N/A
N=2,432
The PACE/PACENET Behavioral Health Laboratory Project
Depression
Bottom Line
View on ClinicalTrials.gov: NCT02440594 ↗Enrolled (actual)
2,432
Serious AEs
—
Results posted
Sep 2019
Primary outcome: Primary: Medical Outcomes Survey Short Form (SF12) Mental Component Subscale (MCS) Score — 47.52; 48.94; 51.03; 51.11 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced BHL Program Services (Behavioral); Standard BHL Program Services (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Medical Outcomes Survey Short Form (SF12) Mental Component Subscale (MCS) Score |
47.52; 48.94; 51.03; 51.11; 51.92; 50.35 | — |
| PRIMARY Zarit Burden Interview (ZBI) |
6.54; 5.37; 5.57; 5.36; 5.37; 5.36 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
8.83; 8.64; 10.07; 10.33; 1.78; 1.79 | — |
| SECONDARY Generalized Anxiety Disorder - 7 (GAD-7) |
4.75; 4.48; 5.85; 6.41; 0.88; 0.79 | — |
| SECONDARY Number of Participants With Moderately Severe to Severe Depression (Per Patient Health Questionnaire-9 (PHQ-9)) |
0; 0; 62; 55; 11; 15 | — |
Summary
The purpose of the current project is to conduct a program evaluation that examines the impact of the The SUpporting Seniors Receiving Treatment And INtervention (SUSTAIN) program - a telephone-based clinical service designed to help identify and manage behavioral health issues among enrollees in the Commonwealth of Pennsylvania Department of Aging's Pharmaceutical Assistance Contract for the Elderly and the PACE Needs Enhancement Tier Program (PACE/PACENET) - on enrollee outcomes and to evaluate the feasibility and impact of an enhancement to the current clinical program.
Eligibility Criteria
Inclusion Criteria
- To be eligible for the Enhanced BHL Program, the only inclusion criterion is to have participated in an initial telephone assessment as part of the current PACE/PACENET BHL Clinical Program.
- Similarly, to be eligible for the BHL Program Evaluations (i.e., BHL Clinical Data Evaluation, 3/6 Month Outcome Evaluation), the inclusion criterion is to have participated in an initial telephone assessment as part of the current PACE/PACENET BHL Clinical Program.
- Enrollment in the current PACE/PACENET BHL Clinical Program. Though not part of the research program, the current program targets older, community-dwelling adults (i.e., 65 years and older) enrolled in the PACE/PACENET programs, who have filled at least one new prescription for an antidepressant, antipsychotic, and/or anxiolytic medication. The BHL program does require the basic ability to communicate by telephone; either the enrollee or an identified caregiver must meet this criterion for participation in the BHL Clinical Program.
Exclusion Criteria
Exclusion criteria for participation in the Enhanced BHL Program and the 3/6 Month Outcome Evaluation are:
- having severe cognitive impairment (BOMC score 14 or greater) in the absence of a caregiver, and/or
- endorsement of psychosis or mania during the initial clinical interview, and/or
- a PHQ score of 25 or greater, and/or
- positive drug abuse screen, and/or
- alcohol dependence.
Enrollees endorsing any of above mentioned exclusions will be offered assistance with referral to community specialty-care resources as part of the PACE/PACENET BHL Clinical Program.
Exclusion criteria for caregiver participation in the TEP component of Enhanced Care is lack of report of cognitive impairment when only the Caregiver interview was completed.
Data sourced from ClinicalTrials.gov (NCT02440594). 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.