Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH100467-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Experimental: Intervention | Experimental | Participants randomized to the intervention arm will receive the mobile personal health record. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Personal Health Record App. | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 12 month post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 month post intervention, 12 month post intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Benjamin Druss, MD, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Viewpoint Health & Oakhurst Medical Center | Conyers | Georgia | 30012 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32362226 | Derived | 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. |
Not provided
Not provided
Not provided
311 participants were eligible and consented to participate.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control or usual care group: had access to the full array o services offered through the behavioral health homes. |
| FG001 | Experimental: Intervention | Participants randomized to the intervention arm will receive the mobile personal health record. Mobile Personal Health Record App. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control or usual care group: had access to the full array of services offered through the behavioral health homes. |
| BG001 | Experimental: Intervention | Participants randomized to the intervention arm will receive the mobile personal health record. Mobile Personal Health Record App. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Chart review data, which were used to assess overall quality of care, were available for all participants at baseline and 12-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 month post intervention |
|
12 months
Serious and non serious adverse events that were reported during the 12 months follow up time.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Control or usual care group: had access to the full array of services offered through the behavioral health homes. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Druss | Emory University | 404-712-9602 | bdruss@emory.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2017 | Jan 14, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 13, 2016 | Feb 4, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | Baseline, 6 month post intervention, 12 month post intervention |
| 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. | Baseline, 6 month post intervention, 12 month post intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| total annual income | Count of Participants | Participants |
|
| Medical Diagnosis | Count of Participants | Participants |
|
| Mental Diagnosis | Count of Participants | Participants |
|
| Experimental: Intervention |
Participants randomized to the intervention arm will receive the mobile personal health record. Mobile Personal Health Record App. |
|
|
| Secondary | 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. | Completion rates for patient interviews were 91.9% at 6-months and 84.6% for 12 months, with similar rates of attrition in both groups. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 month post intervention, 12 month post intervention |
|
|
|
| Secondary | 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. | Completion rates for patient interviews were 91.9% at 6-months and 84.6% for 12 months, with similar rates of attrition in both groups. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 month post intervention, 12 month post intervention |
|
|
|
| Secondary | 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. | Completion rates for patient interviews were 91.9% at 6-months and 84.6% for 12 months, with similar rates of attrition in both groups. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 month post intervention, 12 month post intervention |
|
|
|
| 1 |
| 155 |
| 0 |
| 155 |
| 0 |
| 155 |
| EG001 | Experimental: Intervention | Participants randomized to the intervention arm will receive the mobile personal health record. Mobile Personal Health Record App. | 3 | 156 | 0 | 156 | 0 | 156 |
Not provided
Not provided
Not provided
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| 6-month post-baseline |
|
|
| 12-month post-baseline |
|
|
| 6-month post-baseline |
|
|
| 12-month post-baseline |
|
|
| SF-12 PCS 6-month |
|
|
| SF-12 PCS 12-month |
|
|
| SF-12 MCS Baseline |
|
|
| SF-12 MCS 6-month |
|
|
| SF-12 MCS 12-month |
|
|