- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02964897
Improving Linkage to Health and Other Services for Veterans Leaving Incarceration (PIE)
Veterans Justice Reentry (Post-Incarceration) (QUE 15-284)
Study Overview
Status
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:
- Conduct contextual analysis to identify VHA and community reentry resources, and to describe how reentry Veterans use them.
- 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.
- Spread the peer-support intervention to another, geographically, and contextually different state.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
West Haven, Connecticut, United States, 06516
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
-
-
Massachusetts
-
Bedford, Massachusetts, United States, 01730-1114
- VA Bedford HealthCare System, Bedford, MA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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:
|
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substance Use Care
Time Frame: 3 months after release from incarceration
|
Participant will have made and kept one or more substance use disorder care visits
|
3 months after release from incarceration
|
|
Mental Health
Time Frame: 3 months after release from incarceration
|
Participant will have made and kept one or more outpatient mental health care visits
|
3 months after release from incarceration
|
|
Primary Care
Time Frame: 3 months after release from incarceration
|
Participant will have made and kept one or more primary care visits
|
3 months after release from incarceration
|
Collaborators and Investigators
Collaborators
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
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QUX 16-012
- QUE 15-284 (Other Grant/Funding Number: HSR&D QUERI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Substance Use Disorder
-
Technische Universität DresdenCharite University, Berlin, Germany; Central Institute of Mental Health, MannheimRecruitingAlcoholism | Methamphetamine-dependence | Substance Use Disorders | Cocaine Use Disorder | Alcohol Use Disorder (AUD) | Cannabis Use Disorder | Amphetamine Use DisorderGermany
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use Disorders | Nicotine Use DisorderUnited States
-
Indiana UniversityPatient-Centered Outcomes Research InstituteRecruitingAdolescent | Alcohol Use | Mild Alcohol Use Disorder | Mild Substance Use DisorderUnited States
-
University of BernRecruitingAlcohol Use Disorder (AUD) | Substance Use Disorder (SUD) | Cocaine Use Disorder (CUD)Switzerland
-
Emory UniversityNational Institute on Drug Abuse (NIDA); Georgia Institute of Technology; CUNYCompletedSubstance-Related Disorders | Substance Abuse, Intravenous | Substance Use Disorders | Opioid Use | Substance Abuse | Opioid-use Disorder | Opioid Use Disorder, Severe | Substance WithdrawalUnited States
-
University of California, San FranciscoTobacco Related Disease Research ProgramRecruitingTobacco Use Disorder | Substance Use Disorder (SUD)United States
-
Icahn School of Medicine at Mount SinaiNational Institute on Drug Abuse (NIDA)Active, not recruitingSubstance Use Disorder | Cocaine Use DisorderUnited States
-
Icahn School of Medicine at Mount SinaiNational Institute on Drug Abuse (NIDA)CompletedSubstance Use Disorder | Opioid Use Disorder | Heroin Use DisorderUnited States
-
Woebot HealthNational Institute on Drug Abuse (NIDA); Stanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
Wake Forest University Health SciencesUniversity of Chicago; Rogers Behavioral Health; University of California Santa...RecruitingSubstance Use | Methamphetamine-dependence | Opioid Use | Opioid-use Disorder | Cocaine Use Disorder | Cocaine Use | Methamphetamine AbuseUnited States
Clinical Trials on Peer-support plus usual care from the Health Care for Reentry Veterans program
-
Acibadem UniversityActive, not recruitingHemodialysis Complication | Nurse's Role | Health-Related Behavior | Peer ReviewTurkey
-
University of California, San FranciscoAmerican Academy of Family PhysiciansCompleted
-
Human Development Research Foundation, PakistanColumbia University; Duke University; University of Liverpool; University of EssexCompleted
-
Oregon Health and Science UniversityOregon Health Authority; Clatsop Behavioral Healthcare; Clatsop County CorrectionsNot yet recruitingOpioid Use DisorderUnited States
-
Syracuse VA Medical CenterNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Not yet recruiting
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)Active, not recruitingStage IV Lung Cancer | Stage III Lung Cancer | Stage II Lung CancerUnited States
-
Dena h. Al-TameemiBaghdad Medical CityNot yet recruitingBreast Cancer | Breast Neoplasm | Medication Adherence | Symptom Management | Chemotherapy-Related Toxicities | Quality of Life in Cancer Patients | Accuracy of AI AppIraq
-
University of RochesterCompletedDepression | Quality of Life | Domestic ViolenceUnited States
-
Oregon Health and Science UniversityNational Institute on Drug Abuse (NIDA); Central City ConcernRecruitingOpioid Dependence | Substance Abuse Disorders | Primary Care Patients With Chronic Conditions | Complex Medical PatientsUnited States
-
Indiana UniversityPatient-Centered Outcomes Research InstituteActive, not recruitingGeneralized Anxiety Disorder | Chest Pain | PanicUnited States