NCT02732600

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,616

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 12, 2020

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

3.2 years

First QC Date

April 4, 2016

Results QC Date

May 27, 2020

Last Update Submit

July 19, 2023

Conditions

Keywords

VeteransVeterans HealthPatient CompliancePrimary Health CareHealth Care ProvidersHealth Promotion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Team Development Measure

    Baseline, 6 months, 1 year

  • Peer Fidelity Measure

    6 months, 1 year

  • The Satisfaction Index-Mental Health

    Baseline, 6 months, 1 year

  • Number of Unique Veterans Seen (Adjusted for Employment Period and Hours Worked Per Week)

    one year, across two years

  • Average Number of Visits Per Veteran Per Peer Specialist-Adjusted (Across Both Years)

    across both years

  • +3 more secondary outcomes

Study Arms (2)

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.

Other: Facilitated Implementation

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, 85723, United States

Location

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608, United States

Location

West Palm Beach VA Medical Center, West Palm Beach, FL

West Palm Beach, Florida, 33410, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

VA Northern Indiana Health Care System Marion Campus, Marion, IN

Marion, Indiana, 46953, United States

Location

Lexington VA Medical Center, Lexington, KY

Lexington, Kentucky, 40502, United States

Location

Maine VA Medical Center, Augusta, ME

Togus, Maine, 04330, United States

Location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201, United States

Location

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, 63106, United States

Location

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210, United States

Location

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

Salisbury, North Carolina, 28144, United States

Location

Chillicothe VA Medical Center, Chillicothe, OH

Chillicothe, Ohio, 45601, United States

Location

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220, United States

Location

Chalmers P. Wylie Ambulatory Care Center, Columbus, OH

Columbus, Ohio, 43203-1278, United States

Location

Philadelphia VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Columbia, South Carolina, 29209, United States

Location

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05009-0001, United States

Location

Related Publications (3)

  • 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.

MeSH Terms

Conditions

Mental DisordersPatient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

While the uploaded Study Protocol is in publication form, this represents the only written study protocol. Because the study was classified as non-research, there is no IRB protocol.

Results Point of Contact

Title
Richard Goldberg
Organization
VISN 5 Mental Illness Research, Education, and Clinical Center

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 8, 2016

Study Start

January 1, 2016

Primary Completion

March 31, 2019

Study Completion

October 31, 2019

Last Updated

July 27, 2023

Results First Posted

June 12, 2020

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations