Diabetes, Hyperlipidemia, Hypertension
Conditions
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.
Interventions
BEHAVIORALMobile Personal Health Record App.
Sponsors
National Institute of Mental Health (NIMH)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Composite Quality Score | Baseline, 12 month post intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Assessment of Chronic Illness Care | Baseline, 6 month post intervention, 12 month post intervention | 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 | Baseline, 6 month post intervention, 12 month post intervention | 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 | Baseline, 6 month post intervention, 12 month post intervention | 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. |
Countries
United States
Participant flow
Recruitment details
311 participants were eligible and consented to participate.
Participants by arm
| Arm | Count |
|---|---|
| Control Control or usual care group: had access to the full array of services offered through the behavioral health homes. | 155 |
| Experimental: Intervention Participants randomized to the intervention arm will receive the mobile personal health record.
Mobile Personal Health Record App. | 156 |
| Total | 311 |
Baseline characteristics
| Characteristic | Experimental: Intervention | Control | Total |
|---|---|---|---|
| Age, Continuous | 50.78 years STANDARD_DEVIATION 8.45 | 50.54 years STANDARD_DEVIATION 9.08 | 50.66 years STANDARD_DEVIATION 8.76 |
| Medical Diagnosis Diabetes | 68 Participants | 68 Participants | 136 Participants |
| Medical Diagnosis Heart Disease/CAD/CHD | 13 Participants | 13 Participants | 26 Participants |
| Medical Diagnosis Hyperlipidemia | 72 Participants | 70 Participants | 142 Participants |
| Medical Diagnosis Hypertension | 134 Participants | 123 Participants | 257 Participants |
| Mental Diagnosis Bipolar Disorder | 43 Participants | 41 Participants | 84 Participants |
| Mental Diagnosis Depression | 116 Participants | 122 Participants | 238 Participants |
| Mental Diagnosis Obsessive Compulsive Disorder | 4 Participants | 6 Participants | 10 Participants |
| Mental Diagnosis Post-Traumatic stress Disorder | 35 Participants | 26 Participants | 61 Participants |
| Mental Diagnosis Schizophrenia | 34 Participants | 33 Participants | 67 Participants |
| Race/Ethnicity, Customized Black | 118 Participants | 123 Participants | 241 Participants |
| Race/Ethnicity, Customized Other Race | 9 Participants | 3 Participants | 12 Participants |
| Race/Ethnicity, Customized White | 29 Participants | 29 Participants | 58 Participants |
| Region of Enrollment United States | 156 participants | 155 participants | 311 participants |
| Sex: Female, Male Female | 95 Participants | 92 Participants | 187 Participants |
| Sex: Female, Male Male | 61 Participants | 63 Participants | 124 Participants |
| total annual income $0-$5,000 | 86 Participants | 83 Participants | 169 Participants |
| total annual income $10,000-$15,000 | 18 Participants | 17 Participants | 35 Participants |
| total annual income $5,000-$10,000 | 42 Participants | 43 Participants | 85 Participants |
| total annual income Did not answer | 2 Participants | 4 Participants | 6 Participants |
| total annual income More than $15,000 | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 155 | 3 / 156 |
| other Total, other adverse events | 0 / 155 | 0 / 156 |
| serious Total, serious adverse events | 0 / 155 | 0 / 156 |
Outcome results
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.
Time frame: Baseline, 12 month post intervention
Population: Chart review data, which were used to assess overall quality of care, were available for all participants at baseline and 12-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Composite Quality Score | Baseline | 0.71 score on a scale | Standard Deviation 0.12 |
| Control | Change in Composite Quality Score | 12-month post-baseline | 0.67 score on a scale | Standard Deviation 0.16 |
| Experimental: Intervention | Change in Composite Quality Score | Baseline | 0.70 score on a scale | Standard Deviation 0.11 |
| Experimental: Intervention | Change in Composite Quality Score | 12-month post-baseline | 0.70 score on a scale | Standard Deviation 0.15 |
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.
Time frame: Baseline, 6 month post intervention, 12 month post intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Health-related Quality of Life | SF-12 MCS Baseline | 36.55 score on a scale | Standard Deviation 13.25 |
| Control | Change in Health-related Quality of Life | SF-12 PCS Baseline | 35.70 score on a scale | Standard Deviation 11.62 |
| Control | Change in Health-related Quality of Life | SF-12 MCS 6-month | 38.70 score on a scale | Standard Deviation 13.18 |
| Control | Change in Health-related Quality of Life | SF-12 PCS 12-month | 36.09 score on a scale | Standard Deviation 11.75 |
| Control | Change in Health-related Quality of Life | SF-12 MCS 12-month | 41.16 score on a scale | Standard Deviation 11.61 |
| Control | Change in Health-related Quality of Life | SF-12 PCS 6-month | 36.32 score on a scale | Standard Deviation 11.52 |
| Experimental: Intervention | Change in Health-related Quality of Life | SF-12 MCS 12-month | 41.68 score on a scale | Standard Deviation 14.04 |
| Experimental: Intervention | Change in Health-related Quality of Life | SF-12 PCS 6-month | 37.20 score on a scale | Standard Deviation 11.94 |
| Experimental: Intervention | Change in Health-related Quality of Life | SF-12 PCS 12-month | 37.03 score on a scale | Standard Deviation 12.15 |
| Experimental: Intervention | Change in Health-related Quality of Life | SF-12 MCS Baseline | 35.50 score on a scale | Standard Deviation 12.54 |
| Experimental: Intervention | Change in Health-related Quality of Life | SF-12 MCS 6-month | 39.16 score on a scale | Standard Deviation 13.48 |
| Experimental: Intervention | Change in Health-related Quality of Life | SF-12 PCS Baseline | 35.74 score on a scale | Standard Deviation 11.83 |
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.
Time frame: Baseline, 6 month post intervention, 12 month post intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Patient Activation Measure | Baseline | 57.83 score on a scale | Standard Deviation 13.65 |
| Control | Change in Patient Activation Measure | 6-month post-baseline | 60.88 score on a scale | Standard Deviation 15.18 |
| Control | Change in Patient Activation Measure | 12-month post-baseline | 32.08 score on a scale | Standard Deviation 14.77 |
| Experimental: Intervention | Change in Patient Activation Measure | Baseline | 58.78 score on a scale | Standard Deviation 14.65 |
| Experimental: Intervention | Change in Patient Activation Measure | 6-month post-baseline | 59.82 score on a scale | Standard Deviation 15.89 |
| Experimental: Intervention | Change in Patient Activation Measure | 12-month post-baseline | 61.61 score on a scale | Standard Deviation 16.19 |
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.
Time frame: Baseline, 6 month post intervention, 12 month post intervention
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Change in Patient Assessment of Chronic Illness Care | Baseline | 3.23 score on a scale | Standard Deviation 1 |
| Control | Change in Patient Assessment of Chronic Illness Care | 6-month post-baseline | 3.32 score on a scale | Standard Deviation 1.01 |
| Control | Change in Patient Assessment of Chronic Illness Care | 12-month post-baseline | 3.18 score on a scale | Standard Deviation 0.95 |
| Experimental: Intervention | Change in Patient Assessment of Chronic Illness Care | Baseline | 3.20 score on a scale | Standard Deviation 0.95 |
| Experimental: Intervention | Change in Patient Assessment of Chronic Illness Care | 6-month post-baseline | 3.32 score on a scale | Standard Deviation 0.93 |
| Experimental: Intervention | Change in Patient Assessment of Chronic Illness Care | 12-month post-baseline | 3.25 score on a scale | Standard Deviation 0.94 |