- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07575373
Feasibility of an Interdisciplinary Intervention to Improve Care Transitions for Hospitalized Patients With Substance Use Disorders (IntACT)
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Michael Incze, MD
- Numero di telefono: 801-581-7822
- Email: michael.incze@hsc.utah.edu
Backup dei contatti dello studio
- Nome: Ulises Amaton, BA
- Numero di telefono: 801-581-7822
- Email: ulises.amaton@hsc.utah.edu
Luoghi di studio
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Utah
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Salt Lake City, Utah, Stati Uniti, 84112
- University of Utah Medical Center
-
Contatto:
- Michael Incze, MD
- Numero di telefono: 801-581-7822
- Email: michael.incze@hsc.utah.edu
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Care Linkage
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
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Intervention Acceptability
Lasso di tempo: 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)
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Completed once within 2 weeks of exposure to the intervention
|
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Intervention Appropriateness
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Time to first follow-up visit, assessed using clinic/administrative records and participant self-report.
Lasso di tempo: 6 Months
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Time until participant presents for first follow up visit.
|
6 Months
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Emergency Department visits and hospitalizations
Lasso di tempo: 6 Months
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Number of self-reported ED visits and re-hospitalizations
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6 Months
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Substance use
Lasso di tempo: 6 Months
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Number of self-reported substance uses using Timeline Follow Back
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6 Months
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Participant quality of life
Lasso di tempo: 6 months
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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,
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6 months
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Michael Incze, MD, University of Utah
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB_00195935
- K23DA062174 (Sovvenzione/contratto NIH degli Stati Uniti)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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