PeRsOnalized MethOdone TrEatment (PROMOTE) by Implementing Shared Decision-making: A Pilot and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Feasibility of client survey recruitment and data collection procedures
研究概览
简要总结
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.
详细描述
A combination of cross-sectional (surveys) during the study period and retrospective (Electronic Health Record data) following the study period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Implementation facilitation for shared decision making (Behavioral)
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.
干预措施: Implementation facilitation for shared decision making (Behavioral)
结局指标
主要结局
Feasibility of client survey recruitment and data collection procedures
时间窗: 6-month implementation period
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.
Feasibility of observed client-healthcare professional encounter recruitment and data collection procedures
时间窗: 6-month implementation period
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.
Feasibility of ascertainment of retention in methadone treatment during a 6-month period using site Electronic Health Record (EHR) data
时间窗: 6-month period preceding the implementation period
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.
Feasibility and acceptability of the IF intervention for OTPs.
时间窗: 6-month implementation period
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).
次要结局
- Feasibility of healthcare professional survey recruitment and data collection procedures(6-month implementation period)
- Acceptability of the Spanish version of client survey(6-month implementation period)
- Utilization of Spanish version of client survey(6-month implementation period)
研究者
Paul Joudrey
Assistant Professor
University of Pittsburgh