CompletedNot Applicable

Feasibility Study of a Mobile Digital Personal Health Record for Family-Centered Care Coordination for Children and Youth With Special Healthcare Needs

United States21 participantsStarted 2022-10-06

Plain-language summary

A Fast Healthcare Interoperability Resources (FHIR)-enabled digital personal health record mobile app has the potential to enhance care coordination for families of children and youth with special healthcare needs (CYSHCN) and to inform improvements in family-centered care coordination that will be highly impactful for populations of patients with complex health needs across the age spectrum. The purpose of this study is to evaluate the feasibility of a digital personal health record (PHR) mobile application integrated with electronic health records by FHIR data standards to enhance care coordination for families of 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, non-randomized 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion: * Adult parent/legal guardian (age 18 or older) who is a primary caregiver for a CYSHCN aged 0-16 years * Established care for their child/youth at a participating Duke Pediatrics Primary Care clinic: North Durham, South Durham,Brier Creek or Duke Med-Peds Primary Care sites (established = one or more completed visits in the past 12 months at the clinic) * High level of complex medical needs that could benefit from additional care coordination support (determined by clinical provider at the participating clinic site) * Primary care provider enrolled in the study as a provider participant/clinical provider site champion * Active Duke MyChart (online EHR patient portal) account * Full proxy access activated/enabled for parent to the child/youth's medical record in Epic * Apple iOS device compatible with Caremap app requirements at time of consent Exclusion Criteria: * Non-English speaking * Patients living in long-term, congregate settings - e.g., living in institutionalized settings such as long-term care facility, nursing/long-term rehab facilities * Child is a ward of the state * Lacks requisite technology to access and use mobile app (e.g., device/tablet/smartphone, home internet, active Epic MyChart account) * Lack of decision-making capacity (parent/caregiver or adult patient, clinician-determined)

What they're measuring

Technical feasibility (FHIR data transfer EHR to app)

Timeframe: Up to 6 months

Technical feasibility (FHIR data transfer app to provider dashboard)

Timeframe: Up to 6 months

Implementation (feasibility)

Timeframe: End of study (6 months)

Implementation (acceptability)

Timeframe: End of study (6 months)

Implementation (appropriateness)

Timeframe: End of study (6 months)

Change in parent/caregiver-reported degree of care integration, as measured by Pediatric Integrated Care Survey (PIC)

Timeframe: Baseline, 6 months

Change in health-related quality of life (HR-QOL)

Timeframe: Baseline, 3 months, 6 months

Change in usability, as measured by the System Usability Scale (SUS) (provider)

Timeframe: Baseline, 6 months

Trial details

NCT IDNCT05513235

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Children, Only trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Technical feasibility (FHIR data transfer EHR to app)

Timeframe: Up to 6 months

Technical feasibility (FHIR data transfer app to provider dashboard)

Timeframe: Up to 6 months

Implementation (feasibility)

Timeframe: End of study (6 months)

Implementation (acceptability)

Timeframe: End of study (6 months)

Implementation (appropriateness)

Timeframe: End of study (6 months)

Change in parent/caregiver-reported degree of care integration, as measured by Pediatric Integrated Care Survey (PIC)

Timeframe: Baseline, 6 months

Change in health-related quality of life (HR-QOL)

Timeframe: Baseline, 3 months, 6 months

Change in usability, as measured by the System Usability Scale (SUS) (provider)

Timeframe: Baseline, 6 months