CClinicalTrials.gg
RecruitingNCT07575373IntACTUpdated Aug 10, 2026

Feasibility of an Interdisciplinary Intervention to Improve Care Transitions for Hospitalized Patients With Substance Use Disorders

An interventional study of IntACT and Usual Care in Substance Use Disorders, sponsored by Michael Incze. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Michael Incze · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the feasibility and preliminary effectiveness of a primary care-based Interdisciplinary Addiction Care Transition (IntACT) team that will meet patients with substance use disorders (SUD) during a medical hospitalization and provide intensive care management, peer support, and interim SUD and medical care after discharge while facilitating a transition to long term community-based treatment.

Read the detailed description

This is a single site, unblinded, pilot randomized controlled trial that will enroll patients with SUD during an index hospitalization and randomize them to receive IntACT or usual care over an intervention period of 4 months. The study is designed to evaluate the feasibility and implementation of IntACT while simultaneously measuring preliminary effectiveness outcomes..

Intervention(s)

IntACT Intervention:

Participants randomized to IntACT will receive usual inpatient and outpatient services plus an interdisciplinary addiction care transition team providing: (1) in-hospital discharge planning support, (2) proactive post-discharge outreach and care coordination, (3) intensive care management and peer support, and (4) interim SUD and medical care coordination for up to 4 months post-randomization, with the goal of facilitating transition to longitudinal community-based care.

Upon randomization to the IntACT study arm, a member of the IntACT team (either peer navigator, clinician, or care manager) will deploy to the hospital to meet the participant, introduce their role, and exchange contact information. The IntACT team member will review the discharge plan with the participant and offer to facilitate any needed follow-up care at our partnering outpatient addiction medicine/primary care SPARC Clinic. They will outline a proposed post-discharge outreach plan to make sure that it is feasible and acceptable to the participant, with an expectation to perform the first outreach within 2 business days of discharge. The IntACT team member will also coordinate with the Addiction Consult Service and primary admitting hospital team as needed to address any perceived gaps in discharge care and to introduce themselves and their role, which is to provide added support after discharge and to facilitate linkage to follow-up care. A one-page contact sheet will be provided to the patient with a clinic cell phone number and contact information for both our peer support specialist and care manager during the initial visit. The IntACT team member will continue to communicate with the patient and the care team ad hoc during the remainder of the hospitalization to address any care coordination needs that arise. At our weekly IntACT clinical team meeting, the team will review the new participant's hospital course, medications, and discharge needs. Ensuing discussion will focus on how to best leverage the interdisciplinary IntACT team to improve post-discharge care. For example, the peer support specialist can provide outreach and linkage to daily free support meetings at Utah Support Advocates for Recovery Awareness (USARA) in addition to housing, legal, and vocational resources offered through USARA. The care manager can ensure adequate access to transportation, address food security and housing, and address perceived logistic barriers to engaging in care. The clinician can review medications such as antibiotics and medications for substance use disorder to ensure that there are no gaps in treatment after discharge. Within 2 business days of discharge, the IntACT team will outreach to the patient. This phone call will be focused on inquiring about unexpected symptoms and challenges faced after discharge, reviewing upcoming appointments and discharge medications, and assessing post-discharge substance use needs. The care manager will communicate with the rest of the IntACT team and leverage available community resources to address these needs. If the care manager is unable to reach the participant, they will keep trying together with the peer support specialist and clinician, at least 3 times per week for the first 3 weeks after discharge. This is in addition to any outreach from the research team. While follow up visit frequency will be individualized for each participant, most people will follow up every 1-2 weeks via appointments in SPARC or at another clinic/program of their choosing. For patients that follow up at SPARC, the IntACT team will be present at every clinic visit and available to coordinate on social and medical aspects of care. For patients that follow up elsewhere, care will be at weekly clinic team meetings and remote/asynchronous care will be provided to support a successful transition of care. The IntACT team will help to coordinate appointments with specialists if needed, liaising with their offices regarding scheduling and care plans. Telephone and/or EHR messaging outreach will occur at least weekly for the first month, then ad hoc for the remainder of the 4-month intervention period. These outreach calls may come from any member of the IntACT team. Care manager outreach will focus on assessing and addressing SUD-related and biopsychosocial aspects of follow-up care. Peer support specialist outreach will focus on community building and connection to SUD support resources. Clinician outreach will focus on medical and SUD treatment-related issues. In-person contact with the IntACT team will primarily be limited to regularly scheduled medical visits or outreach during any subsequent hospitalizations, with the exception of our peer support specialist who may accompany the participant to community meetings based on preference. There are no additional visits required of the patient to receive clinical care through IntACT.

Usual Care:

Participants randomized to Usual Care will receive standard of care services routinely available at University of Utah Health, including inpatient addiction consult services when ordered, discharge planning by hospital medical and social work teams, and referrals/follow-up options based on insurance and patient preference. Usual Care participants will not receive the structured IntACT intervention components provided in the intervention arm, including proactive post-discharge outreach by the IntACT care manager/peer support specialist, intensive care management, dedicated peer navigation, scheduled interdisciplinary team review, or interim addiction/primary care transition services delivered by the IntACT team as part of the study. If a Usual Care participant independently establishes care with SPARC clinic or other services through standard referral pathways, this will be permitted and will be captured as part of outcome assessment.

After 4 months, the official intervention period will stop. Participants in both groups will still able to continue care with their current medical and SUD treatment teams, which may include members of IntACT.

