Calls and Coordination for Transitions of Care at Re-entry (Call2Care)

Health Systems Innovations for Supporting Transitions of Care for Incarcerated People Living With Substance Use Disorders

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Medical Conditions; Substance Use Disorder (SUD); Prisoners; Substance Use History; Psychiatric Condition
• Intervention / Treatment: Other: In-person visit with study team member; Other: Phone calls and texts; Other: In-person visit with NCM; Other: Phone calls and texts - NCM

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 488
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maggie Chilsen; Phone Number: 608-263-2704; Email: mchilsen@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin
      • Contact: Maggie Chilsen; Phone Number: 608-263-2704; Email: mchilsen@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phone Group; Participants will receive phone calls and texts.	Other: In-person visit with study team member; Participants meet with a study team member before they are released from prison.; Other: Phone calls and texts; Study team member calls and texts participants after they are released from prison.
Experimental: Phone + Nurse Case Manager (NCM) Group; Participants will work with a nurse case manager, who will call and text.	Other: In-person visit with NCM; Participants meet with a NCM before they are released from prison.; Other: Phone calls and texts - NCM; Nurse case manager calls and texts participants after they are released from prison.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Marguerite Burns, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2024-1669; A538500 (Other Identifier: UW- Madison); SMPH/POP HEALTH SCI/POP HLTH (Other Identifier: UW- Madison); 2R01DA047889-06 (U.S. NIH Grant/Contract); Protocol Version 11/8/2024 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• 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