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TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following Hospitalization (TRTME)

2026年8月18日 更新者：T. John Winhusen, PhD

A Pilot Randomized Controlled Trial to Improve Outpatient Initiation of Medication for Opioid Use Disorder (MOUD) Following Hospitalization: The TRTME (Tailored Overdose Risk Feedback, Testimonials for MOUD Treatment, and Education on MOUD and Opioid Overdose) Trial

The primary objective of this study is to evaluate the ability of TRTME to increase initiation of MOUD outpatient treatment and MOUD knowledge in hospitalized patients with OUD deemed to be good candidates for MOUD by the UCMC Addiction Consult Team (ACT). The secondary objective is to evaluate the ability of TRTME to decrease stigma and increase drug self-efficacy.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to TRTME or Control. Participants will receive the assigned intervention following randomization, will complete a post-assessment following treatment receipt, and will complete a follow-up phone call at approximately one month posthospital discharge.

All participants will complete assessments of their opioid-overdose and MOUD knowledge and their risk for experiencing an opioid-overdose during baseline. TRTME participants will be offered a 15-minute intervention in which a trained research staff member reviews personal feedback reports with the recipient to provide information on: 1) the items missed on the knowledge assessment; and 2) their personal overdose risk factors. TRTME participants will also have the opportunity to view short videos from patients talking about their experiences with methadone or buprenorphine treatment. Control participants will be offered two SAMHSA handouts.

Enrollment is expected to take place over a period of approximately 7.5 months. Duration of study participation will be approximately 5 weeks.

研究の種類

介入

入学 (推定)

30

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

  • 名前：Lindsay Bybee, MS
  • 電話番号：5135858282
  • メール：saskowld@uc.edu

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Ohio
      • Cincinnati、Ohio、アメリカ、45229
        • 募集
        • University of Cincinnati Addiction Sciences Division

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:

  1. 18 years of age or older;
  2. A good candidate for methadone or buprenorphine treatment according to a member of the UCMC Addiction Consult Team

Exclusion Criteria:

  1. Have a current planned discharge to a nursing facility
  2. be currently in jail, prison, or any inpatient overnight facility as required by court of law or have pending legal action with high probability of incarceration or court-mandated inpatient treatment
  3. Unable to demonstrate adequate understanding of study procedures during the consent process

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：ヘルスサービス研究
  • 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
介入なし：Control
Control participants will be offered two SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; and 2) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
実験的：TRTME
TRTME participants will be offered a 15-minute intervention in which a trained research staff member reviews personal feedback reports with the recipient to provide information on: 1) the items missed on the knowledge assessment; and 2) their personal overdose risk factors. TRTME participants will also have the opportunity to view short videos from patients talking about their experiences with methadone or buprenorphine treatment.
行動：TRTME
The TRTME intervention includes three elements that have all been previously studied by our research team: 1) brief, personally-tailored education to correct inaccurate, common misconceptions about MOUD and to address knowledge gaps about opioid-overdose; 2) with personally-tailored feedback on the individual's risk factors for experiencing an opioid-overdose; and 3) review of MOUD testimonial videos.

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
Outpatient MOUD initiation
時間枠：30 days

The primary outcome is verified enrollment in outpatient MOUD within 30 days post-discharge.

Participants will be asked about their enrollment in MOUD approximately 30 days after their discharge from the hospital. Participants reporting having enrolled in treatment will be asked to provide a release of information for the treatment program to verify date of treatment enrollment.
30 days

二次結果の測定

結果測定
メジャーの説明
時間枠
MOUD knowledge score
時間枠：Immediately after the intervention
The key secondary outcome is MOUD knowledge as measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation. The OOTAS is comprised of 4 sections: 1) opioid-overdose risk factors; 2) signs of an opioid-overdose; 3) how to respond to an opioid-overdose; and 4) misconceptions about MOUD. The OOTAS has been successfully used to measure MOUD knowledge and knowledge change in three studies. The OOTAS includes 10 true-false questions to assess MOUD knowledge, yielding a potential score of 0-10.Secondary Outcome Measures
Immediately after the intervention
MOUD Stigma
時間枠：Immediately after the intervention

There are no existing validated measures for assessing MOUD stigma in patients who are good candidates for MOUD but have not yet entered treatment. The Medication for Opioid Use Disorder Attitudes Scale (MOUD-AS) was created by OpenEvidence based on stigmatizing beliefs about MOUD among patients considering treatment. The MOUD-AS includes 16 items scored from

1 (strongly disagree) to 5 (strongly agree). The total score, which has a potential range of 16-80, is the outcome of interest.
Immediately after the intervention
Drug Self-efficacy
時間枠：Immediately after the intervention
Self-efficacy in quitting drug use will be assessed with the Thoughts about abstinence (TAA) instrument. This measure assesses the participant's desire to quit, expected success in quitting and estimated difficulty in avoiding drug use. Our MOUD education intervention has been found to increase expected success in quitting drug use as measured by the TAA.
Immediately after the intervention
Opioid-overdose knowledge score
時間枠：Immediately after the intervention
Opioid-overdose knowledge will be measured by the first three sections of the OOTAS. The OOTAS has been successfully used to measure opioid-overdose knowledge and knowledge change in three prior studies conducted with individuals with OUD. The OOTAS includes 31 true-false questions to assess opioid-overdose knowledge, yielding a potential score of 0-31.
Immediately after the intervention

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

T. John Winhusen, PhD

捜査官

  • 主任研究者：T. John Winhusen, PhD.、University of Cincinnati

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 (推定)

2026年8月12日

一次修了 (推定)

2027年2月28日

研究の完了 (推定)

2027年2月28日

試験登録日

最初に提出

2026年8月11日

QC基準を満たした最初の提出物

2026年8月18日

最初の投稿 (実際)

2026年8月21日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月21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18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

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 2026-0331

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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

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