Feasibility of Implementation of a Mobile Digital Personal Health Record to Coordinate Care for Children and Youth With Special Health Care Needs in Primary Care: Protocol for a Mixed Methods Study

Background Electronic health record (EHR)–integrated digital personal health records (PHRs) via Fast Healthcare Interoperability Resources (FHIR) are promising digital health tools to support care coordination (CC) for children and youth with special health care needs but remain widely unadopted; as their adoption grows, mixed methods and implementation research could guide real-world implementation and evaluation. Objective This study (1) evaluates the feasibility of an FHIR-enabled digital PHR app for CC for children and youth with special health care needs, (2) characterizes determinants of implementation, and (3) explores associations between adoption and patient- or family-reported outcomes. Methods This nonrandomized, single-arm, prospective feasibility trial will test an FHIR-enabled digital PHR app’s use among families of children and youth with special health care needs in primary care settings. Key app features are FHIR-enabled access to structured data from the child’s medical record, families’ abilities to longitudinally track patient- or family-centered care goals, and sharing progress toward care goals with the child’s primary care provider via a clinician dashboard. We shall enroll 40 parents or caregivers of children and youth with special health care needs to use the app for 6 months. Inclusion criteria for children and youth with special health care needs are age 0-16 years; primary care at a participating site; complex needs benefiting from CC; high hospitalization risk in the next 6 months; English speaking; having requisite technology at home (internet access, Apple iOS mobile device); and an active web-based EHR patient portal account to which a parent or caregiver has full proxy access. Digital prescriptions will be used to disseminate study recruitment materials directly to eligible participants via their existing EHR patient portal accounts. We will apply an intervention mixed methods design to link quantitative and qualitative (semistructured interviews and family engagement panels with parents of children and youth with special health care needs) data and characterize implementation determinants. Two CC frameworks (Pediatric Care Coordination Framework; Patient-Centered Medical Home) and 2 evaluation frameworks (Consolidated Framework for Implementation Research; Technology Acceptance Model) provide theoretical foundations for this study. Results Participant recruitment began in fall 2022, before which we identified >300 potentially eligible patients in EHR data. A family engagement panel in fall 2021 generated formative feedback from family partners. Integrated analysis of pretrial quantitative and qualitative data informed family-centered enhancements to study procedures. Conclusions Our findings will inform how to integrate an FHIR-enabled digital PHR app for children and youth with special health care needs into clinical care. Mixed methods and implementation research will help strengthen implementation in diverse clinical settings. The study is positioned to advance knowledge of how to use digital health innovations for improving care and outcomes for children and youth with special health care needs and their families. Trial Registration ClinicalTrials.gov NCT05513235; https://clinicaltrials.gov/study/NCT05513235 International Registered Report Identifier (IRRID) DERR1-10.2196/46847


RESUME AND SUMMARY OF DISCUSSION:
This study R21 health services research grant application from Dr. David Ming, from Duke University, in Durham, NC, proposes a study to evaluate the feasibility of a digital personal health record (PHR) mobile application integrated with electronic health records by Fast Healthcare Interoperability Resources (FHIR) data standards to enhance care coordination for families of children and youth with special healthcare needs (CYSHCN).The reviewers agreed on the high significance of this proposed study noting that twenty percent of children have special health care needs and require care coordination between multiple subspecialists and communication of family health insights at home, and potentially care across disparate systems.They added that significant care coordination needs apply to adults with multiple care conditions (MCC) as well as children with special care needs, so success would potentially impact other patient groups.The reviewers also noted that the study is highly innovative.The proposed study will develop the first FHIRenabled digital personal health record mobile app to improve care coordination with secure access and sharing of EHR data and family reported health insights, not yet been tested for regular clinical care.It includes a strong scientific premise, Good experimental design and evaluation.Good description of technology, bidirectional sharing of information, and a prototype that already exists.The research team is building on significant track record of work that logically leads to this study.However, the reviewers noted some minor weaknesses.The study should focus more on how the app will address underserved families from lower socio-economical backgrounds, who face literacy challenges, and who could particularly benefit from care coordination.The study relies on Fast Healthcare Interoperability Resources (FHIR) technology, which is not universally implemented and available, potentially limiting generalizability of the findings.The methods could better describe the details needed for the qualitative interviews and the degree to which intervention will fit into the clinical workflow.Also, the reviewers noted concerns with a limited sample size of families and providers involved.Based on the Scientific and Technical Merit of the application, this application received a score of 29.

