NCT07575373

Brief 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.

Trial Health

63
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Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

April 27, 2026

Last Update Submit

May 2, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    14 Days

  • 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.

    6 Months

  • 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)

    Completed once within 2 weeks of exposure to the intervention

  • 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)

    Completed once within 2 weeks of exposure to the intervention

  • 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)

    Completed once within 2 weeks of exposure to the intervention

Secondary Outcomes (4)

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

    6 Months

  • Emergency Department visits and hospitalizations

    6 Months

  • Substance use

    6 Months

  • Participant quality of life

    6 months

Study Arms (2)

IntACT Intervention

EXPERIMENTAL

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

Behavioral: IntACT

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care

Interventions

IntACTBEHAVIORAL

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.

IntACT Intervention
Usual CareBEHAVIORAL

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.

Usual Care

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Medical Center

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Michael Incze, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 8, 2026

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 15, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations