PROMOTE: A Pilot and Feasibility Study (PROMOTE)
2026년 8월 6일 업데이트: Paul Joudrey, University of Pittsburgh
PeRsOnalized MethOdone TrEatment (PROMOTE) by Implementing Shared Decision-making: A Pilot and Feasibility Study
To assess the feasibility and acceptability of implementing and evaluating shared decision making (SDM) within a single opioid treatment program (OTP) using Implementation Facilitation (IF), and to obtain pilot data on key implementation and effectiveness outcomes to inform a future full-scale hybrid type 3 implementation-effectiveness trial.
연구 개요
상세 설명
A combination of cross-sectional (surveys) during the study period and retrospective (Electronic Health Record data) following the study period.
연구 유형
관찰
등록 (추정된)
58
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Research Program Manager
- 전화번호: +1-412-624-7263
- 이메일: dmo36@pitt.edu
연구 장소
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Arizona
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Mesa, Arizona, 미국, 85213
- Community Medical Services Mesa, AZ on Main
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연락하다:
- Clinic Manager
- 전화번호: 480-977-1500
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Mesa on Main, a single OTP clinic in Arizona operated by Community Medical Services (CMS), will participate as the pilot study site.
The investigators will enroll clients and healthcare professionals from Mesa on Main to participate in cross-sectional surveys, qualitative interviews, and EHR data collection.
설명
Inclusion Criteria:
CLIENT INCLUSION CRITERIA
- Age ≥18 years old
- Receiving methadone treatment (i.e., self-report of ingestion of at least one administered or dispensed dose of methadone in past 7 days) at the pilot OTP
- Able and willing to provide informed consent
- Able to read and write in English or Spanish
HEALTHCARE PROFESSIONAL INCLUSION CRITERIA
- ≥18 years old
- Partners with clients to make methadone treatment decisions (e.g., peer navigator, physician, advanced practice provider, nurse, counselor)
- Able and willing to provide informed consent
- Able to read and write in English
CLIENT EHR INCLUSION CRITERIA
- ≥18 years old
- Documented receipt of at least one dose of methadone treatment (i.e., administrated or dispensed) from the participating OTP during a 6-month study period
SEMI-STRUCTURED INTERVIEW INCLUSION CRITERIA
- Clients and healthcare professionals eligible as described above may be included in semi-structured interviews. We will also include the OTP organizational leadership (e.g., clinic director, medical director, regional director). The investigators will purposively sample clients, healthcare professionals, and OTP leadership to contrast positional differences in experiences of SDM and its implementation. The investigators may modify this sampling approach based on preliminary results and advisory board feedback.
Exclusion Criteria:
CLIENT EXCLUSION CRITERIA
- Do not meet client inclusion criteria
- For the client survey, each client may complete the survey only once during the 6-month implementation period.
HEALTHCARE PROFESSIONAL EXCLUSION CRITERIA
- The investigators will exclude healthcare professionals who do not meet inclusion criteria
CLIENT EHR EXCLUSION CRITERIA
- The investigators will exclude clients who do not meet inclusion criteria
SEMI-STRUCTURED INTERVIEW EXCLUSION CRITERIA
- The investigators will exclude clients or healthcare professionals who do not meet inclusion criteria.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Patient Implementation Intervention
Implementation Facilitation (IF) is a systematic approach to integrating implementation activities to support and enable individual and organizational adoption of innovations.
The IF-based implementation intervention for shared decision making in a single opioid treatment program will occur over a period of 6 months.
Patient cohort -all consented patient participants will be exposed to the Implementation Intervention.
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Implementation Facilitation (IF) is a systematic approach to integrating implementation activities to support and enable individual and organizational adoption of innovations.
IF will be tailored to support shared decision making in a single opioid treatment program (OTP) and will be implemented over a 6-month period to assess feasibility of this implementation intervention in an OPT setting.
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Health Care Provider Implementation Intervention
Implementation Facilitation (IF) is a systematic approach to integrating implementation activities to support and enable individual and organizational adoption of innovations.
The IF-based implementation intervention for shared decision making in a single opioid treatment program will occur over a period of 6 months.
Health care provider (HCP) cohort -all consented HCP participants will be exposed to the Implementation Intervention.
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Implementation Facilitation (IF) is a systematic approach to integrating implementation activities to support and enable individual and organizational adoption of innovations.
IF will be tailored to support shared decision making in a single opioid treatment program (OTP) and will be implemented over a 6-month period to assess feasibility of this implementation intervention in an OPT setting.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of client survey recruitment and data collection procedures
기간: 6-month implementation period
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Feasibility is defined as (a) recruiting n ≥ 50 clients who (b) complete the client survey during the pilot implementation period.
The investigators will calculate the frequency and proportion of clients (a) recruited (start the survey) and (b) who complete the survey.
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6-month implementation period
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Feasibility of observed client-healthcare professional encounter recruitment and data collection procedures
기간: 6-month implementation period
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Feasibility of observed client-healthcare professional encounter recruitment is defined as obtaining n ≥ 20 eligible observed encounters during the pilot implementation period.
The investigators will calculate the frequency and proportion of clients and healthcare providers who participate in an observed encounter.
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6-month implementation period
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Feasibility of ascertainment of retention in methadone treatment during a 6-month period using site Electronic Health Record (EHR) data
기간: 6-month period preceding the implementation period
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Feasibility is defined as successful estimation of retention in methadone treatment as defined as [1 - Pr(discontinuation of methadone)] during a 6-month period as measured by EHR data.
The investigators are assessing feasibility of obtaining this data and estimating retention from it and therefore the period from which data is obtained is irrelevant.
The probability of retention in treatment during the 6-month implementation period will be calculated as the complement of the probability of discontinuation [1 - Pr(discontinuation)], as measured via EHR data of dates of new episodes of methadone treatment (>7 days between doses).
Using a survival analytic approach accounting for recurrent events, the investigators will calculate the hazard rate for the pilot period and plot the hazard of discontinuation for visual assessment.
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6-month period preceding the implementation period
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Feasibility and acceptability of the IF intervention for OTPs.
기간: 6-month implementation period
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Feasibility and acceptability of the IF intervention will be assessed qualitatively by recruiting 25 clients and 10 healthcare professionals for semi-structured interviews and documentation of IF activities via the IF activities log.
Qualitative and IF tracking log results will be presented to the study advisory board for final determination of feasibility and acceptability (Yes/No).
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6-month implementation period
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of healthcare professional survey recruitment and data collection procedures
기간: 6-month implementation period
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Feasibility is defined as (a) recruiting n ≥ 8 healthcare professionals who (b) complete the healthcare professional survey during the pilot implementation period.
The investigators will calculate the frequency and proportion of healthcare professionals (a) recruited (start the survey) and (b) who complete the survey.
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6-month implementation period
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Acceptability of the Spanish version of client survey
기간: 6-month implementation period
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a) The proportion of clients who opt to take and complete the Spanish version of the survey versus the proportion of clients who opt to take and complete the English version.
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6-month implementation period
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Utilization of Spanish version of client survey
기간: 6-month implementation period
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The number of completed Spanish surveys divided by the total number of client surveys completed.
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6-month implementation period
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Paul Joudrey, MD, MPH, University of Pittsburgh
- 수석 연구원: Cristina Murray-Krezan, PhD, University of Pittsburgh
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 5월 1일
연구 완료 (추정된)
2027년 6월 1일
연구 등록 날짜
최초 제출
2026년 7월 30일
QC 기준을 충족하는 최초 제출
2026년 8월 6일
처음 게시됨 (실제)
2026년 8월 11일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 6일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- STUDY26030108
- 1R61DA063659 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .