had an underlying congenital cardiac condition, thus predicating the need for long-term anticoagulation. Eighteen children required warfarin post-Fontan procedure and 4 children had mechanical heart valves. Of the 24 patients, 16 were male and 8 were female.

Table 1.

Patient characteristics.

Variable	Mean (minimum to maximum)
Age at commencement of self-management (y)	11 (4-17)
Age at commencement of warfarin (y)	4.5 (0.4-9.8)
Time on warfarin at self-management commencement (y)	6.7 (1.3-14.6)
	N
Target INR range of 2.0-3.0	n = 20
Target INR range of 2.5-3.5 or 3.0-4.0	n = 4
Indication for warfarin
Post-Fontan procedure	n = 18
Stroke/Post-Fontan	n = 2
Mechanical mitral valve	n = 2
Mechanical aortic valve	n = 2

INR, international normalized ratio.

For a mean time of 10 months of PSM, 460 INR tests were performed. The percentage of all INRs in range for the cohort for the period of PSM was 74% (n = 341). The mean TTR during PSM using cluster analysis was 79.9%. The mean difference in TTR pre-PSM and during PSM based on the cluster analysis was 8.7% (95% CI, 4.3-13; P < .001). Twenty of the 24 patients increased the time when their INR was in the target therapeutic range during PSM. One child’s TTR remained the same but had a higher target range, and thus, maintaining stability is recognized to be more difficult [17]. Three children had a drop in their TTR: one due to poor adherence to testing and 2 other children faced difficulties as their families had significant health challenges during the study period.

Twenty-two children had TTR achievement greater than 60%: one child had a TTR achievement of 59% and one child had a TTR achievement of 56%. Both children with TTR of less than 60% had a higher target therapeutic range of 2.5 to 3.5 and required more INR tests to monitor their warfarin therapy.

All but one family were adherent to the PSM program and uploaded INRs and dosing decisions to the portal for the entire study period. As presented in Table 2, parents’ dosing decisions matched the nomogram for 92.6% of INRs reported and the majority of the decisions (78%) matched the nomogram for the recommended time for the next INR. Only 32% (9 of 28) of subtherapeutic INR results were due to a missed warfarin dose.

Table 2.

Outcomes for the period of self-management.

Outcomes	Minimum to maximum	Mean
Months of self-management	7-16	10 mo
TTR pre–self-management	57%-84%	71.2%
TTR post–self-management	56%-100%	79.9%
Number of INRs uploaded to portal	8-47	13a

Outcomes	N	n (%)
Parents dosing matched nomogram	N = 460	426 (92.6%)
Time of next INR matched nomogram	N = 460	360 (78.3%)
INR tests performed earlier/later than nomogram recommendation	Earlier	51 (11%)
	Later	49 (10.7%)

INR, international normalized ratio; TTR, time in therapeutic INR range.

^aMedian.

Families are advised to contact the hematology department when the INR is >5.0. There were 3 occasions when a child’s INR was >5.0, and all 3 families contacted the Clinical Haematology Department and had dosing decisions made by a clinician. One child had a target therapeutic range of 3.0 to 4.0 and experienced repeated viral illness, resulting in a number of INRs >5.0 (all dosed by clinicians). Two further children became unwell with a viral illness and had an INR of >5.0. There were no bleeding or thrombotic events during the study period.

3.1. Family confidence and competence with warfarin self-management

Eight families consented and participated in a phone interview. Three interviews were conducted with a parent and a child and the other 5 interviews were conducted with a mother only. The major theme identified from the interviews was “empowerment.” Minor themes that emerged included “gaining of knowledge over time to support self-management decisions”; “trust and responsibility given to families builds their confidence”; “saving time”; “availability of resources as a safety net.” Parents and children also provided feedback about the functionality of Epic My RCH Portal.

These themes are displayed in the Figure and quotes to demonstrate the themes are presented in Table 3.

Figure.

Theme of empowerment and the sub-themes that contribute to feelings on empowerment in children and parents on warfarin PSM program.

Table 3.

Quotes depicting themes identified from interviews.

