Clinical trial NCT05056493: Caremap: A Digital Personal Health Record for Complex Care Coordination
Official title: Caremap: A Digital Personal Health Record for Complex Care Coordination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children/Youth With Special Healthcare Needs
Adults With Multiple Chronic Conditions
Keywords: complex care
mobile health
care coordination
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Boston Children's Hospital
First posted: 2021-09-24
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will implement a new mobile application ('app') called Caremap to improve care coordination for patients with complex health needs. The goal is to pilot test the mobile app with patients/families and clinic doctors to gather input on how well the app works and how to make it better. Investigators plan to enroll up to 40 participants from Duke University for this study. The study is sponsored by Duke's Institute for Health Innovation.


Eligibility criteria: Inclusion criteria for parents/caregivers of children/youth with special health care needs (CYSHCN):

* Adult parent/legal guardian (age 18 or older) of a CYSHCN
* Established care for their child/youth at Duke Pediatrics Primary Care or Duke Children's Cystic Fibrosis clinic (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 pilot site)
* Primary 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

Inclusion criteria for adult patients with multiple chronic conditions (MCC):

* Adult patient (age 18 or older) with MCC
* Established care for the patient at Duke Geriatrics clinic or Duke Pulmonary Transplant clinic (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 provider enrolled in the study as a provider participant/clinical provider site champion
* Active Duke MyChart (online EHR patient portal) account
* Apple iOS device compatible with Caremap app requirements at time of consent

Inclusion criteria for clinical provider site champions (to participate in interviews and quantitative provider-reported surveys):

* Currently practicing at Duke Health
* Primary site of work is participating clinic site

Exclusion criteria:

* Non-English speaking
* Living in long-term, congregate settings - e.g., living in institutionalized settings such as long-term care facility, nursing/long-term rehab facilities
* 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 (clinician-determined; e.g., patients with advanced dementia)

Primary outcomes:
measure: Implementation feasibility as measured by feasibility intervention measure (FIM)
timeFrame: 6 months
measure: Technical feasibility as measured by proportion of Fast Healthcare Interoperability Resources (FHIR)-enabled data transfer request that were successfully executed
timeFrame: Weekly, up to 6 months
measure: Changes in perceptions of care integration as measured by Pediatric Integrated care survey (PICS)
timeFrame: Baseline, 6 months
measure: Change in parent report of their child's health-related quality of life (HR-QOL), as measured by the PROMIS (7+2) Parent Proxy Global Health Survey
timeFrame: Baseline, 3 months, 6 months
measure: Change in patient-reported health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Changes in adoption as measured by quantitative measurement of app engagement by patient or parent/caregiver
timeFrame: Weekly, up to 6 months
measure: Changes in adoption as measured by quantitative measurement of app engagement by provider
timeFrame: Monthly, up to 6 months
measure: Changes in adoption as measured by quantitative measurement of app prescription by provider
timeFrame: Monthly, up to 6 months
measure: Adaptations made by families and providers during real-world use as measured by survey
timeFrame: Monthly, up to 6 months
measure: Mobile app usability as measured by the System Usability Scale (SUS)
timeFrame: 6 months
measure: Change in parent/caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)
timeFrame: Baseline, 6 months
measure: Change in patient activation and ability to self manage chronic conditions, as measured by the Patient Activation Measure (PAM)
timeFrame: Baseline, 6 months
measure: Changes in caregiver or patient report of global health status as measured by a numeric rating scale of 1 (poor) to 10 (excellent)
timeFrame: Weekly for 6 months
measure: Changes in acute and outpatient healthcare utilization, as measured by summary of clinical encounters
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke Health
name: David Y Ming, MD
role: PRINCIPAL_INVESTIGATOR
References: