NCT06794983

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
488

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress18%
Sep 2025Apr 2029

First Submitted

Initial submission to the registry

January 23, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

September 19, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3.6 years

First QC Date

January 23, 2025

Last Update Submit

March 11, 2026

Conditions

Substance Use Disorder (SUD)PrisonersSubstance Use HistoryChronic Medical ConditionsPsychiatric Condition

Outcome Measures

Primary Outcomes (1)

  • Number of participants who attend a Non-Emergency Outpatient Visit within 60 Days of Release From Prison

    2 months post-release, approximately 5 months on study

Secondary Outcomes (1)

  • Number of participants who attend a Non-Emergency Outpatient Visit for Substance Use Disorder within 60 Days of Release From Prison

    2 months post-release, approximately 5 months on study

Study Arms (2)

Phone Group

EXPERIMENTAL

Participants will receive phone calls and texts.

Other: In-person visit with study team memberOther: Phone calls and texts

Phone + Nurse Case Manager (NCM) Group

EXPERIMENTAL

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

Other: In-person visit with NCMOther: Phone calls and texts - NCM

Interventions

In-person visit with study team memberOTHER

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

Phone Group
In-person visit with NCMOTHER

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

Phone + Nurse Case Manager (NCM) Group
Phone calls and textsOTHER

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

Phone Group
Phone calls and texts - NCMOTHER

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

Phone + Nurse Case Manager (NCM) Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • ineligible for WI Medicaid
  • no substance use history
  • not living with, or no history of, chronic medical or psychiatric condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Marguerite Burns

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maggie Chilsen

CONTACT

608-263-2704mchilsen@wisc.edu

Study Design

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

Study Record Dates

First Submitted

January 23, 2025

First Posted

January 27, 2025

Study Start

September 19, 2025

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Locations

US(1)