PrisonersCall2CareNCT06794983
Calls and Coordination for Transitions of Care at Re-entry
A study testing In-person visit with study team member, In-person visit with NCM and Phone calls and texts in people with Prisoners and Substance Use History, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prisoners, Substance Use History, Chronic Medical Conditions
- What is being tested?
- In-person visit with study team member, In-person visit with NCM and Phone calls and texts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2025to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- ineligible for WI Medicaid
- no substance use history
- not living with, or no history of, chronic medical or psychiatric condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53705
Maggie Chilsen, 608-263-2704, mchilsen@wisc.edu
About this study
Official title: 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
Read the 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.
- Conditions
- Prisoners, Substance Use History, Chronic Medical Conditions, Psychiatric Condition, Substance Use Disorder (SUD)
- Being tested
- In-person visit with study team member, In-person visit with NCM, Phone calls and texts, Phone calls and texts - NCM
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person visit with study team memberOther
Participants meet with a study team member before they are released from prison.
In-person visit with NCMOther
Participants meet with a NCM before they are released from prison.
Phone calls and textsOther
Study team member calls and texts participants after they are released from prison.
Phone calls and texts - NCMOther
Nurse case manager calls and texts participants after they are released from prison.
| Study group | Role | What they receive |
|---|---|---|
| Phone Group | Experimental | Participants will receive phone calls and texts. Receives: Other: In-person visit with study team member; Other: Phone calls and texts |
| Phone + Nurse Case Manager (NCM) Group | Experimental | Participants will work with a nurse case manager, who will call and text. Receives: Other: In-person visit with NCM; Other: Phone calls and texts - NCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who attend a Non-Emergency Outpatient Visit within 60 Days of Release From Prison
Measured: 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
Measured: 2 months post-release, approximately 5 months on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start19 Sep 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrisonersStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Marguerite Burns, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794983
- Sponsor's protocol ID
- 2024-1669
- Other IDs
- 2R01DA047889-06, A538500, Protocol Version 11/8/2024, SMPH/POP HEALTH SCI/POP HLTH
- Acronym
- Call2Care
- Status last verified
- Mar 2026
- First submitted
- 23 Jan 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Systems Innovations for Supporting Transitions of Care for Incarcerated People Living With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT06794983
- Acronym / sponsor ID
- Call2Care / 2024-1669
- Conditions
- Prisoners, Substance Use History, Chronic Medical Conditions, Psychiatric Condition, Substance Use Disorder (SUD)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 19 Sep 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phone Group | Experimental | Other: In-person visit with study team member, Other: Phone calls and textsParticipants will receive phone calls and texts. |
| Phone + Nurse Case Manager (NCM) Group | Experimental | Other: In-person visit with NCM, Other: Phone calls and texts - NCMParticipants will work with a nurse case manager, who will call and text. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- ineligible for WI Medicaid
- no substance use history
- not living with, or no history of, chronic medical or psychiatric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person visit with study team memberParticipants meet with a study team member before they are released from prison. | Other | Phone Group |
| In-person visit with NCMParticipants meet with a NCM before they are released from prison. | Other | Phone + Nurse Case Manager (NCM) Group |
| Phone calls and textsStudy team member calls and texts participants after they are released from prison. | Other | Phone Group |
| Phone calls and texts - NCMNurse case manager calls and texts participants after they are released from prison. | Other | Phone + Nurse Case Manager (NCM) Group |
Primary outcome
Number of participants who attend a Non-Emergency Outpatient Visit within 60 Days of Release From Prison
Time frame: 2 months post-release, approximately 5 months on study
1 secondary outcome
Number of participants who attend a Non-Emergency Outpatient Visit for Substance Use Disorder within 60 Days of Release From Prison
Time frame: 2 months post-release, approximately 5 months on study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes
Related trials for Prisoners
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PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy
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Prevention and Mass Screening of TB in Prisons in Paraguay
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marguerite Burns principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person visit with study team member, In-person visit with NCM and Phone calls and texts in people with Prisoners and Substance Use History, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maggie Chilsen (608-263-2704, mchilsen@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who attend a Non-Emergency Outpatient Visit within 60 Days of Release From Prison (time frame: 2 months post-release, approximately 5 months on study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.