PROMOTE: A Pilot and Feasibility Study

NCT07758439 | Not Yet Recruiting

• 2 other identifiers: STUDY260301081R61DA063659
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shared Decision Making

Keywords

shared decision making; opioid treatment program; implementation facilitation

Outcome Measures

Primary Outcomes (4)

• Feasibility of client survey recruitment and data collection procedures

  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.

  6-month implementation period

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

  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.

  6-month implementation period

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

  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.

  6-month period preceding the implementation period

• Feasibility and acceptability of the IF intervention for OTPs.

  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).

  6-month implementation period

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Behavioral: Implementation facilitation for shared decision making

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.

Behavioral: Implementation facilitation for shared decision making

Interventions

Implementation facilitation for shared decision making BEHAVIORAL

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.

Health Care Provider Implementation Intervention; Patient Implementation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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
• ≥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
• ≥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
• 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.

You may not qualify if:

• For the client survey, each client may complete the survey only once during the 6-month implementation period.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Yale University: collaborator
• New York University: collaborator
• Berkshire Medical Center: collaborator
• Community Medical Services, LLC: collaborator
• Penn State College of Medicine: collaborator

Study Sites (1)

Community Medical Services Mesa, AZ on Main

Mesa, Arizona, 85213, United States

Location

Study Officials

• Paul Joudrey, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Cristina Murray-Krezan, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Program Manager

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)