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Caremap: A Digital Personal Health Record for Complex Care Coordination

Primary Purpose

Children/Youth With Special Healthcare Needs, Adults With Multiple Chronic Conditions

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caremap app
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Children/Youth With Special Healthcare Needs focused on measuring complex care, mobile health, care coordination

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Clinical Providers

Parent/Caregivers

Arm Description

Clinical provider site champions will be invited to participate in web-based quantitative surveys and a semi-structured interview

Patient and parent/caregiver subjects from the participating clinic sites will be enrolled. These participants are all adults - parents or caregivers of children and youth with special health care needs (CYSHCN) and adult patients with multiple chronic conditions (MCC) who are already receiving care at Duke Health.

Outcomes

Primary Outcome Measures

Implementation feasibility as measured by feasibility intervention measure (FIM)
The feasibility intervention measure is a 4 item survey using a 5-level Likert scale (1=completely disagree; 5=completely agree).
Technical feasibility as measured by proportion of Fast Healthcare Interoperability Resources (FHIR)-enabled data transfer request that were successfully executed
Technical feasibility will be defined as proportion of requests for transfer of patient-level data between the electronic health record (EHR) and the app that were successfully completed.
Changes in perceptions of care integration as measured by Pediatric Integrated care survey (PICS)
The PICS is a 20-item survey that gathers parents perspectives on the degree of care integration received by their child using a 6-level Likert scale (1=never; 6=always).
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
For participants who are parents of children with complex health needs, the PROMIS (7+2) Pediatric Global Health Survey is a 9-item parent-reported survey that gathers parent perspectives on their child's overall HR-QOL. Four of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; three of the 9 survey items use a 5-level Likert scale with 1=never and 5=always; and three of the 9 survey items use a 5-level Likert scale with 1=never and 5=almost always.
Change in patient-reported health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey
For participants who are adult patients with complex health needs, the PROMIS Global Health Survey is a 10-item patient-reported survey that gathers patient perspectives on their own overall HR-QOL. Six of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; one of the 9 survey items uses a 5-level Likert scale with 1=not at all and 5=completely; one of the 9 survey items uses a 5-level Likert scale with 1=never and 5=always; one of the 9 survey items uses a 5-level Likert scale with 1=none and 5=very severe; and one of the 9 survey items uses a 0-10 scale (0=no pain; 10=worst pain imaginable).

Secondary Outcome Measures

Changes in adoption as measured by quantitative measurement of app engagement by patient or parent/caregiver
App engagement will be defined by number of app log-ins by the parent/patient
Changes in adoption as measured by quantitative measurement of app engagement by provider
App engagement will be defined by number of views of the clinician dashboard by the provider
Changes in adoption as measured by quantitative measurement of app prescription by provider
App prescription is the process by which a clinical providers recommends the app to their patient(s) by sending the link for downloading the app, app user overview materials, and study-related materials (including e-informed consent) to the patient directly through the EHR online patient portal. This process is called a "digital prescription" of the app and will be tracked as a marker of app adoption by providers.
Adaptations made by families and providers during real-world use as measured by survey
Adaptation survey is a 5-item item survey based on the published Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) and is designed to gather patient/parent and providers perspectives on how they have adapted the use and implementation of Caremap in real-world settings.
Mobile app usability as measured by the System Usability Scale (SUS)
The System Usability Scale is a 10 item survey that gathers user-reported ratings (from parents/patients and providers) of the usability of the Caremap app
Change in parent/caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)
The Parent-Patient Activation Measure (P-PAM) is a 13-item parent-reported survey that uses a 4-level Likert scale (1=disagree strongly; 4=agree strongly).
Change in patient activation and ability to self manage chronic conditions, as measured by the Patient Activation Measure (PAM)
The PAM is a 13-item survey that uses a 4-level Likert scale (1=disagree strongly; 4=agree strongly).
Changes in caregiver or patient report of global health status as measured by a numeric rating scale of 1 (poor) to 10 (excellent)
The numeric rating scale is 1 question
Changes in acute and outpatient healthcare utilization, as measured by summary of clinical encounters
Acute encounters include hospital admissions and emergency department visits; and outpatient encounters include primary and specialty clinic visits

Full Information

First Posted
September 20, 2021
Last Updated
June 26, 2023
Sponsor
Duke University
Collaborators
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05056493
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children/Youth With Special Healthcare Needs, Adults With Multiple Chronic Conditions
Keywords
complex care, mobile health, care coordination