Minor theme	Quotes from parents and children
Gaining of knowledge over time to support self-management decisions	Parent of a 17-year-old person: “You guys have worked with us and you will make the dose changes but will take on board what we have said or suggested or that sort of thing.” Parent of a 13-year-old person: “Yes so obviously we were naturally nervous to start with but it didn’t take long to get into the swing of it and feel comfortable and confident with what we had to do. Yes I found the training very helpful, it was easy, you guys did it all last time with me, it really has become quite easy for us now we have less contact with medical professionals and only when we need it, which suits us well as we have a lot of contact with medical profession but the more we can manage ourselves the better particularly because of where we live. So yes the training was great and you I know the information you provided the one little flowchart with what to do if your low or high and that kind of thing that is our key reference point so that is really helpful.”
Trust and responsibility given to families builds their confidence	Parent of a 13-year-old person: “It’s been great for his confidence, actually you know just in terms of taking responsibility.” Parent of a 17-year-old person: “I think, I mean it’s a big level of trust that your giving families to do this because there are risks and so I think anything that can increase the reliability of families is good for everyone because if not, things could go wrong.” Parent of a 10-year-old person: “Yep we are more than happy and confident with doing it, we haven’t had any issues really we had that period where it was a little bit up and down but with all your support it is easy to deal with.” Parent of an 8-year-old person: “I think we feel really confident with that now. It would probably only be if she missed a dose we would call up but we would still feel confident that we know what to do with it. So we would know maybe do we do a 4 or a 5 but we do feel really confident with it. I think because she had such a difficult transition and even recently we noticed a decrease in pattern and increased her testing over a period of a couple of weeks and noticed it was still decreasing so we would increase a tablet and we were able to track the pattern very closely and not have to always call up and second guess ourselves.” Parent of an 8-year-old person: “I feel very confident it gives you the confidence because to me it is a lot safer if I have any questions about his levels in my head I just do it because like you say it takes 1 minute.”
Saving time	Parent of an 18-year-old person: “I love self-management. It decreased the amount of time I have to be thinking about it and contact somebody as you can just manage it yourself. It has been really good.” Parent of a 9-year-old person: “it is convenient because we don’t have to ring the answering machine to get our answer that’s what I like about it. We still pick a day and a time and it is still done at the same time as we used to.” 15-year-old patient: “I think it’s much easier because I don’t have to go in and I can just do it all at home and we don’t have to bother ringing up anymore after my test so its just so much easier.”
Availability of resources as a safety net	Parent of a 17-year-old person: “I think the biggest help aside for the initial appointment we had where we went through that, the biggest help has been the flow charts that are on the fridge because sometimes XX will say oh that means mum we have to have another test in 2 weeks, no it’s a week, no mum its 2 weeks. So we go back to the flow chart and its 2 weeks. It’s very detailed and it covers all the different possibilities, have you missed a dose, or have you been unwell or an extra dose, that’s been great to come back to because it is a concrete guide you know so for me that has been the most helpful in getting confidence in doing that.” Parent of an 18-year-old person: “I feel really confident especially with the resource you gave, if it is out of whack in any way. Parent of a 10-year-old person; “I thought it was brilliant all of it. I was really blown away with what you guys provided with that. And as a nurse myself I was a bit anxious about it all, but I thought it was all really brilliant, it is a fantastic program that you guys have got going. I had more anxiety about going into town to get his tests down. That was more of an issue and worry to me than doing it ourselves. So yeah it’s been really good. Parent of an 8-year-old person: I think it is just is kind of obvious because you are accessible and stuff like that … with you’re not going to panic at 1.8 or 1.9 or even 1.5, you think we need a dosing change or find a reason like you missed a dose and I guess I wouldn’t muck around I would just ring you if it was ever over 4 or anything. So I feel if one of those things happen your just on the old system and you just get the professional help and that is easy to get and I think everything you have said is fine.” 15-year-old patient: “Well I am competent in it yeah and I find it pretty easy and I am definitely confident in changing or knowing when to change my dosage and definitely the helpful haematology is very useful.”
The My RCH Portal	Parent of a 17-year-old person: “…however because there is a character limit on I think the question dosing comments which is probably good for me because I would write an essay, I think the word limit should maybe be 50 words just because if you needed to explain something which most of the time you don’t but if you needed to you kind of cant really fit a few sentences in that bit. I don’t know whether this is really problem for the hospital but we found our biggest problem was forgetting to do the INR even though we have got it in google calendars and both have access to it so I don’t know whether you could push notifications or something on the app” Parent of a 15-year-old person: “The functionality of the portal as a whole is working well, I just find it hard to delete if you put something wrong in, whether it’s been updated since I had the issues, I think it’s pretty functional. I have been able to do it on my phone and my computer I haven’t noticed anything that really sticks out that needs fixing. I think on the whole it is fine. I wonder whether you know what would be actually handy is even putting a reminder on it, if I were to put due to test in 4 weeks if there was a calendar reminder.”

3.2. Empowerment

All parents commented that the PSM program empowered them and/or gave them some control over their child’s chronic condition. All children in this study had been diagnosed with a congenital cardiac condition at birth and had required multiple surgeries and hospital admissions. This has meant that families were reliant on the hospital for complex and life-saving care for their child. This program was described by families as an opportunity for them to independently manage their child’s warfarin treatment, and thus, they were less reliant on the hospital. One parent also commented that the program reduced the anxiety associated with appointments and blood tests. PSM was seen by families as a positive experience. Families said they felt ready for PSM and supported to undertake PSM due to the support from the Clinical Haematology Department and Anticoagulation CNCs.

