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

NCT05513235 | Completed

• 2 other identifiers: Pro00109514R21HS028699
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Children, Only; Children and Youth With Special Healthcare Needs

Keywords

Care coordination; Digital health; Mobile application; Primary care

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (8)

• Change in usability, as measured by the System Usability Scale (SUS) (parent/caregiver)

  Baseline, 6 months

• Change in caregiver strain, as measured by the Caregiver Strain Questionnaire (Short Form 7; CGSQ-SF7)

  Baseline, 3 months, 6 months

• Change in confidence in avoiding hospitalization

  Baseline, 3 months, 6 months

• Net promoter score (NPS) (parent/caregiver)

  End of study (6 months)

• Change in global health status

  Weekly, up to 6 months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Digital personal health record OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Boston Children's Hospital: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Ming DY, Wong W, Jones KA, Antonelli RC, Gujral N, Gonzales S, Rogers U, Ratliff W, Shah N, King HA. 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. JMIR Res Protoc. 2023 Sep 20;12:e46847. doi: 10.2196/46847.

  PMID: 37728977 DERIVED

Study Officials

• David Y Ming, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-randomized single group feasibility study design

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 24, 2022
• Study Start: October 6, 2022
• Primary Completion: September 30, 2024
• Study Completion: November 15, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)