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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Children, Only; Children and Youth With Special Healthcare Needs
• Intervention / Treatment: Other: Digital personal health record

Detailed Description

Coordinating complex care across multiple providers and services can be stressful and isolating for families of children and youth with special healthcare needs (CYSHCN); thus, better care coordination solutions are needed. Digital personal health records (PHRs) 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. Fast Healthcare Interoperability Resources (FHIR)-an application programming interface (API) standard that represents and exchanges health information-are central to digital PHRs being able to fulfill their promise. Despite their importance, FHIR technologies are not yet widely adopted. The researchers previously collaborated with Boston Children's Hospital on development of Caremap, a FHIR-enabled digital PHR mobile app that was co-designed with families and clinicians, to coordinate care for CYSHCN. Caremap has been positively reviewed by families in preliminary testing, and this followup research will implement and evaluate the Caremap mobile app in a real-world setting.

The specific aims of the study are as follows:

1. Evaluate the feasibility of a digital PHR mobile application with FHIR-enabled EHR integration to coordinate care for CYSHCN.
2. Identify barriers and facilitators of mobile app implementation via a mixed-methods evaluation.
3. Explore associations between mobile app adoption by families and family-reported outcomes.

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 mixed-methods design, researchers will evaluate quantitative feasibility data and qualitative data from semi-structured interviews with families and providers and family stakeholder engagement panels to identify implementation barriers and facilitators. Using pre/post analyses of baseline and 6-month family-reported survey measures, they will explore associations between app adoption and family-reported outcomes.

If successful, the findings will support a future multisite, randomized trial to evaluate the effectiveness of enhanced care coordination 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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Parents of eligible children and youth with special healthcare needs will use a digital personal record mobile application to coordinate care for six months.	Other: Digital personal health record; The digital personal health record is a mobile application ('app') entitled Caremap. The mobile app will be downloaded and accessible by parents/caregivers to help coordinate care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical feasibility (FHIR data transfer EHR to app)	Quantitative measurement of technical feasibility assessed by success rate of FHIR-enabled EHR data transfer to app	Up to 6 months
Technical feasibility (FHIR data transfer app to provider dashboard)	Quantitative measurement of technical feasibility processes assessed by success rate of FHIR-enabled transfer of family-reported health insights from app to EHR provider dashboard	Up to 6 months
Implementation (feasibility)	User-reported surveys of implementation outcomes assessed by the Feasibility of Intervention Measure (FIM), a 4-item scale that assesses whether a given method or condition can be successfully used in a specific setting. Responses to all survey items use a 5-point Likert scale from minimum 1 (completely disagree) to maximum 5 (completely agree). Higher scores are correlated with more positive responses.	End of study (6 months)
Implementation (acceptability)	User-reported surveys of implementation outcomes assessed by the Acceptability of Intervention Measure (AIM), a 4-item scale that assesses whether a treatment or condition is satisfactory or agreeable to stakeholders. Responses to all survey items use a 5-point Likert scale from minimum 1 (completely disagree) to maximum 5 (completely agree). Higher scores are correlated with more positive responses.	End of study (6 months)
Implementation (appropriateness)	User-reported surveys of implementation outcomes assessed by the Intervention Appropriateness Measure (IAM), a 4-item scale that assesses perceived compatibility or fit of a treatment or condition for a given setting or issue. Responses to all survey items use a 5-point Likert scale from minimum 1 (completely disagree) to maximum 5 (completely agree). Higher scores are correlated with more positive responses.	End of study (6 months)
Change in parent/caregiver-reported degree of care integration, as measured by Pediatric Integrated Care Survey (PIC)	Parent/caregiver report of experiences with care integration will be measured using the validated core 19-item PICS instrument. A composite score is calculated separately for each of the 5 survey constructs: access, communication, family impact, care goal creation, and team functioning.	Baseline, 6 months
Change in health-related quality of life (HR-QOL)	Parent/caregiver report of child's health-related QOL using the 9-item PROMIS Global 7+2 HR-QOL instrument, as well as a 2-item instrument assessing parent/caregiver perspectives on the impact of the child's conditions on their own and the parent/caregiver's usual activities and routines	Baseline, 3 months, 6 months
Change in usability, as measured by the System Usability Scale (SUS) (provider)	Provider report of experience and usability of the mobile app's provider dashboard using the 10-item SUS. This scale assesses participants' views of the usability of the app using a 5-point Likert scale from strongly agree to strongly disagree. Baseline version assesses their views on how usable they think the app will be, while the post version assesses their views on how usable the app actually was.	Baseline, 6 months
Net promoter score (NPS) (provider)	Provider-reported degree to which they would recommend the mobile app for use by others. NPS is a single item that measures the loyalty of customers to a company. NPS scores are measured with a single-question survey and reported with a number from the range -100 to +100, a higher score is desirable.	End of study (6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in usability, as measured by the System Usability Scale (SUS) (parent/caregiver)	Parent/caregiver report of experience and usability of the mobile app using the 10-item SUS. This scale assesses participants' views of the usability of the app using a 5-point Likert scale from strongly agree to strongly disagree. Baseline version assesses their views on how usable they think the app will be, while the post version assesses their views on how usable the app actually was.	Baseline, 6 months
Change in caregiver strain, as measured by the Caregiver Strain Questionnaire (Short Form 7; CGSQ-SF7)	Parent/caregiver report of degree of strain experienced as a result of their child's health with responses on a 5-point scale (1=not a problem at all; 5=very much a problem).	Baseline, 3 months, 6 months
Change in confidence in avoiding hospitalization	Parent/caregiver-reported confidence in ability to avoid unplanned hospitalization in the next one month	Baseline, 3 months, 6 months
Net promoter score (NPS) (parent/caregiver)	Parent/caregiver-reported degree to which they would recommend the mobile app for use by others. NPS is a single item that measures the loyalty of customers to a company. NPS scores are measured with a single-question survey and reported with a number from the range -100 to +100, a higher score is desirable.	End of study (6 months)
Change in global health status	Parent/caregiver report of their child's overall health status on a single item: 1 (poor) to 10 (excellent) numeric rating scale.	Weekly, up to 6 months
Adoption (family engagement)	Quantitative measurement of family engagement with the app, assessed by weekly app log-ins by families.	Up to 6 months
Adoption (provider engagement)	Quantitative measurement of provider engagement, assessed by count of views of EHR provider dashboard.	Up to 6 months
Adoption (app prescriptions)	Quantitative measurement of prescription of the app to patients, assessed by count of times mobile app prescribed by provider for use.	Up to 6 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Boston Children's Hospital; Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: David Y Ming, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Primary care; Mobile application; Digital health; Care coordination
• Other Study ID Numbers: Pro00109514; R21HS028699 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No