- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02732600
Evaluation of Peer Specialists on VA PACTs (Peers on PACT)
Program Evaluation of Peer Specialists on VA PACTS: A Quality Improvement Project (QUE 15-289)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Peer Specialists are individuals with mental illness currently deployed to serve Veterans in specialty mental health clinics based upon their lived experiences. Peer Specialist delivered interventions have been shown to improve patient activation in multiple studies. In August 2014, the White House issued an Executive Action mandating that 25 VA medical centers pilot the deployment of Peer Specialists in their Patient Aligned Care Teams (PACTs). This project expands upon this nationally mandated Peer Specialist pilot with the integration of a cluster randomized implementation trial. This quality improvement project will evaluate the impact of facilitated implementation vs. standard implementation to support on the deployment of Peer Specialists in PACTs.
The 25 sites will be divided into three cohorts (n=8,8,9). Each cohort will begin over three successive six-month blocks beginning in early 2016. Within each cohort, sites will be randomized to receive either facilitated or standard implementation. Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation. Standard Implementation sites will receive written guidance and limited consultation by the investigators' team. The investigators will compare the groups on 1) the percent of their target population that actually received PS services; 2) ratings on PS workload productivity including ; 3) Peer Implementation and Services scores; 4) assessment of Veteran's change over time on the outcome variables of satisfaction, activation, and functioning ; 5) qualitative analysis of how well PSs were deployed and their impact.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85723
- Southern Arizona VA Health Care System, Tucson, AZ
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California
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Palo Alto, California, United States, 94304-1290
- VA Palo Alto Health Care System, Palo Alto, CA
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San Francisco, California, United States, 94121
- San Francisco VA Medical Center, San Francisco, CA
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Connecticut
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West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
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Florida
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Gainesville, Florida, United States, 32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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West Palm Beach, Florida, United States, 33410
- West Palm Beach VA Medical Center, West Palm Beach, FL
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Georgia
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Decatur, Georgia, United States, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Illinois
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Chicago, Illinois, United States, 60612
- Jesse Brown VA Medical Center, Chicago, IL
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Hines, Illinois, United States, 60141-5000
- Edward Hines Jr. VA Hospital, Hines, IL
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Indiana
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Marion, Indiana, United States, 46953
- VA Northern Indiana Health Care System Marion Campus, Marion, IN
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Kentucky
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Lexington, Kentucky, United States, 40502
- Lexington VA Medical Center, Lexington, KY
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Maine
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Togus, Maine, United States, 04330
- Maine VA Medical Center, Augusta, ME
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Maryland
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Baltimore, Maryland, United States, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Massachusetts
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Bedford, Massachusetts, United States, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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Michigan
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Detroit, Michigan, United States, 48201
- John D. Dingell VA Medical Center, Detroit, MI
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Missouri
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Saint Louis, Missouri, United States, 63106
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO
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New York
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Syracuse, New York, United States, 13210
- Syracuse VA Medical Center, Syracuse, NY
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North Carolina
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Salisbury, North Carolina, United States, 28144
- Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
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Ohio
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Chillicothe, Ohio, United States, 45601
- Chillicothe VA Medical Center, Chillicothe, OH
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Cincinnati, Ohio, United States, 45220
- Cincinnati VA Medical Center, Cincinnati, OH
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Columbus, Ohio, United States, 43203-1278
- Chalmers P. Wylie Ambulatory Care Center, Columbus, OH
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Philadelphia VA Medical Center, Philadelphia, PA
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Pittsburgh, Pennsylvania, United States, 15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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South Carolina
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Columbia, South Carolina, United States, 29209
- Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
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Vermont
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White River Junction, Vermont, United States, 05009-0001
- White River Junction VA Medical Center, White River Junction, VT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Included sites must be VA PACT Primary Care Health teams with existing Peer Specialists who are able to include an existing Peer Specialist on their team for a minimum of 10 hours per week for one year
Exclusion Criteria:
- Non VA PACT teams, VA sites without an existing Peer Specialists, and VA PACT primary care teams that cannot commit a Peer Specialist to Primary Care for a minimum of 10 hours per week are excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Implementation
Standard Implementation sites will receive written guidance and limited consultation by the investigators' team.
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Experimental: Facilitated Implementation
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation.
|
Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Activation Measure Change
Time Frame: Baseline, 6 months, 1 year
|
The Patient Activation Measure (PAM) is a 13-item survey that measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient.
It has been shown to be reliable, valid, sensitive to change and correlates with measures of improved self-management.
Scores for this outcome range from Zero to One Hundred with higher scores indicating higher levels of patient activation (better outcome).
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Baseline, 6 months, 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Team Development Measure
Time Frame: Baseline, 6 months, 1 year
|
The Team Development Measure is a 31 item self-report survey that evaluates the degree to which a team has and uses the components needed for highly effective teamwork including cohesiveness, communication, role clarity, and goals and means clarity.
All components min scores are zero % and maximum is 100%; higher percentages mean positive responses.
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Baseline, 6 months, 1 year
|
|
Peer Fidelity Measure
Time Frame: 6 months, 1 year
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The Peer Fidelity Measure assesses: a) peer specialist services and b) peer specialist implementation.
