Mental IllnessPeers on PACTNCT02732600
Evaluation of Peer Specialists on VA PACTs
A study testing Facilitated Implementation in people with Mental Illness and Physical Illness, run by VA Office of Research and Development at 25 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness, Physical Illness
- What is being tested?
- Facilitated Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,616 participants
- Where
- 25 sitesUnited States
- Study dates
- 1 Jan 2016to 31 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Chillicothe VA Medical Center, Chillicothe, OH
Chillicothe, Ohio, 45601
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, 45220
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, South Carolina, 29209
Chalmers P. Wylie Ambulatory Care Center, Columbus, OH
Columbus, Ohio, 43203-1278
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, 30033
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-5000
Lexington VA Medical Center, Lexington, KY
Lexington, Kentucky, 40502
VA Northern Indiana Health Care System Marion Campus, Marion, IN
Marion, Indiana, 46953
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
Philadelphia VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, 28144
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210
Maine VA Medical Center, Augusta, ME
Togus, Maine, 04330
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, 85723
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
West Palm Beach VA Medical Center, West Palm Beach, FL
West Palm Beach, Florida, 33410
White River Junction VA Medical Center, White River Junction, VT
White River Junction, Vermont, 05009-0001
About this study
Official title: Program Evaluation of Peer Specialists on VA PACTS: A Quality Improvement Project (QUE 15-289)
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.
Read the 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.
- Conditions
- Mental Illness, Physical Illness
- Being tested
- Facilitated Implementation
- Keywords
- Veterans, Veterans Health, Patient Compliance, Primary Health Care, Health Care Providers, Health Promotion
- Medical subject headings
- Mental Disorders, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated ImplementationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Standard Implementation | No intervention | Standard Implementation sites will receive written guidance and limited consultation by the investigators' team. |
| Facilitated Implementation | Experimental | 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. Receives: Other: Facilitated Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 6 months, 1 year
Secondary outcomes (8)
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.
Measured: Baseline, 6 months, 1 year
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)
Measured: 6 months, 1 year
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.
Measured: Baseline, 6 months, 1 year
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
Measured: one year, across two years
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
Measured: across both years
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
Measured: one year and across both years
Time to First Service
This variable represents count of days from time study at each site started (baseline) until first service was delivered.
Measured: variable from baseline to time of first service delivered by Peer Specialists
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
Measured: 1st year only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study start1 Jan 2016
- Primary completion31 Mar 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,616 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Matthew J. Chinman, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PARichard W Goldberg, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732600
- Sponsor's protocol ID
- QUX 16-001
- Acronym
- Peers on PACT
- Status last verified
- Jul 2023
- First submitted
- 4 Apr 2016
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36127539Chinman 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.
PubMed 34099004Chinman 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.
PubMed 28464935
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program Evaluation of Peer Specialists on VA PACTS: A Quality Improvement Project (QUE 15-289)
- ClinicalTrials.gov ID
- NCT02732600
- Acronym / sponsor ID
- Peers on PACT / QUX 16-001
- Conditions
- Mental Illness, Physical Illness
- Keywords
- Veterans, Veterans Health, Patient Compliance, Primary Health Care, Health Care Providers, Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,616 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- US Department of Veterans Affairs
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Posted 12 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Implementation | No intervention | –Standard Implementation sites will receive written guidance and limited consultation by the investigators' team. |
| Facilitated Implementation | Experimental | Other: Facilitated ImplementationFacilitated 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitated ImplementationFacilitated 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 | Other | Facilitated Implementation |
Primary outcome
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).
8 secondary outcomes
Team Development Measure
Time frame: Baseline, 6 months, 1 year
Peer Fidelity Measure
Time frame: 6 months, 1 year
The Satisfaction Index-Mental Health
Time frame: Baseline, 6 months, 1 year
Number of Unique Veterans Seen (Adjusted for Employment Period and Hours Worked Per Week)
Time frame: one year, across two years
Average Number of Visits Per Veteran Per Peer Specialist-Adjusted (Across Both Years)
Time frame: across both years
Average Total Number of Services Provided-Adjusted (First Year Only and Across Both Years)
Time frame: one year and across both years
Time to First Service
Time frame: variable from baseline to time of first service delivered by Peer Specialists
Average Number of Visits Per Veteran Per Peer Specialist-Adjusted (First Year Only)
Time frame: 1st year only
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36127539Peeples 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.
- Derived from this study: PubMed 34099004Chinman 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.
- Derived from this study: PubMed 28464935Chinman 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.
- Individual participant dataSharing planned: No
Related trials for Mental Illness
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew J. Chinman, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Richard W Goldberg, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Implementation in people with Mental Illness and Physical Illness, run by VA Office of Research and Development at 25 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 1 inclusion and 1 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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 12 Jun 2020). 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?
Patient Activation Measure Change (time frame: Baseline, 6 months, 1 year). 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 NCT02732600, which also lists 3 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 27 Jul 2023.