DESCRIPTION (provided by applicant):
Coordinating care across a complex web of providers and services on their own is stressful and isolating for families of children and youth with special healthcare needs (CYSHCN); thus, better care coordination solutions are critically needed.Digital personal health records (PHR) that allow families to securely access, manage, and share their child's health data across multiple information and electronic health record (EHR) systems are promising solutions.Central to digital PHRs being able to fulfill their promise are Fast Healthcare Interoperability Resources (FHIR) -updated data standards that facilitate secure data access and sharing between third party mobile applications (apps) and EHRs.Despite their importance, FHIR technologies have yet to be widely adopted.A FHIR-enabled digital PHR mobile app (Caremap) was co-designed with families and clinicians to coordinate care for CYSHCN and has been positively reviewed by families in preliminary testing.Implementation and evaluation of the Caremap mobile app in real-world setting is now the critical next step forward.We will conduct a single group, non-randomized, feasibility study with 40 families (adult parents/caregivers) of CYSHCN in pediatric primary care clinics to use the digital PHR mobile application as a tool for coordinating their child's care over a 6-month period.The primary study outcome of overall feasibility will include measures of technical feasibility (FHIR-enabled integration of the mobile app with the EHR) and implementation outcomes in real-world clinical environments.Using a convergent mixed methods design, we will merge quantitative feasibility data and two qualitative data sources (semi-structured interviews with families and providers; family stakeholder engagement panels) to identify implementation barriers and facilitators.Using pre/post analyses of baseline and 6-month family-reported survey measures, we will explore associations between level of family app adoption and family-reported outcomes.This proposal is highly innovative because it will be the first FHIR-enabled digital PHR mobile app implemented to enhance care coordination for CYSHCN via secure access and sharing of EHR data and familyreported health insights.The findings will be highly significant because they will support a future multisite pragmatic, cluster randomized trial to evaluate the effectiveness of enhanced care coordination MING, D with a digital PHR mobile app compared to usual care coordination.Due to similarities in needs between CYSHCN and adults with multiple chronic conditions, the study's findings will inform improvements in family-centered care coordination that will be highly impactful for complex populations across the age spectrum.

PUBLIC HEALTH RELEVANCE:
This study will evaluate the feasibility of a digital personal health record (PHR) mobile application integrated with electronic health records by Fast Healthcare Interoperability Resources (FHIR) data standards to enhance care coordination for families of children and youth with special healthcare needs (CYSHCN).The study will enroll 40 families (adult parents/caregivers) of CYSHCN in pediatric primary care clinics to use the digital PHR mobile application as a tool for coordinating their child's care over a 6-month period.Using a single group, nonrandomized study design and convergent mixed methods analyses, the study will: (a) determine the feasibility of FHIR-enabled integration of the mobile application with electronic health records for care coordination; (b) identify barriers and facilitators to implementation in real-world settings; and (c) examine associations between level of app adoption by families and family-reported outcome measures.

CRITIQUE NOTE:
The sections that follow are the essentially unedited, verbatim comments of the individual committee members assigned to review this application.The attached commentaries may not necessarily reflect the position of the reviewers at the close of group discussion, nor the final majority opinion of the group.The above RESUME/SUMMARY OF DISCUSSION represents the evaluation of the application by the entire committee.

CRITIQUE 1
Significance: 2 Investigator(s): 1 Innovation: 3 Approach: 4 Environment: 1 Overall Impact: CYSHCN is a very important subset of pediatrics patients group who need a majority of sources in pediatric care, but also suffer from care coordination problems.The proposed app has strong features such as utilizing SMART/FHIR functions to be embedded in EHR and improves familycare team interaction and information exchange.The proposal is well written with clear description of app, its features, and aims to be studied.The approach is well written with some minor issues to be easily fixed.It would be also important to consider Health Literacy level of users in their analysis for adoption, implementation as well as barriers to use the app.

Significance: Strengths
• CYSHCN is an important subset of pediatrics patients group who need a majority of sources in pediatric care, but also suffer from care coordination problems.• Families are safety net for the care of CYSHCN, and need support in the care of their kids.
• The proposed app has strong features such as utilizing SMART/FHIR functions to be embedded in EHR and improves family-care team interaction and information exchange.• Very well written and conceived proposal.
• Pilot data shows prior acceptability, high usability of the product, in fact it is already offered in Apple app store for free download and use by any parents.

Weaknesses
• Underserved and under educated families are the ones who suffer most in the care coordination of their medically complex kids.The researchers should consider this, and make sure to recruit and show the outcomes from this group of families' perspectives.• Health literacy should be collected and considered in the analysis.

Innovation: Strengths
• Innovation comes with one of the first app to be used for the care coordination of complex care kids with EHR integration.Weaknesses • None noted.

Approach: Strengths
• The approach is well written with all required steps to address each aims.
• Using the conceptual frameworks such as CFIR, TAM is a plus.
• Pre-Post design with a group of 40 parents.
• Detailed description of the app, how it works, and all limitations with alternative plans proposed.

