Not Yet RecruitingNot Applicable

PROMOTE: A Pilot and Feasibility Study

United States58 participantsStarted 2026-09

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility of client survey recruitment and data collection procedures

Timeframe: 6-month implementation period

Feasibility of observed client-healthcare professional encounter recruitment and data collection procedures

Timeframe: 6-month implementation period

Feasibility of ascertainment of retention in methadone treatment during a 6-month period using site Electronic Health Record (EHR) data

Timeframe: 6-month period preceding the implementation period

Feasibility and acceptability of the IF intervention for OTPs.

Timeframe: 6-month implementation period

Trial details

NCT IDNCT07758439

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-05

Contact for this trial

Research Program Manager

+1-412-624-7263 dmo36@pitt.edu

View on ClinicalTrials.gov More Shared Decision Making trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility of client survey recruitment and data collection procedures

Timeframe: 6-month implementation period

Feasibility of observed client-healthcare professional encounter recruitment and data collection procedures

Timeframe: 6-month implementation period

Feasibility of ascertainment of retention in methadone treatment during a 6-month period using site Electronic Health Record (EHR) data

Timeframe: 6-month period preceding the implementation period

Feasibility and acceptability of the IF intervention for OTPs.

Timeframe: 6-month implementation period