Randomization: Randomization will be conducted at a single site using asymmetric allocation to favor the intervention arm. Participants will be randomized in a 3:2 ratio to either the IntACT intervention or Usual Care using random permuted blocks.

The randomization sequence and allocation procedures will be implemented via in-house, REDCap-based software application developed and maintained by the University of Utah. The randomization system will conceal the allocation sequence until the time of assignment. After baseline assessments and confirmation of eligibility, research staff will access the web-based system, which will assign the participant to IntACT or Usual Care according to the randomization algorithm

Blinding: Participants, clinicians, and the research team cannot be blinded due to the nature of the intervention.

Study duration: The IntACT intervention period is 4 months, followed by a close-out assessment by the study team at 6 months post-randomization. Total study duration is expected to be approximately 24 months including start-up, enrollment, and follow-up.

02

Conditions studied

  • Substance Use Disorders
03

In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's planned enrollment of 75 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

This is the only study on the registry with Michael Incze as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 18 years and older
  • Hospitalized at University of Utah Medical Center (UUMC) for any medical reason, and
  • Electronic Health Record (EHR) documented diagnosis of any SUD.

Exclusion criteria

Exclusion Criteria:

  • Currently incarcerated
  • Tobacco use as only documented substance use disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    IntACT Intervention

    Participants randomized to IntACT will receive usual inpatient and outpatient services plus an interdisciplinary addiction care transition team.

    Behavioral: IntACT

  • Active comparator
    Usual Care

    Participants randomized to Usual Care will receive standard of care services routinely available at University of Utah Health.

    Behavioral: Usual Care

Interventions

  • BehavioralIntACT

    Participants randomized to IntACT will receive usual inpatient and outpatient services plus an interdisciplinary addiction care transition team providing: (1) in-hospital discharge planning support, (2) proactive post-discharge outreach and care coordination, (3) intensive care management and peer support, and (4) interim SUD and medical care coordination for up to 4 months post-randomization, with the goal of facilitating transition to longitudinal community-based care.

  • BehavioralUsual Care

    Participants randomized to Usual Care will receive standard of care services routinely available at University of Utah Health, including inpatient addiction consult services when ordered, discharge planning by hospital medical and social work teams, and referrals/follow-up options based on insurance and patient preference. Usual Care participants will not receive the structured IntACT intervention components provided in the intervention arm, including proactive post-discharge outreach by the IntACT care manager/peer support specialist, intensive care management, dedicated peer navigation, scheduled interdisciplinary team review, or interim addiction/primary care transition services delivered by the IntACT team as part of the study. If a Usual Care participant independently establishes care with SPARC clinic or other services through standard referral pathways, this will be permitted and will be captured as part of outcome assessment.

06

What researchers measure

Primary outcomes

  1. Care Linkage

    percentage of patients who attend any follow up visit within 14 days of hospital discharge. Assessed using administrative records and patient self-report.

    Time frame: 14 Days

  2. Retention in Treatment

    Percentage of patients who have attended a medical or substance use treatment appointment within the past 30 days. Assessed at 2 months, 4 months, and 6 months after randomization. Assessed using clinic/administrative records and patient-self-report.

    Time frame: 6 Months

  3. Intervention Feasibility

    Implementation-related outcomes will be collected from N=20 clinicians who are exposed to the IntACT intervention and IntACT team members, respectively. Implementation outcomes include Feasibility, assessed via the 4-item Feasibility of Intervention measure (range 0-12, higher is more feasible)

    Time frame: Completed once within 2 weeks of exposure to the intervention

  4. Intervention Acceptability

    Implementation-related outcomes will be collected from N=20 clinicians who are exposed to the IntACT intervention and IntACT team members, respectively. Implementation outcomes include Acceptability, assessed via the 4-item Acceptability of Intervention measure (range 0-12, higher is more acceptible)

    Time frame: Completed once within 2 weeks of exposure to the intervention

  5. Intervention Appropriateness

    Implementation-related outcomes will be collected from N=20 clinicians who are exposed to the IntACT intervention and IntACT team members, respectively. Implementation outcomes include Appropriateness, assessed via the 4-item Intervention Appropriateness Measure (range 0-12, higher is more appropriate)

    Time frame: Completed once within 2 weeks of exposure to the intervention

Secondary outcomes

  1. Time to first follow-up visit, assessed using clinic/administrative records and participant self-report.

    Time until participant presents for first follow up visit.

    Time frame: 6 Months

  2. Emergency Department visits and hospitalizations

    Number of self-reported ED visits and re-hospitalizations

    Time frame: 6 Months

  3. Substance use

    Number of self-reported substance uses using Timeline Follow Back

    Time frame: 6 Months

  4. Participant quality of life

    Quality of life outcomes measured by the 12-Item Short Form Health Survey (range 0-100, hgiher score means greater quality of life), a self-reported questionnaire assessing functional health and well-being,

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
  • University of Utah Medical Center
    Salt Lake City, Utah 84112, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07575373
Lead sponsor
Michael Incze
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Michael Incze (Associate Professor, University of Utah) — Sponsor-investigator
First posted
May 8, 2026
Start date
Jun 21, 2026
Primary completion
Sep 15, 2027 (estimated)
Completion
Sep 15, 2027 (estimated)
Last update
Aug 10, 2026

Study contacts

Michael Incze, MD
Contact
michael.incze@hsc.utah.edu
801-581-7822
Ulises Amaton, BA
Contact
ulises.amaton@hsc.utah.edu
801-581-7822
Michael Incze, MD
principal investigator · University of Utah

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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