N/A
N=1,229
Optimizing Behavioral Health Homes for Adults With Serious Mental Illness
Chronic Disease · Mental Health · Behavioral Health · Cardiovascular Disease · Diabetes Mellitus Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02318797 ↗Enrolled (actual)
1,229
Serious AEs
0.7%
Results posted
Feb 2018
Primary outcome: Primary: Change in Patient Activation in Care (PAM, a 13-item Scale) — 56.99; 56.77; 56.84; 58.74 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Patient Self-Directed Care (Behavioral); Provider-Supported Integrated Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient Activation in Care (PAM, a 13-item Scale) |
56.99; 56.77; 56.84; 58.74; 58.36; 57.46 | <0.0001 sig |
| PRIMARY Change in Health Status ( SF-12v2™): Physical Health Sub-scale |
42.12; 42.47; 41.19; 42.26; 41.33; 41.19 | 0.4103 |
| PRIMARY Change in Engagement in Primary/Specialty Care |
9.87; 8.72; 11.33; 11.77; 11.05; 10.88 | 0.4582 |
| PRIMARY Change in Health Status ( SF-12v2™): Mental Health Sub-scale |
36.59; 39.57; 37.79; 40.78; 39.42; 39.80 | 0.2179 |
| SECONDARY Change in Hope (Hope Scale) |
6.24; 6.46; 6.24; 6.57; 6.47; 6.56 | 0.0058 sig |
| SECONDARY Change in Quality of Life (QLESQ) |
42.00; 44.38; 42.29; 45.76; 44.52; 44.35 | 0.0014 sig |
| SECONDARY Change in Medication Adherence - Diabetes |
0.78; 0.89; 0.86; 0.91; 0.83; 0.91 | 0.0001 sig |
| SECONDARY Change in Functional Status (Sheehan Disability Scale) |
13.82; 12.71; 12.97; 11.33; 12.71; 12.29 | 0.5566 |
| SECONDARY Change in Emergent Care Use (Claims Data) |
3.83; 2.36; 3.21; 2.37; 2.68; 2.19 | 0.002 sig |
| SECONDARY Change in Lab Monitoring - Overall |
1.67; 1.37; 1.60; 1.49; 1.52; 1.30 | 0.0029 sig |
| SECONDARY Change in Patient Satisfaction With Care |
2.99; 3.17; 3.17; 3.23; 3.25; 3.31 | 0.0021 sig |
| SECONDARY Change in Medication Adherence - Antipsychotics |
0.73; 0.81; 0.70; 0.80; 0.74; 0.82 | 0.1183 |
| SECONDARY Change in Medication Adherence - Hypertension |
0.75; 0.76; 0.73; 0.79; 0.76; 0.82 | 0.0745 |
| SECONDARY Change in Medication Adherence - Antidepressants |
0.79; 0.84; 0.79; 0.86; 0.81; 0.84 | 0.1653 |
| SECONDARY Change in Lab Monitoring - Glucose |
1.55; 1.21; 1.46; 1.33; 1.41; 1.16 | <0.0001 sig |
| SECONDARY Change in Lab Monitoring - Lipids |
0.37; 0.41; 0.35; 0.46; 0.40; 0.46 | 0.0202 sig |
| SECONDARY Change in Lab Monitoring - EKG |
0.12; 0.15; 0.13; 0.16; 0.10; 0.12 | 0.4715 |
Summary
Adults with serious mental illness (SMI) frequently have unmet medical needs which place them at risk for adverse health outcomes. While there are proven ways to manage and/or prevent serious medical conditions common among this population, information is needed to understand their impact on outcomes that matter most for patients, particularly in community mental health centers (CMHCs) where most adults with SMI receive their care and rural areas where locating and receiving health care services can be challenging.
The investigators will test two promising ways for promoting the health, wellness, and recovery of adults with SMI. One way will help patients manage their health and health care through self-management strategies, including the use of a web portal, and peer support (patient self-directed care) and the other through interactions with nurses during clinic visits (provider-supported integrated care).
The investigators will compare the two interventions on three primary patient-centered outcomes (i.e. patient activation in care, health status, engagement in primary/specialty care). The investigators hypothesize that:
1. Patient self-directed care will result in improvement in patient activation.
2. Provider-supported integrated care will result in greater improvement in frequency in primary/specialty care visits.
3. Both interventions will result in significant improvements in the three primary outcomes.
The investigators will collect information from patients, caregivers, and clinic staff at different points in time during the study. Patients will be asked to complete questionnaires and additional data on their service use will be gathered. Some patients and providers will also be interviewed about their experiences with care. The investigators will examine these data to learn if, how, and why the new services improve outcomes over time. This information will help us understand patient and other stakeholder views about the services and, if appropriate, ensure their continued and/or expanded availability.
Eligibility Criteria
Inclusion Criteria
- Adults age 18 and older
- Serious mental illness (schizophrenia, bipolar disorder, major depression)
- Receive services at one of the 11 participating community mental health centers
- At least one claim for outpatient case management or peer specialist services
Exclusion criteria
- Not willing to provide informed consent
- Assessed by clinicians as being too ill to be treated on an outpatient basis
- Unable to speak, read, or understand English at the minimum required level
Data sourced from ClinicalTrials.gov (NCT02318797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.