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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02732600
Other study ID # QUX 16-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2016
Est. completion date October 31, 2019

Study information

Verified date July 2023
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In August 2014, the White House issued an Executive Action mandating that 25 VA medical centers place Peer Specialists (Veterans recovered from mental illness who are trained to support other Veterans with mental illness) on Primary Care Teams. Research shows that the success of adding new staff to existing teams can be improved by outside aid and facilitation. This quality improvement project will evaluate whether providing expanded support to half of the Primary Care Teams will lead to better outcomes when compared with teams that do not get extra support.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5616
Est. completion date October 31, 2019
Est. primary completion date March 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
United States Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Baltimore Maryland
United States Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Bedford Massachusetts
United States Jesse Brown VA Medical Center, Chicago, IL Chicago Illinois
United States Chillicothe VA Medical Center, Chillicothe, OH Chillicothe Ohio
United States Cincinnati VA Medical Center, Cincinnati, OH Cincinnati Ohio
United States Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC Columbia South Carolina
United States Chalmers P. Wylie Ambulatory Care Center, Columbus, OH Columbus Ohio
United States Atlanta VA Medical and Rehab Center, Decatur, GA Decatur Georgia
United States John D. Dingell VA Medical Center, Detroit, MI Detroit Michigan
United States North Florida/South Georgia Veterans Health System, Gainesville, FL Gainesville Florida
United States Edward Hines Jr. VA Hospital, Hines, IL Hines Illinois
United States Lexington VA Medical Center, Lexington, KY Lexington Kentucky
United States VA Northern Indiana Health Care System Marion Campus, Marion, IN Marion Indiana
United States VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California
United States Philadelphia VA Medical Center, Philadelphia, PA Philadelphia Pennsylvania
United States VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA Pittsburgh Pennsylvania
United States St. Louis VA Medical Center John Cochran Division, St. Louis, MO Saint Louis Missouri
United States Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC Salisbury North Carolina
United States San Francisco VA Medical Center, San Francisco, CA San Francisco California
United States Syracuse VA Medical Center, Syracuse, NY Syracuse New York
United States Maine VA Medical Center, Augusta, ME Togus Maine
United States Southern Arizona VA Health Care System, Tucson, AZ Tucson Arizona
United States VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut
United States West Palm Beach VA Medical Center, West Palm Beach, FL West Palm Beach Florida
United States White River Junction VA Medical Center, White River Junction, VT White River Junction Vermont

Sponsors (2)

Lead Sponsor Collaborator
VA Office of Research and Development US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Activation Measure Change 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). Baseline, 6 months, 1 year
Secondary Team Development Measure 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. Baseline, 6 months, 1 year
Secondary Peer Fidelity Measure 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) 6 months, 1 year
Secondary The Satisfaction Index-Mental Health 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. Baseline, 6 months, 1 year
Secondary Number of Unique Veterans Seen (Adjusted for Employment Period and Hours Worked Per Week) 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, across two years
Secondary Average Number of Visits Per Veteran Per Peer Specialist-Adjusted (Across Both Years) 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
Secondary Average Total Number of Services Provided-Adjusted (First Year Only 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
Secondary Time to First Service This variable represents count of days from time study at each site started (baseline) until first service was delivered. variable from baseline to time of first service delivered by Peer Specialists
Secondary Average Number of Visits Per Veteran Per Peer Specialist-Adjusted (First 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
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