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NCT Number: NCT07758439

PROMOTE: 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.

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Key information

Conditions

Shared Decision Making

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Community Medical Services Mesa, AZ on Main

Mesa, Arizona, 85213, United States

Location contact

Clinic Manager

CONTACT

480-977-1500

About this study

A combination of cross-sectional (surveys) during the study period and retrospective (Electronic Health Record data) following the study period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of client survey recruitment and data collection procedures

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Feasibility and acceptability of the IF intervention for OTPs.

    Time frame: 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).

Secondary outcomes

  1. Feasibility of healthcare professional survey recruitment and data collection procedures

    Time frame: 6-month implementation period

    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.

  2. Acceptability of the Spanish version of client survey

    Time frame: 6-month implementation period

    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.

  3. Utilization of Spanish version of client survey

    Time frame: 6-month implementation period

    The number of completed Spanish surveys divided by the total number of client surveys completed.

Study contacts

Contact information is provided by the study sponsor or research team.

Research Program Manager

CONTACT

[email protected]

+1-412-624-7263

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

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

Registry information

Official study title

PeRsOnalized MethOdone TrEatment (PROMOTE) by Implementing Shared Decision-making: A Pilot and Feasibility Study

Acronym: PROMOTE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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