TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following Hospitalization (TRTME)
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
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Lindsay Bybee, MS
- 전화번호: 5135858282
- 이메일: saskowld@uc.edu
연구 연락처 백업
- 이름: Ben Kropp Kropp, MSLS
- 전화번호: 5135858287
- 이메일: kroppbn@ucmail.uc.edu
연구 장소
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Ohio
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Cincinnati, Ohio, 미국, 45229
- 모병
- University of Cincinnati Addiction Sciences Division
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 18 years of age or older;
- A good candidate for methadone or buprenorphine treatment according to a member of the UCMC Addiction Consult Team
Exclusion Criteria:
- Have a current planned discharge to a nursing facility
- 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
- Unable to demonstrate adequate understanding of study procedures during the consent process
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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간섭 없음: 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.
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Outpatient MOUD initiation
기간: 30 days
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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
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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MOUD knowledge score
기간: Immediately after the intervention
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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
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Immediately after the intervention
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MOUD Stigma
기간: Immediately after the intervention
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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
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Drug Self-efficacy
기간: Immediately after the intervention
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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.
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Immediately after the intervention
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Opioid-overdose knowledge score
기간: Immediately after the intervention
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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.
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Immediately after the intervention
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: T. John Winhusen, PhD., University of Cincinnati
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2026-0331
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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