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Linkage to CarePIENCT02964897

Improving Linkage to Health and Other Services for Veterans Leaving Incarceration

A study of Linkage to Care and Homelessness, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
2 sitesUnited States
Study dates
27 Nov 2017to 15 Sep 2021
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • VA Bedford HealthCare System, Bedford, MA

    Bedford, Massachusetts, 01730-1114

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

    West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: Veterans Justice Reentry (Post-Incarceration) (QUE 15-284)

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.

Read the detailed description

Veterans leaving incarceration (henceforth, "reentry Veterans") are among the most underserved by the VA and thus are an increasingly high priority population. The Bureau of Justice Statistics estimates that 140,000 Veterans are incarcerated in the U.S. at a given time, approximately 80% of whom are eligible for VA benefits. Many of these Veterans had problems with substance use disorders (SUD)(including alcohol) and/or mental health (MH) issues prior to being incarcerated.

The VA's national Health Care for Reentry Veterans (HCRV) program identifies 10,000-15,000 incarcerated Veterans annually preparing to transition back to the community. A HCRV outreach specialist works with incarcerated VHA-eligible Veterans to establish a post-release plan for linkage to VHA services. This program, with 1-2 outreach specialists per state, has improved the connection between reentry Veterans and the VHA. However, the investigators' analyses of homeless program data linked to VHA administrative data indicate that 43% of eligible HCRV Veterans do not have a VHA outpatient contact in the first 4 months post incarceration. Reducing this number is critical given the elevated rates of chronic health conditions, as well as MH or SUDs in this population.

To address this gap, the investigators will work with the national HCRV office to implement an evidence-based peer support intervention to extend the reach and effectiveness of the HCRV program in linking Veterans to VHA. Peers with incarceration experience are likely to better understand and connect with Veterans on a personal level than the outreach specialist, and thus are more likely to maintain contact and link to VHA during the first months post-release. Peers are gaining popularity in forensic settings (called "forensic peer specialists") with civilian populations and would likely be beneficial for a Veteran population .

The aims of this project are:

  1. Conduct contextual analysis to identify VHA and community reentry resources, and to describe how reentry Veterans use them.
  2. Implement peer-support, in one state, to link reentry veterans to VHA primary, mental health, and SUD services. The investigators will use external and internal facilitation as the implementation strategy.
  3. Spread the peer-support intervention to another, geographically, and contextually different state.
Being tested
Peer-support plus usual care from the Health Care for Reentry Veterans program, Usual care from the Health Care for Reentry Veterans program
Keywords
justice involvement, Homeless, Vulnerable Populations, Linkage to care, Veterans
Medical subject headings
Substance-Related Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called peer mentoring; forensic peer support

    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.

  • Usual care from the Health Care for Reentry Veterans programBehavioural

    Also called HCRV reentry support

    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.

Study groups in NCT02964897
Study groupRoleWhat they receive
Intervention Arm with Peer SupportExperimentalVeterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program.
Receives: Behavioral: Peer-support plus usual care from the Health Care for Reentry Veterans program
Comparison Arm with Usual CareOtherVeterans 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.
Receives: Behavioral: Usual care from the Health Care for Reentry Veterans program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Substance Use Care

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

    Measured: 3 months after release from incarceration

  2. Mental Health

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

    Measured: 3 months after release from incarceration

  3. Primary Care

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

    Measured: 3 months after release from incarceration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2016 (estimated)
  2. Study start27 Nov 2017
  3. Primary completion15 Sep 2020
  4. Study completion15 Sep 2021

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964897
Sponsor's protocol ID
QUX 16-012
Other IDs
QUE 15-284
Acronym
PIE
Status last verified
Jul 2023
First submitted
4 Nov 2016
Last updated
21 Jul 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30915620

  • 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.

    PubMed 28899394

Questions about this trial

What is this clinical trial studying?

A study of Linkage to Care and Homelessness, run by VA Office of Research and Development at 2 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 5 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 21 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 2 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 8 Oct 2021). 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?

Substance Use Care (time frame: 3 months after release from incarceration). The study lists 3 primary outcomes in all. 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 NCT02964897, which also lists 2 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 21 Jul 2023.

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