Caremap: A Digital Personal Health Record for Complex Care Coordination

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Primary Purpose

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Caremap app

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

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

NCT ID

NCT05056493

First Posted

September 20, 2021

Last Updated

June 26, 2023

Sponsor

Duke University

Collaborators

Boston Children's Hospital

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

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

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial