PROMOTE: A Pilot and Feasibility Study (PROMOTE)
2026年8月6日 更新者：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.
調査の概要
詳細な説明
A combination of cross-sectional (surveys) during the study period and retrospective (Electronic Health Record data) following the study period.
研究の種類
観察的
入学 (推定)
58
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：Research Program Manager
- 電話番号：+1-412-624-7263
- メール：dmo36@pitt.edu
研究場所
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Arizona
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Mesa、Arizona、アメリカ、85213
- Community Medical Services Mesa, AZ on Main
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コンタクト：
- Clinic Manager
- 電話番号：480-977-1500
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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
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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.
|
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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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 |
|---|---|---|
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Feasibility of client survey recruitment and data collection procedures
時間枠：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
時間枠：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
時間枠：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.
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility of healthcare professional survey recruitment and data collection procedures
時間枠：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
時間枠：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
時間枠：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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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
協力者
捜査官
- 主任研究者：Paul Joudrey, MD, MPH、University of Pittsburgh
- 主任研究者：Cristina Murray-Krezan, PhD、University of Pittsburgh
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9月1日
一次修了 (推定)
2027年5月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年7月30日
QC基準を満たした最初の提出物
2026年8月6日
最初の投稿 (実際)
2026年8月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月11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6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
- STUDY26030108
- 1R61DA063659 (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?
いいえ
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
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