Below are some quotes to illustrate the theme of empowerment identified from the phone interviews. Quotes related to the minor themes identified are presented in Table 2.

3.2.1. Parent of a 13-year-old person

“It’s been very empowering in lots of ways to feel like we can make decisions over his own management but then to have the parameters you give us to work within I guess is our safety net to use. And actually, for him as a young person managing his own cardiac condition, I have noticed how much he has grown and changed in a positive way. He very much has control of his own, he does his own POC tests except I keep records and upload it onto the portal.”

3.2.2. Parent of a 17-year-old person

“Ah look for me, I think it has been a god send, I think it’s been really, really empowering and I am sort of a bit nervous about handing him over to a pathology place because they’re the ones that are going to do the dosing changes, which is what they are trained for, but you guys have worked with us and you will make the dose changes but will take on board what we have said or suggested or that sort of thing.”

3.3. Gaining of knowledge over time to support self-management decisions

This theme reflects that families who signed up for the program were familiar with warfarin; that their child had required warfarin for a number of years, and that they had in the past worked in partnership with the clinicians to make dosing decisions. Parents expressed that they had a baseline knowledge of warfarin management, which helped them when making dosing decisions at home.

3.4. Trust and responsibility given to families builds their confidence

Families were thankful of the trust and responsibility given to them and that made them feel confident in their ability to self-manage their child’s warfarin. There was an acknowledgment that it was a big responsibility, but they felt ready and supported to undertake the new responsibility for the benefit of their child and their family.

3.5. Saving time

Parents reported that the warfarin PSM program helped them to save time and that they spent less time thinking about managing their child’s warfarin therapy.

3.6. Availability of resources as a safety net

The resources supplied to families (the warfarin nomogram and flowcharts) and the option to contact the Clinical Haematology Department anytime they needed to were described by one parent as a “safety net.” Parents felt independent and empowered to make decisions for their child using the nomogram and resources, but also felt supported and not left on their own if they needed help or advice.

3.7. The Epic My RCH Portal (MyChart)

Families were specifically asked about the functionality of the Epic My RCH Portal and uploading of the INR results and dosing decisions during the phone interviews. Overall, feedback about the portal was that it was easy to use and easy to access. Families requested that the My RCH Portal could provide reminders on when INRs are due and that provision for a longer comment to be added for each INR test and dosing decision would be beneficial to allow families to convey more clinical information about their child. Some families reported that it took them some practice to appreciate the functionality of the My RCH Portal; however, with time, they were able to use it confidently.

4. Discussion

The PSM program that was implemented and evaluated in this study was successful in significantly increasing the time when each child’s INR was in the therapeutic range. Importantly, the infrastructure to support the families to self-manage their child’s warfarin met the needs of families by offering dosing advice and a clear decision-making framework that considered the child’s individual target therapeutic range and clinical status. The use of an EMR and patient portal ensured seamless communication between families and clinicians regarding dosing decisions, results, and testing schedule for the children. Importantly, for those families that were motivated to learn PSM, this program empowered families and built confidence in the families to manage their child’s health.

International evidence suggests that achievement of a TTR of more than 30% reduces the risk of thrombosis in warfarinized children [18]. In a small cohort of children with congenital heart disease (CHD), this PSM program achieved a TTR of 80%; with 22 out of 24 children achieving an individual TTR of >60%. This represents good warfarin control, thus minimizing the risk of bleeding or thrombotic complications. The TTR achievement in this study is similar to 2 previous studies of pediatric PSM where both achieved a TTR of >80%; the former in a cohort of 14 children for a period of 12 months and the latter in a cohort of 42 children for a period of 6 months [9,10].

The families in this study demonstrated adequate knowledge and understanding of warfarin management not only by achieving a high TTR but also by their adherence to the new warfarin dosing nomogram in >90% of cases. Families demonstrated that they could follow the nomogram to achieve warfarin stability and make accurate clinical decisions about warfarin dosing and INR testing. One study of warfarin PSM in children used an algorithm to inform parent’s dosing [10]. Adherence to the algorithm was measured by the frequency of dosing errors per patient, which ranged from 0 to 4 [10]. Although the families in this study were able to use the new nomogram appropriately, ongoing evaluation of the new nomogram is suggested. Further assessment of the nomogram will help determine if it is suitable to assist both families on PSM and clinicians practicing outside of specialized anticoagulation clinics or those with less experience in warfarin dosing in complex pediatric patients.

