Back to resultsA Mobile Personal Health Record for Behavioral Health Homes (mPHR)
Primary Purpose
Hypertension, Hyperlipidemia, Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Personal Health Record App.
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- one or more of the following conditions: hyperlipidemia, hypertension, diabetes
- able to give consent
- patient in the behavioral health home
Exclusion Criteria:
- Unable to give consent
Sites / Locations
- Viewpoint Health & Oakhurst Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Experimental: Intervention
Arm Description
Participants randomized to the intervention arm will receive the mobile personal health record.
Outcomes
Primary Outcome Measures
Change in Composite Quality Score
It is a measure of quality of care. The aggregate score represents the total number of eligible services received for an individual generated by dividing all instances in which recommended care was delivered by the number of times a participant was eligible for the indicator. The score ranges from 0 to 1 with higher scores indicating receipt of recommended care/services.
Secondary Outcome Measures
Change in Patient Assessment of Chronic Illness Care
20-item patient self-report instrument that assesses the extent to which patients with chronic illness report receiving care that aligns with the Chronic Care Model. The summary score ranges from 1 to 5 with a higher score indicating patient's perception of greater involvement in self-management and receipt of chronic care counseling.
Change in Patient Activation Measure
Assesses a patients' perceived ability to manage their illnesses and their healthcare visits. Patient Activation Measure Scores were summed to calculate the overall raw score then transformed to an activation scale ranging from 0 to 100. Higher scores indicate greater patient activation.
Change in Health-related Quality of Life
Measured using the Physical and Mental Component Summary scales of the SF-12. Assesses a patients' perceived health related quality of life.
The composite physical (PCS) and mental component (MCS) summary scores for the SF-12 are each scored on a 0-100 scale. Higher scores indicate better functioning.
Full Information
NCT ID
NCT01890226
First Posted
June 25, 2013
Last Updated
February 4, 2020
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01890226
Brief Title
A Mobile Personal Health Record for Behavioral Health Homes
Acronym
mPHR
Official Title
A Mobile Personal Health Record for Behavioral Health Homes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
January 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Poor quality of medical care is a major contributor to excess medical morbidity and premature mortality in persons with serious mental illnesses (SMI). To address this problem, community mental health providers are increasingly partnering with safety net medical providers to develop behavioral health homes, integrated clinics in which persons with SMI receive coordinated medical and mental health care. However, behavioral health homes have faced logistical and privacy challenges in integrating electronic medical records across organizations.
This application proposes to develop and test a mobile Personal Health Record (mPHR) to overcome this problem while more fully engaging patients in their health care. The study will develop, test, and disseminate the mPHR. The investigators will develop the app building on experience and preliminary data from a PC-based PHR project, and link it to the medical and mental health EHR in a behavioral health home. Next, the investigators will conduct a randomized trial of the mPHR in 300 subjects randomized to the mPHR or usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hyperlipidemia, Diabetes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
311 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Experimental: Intervention
Arm Type
Experimental
Arm Description
Participants randomized to the intervention arm will receive the mobile personal health record.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Personal Health Record App.
Primary Outcome Measure Information:
Title
Change in Composite Quality Score
Description
It is a measure of quality of care. The aggregate score represents the total number of eligible services received for an individual generated by dividing all instances in which recommended care was delivered by the number of times a participant was eligible for the indicator. The score ranges from 0 to 1 with higher scores indicating receipt of recommended care/services.
Time Frame
Baseline, 12 month post intervention
Secondary Outcome Measure Information:
Title
Change in Patient Assessment of Chronic Illness Care
Description
20-item patient self-report instrument that assesses the extent to which patients with chronic illness report receiving care that aligns with the Chronic Care Model. The summary score ranges from 1 to 5 with a higher score indicating patient's perception of greater involvement in self-management and receipt of chronic care counseling.
Time Frame
Baseline, 6 month post intervention, 12 month post intervention
Title
Change in Patient Activation Measure
Description
Assesses a patients' perceived ability to manage their illnesses and their healthcare visits. Patient Activation Measure Scores were summed to calculate the overall raw score then transformed to an activation scale ranging from 0 to 100. Higher scores indicate greater patient activation.
Time Frame
Baseline, 6 month post intervention, 12 month post intervention
Title
Change in Health-related Quality of Life
Description
Measured using the Physical and Mental Component Summary scales of the SF-12. Assesses a patients' perceived health related quality of life.
The composite physical (PCS) and mental component (MCS) summary scores for the SF-12 are each scored on a 0-100 scale. Higher scores indicate better functioning.
Time Frame
Baseline, 6 month post intervention, 12 month post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
one or more of the following conditions: hyperlipidemia, hypertension, diabetes
able to give consent
patient in the behavioral health home
Exclusion Criteria:
Unable to give consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Druss, MD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Viewpoint Health & Oakhurst Medical Center
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30012
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32362226
Citation
Druss BG, Li J, Tapscott S, Lally CA. Randomized Trial of a Mobile Personal Health Record for Behavioral Health Homes. Psychiatr Serv. 2020 Aug 1;71(8):803-809. doi: 10.1176/appi.ps.201900381. Epub 2020 May 4.
Results Reference
derived
Learn more about this trial
A Mobile Personal Health Record for Behavioral Health Homes
We'll reach out to this number within 24 hrs