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Mental DisorderPEERNCT00781079

Do Consumer Providers Enhance Recovery?

A study testing Consumer Provider in people with Mental Disorder, run by VA Office of Research and Development at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Mental Disorder
What is being tested?
Consumer Provider
Could I receive a placebo?
No, everyone receives an active treatment
How many people
285 participants
Where
7 sitesUnited States
Study dates
Apr 2008to Jan 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient must have a Serious Mental Illness;
  • Patient must be working with a VA Intensive Case Management team

Who cannot join

  • Prior exposure to intervention; Reduced capacity;
  • Patient is no longer working with a VA Intensive Case Management

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Richard L. Roudebush VA Medical Center, Indianapolis, IN

    Indianapolis, Indiana, 46202-2884

  • VA Southern Nevada Healthcare System, North Las Vegas, NV

    Las Vegas, Nevada, 89106

  • VA Loma Linda Healthcare System, Loma Linda, CA

    Loma Linda, California, 92357

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073

Other trials in United States

About this study

Official title: Promoting Recovery Using Mental Health Consumer Providers

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.

Read the detailed 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.

Conditions
Mental Disorder
Being tested
Consumer Provider
Keywords
Organization Innovation, Opinion Leaders, Schizophrenia
Medical subject headings
Mental Disorders, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Consumer ProviderBehavioural

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

Study groups in NCT00781079
Study groupRoleWhat they receive
Consumer ProviderExperimentalAdding a Consumer Provider to Intensive Case Management Teams (called MHICM in the VA)
Receives: Behavioral: Consumer Provider
Care as UsualNo interventionCare as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: immediately before the intervention (BL), and 12 months post intervention (Post).

Secondary outcomes (5)
  1. 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.

    Measured: immediately before the intervention (BL), and 12 months post intervention (Post).

  2. 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.

    Measured: immediately before the intervention (BL), and 12 months post intervention (Post).

  3. 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.

    Measured: immediately before the intervention (BL), and 12 months post intervention (Post)

  4. 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.

    Measured: 12 months prior to the intervention (BL1), immediately before the intervention (BL2), and 12 months post intervention (Post).

  5. 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.

    Measured: immediately before the intervention (BL), and 12 months post intervention (Post).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionApr 2011
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00781079
Sponsor's protocol ID
IIR 06-227
Acronym
PEER
Status last verified
Sep 2018
First submitted
27 Oct 2008
Last updated
11 Oct 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20374985
  • 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.

    PubMed 23276242
  • 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. doi: 10.1007/s11414-013-9343-1.

    PubMed 23657754
  • 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.

    PubMed 24091610
  • 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.

    PubMed 24549400
  • 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(1):122. doi: 10.1007/s11414-013-9377-4. No abstract available.

    PubMed 24217992

Questions about this trial

What is this clinical trial studying?

A study testing Consumer Provider in people with Mental Disorder, run by VA Office of Research and Development at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BASIS-R (time frame: immediately before the intervention (BL), and 12 months post intervention (Post).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00781079, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.

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