PROMOTE: A Pilot and Feasibility Study (PROMOTE)

August 6, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Research Program Manager
  • Phone Number: +1-412-624-7263
  • Email: dmo36@pitt.edu

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Community Medical Services Mesa, AZ on Main
        • Contact:
          • Clinic Manager
          • Phone Number: 480-977-1500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6-month implementation period
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.
6-month implementation period
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.
6-month period preceding the implementation period
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).
6-month implementation period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
6-month implementation period
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.
6-month implementation period
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.
6-month implementation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Yale University
New York University
Berkshire Medical Center
Penn State College of Medicine
Community Medical Services, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Joudrey, MD, MPH, University of Pittsburgh
  • Principal Investigator: Cristina Murray-Krezan, PhD, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY26030108
  • 1R61DA063659 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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