NCT02964897

Brief Summary

Veterans leaving incarceration and re-entering their communities (often described as "reentry" Veterans) face a number of challenges, including uncertainty about housing, vulnerability to substance use and relapse, on-going mental health concerns, and often multiple health conditions require timely continuity of care. The purpose of the project is to increase support for Veterans post-incarceration through the addition of trained peers with lived experience of being a Veteran and a history of incarceration. Emphasis will be on peers who will help link Veterans to Veterans Health Administration (VHA) services, including housing and healthcare. Peers will provide linkage with Health Care Reentry Veterans program specialists, transportation to appointments, and support in community reintegration. Peers will assist reentry veterans to make a successful transition and get and stay engaged in their care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

November 4, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

November 27, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
23 days until next milestone

Results Posted

Study results publicly available

October 8, 2021

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

2.8 years

First QC Date

November 4, 2016

Results QC Date

September 15, 2021

Last Update Submit

July 19, 2023

Conditions

Linkage to CareHomelessnessSubstance Use DisorderMental Health

Keywords

justice involvementHomelessVulnerable PopulationsLinkage to careVeterans

Outcome Measures

Primary Outcomes (3)

  • Substance Use Care

    Participant will have made and kept one or more substance use disorder care visits

    3 months after release from incarceration

  • Mental Health

    Participant will have made and kept one or more outpatient mental health care visits

    3 months after release from incarceration

  • Primary Care

    Participant will have made and kept one or more primary care visits

    3 months after release from incarceration

Study Arms (2)

Intervention Arm with Peer Support

EXPERIMENTAL

Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program.

Behavioral: Peer-support plus usual care from the Health Care for Reentry Veterans program

Comparison Arm with Usual Care

OTHER

Veterans in this arm will be receiving usual care from the Health Care for Reentry Veterans program (but they will not receive the peer-support intervention). They will be selected to be frequency-matched to veterans in the intervention arm by date of release from incarceration.

Behavioral: Usual care from the Health Care for Reentry Veterans program

Interventions

Peer-support plus usual care from the Health Care for Reentry Veterans programBEHAVIORAL

a peer mentor who is also a veteran will establish a relationship with each subject and provide instrumental and emotional support to the subject during the first 6 months of the subject's release from incarceration. This is in addition to the usual reentry support provided by the Health Care for Reentry Veterans program.

Also known as: peer mentoring; forensic peer support
Intervention Arm with Peer Support
Usual care from the Health Care for Reentry Veterans programBEHAVIORAL

Health Care for Reentry Veterans program provides reentry planning while the veteran is incarcerated. An outreach worker visits the veteran in the incarceration facility to conduct a needs assessment and help create a reentry plan to cover issues such as where they will be housed, what health care appointments they will need in the first 30 days, whether they need legal assistance, etc.

Also known as: HCRV reentry support
Comparison Arm with Usual Care

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Phase 1
  • Veteran released from a Massachusetts state prison or county jail.
  • (for intervention subjects: interested in receiving reentry services) Phase 2
  • Veteran released from a Connecticut state prison or jail.
  • (for intervention subjects: interested in receiving reentry services)

You may not qualify if:

  • \- No history of dementia or other serious cognitive condition that would prevent them from being interviewed or completing a survey questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

West Haven, Connecticut, 06516, United States

Location

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

Related Publications (2)

  • Kim B, McCullough MB, Simmons MM, Bolton RE, Hyde J, Drainoni ML, Fincke BG, McInnes DK. A novel application of process mapping in a criminal justice setting to examine implementation of peer support for veterans leaving incarceration. Health Justice. 2019 Mar 26;7(1):3. doi: 10.1186/s40352-019-0085-x.

    PMID: 30915620DERIVED

  • Simmons MM, Fincke BG, Drainoni ML, Kim B, Byrne T, Smelson D, Casey K, Ellison ML, Visher C, Blue-Howells J, McInnes DK. A two-state comparative implementation of peer-support intervention to link veterans to health-related services after incarceration: a study protocol. BMC Health Serv Res. 2017 Sep 12;17(1):647. doi: 10.1186/s12913-017-2572-x.

    PMID: 28899394DERIVED

MeSH Terms

Conditions

Substance-Related DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPersonal SatisfactionBehavior

Limitations and Caveats

Because of our use of a historical comparison group, the context in which they received reentry services and their individual characteristics may have differed from the intervention group.

Results Point of Contact

Title
Keith McInnes, Principal Investigator
Organization
Center for Healthcare Organization and Implementation Research, VA Bedford Healthcare System
donald.mcinnes@va.gov
617-504-1630

Study Officials

  • Donald K McInnes, ScD MS BA

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR

  • Allen L. Gifford, MD

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 16, 2016

Study Start

November 27, 2017

Primary Completion

September 15, 2020

Study Completion

September 15, 2021

Last Updated

July 21, 2023

Results First Posted

October 8, 2021

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)