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical Providers
Arm Type
Experimental
Arm Description
Clinical provider site champions will be invited to participate in web-based quantitative surveys and a semi-structured interview
Arm Title
Parent/Caregivers
Arm Type
Experimental
Arm Description
Patient and parent/caregiver subjects from the participating clinic sites will be enrolled. These participants are all adults - parents or caregivers of children and youth with special health care needs (CYSHCN) and adult patients with multiple chronic conditions (MCC) who are already receiving care at Duke Health.
Intervention Type
Other
Intervention Name(s)
Caremap app
Intervention Description
The Caremap app is intended for organizing and tracking patient-reported health insights over time and sharing those trends and patient-centered goals with their providers, not for urgent/emergent clinical communication. Information shared with providers through the app will be used for clinical care at the discretion of their provider. Use of the app to share information and health insights will not replace usual, existing channels for patient-provider communication (e.g., MyChart, phone calls, email, pager, etc.).
Primary Outcome Measure Information:
Title
Implementation feasibility as measured by feasibility intervention measure (FIM)
Description
The feasibility intervention measure is a 4 item survey using a 5-level Likert scale (1=completely disagree; 5=completely agree).
Time Frame
6 months
Title
Technical feasibility as measured by proportion of Fast Healthcare Interoperability Resources (FHIR)-enabled data transfer request that were successfully executed
Description
Technical feasibility will be defined as proportion of requests for transfer of patient-level data between the electronic health record (EHR) and the app that were successfully completed.
Time Frame
Weekly, up to 6 months
Title
Changes in perceptions of care integration as measured by Pediatric Integrated care survey (PICS)
Description
The PICS is a 20-item survey that gathers parents perspectives on the degree of care integration received by their child using a 6-level Likert scale (1=never; 6=always).
Time Frame
Baseline, 6 months
Title
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
Description
For participants who are parents of children with complex health needs, the PROMIS (7+2) Pediatric Global Health Survey is a 9-item parent-reported survey that gathers parent perspectives on their child's overall HR-QOL. Four of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; three of the 9 survey items use a 5-level Likert scale with 1=never and 5=always; and three of the 9 survey items use a 5-level Likert scale with 1=never and 5=almost always.
Time Frame
Baseline, 3 months, 6 months
Title
Change in patient-reported health-related quality of life (HR-QOL), as measured by the PROMIS Global Health Survey
Description
For participants who are adult patients with complex health needs, the PROMIS Global Health Survey is a 10-item patient-reported survey that gathers patient perspectives on their own overall HR-QOL. Six of the 9 survey items use a 5-level Likert scale with 1=poor and 5=excellent; one of the 9 survey items uses a 5-level Likert scale with 1=not at all and 5=completely; one of the 9 survey items uses a 5-level Likert scale with 1=never and 5=always; one of the 9 survey items uses a 5-level Likert scale with 1=none and 5=very severe; and one of the 9 survey items uses a 0-10 scale (0=no pain; 10=worst pain imaginable).
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Changes in adoption as measured by quantitative measurement of app engagement by patient or parent/caregiver
Description
App engagement will be defined by number of app log-ins by the parent/patient
Time Frame
Weekly, up to 6 months
Title
Changes in adoption as measured by quantitative measurement of app engagement by provider
Description
App engagement will be defined by number of views of the clinician dashboard by the provider
Time Frame
Monthly, up to 6 months
Title
Changes in adoption as measured by quantitative measurement of app prescription by provider
Description
App prescription is the process by which a clinical providers recommends the app to their patient(s) by sending the link for downloading the app, app user overview materials, and study-related materials (including e-informed consent) to the patient directly through the EHR online patient portal. This process is called a "digital prescription" of the app and will be tracked as a marker of app adoption by providers.
Time Frame
Monthly, up to 6 months
Title
Adaptations made by families and providers during real-world use as measured by survey
Description
Adaptation survey is a 5-item item survey based on the published Framework for Reporting Adaptations and Modifications to Evidence-Based Interventions (FRAME) and is designed to gather patient/parent and providers perspectives on how they have adapted the use and implementation of Caremap in real-world settings.
Time Frame
Monthly, up to 6 months
Title
Mobile app usability as measured by the System Usability Scale (SUS)
Description
The System Usability Scale is a 10 item survey that gathers user-reported ratings (from parents/patients and providers) of the usability of the Caremap app
Time Frame
6 months
Title
Change in parent/caregiver self-management, as measured by the Parent-Patient Activation Measure (P-PAM)
Description
The Parent-Patient Activation Measure (P-PAM) is a 13-item parent-reported survey that uses a 4-level Likert scale (1=disagree strongly; 4=agree strongly).
Time Frame
Baseline, 6 months
Title
Change in patient activation and ability to self manage chronic conditions, as measured by the Patient Activation Measure (PAM)
Description
The PAM is a 13-item survey that uses a 4-level Likert scale (1=disagree strongly; 4=agree strongly).
Time Frame
Baseline, 6 months
Title
Changes in caregiver or patient report of global health status as measured by a numeric rating scale of 1 (poor) to 10 (excellent)
Description
The numeric rating scale is 1 question
Time Frame
Weekly for 6 months
Title
Changes in acute and outpatient healthcare utilization, as measured by summary of clinical encounters
Description
Acute encounters include hospital admissions and emergency department visits; and outpatient encounters include primary and specialty clinic visits
Time Frame
Baseline, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Y Ming, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Caremap: A Digital Personal Health Record for Complex Care Coordination

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