The importance of education to support parents of children on warfarin has been widely reported [[19], [20], [21], [22], [23]]. The role of education in a PSM program is central to ensure that families make informed warfarin dosing decisions [10]. There are many factors that affect the stability of warfarin management in children and thus impart that adequate knowledge to parents about these factors is imperative [6]. Parents reported that the responsibility delegated to them improved their confidence and that they had built knowledge of their child’s warfarin therapy over time. This suggests that warfarin PSM is something for families to work toward over time; after an initial period of clinician dosing in which families become familiar with the nuances of their own child’s warfarin dose requirements and response to changes in dose or clinical status. The relationship with the clinical team was central to building knowledge and confidence; this highlights the significance of having a dedicated anticoagulation service to support children on warfarin and their families and how specialized education and clinical expertise contribute to empowering families and improving outcomes [24]. This has been echoed in other studies of pediatric PSM and PST programs for children [5,8,10,20,21,25].

The findings of this study suggest that for some adolescent patients, PSM may help with their transition from pediatric services to adult services. Participating in the PSM program supported the young adults to improve their understanding of their warfarin therapy and helped them feel knowledgeable, competent, and confident. Parents reported that PSM made the process of transition much smoother. The process of transition for adolescents on warfarin has not been explored in detail, and more research can be undertaken to investigate the strategies available to make this process easier for families and young adults. Based on evidence related to transition for adolescents with other chronic health issues, education and promoting self-care activities are central to maximizing lifelong functioning and wellbeing [11,26]. Furthermore, evidence suggests that patient portals are acceptable to adolescents as a method to give them a comprehensive view of their health needs [27].

The Epic My RCH Portal supported communication between families and clinicians but also allowed families to remain independent in their dosing decisions. Epic provided a safeguard by sending alerts to clinicians when a child’s INR was out of range, and ensured that INRs results were visible within the child’s medical record. The portal was easy to use for families. This model of care, using an EMR to track family decisions and integrate POC testing results and dosing with an existing EMR, has been successful and may be suitable for other pediatric patient cohorts performing any POC tests at home. Evidence from adult patients with diabetes suggests that engagement with clinicians via the patient portal promoted self-efficacy and diabetes self-management [28]. This study presents the first data to support that the use of a patient portal for reporting POC tests in pediatrics is possible and successful.

The study does have limitations. This was a small cohort of families who were highly motivated to commence warfarin PSM and self-selected for the study. This introduces selection bias into the study; however, such bias is reflective of clinical practice in which families who are highly engaged and motivated are more likely to nominate themselves for PSM. Ethnicity and race are not recorded as standard demographic data in the EMR at our institution, and thus these data are not presented. Hence, the results have limited generalizability to other samples of children requiring warfarin.

The lower-than-expected participation in the study was due to many families reporting that they were happy with the status quo; PST at home and clinician dosing. This exemplifies the point that PSM is not desired nor is suitable for all children on warfarin and their families. PSM is a model of care that empowers families and can maintain warfarin stability but is also one that is suitable for select families who are already performing PST and are motivated to learn PSM.

Future research could explore families’ reluctance to change to PSM and whether this may be associated with the significant mental load that parents already carry in caring for a child with CHD or other chronic health conditions [29]. All children in the study had CHD and the majority had a target INR range of 2.0 to 3.0. Although this is reflective of a large proportion of children requiring warfarin [3,8,[30], [31], [32]], the sample is not representative of all children on warfarin. There was an existing relationship between participants and investigators, which could have influenced parent’s responses in the phone interviews and their comfort in expressing any issues they faced during the program. The influence of the Hawthorne effect [33] is also acknowledged as families entering the PSM program were part of this study, and thus, it is possible that families increased their adherence and were motivated to engage in the program more than if they were not part of the study. Families were motivated to engage in PSM as they saw the potential benefits for themselves; the fact that they consented to the study to allow the measurement of outcomes associated with the program was perhaps less important. As the program has continued beyond the study period, anecdotally, there has been no real change in the level of engagement of families. The effect of the surveillance on the results may have improved outcomes, but we believe this to be very minimal.

5. Conclusion

This study demonstrates that communication via the Epic Patient Portal is satisfactory to children and families, and offers a suitable option for warfarin PSM. Using the patient portal for PSM transformed an existing therapeutic relationship between clinicians and families; families were empowered to manage their child’s warfarin but are still connected to clinicians remotely. This study represents diversification of how the patient/clinician relationship can exist in the digital age, something that requires further investigation to understand the patient and clinician perspectives. This study represents outcomes for a select cohort of highly motivated families who self-selected for PSM and hence are not generalizable to the wider cohort of children on long-term warfarin. However, the PSM program and the use of a patient portal had multiple benefits for participants as it provided a sense of empowerment, built confidence, consolidated knowledge, and was seen to promote effective transition to adult services. A PSM program such as this, which uses an EMR and patient portal to communicate POC results to clinicians, can potentially improve disease management and self-efficacy for other populations of children living with chronic illness.