PIE: Improving Linkage to Health and Other Services for Veterans Leaving Incarceration

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT02964897
• Collaborator: US Department of Veterans Affairs (U.S. Fed)
• Enrollment: 79
• Locations: 2
• Arms: 2
• Actual Duration (Months): 45.6
• Patients Per Site: 39.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Linkage to Care; Homelessness; Substance Use Disorder; Mental Health	Behavioral: Peer-support plus usual care from the Health Care for Reentry Veterans program; Behavioral: Usual care from the Health Care for Reentry Veterans program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Veterans Justice Reentry (Post-Incarceration) (QUE 15-284)
• Actual Study Start Date: Nov 27, 2017
• Actual Primary Completion Date: Sep 15, 2020
• Actual Study Completion Date: Sep 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Arm with Peer Support 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; 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.; Other Names: peer mentoring; forensic peer support
Other: Comparison Arm with Usual Care 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; 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.; Other Names: HCRV reentry support

Outcome Measures

Primary Outcome Measures

1. Substance Use Care [3 months after release from incarceration]

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

2. Mental Health [3 months after release from incarceration]

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

3. Primary Care [3 months after release from incarceration]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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)

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut	United States	06516
2	VA Bedford HealthCare System, Bedford, MA	Bedford	Massachusetts	United States	01730

Sponsors and Collaborators

• VA Office of Research and Development
• US Department of Veterans Affairs

Investigators

• Principal Investigator: Donald K McInnes, ScD MS BA, VA Bedford HealthCare System, Bedford, MA
• Principal Investigator: Allen L. Gifford, MD, VA Bedford HealthCare System, Bedford, MA

Study Documents (Full-Text)

• Study Protocol - Sep 7, 2021
• Statistical Analysis Plan - Sep 7, 2021

More Information

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02964897
• Other Study ID Numbers: QUX 16-012; QUE 15-284
• First Posted: Nov 16, 2016
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by VA Office of Research and Development: justice involvement; Homeless; Vulnerable Populations; Linkage to care; Veterans
• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

Participant Flow

Arm/Group Title	Intervention Arm With Peer Support	Comparison Arm With Usual Care
Arm/Group Description	Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program. Peer-support plus usual care from the Health Care for Reentry Veterans program: 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.	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. Usual care from the Health Care for Reentry Veterans program: 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.
Period Title: Overall Study
STARTED	43	36
COMPLETED	43	36
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention Arm With Peer Support	Comparison Arm With Usual Care	Total
Arm/Group Description	Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program. Peer-support plus usual care from the Health Care for Reentry Veterans program: 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.	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. Usual care from the Health Care for Reentry Veterans program: 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.	Total of all reporting groups
Overall Participants	43	36	79
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.3 (13)	53.8 (14)	51.4 (14)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	43 100%	36 100%	79 100%
Race/Ethnicity, Customized (Count of Participants)
African American or Black	10 23.3%	6 16.7%	16 20.3%
White	31 72.1%	30 83.3%	61 77.2%
Multiple/other/declined	2 4.7%	0 0%	2 2.5%
Region of Enrollment (Count of Participants)
United States	43 100%	36 100%	79 100%
Marital status (Count of Participants)
Not partnered (single, divorced, separated, widowed)	37 86%	34 94.4%	71 89.9%
Married or other partner relationship	6 14%	2 5.6%	8 10.1%
Self-rated health (Count of Participants)
Excellent	6 14%	8 22.2%	14 17.7%
Very good	9 20.9%	3 8.3%	12 15.2%
Good	17 39.5%	12 33.3%	29 36.7%
Fair	8 18.6%	5 13.9%	13 16.5%
Poor	3 7%	4 11.1%	7 8.9%
Missing	0 0%	4 11.1%	4 5.1%

Outcome Measures

1. Primary Outcome

Title	Substance Use Care
Description	Participant will have made and kept one or more substance use disorder care visits
Time Frame	3 months after release from incarceration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm With Peer Support	Comparison Arm With Usual Care
Arm/Group Description	Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program. Peer-support plus usual care from the Health Care for Reentry Veterans program: 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.	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. Usual care from the Health Care for Reentry Veterans program: 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.
Measure Participants	43	36
Count of Participants [Participants]	37 86%	7 19.4%

2. Primary Outcome

Title	Mental Health
Description	Participant will have made and kept one or more outpatient mental health care visits
Time Frame	3 months after release from incarceration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm With Peer Support	Comparison Arm With Usual Care
Arm/Group Description	Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program. Peer-support plus usual care from the Health Care for Reentry Veterans program: 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.	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. Usual care from the Health Care for Reentry Veterans program: 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.
Measure Participants	43	36
Count of Participants [Participants]	42 97.7%	23 63.9%

3. Primary Outcome

Title	Primary Care
Description	Participant will have made and kept one or more primary care visits
Time Frame	3 months after release from incarceration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Arm With Peer Support	Comparison Arm With Usual Care
Arm/Group Description	Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program. Peer-support plus usual care from the Health Care for Reentry Veterans program: 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.	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. Usual care from the Health Care for Reentry Veterans program: 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.
Measure Participants	43	36
Count of Participants [Participants]	25 58.1%	24 66.7%

Adverse Events

Time Frame	1 Year
Adverse Event Reporting Description	For the comparison group it was a historical control, only those living were included.
Arm/Group Title	Intervention Arm With Peer Support		Comparison Arm With Usual Care
Arm/Group Description	Veterans in this arm will receive the peer-support intervention, in addition to the usual care from the Health Care for Reentry Veterans Program. Peer-support plus usual care from the Health Care for Reentry Veterans program: 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.		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. Usual care from the Health Care for Reentry Veterans program: 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.
All Cause Mortality
	Intervention Arm With Peer Support		Comparison Arm With Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/43 (2.3%)		0/36 (0%)
Serious Adverse Events
	Intervention Arm With Peer Support		Comparison Arm With Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/43 (2.3%)		0/36 (0%)
General disorders
Death	1/43 (2.3%)	1	0/36 (0%)	0
Other (Not Including Serious) Adverse Events
	Intervention Arm With Peer Support		Comparison Arm With Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/36 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.