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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00781079
Other study ID # IIR 06-227
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2008
Est. completion date January 2012

Study information

Verified date September 2018
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 285
Est. completion date January 2012
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patient must have a Serious Mental Illness;

- Patient must be working with a VA Intensive Case Management team

Exclusion Criteria:

- Prior exposure to intervention; Reduced capacity;

- Patient is no longer working with a VA Intensive Case Management

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Consumer Provider
Adding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)

Locations

Country Name City State
United States Richard L. Roudebush VA Medical Center, Indianapolis, IN Indianapolis Indiana
United States VA Southern Nevada Healthcare System, North Las Vegas, NV Las Vegas Nevada
United States VA Loma Linda Healthcare System, Loma Linda, CA Loma Linda California
United States VA Long Beach Healthcare System, Long Beach, CA Long Beach California
United States VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Pittsburgh Pennsylvania
United States VA San Diego Healthcare System, San Diego, CA San Diego California
United States VA Greater Los Angeles Healthcare System, West Los Angeles, CA West Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (6)

Chinman M, George P, Dougherty RH, Daniels AS, Ghose SS, Swift A, Delphin-Rittmon ME. Peer support services for individuals with serious mental illnesses: assessing the evidence. Psychiatr Serv. 2014 Apr 1;65(4):429-41. doi: 10.1176/appi.ps.201300244. Rev — View Citation

Chinman M, Oberman RS, Hanusa BH, Cohen AN, Salyers MP, Twamley EW, Young AS. A cluster randomized trial of adding peer specialists to intensive case management teams in the Veterans Health Administration. J Behav Health Serv Res. 2015 Jan;42(1):109-21. d — View Citation

Chinman M, Oberman RS, Hanusa BH, Cohen AN, Salyers MP, Twamley EW, Young AS. Erratum to: A Cluster Randomized Trial of Adding Peer Specialists to Intensive Case Management Teams in the Veterans Health Administration. J Behav Health Serv Res. 2015 Jan;42( — View Citation

Chinman M, Salzer M, O'Brien-Mazza D. National survey on implementation of peer specialists in the VA: implications for training and facilitation. Psychiatr Rehabil J. 2012 Dec;35(6):470-3. doi: 10.1037/h0094582. — View Citation

Chinman M, Shoai R, Cohen A. Using organizational change strategies to guide peer support technician implementation in the Veterans Administration. Psychiatr Rehabil J. 2010 Spring;33(4):269-77. doi: 10.2975/33.4.2010.269.277. — View Citation

Hamilton AB, Chinman M, Cohen AN, Oberman RS, Young AS. Implementation of consumer providers into mental health intensive case management teams. J Behav Health Serv Res. 2015 Jan;42(1):100-8. doi: 10.1007/s11414-013-9365-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary BASIS-R The BASIS-R is a 24 item, comprehensive instrument assessing a range of psychiatric symptoms and problems. It is valid and reliable in both inpatient and outpatient settings in populations with SMI. All items have five response options ranging from 0 to 4, with higher scores indicating more problems (range in possible scores is 0 to 96). immediately before the intervention (BL), and 12 months post intervention (Post).
Secondary Mental Health Recovery Measure (MHRM) The Mental Health Recovery Measure (MHRM) is a 30-item, 5-point behaviorally-anchored self-report measure based upon recovery experiences of persons with psychiatric disabilities. The MHRM total score has good validity, correlating strongly with the Empowerment Scale and Community Living Skills Scales, yet assessing unique aspects of recovery. Range of total score is 0 to 144, with higher scores meaning better recovery. immediately before the intervention (BL), and 12 months post intervention (Post).
Secondary Patient Activation Measure The mental health version of the Patient Activation Measure (PAM) is a single 13-item scale designed to assess patient's knowledge, skill, and confidence in health self-management. Respondents endorse items (e.g., "I know what each of my prescribed medications do") on a scale from 1 ("disagree strongly") to 4 ("agree strongly"). Raw scores are converted using the established methodology for the PAM to an activation score from 0 (lowest)-100 (highest). Identifying levels of activation is based on whether an activation score falls within a previously determined range of scores. Level 1, the lowest level of activation, includes activation scores of 47 or lower; Level 2 includes scores of 47.1 to 55.1; Level 3 includes scores of 55.2 to 67.0; and Level 4 (the highest activation level) includes scores of 67.1 or above. This version has similar psychometric properties as the original 13-item PAM and correlates with related constructs in other samples of people with SMI. immediately before the intervention (BL), and 12 months post intervention (Post).
Secondary Recovery Self-Assessment: Person in Recovery Version Perceptions of the recovery orientation of the program were assessed with the Recovery Self-Assessment (RSA), a 36 item survey that assesses domains of recovery-orientated practice (e.g., focus on life goals, involvement of patients in their own care). The RSA has high internal consistency and is thought to represent a more recovery-oriented or recovery-supportive environment. Each item ranges from 1 to 5. The total score (all 36 items averaged together) also is reported on that scale, with higher meaning more recovery. immediately before the intervention (BL), and 12 months post intervention (Post)
Secondary Illness Management and Recovery Scale: Client Self-Rating The Illness Management and Recovery Scale (IMR) has 15 items (rated on 5-point behaviorally anchored scales) that assess progress toward goals, knowledge about mental illness, involvement with significant others and self-help, time in structured roles, impairment in functioning, symptom distress and coping, relapse prevention and hospitalizations, use of medications, and alcohol and drug use. A total IMR score is made of the mean of the items and has demonstrated good internal consistency, stability (test-retest after two weeks), and convergent validity, correlating with the Recovery Assessment Scale and the Colorado Symptom Index. The total score is reported on the scale of 1 to 5 with higher scores mean better recovery. 12 months prior to the intervention (BL1), immediately before the intervention (BL2), and 12 months post intervention (Post).
Secondary Quality of Life Interview, Brief Version Subjective ratings of overall quality of life and the quality of social relationships, daily life, and family interactions was assessed using a combination of selected scales from the Quality of Life Instrument-Brief Version (QOLI), which been used extensively with a wide range of populations including those who are homeless, have a dual diagnosis, and are ethnic minorities. Because of low internal consistencies of subscales in our sample, a factor analysis was conducted which indicated that a larger scale that included the items from the overall quality of life, social relationships, daily life, and family interactions scales would be more reliable (all items averaged together). The score ranges from 1 to 5, with 1 meaning more quality of life. immediately before the intervention (BL), and 12 months post intervention (Post).
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