Calls and Coordination for Transitions of Care at Re-entry

NCT ID: NCT06794983

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-19

Study Completion Date

2028-10-01

Brief Summary

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The goal of this clinical trial is to learn if a short program for people being released from prison can help connect them to medical care. The main question it aims to answer is:

* Will there be more non-emergency, outpatient clinic visits?

Researchers will compare the number of clinic visits between people who use a Nurse Case Manager (NCM) to people in enhanced usual care.

Participants will:

* Complete surveys
* Talk to a study team member 2-3 times, or talk to a study team member 2-3 times and talk to an NCM 6-11 times

Detailed Description

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The objective of this clinical trial is to test the effectiveness of a transitional care program adapted to meet the healthcare needs of adults after release from prison. The goal of the transitional care intervention being tested is to help the study participants connect to primary care within 60 days of release through weekly check-in calls. Participants in this study are enrolled approximately 6 months before their anticipated release. One group will receive weekly phone calls for up to 60 days post-release. Additionally, novel, linked administrative datasets will be leveraged to enhance, contextualize, and clarify policy implications of the clinical trial results.

Conditions

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Prisoners Substance Use History Chronic Medical Conditions Psychiatric Condition Substance Use Disorder (SUD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Phone Group

Participants will receive phone calls and texts.

Group Type EXPERIMENTAL

In-person visit with study team member

Intervention Type OTHER

Participants meet with a study team member before they are released from prison.

Phone calls and texts

Intervention Type OTHER

Study team member calls and texts participants after they are released from prison.

Phone + Nurse Case Manager (NCM) Group

Participants will work with a nurse case manager, who will call and text.

Group Type EXPERIMENTAL

In-person visit with NCM

Intervention Type OTHER

Participants meet with a NCM before they are released from prison.

Phone calls and texts - NCM

Intervention Type OTHER

Nurse case manager calls and texts participants after they are released from prison.

Interventions

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In-person visit with study team member

Participants meet with a study team member before they are released from prison.

Intervention Type OTHER

In-person visit with NCM

Participants meet with a NCM before they are released from prison.

Intervention Type OTHER

Phone calls and texts

Study team member calls and texts participants after they are released from prison.

Intervention Type OTHER

Phone calls and texts - NCM

Nurse case manager calls and texts participants after they are released from prison.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age 18 or older
* eligibility for WI Medicaid and intention to enroll before release
* substance use history (i.e., "have you ever considered your alcohol or drug use to be a problem?"), and
* living with, or history of, a chronic medical or psychiatric condition other than substance use disorder. This is defined as ever having been diagnosed with a medical or psychiatric chronic condition, or currently taking prescription medications for a chronic condition.
* able to read, understand, and speak English.

Exclusion Criteria

* ineligible for WI Medicaid
* no substance use history
* not living with, or no history of, chronic medical or psychiatric condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marguerite Burns

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Maggie Chilsen

Role: CONTACT

608-263-2704

Facility Contacts

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Maggie Chilsen

Role: primary

608-263-2704

Other Identifiers

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2R01DA047889-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A538500

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 11/8/2024

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH/POP HEALTH SCI/POP HLTH

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1669

Identifier Type: -

Identifier Source: org_study_id

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