The first part has 5 domains of peer services critical to the VA's peer support model (e.g., being a role model that recovery is possible; share personal recovery story).
The second has 7 domains of implementation factors shown to either help or hinder PS deployment (e.g., role clarity, support for PS at higher organizational levels, regular supervision).
Each domain has 1-2 questions (responses ranging from 1= not at all through 5=Very much with higher scores indicating higher fidelity.
Min Value=1 and Max value =5.
The Peer Fidelity Measure will be administered to both Peer Specialists and their supervisors.
Analyses looked at discrepancies (difference in difference) between Peer Specialists and their Supervisors at each time point.
Min discrepancy score is -4 and Max discrepancy score is 4. (calculated as Peer Specialist minus Peer Supervisor score)
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6 months, 1 year
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The Satisfaction Index-Mental Health
Time Frame: Baseline, 6 months, 1 year
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The Satisfaction Index-Mental Health is a 12-item, unidimensional measure of patient satisfaction with care.
It has been used with Veteran populations and has been shown to be valid, reliable, and sensitive to change in a sample of Veterans with mental illnesses being treated in primary care settings.
It will be administered to Veterans who receive care from the Peer Specialists involved in the project.
Minimum score is 12 and the maximum score is 72; higher scores mean more satisfaction.
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Baseline, 6 months, 1 year
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Number of Unique Veterans Seen (Adjusted for Employment Period and Hours Worked Per Week)
Time Frame: one year, across two years
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This adjusted workload variables took into consideration both the employment period (many PSs did not start immediately or may have left prior to the end of the 2 years) and weekly hours worked (varying from one hour to 40 hours per week).
Visits during each PS's employment period were divided by the total number of hours worked, then multiplied by 40 to calculate adjusted values for operationalization above.
Because this variable was significantly skewed, we used a log transformation to improve their distributional properties.
Differences between intervention conditions were then compared with a series of Analyses of Covariance models with age, gender and race as covariates.
Since these variables are measured at the PS level, the covariates were the average across the Veterans sesn by each PS (mean age, percent White and percent male).
N's are number of Veterans
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one year, across two years
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Average Number of Visits Per Veteran Per Peer Specialist-Adjusted (Across Both Years)
Time Frame: across both years
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See Variable 5 above for details about adjustment. Since this variable this is a Veteran level variable, a General Linear Mixed Model (GSLMM) was used with PS specified as a random effect and Veteran age, race and gender. N's are number of Veterans |
across both years
|
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Average Total Number of Services Provided-Adjusted (First Year Only and Across Both Years)
Time Frame: one year and across both years
|
This adjusted workload variables took into consideration both the employment period (many PSs did not start immediately or may have left prior to the end of the 2 years) and weekly hours worked (varying from one hour to 40 hours per week).
Visits during each PS's employment period were divided by the total number of hours worked, then multiplied by 40 to calculate adjusted values for operationalization above.
Because this variable was significantly skewed, we used a log transformation to improve their distributional properties.
Differences between intervention conditions were then compared with a series of Analyses of Covariance models with age, gender and race as covariates.
Since these variables are measured at the PS level, the covariates were the average across the Veterans sesn by each PS (mean age, percent White and percent male).
N's are number of Veterans
|
one year and across both years
|
|
Time to First Service
Time Frame: variable from baseline to time of first service delivered by Peer Specialists
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This variable represents count of days from time study at each site started (baseline) until first service was delivered.
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variable from baseline to time of first service delivered by Peer Specialists
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Average Number of Visits Per Veteran Per Peer Specialist-Adjusted (First Year Only)
Time Frame: 1st year only
|
See Variable 5 above for details about adjustment. Since this variable this is a Veteran level variable, a General Linear Mixed Model (GSLMM) was used with PS specified as a random effect and Veteran age, race and gender. N's are number of Veterans |
1st year only
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Matthew J. Chinman, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
- Principal Investigator: Richard W Goldberg, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Publications and helpful links
General Publications
- Peeples AD, Muralidharan A, McCarthy S, Goldberg R, Kuykendall L, Vineyard N, Chinman M. Barriers and Enablers to Implementing Peer Specialists in Veterans Health Administration Primary Care: a Qualitative Study. J Gen Intern Med. 2023 Feb;38(3):707-714. doi: 10.1007/s11606-022-07782-0. Epub 2022 Sep 20.
- Chinman M, Goldberg R, Daniels K, Muralidharan A, Smith J, McCarthy S, Medoff D, Peeples A, Kuykendall L, Vineyard N, Li L. Implementation of peer specialist services in VA primary care: a cluster randomized trial on the impact of external facilitation. Implement Sci. 2021 Jun 7;16(1):60. doi: 10.1186/s13012-021-01130-2.
- Chinman M, Daniels K, Smith J, McCarthy S, Medoff D, Peeples A, Goldberg R. Provision of peer specialist services in VA patient aligned care teams: protocol for testing a cluster randomized implementation trial. Implement Sci. 2017 May 2;12(1):57. doi: 10.1186/s13012-017-0587-7.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- QUX 16-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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