Weaknesses
• We are not sure if 40 would be sufficient sample size especially with the quantitative survey analysis.• Some of the sample sizes are not clear.For instance, they need to clarify that if 10-12 parents for the interview part (barriers and facilitators) are among those 40 parents, and how they pick them.Because there is one cohort group, I would expect to see they interview at least half of the sample to capture barriers and facilitators, since there might be significant difference in type of patient diseases, health literacy level of parents, parents' experiences due to severity or needs of their children's situation.• In aim 2, They only interview 4 providers, which is really small sample size.This app is an interactive app, so providers' involvement and engagement is necessary to make this app successful for parents.That being said, they should interview at least 10 providers to get meaningful result from providers' perspective.• The PI talks about second source of qualitative data source as the "family panel", however do not provide any more information.Who are these family panel?Are they among those 40 parents?If they are not, are they potential users?How do you make sure their perspectives ( if not users) will not bias the data you get from your primary sample of 40 users (intervention group?)

Environment: Strengths
• Great environment with all needed support.
To address this issue, the investigators have developed a PHR prototype which will integrate with the EHR through FHIR technology.In their study, they will evaluate the feasibility of use of a PHR and qualitatively assess the facilitators and barriers to implementation and use.Overall enthusiasm for this proposal is high, given the significant impact a PHR would have to both children and adults with special health care needs and MCC, as well as the experience of the team and institution with use of FHIR technology.The primary weakness of the proposal is that it relies on FHIR technology, which is not universally implemented and available, potentially limiting generalizability of the findings.

Significance: Strengths
• 20% of children have special health care needs and require care coordination between multiple subspecialists or team.• Communication of family health insights at home, and potentially care across disparate systems, is not easily shareable or visible to providers.• Significant care coordination needs apply to adults with MCC as well as children with special care needs, so success would potentially impact other patient groups.

Weaknesses
• Success requires FHIR technology which has been variably utilized by health systems, thus may limit generalizability.

Investigator(s): Strengths
• Team competed and won Maternal Child Health Bureau Grand Challenge on care coordination with development of their app.• Team includes expertise in digital health, care coordination, implementation science, and mixed methods/qualitative assessment-requisite expertise is represented.• PI runs a complex care service focused on the study population and has training in implementation science; he is devoting 20% time to application; currently holds an active K12 award.
• LOS from Duke Technology Digital Strategy Office promoting ability to integrate with FHIR standards and Boston IT who developed the app for ongoing integration.

Weaknesses
• K12 effort will have to be adjusted for R21.

Innovation: Strengths
• The use of a personal health record that integrates with the EHR through FHIR technology to allow bidirectional sharing of information is transformative.• A PHR prototype has been developed and assessed by families with high acceptance.
• If successful, it could be used by adults with MCC and many others to share healthcare information with various providers.• Some risk due to FHIR technology but high reward.

Weaknesses
• Availability of FHIR technology and acceptance -not universal.
• Issues with FHIR technology -data matching, existing domain information, etc.

Approach: Strengths
• Concrete use of several frameworks for both the design of the HIT application and for assessment (TAM and CFIR).• Assessment of technical and implementation feasibility using some standard measures and also assessment of usability.• Bidirectional communication between the EHR and app to facilitate communication of information from provider to family and from family to provider.• Family shared information is integrated into a provider dashboard that is visible in the EHR, so does not require multiple sites for access -shows ePRO trends as well as recent visits, goals, medications.
• Evaluating meaningful outcomes that include both family perception of care (PICS for care coordination and QOL assessment) and usability as well as healthcare utilization (ED use, hospitalizations).

Weaknesses
• Not a lot of information about qualitative interviews post-implementation (themes and coding) except guidance by CFIR.• Not clear that standardized pediatric ePROs will be utilized for family reported data (like PROMIS pediatric measures).• Not clear the information that the provider will be evaluating and the time involved.• 6 month follow up time period is short but necessary within the time limits of the grant.

Environment: Strengths
• Both Duke and Boston have adequate resources and support to accomplish the aims of the grant.

Protections for Human Subjects: Acceptable
• Duke Health Digital Strategy Office and Duke Mobile App Gateway resources.• Duke Implementation Science Core.• Boston Digital Health and Innovation Accelerator.• LOS demonstrating the collaboration of the Duke DSO with Boston Digital Health and Innovation Accelerator.• Overall description of Duke Primary Care is provided and demonstrates adequate patient numbers and distribution for study.Weaknesses • None noted. .Protections appear appropriate, including for use of mobile app with PHI Appendix: Acceptable.SDRD is included and describes the hardware/software/security required for use of the FHIR-enabled mobile app Budget and Period of Support: Budget is appropriate.

Data and Safety Monitoring Plan: Acceptable
.No DSMB but adequate oversight by PI for 40 enrolled families Acceptable.Anticipated to have a high number of women based on past studies but appropriately justified.
Inclusion of Individuals Across the Lifespan: Acceptable.Study will enroll adult parents of children with health care needs, appropriate justification provided for not enrolling children