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

5 de agosto de 2026 actualizado por: Michael Incze

Evaluating the Feasibility of an Interdisciplinary Primary Care-based Intervention to Improve Transitions to Follow-Up Care for Hospitalized Patients With Substance Use Disorders: A Pilot Randomized Controlled Trial

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.

Descripción general del estudio

Estado

Reclutamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

75

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • Utah
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Reclutamiento
        • University of Utah Medical Center
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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:

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: IntACT Intervention
Participants randomized to IntACT will receive usual inpatient and outpatient services plus an interdisciplinary addiction care transition team.
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.
Comparador activo: Usual Care
Participants randomized to Usual Care will receive standard of care services routinely available at University of Utah Health.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Care Linkage
Periodo de tiempo: 14 Days
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
Periodo de tiempo: 6 Months
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
Periodo de tiempo: Completed once within 2 weeks of exposure to the intervention
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
Periodo de tiempo: Completed once within 2 weeks of exposure to the intervention
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
Periodo de tiempo: Completed once within 2 weeks of exposure to the intervention
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to first follow-up visit, assessed using clinic/administrative records and participant self-report.
Periodo de tiempo: 6 Months
Time until participant presents for first follow up visit.
6 Months
Emergency Department visits and hospitalizations
Periodo de tiempo: 6 Months
Number of self-reported ED visits and re-hospitalizations
6 Months
Substance use
Periodo de tiempo: 6 Months
Number of self-reported substance uses using Timeline Follow Back
6 Months
Participant quality of life
Periodo de tiempo: 6 months
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,
6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Michael Incze, MD, University of Utah

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de junio de 2026

Finalización primaria (Estimado)

15 de septiembre de 2027

Finalización del estudio (Estimado)

15 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

27 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de mayo de 2026

Publicado por primera vez (Actual)

8 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB_00195935
  • K23DA062174 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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