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

2026年8月5日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

75

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

    • Utah
      • Salt Lake City、Utah、アメリカ、84112
        • 募集
        • University of Utah Medical Center
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
アクティブコンパレータ: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Care Linkage
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Time to first follow-up visit, assessed using clinic/administrative records and participant self-report.
時間枠:6 Months
Time until participant presents for first follow up visit.
6 Months
Emergency Department visits and hospitalizations
時間枠:6 Months
Number of self-reported ED visits and re-hospitalizations
6 Months
Substance use
時間枠:6 Months
Number of self-reported substance uses using Timeline Follow Back
6 Months
Participant quality of life
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Michael Incze, MD、University of Utah

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年6月21日

一次修了 (推定)

2027年9月15日

研究の完了 (推定)

2027年9月15日

試験登録日

最初に提出

2026年4月27日

QC基準を満たした最初の提出物

2026年5月2日

最初の投稿 (実際)

2026年5月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月10日

QC基準を満たした最後の更新が送信されました

2026年8月5日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IRB_00195935
  • K23DA062174 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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