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Clinical Trial Summary

Serious mental illness (SMI) is the second most costly disorder treated in the VHA, yet clinical outcomes for these patients in public sector settings are often poor due to a combination of low quality care and severe cognitive and functional impairments evidenced by this group. While these problems are multifaceted, studies outside the VHA have shown that using "consumer providers" (CPs) can improve and augment public care. Similar to recovering addiction counselors, CPs are individuals with SMI who use their lived experiences to provide services to others with SMI. CPs can reach out to patients that are difficult to engage, assist patients with tasks of daily living, offer a variety of rehabilitation (vocational, social, residential) services, be role models and offer hope for recovery, and facilitate support groups. Randomized controlled and quasi-experimental trials, all done outside the VHA, have shown that CPs can provide services that yield at least equivalent patient outcomes with particular benefits noted on intensive case management teams. Based on these successes both the President's New Freedom Commission and the Veteran Administration's Mental Health Strategic Plan call for broader dissemination of CPs as way to make mental health services more recovery-oriented, a recent national priority. Because of these recent calls, employing mentally ill veterans has just begun, although no effort has been made to evaluate their impact inside the VA mental health system. Yet its success outside the VHA and the recent emphasis on recovery-oriented care suggests the need to test this model in the VHA.


Clinical Trial Description

Background/Rationale Serious mental illness (SMI) is the second most costly disorder treated in the VHA, yet clinical outcomes for these patients are often poor due to a combination of low quality care and severe cognitive and functional impairments. While these problems are multifaceted, studies outside the VHA have shown that using "consumer providers" (CPs) can improve and augment care. Similar to recovering addiction counselors, CPs are individuals with SMI who use their lived experiences to provide services to others with SMI. CPs can reach out to patients that are difficult to engage, assist patients with tasks of daily living, offer a variety of rehabilitation (vocational, social, residential) services, be role models and offer hope for recovery, and facilitate support groups. Randomized controlled and quasi-experimental trials outside the VHA have shown that CPs can provide services that yield at least equivalent patient outcomes with particular benefits noted on intensive case management teams. VHA has hired about 250 CPs to date, although their impact has not been documented. Yet its success outside the VHA and the recent emphasis on recovery-oriented care suggests the need to test this model in the VHA.

Objectives To conduct a randomized controlled trial testing the impact on patient level and team level outcomes of the implementation of CP services on six mental health intensive case management (MHICM) teams in VISN-22. The specific aims were to: 1) Evaluate the acceptability, facilitators of and barriers to the inclusion of two CPs to each intervention MHICM team. 2) Evaluate the effect of including CPs on the degree to which MHICM teams services are recovery-oriented. 3) Evaluate the effect of including CPs on veterans' clinical and recovery-focused outcomes. Our hypotheses were that CPs would be feasible and acceptable, that teams would become more recovery-oriented, and that the involvement of CPs would lead to greater gains in recovery, quality of life, empowerment with regard to illness, and to a lesser extent, symptoms compared to patients on teams without CPs.

Methods This project was a "cluster randomized controlled trial" comparing 3 CP-MHICM teams (with CPs) to 3 control teams (i.e., without a CP), at MHICM sites within VISN-22. All patients on the 6 MHICM teams' caseload during each site's recruitment period were eligible. 282 MHICM patients were enrolled, 149 at the intervention sites and 133 at the control sites. Each intervention MHICM team used a strategic planning process to tailor the CP intervention to local priorities and structures, involving multiple meetings to discuss the CP's role, hiring, and incorporation of CPs into the team. The project hired the CPs, provided training, assisted in their implementation on the teams and provided ongoing supervision. The CPs worked for about 12 months.

Using a patient survey, the study assessed impacts of CPs on patient level outcomes including recovery-orientation of their team (Recovery Self-assessment scale), individual recovery (Mental Health Recovery Measure, Illness Self-Management Scale), quality of life (Quality of Life Interview), symptoms (BASIS-24), and patient activation (Patient Activation Measure). The patient level outcome assessments were conducted pre and post intervention. Final follow-up assessment rates ranged from 71- 95% at intervention sites and 80 - 88% at control sites.

We conducted site visits with all six MHICM teams using a validated, standardized protocol, rating each team's level of recovery orientation before and after the deployment of the CPs on the Recovery-Oriented Practices Index (ROPI). We conducted 23 focus groups and interviews with patients, providers and CPs at all intervention sites (about 8 per site) at the post time point to assess barriers and facilitators to CP implementation. All focus groups and interviews were recorded, transcribed, and coded using Atlas.ti.

The analyses of the patient survey data were comparisons of changes between baseline and followup scores with regression analyses of the change scores for all the outcomes mentioned above. The first analyses was whether the intervention group was significantly related to change considering only treatment group and statistically controlling for baseline score. The second was the same as the first, adding demographics (age, gender, race, living situation and education level) and site as fixed covariates. The ROPI ratings were made on a very small number of units (6 teams), therefore the results were descriptive and involved a percent change from pre to post. The focus groups and interviews were each summarized and then summarized by site. The study team discussed the results. Using the constant comparison method, salient topics were compared within and across roles and sites.

Status Completed. Major activities and accomplishments included hiring 6 CPs who together logged over 2000 clinical encounters over the funding period of the project. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00781079
Study type Interventional
Source VA Office of Research and Development
Contact
Status Completed
Phase N/A
Start date April 2008
Completion date January 2012

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