Shared Decision MakingPROMOTENCT07758439
PROMOTE: A Pilot and Feasibility Study
An observational study of Shared Decision Making, run by University of Pittsburgh at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shared Decision Making
- What is being tested?
- Implementation facilitation for shared decision making
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- ≥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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Community Medical Services Mesa, AZ on Main
Mesa, Arizona, 85213
Clinic Manager, 480-977-1500
About this study
Official title: 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.
Read the detailed description
A combination of cross-sectional (surveys) during the study period and retrospective (Electronic Health Record data) following the study period.
- Conditions
- Shared Decision Making
- Being tested
- Implementation facilitation for shared decision making
- Keywords
- shared decision making, opioid treatment program, implementation facilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation facilitation for shared decision makingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Implementation facilitation for shared decision making |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 6-month implementation period
Secondary outcomes (3)
Feasibility of healthcare professional survey recruitment and data collection procedures
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.
Measured: 6-month implementation period
Acceptability of the Spanish version of client survey
- 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.
Measured: 6-month implementation period
Utilization of Spanish version of client survey
The number of completed Spanish surveys divided by the total number of client surveys completed.
Measured: 6-month implementation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shared Decision MakingStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Yale University, New York University, Berkshire Medical Center, Community Medical Services, LLC, Penn State College of Medicine
- Responsible party
- Principal investigator, Paul Joudrey, University of Pittsburgh
- Investigators
- Paul Joudrey, MD, MPH, Principal investigator, University of PittsburghCristina Murray-Krezan, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758439
- Sponsor's protocol ID
- STUDY26030108
- Other IDs
- 1R61DA063659
- Acronym
- PROMOTE
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PeRsOnalized MethOdone TrEatment (PROMOTE) by Implementing Shared Decision-making: A Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT07758439
- Acronym / sponsor ID
- PROMOTE / STUDY26030108
- Conditions
- Shared Decision Making
- Keywords
- shared decision making, opioid treatment program, implementation facilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Yale University, New York University, Berkshire Medical Center, Community Medical Services, LLC, Penn State College of Medicine
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A combination of cross-sectional (surveys) during the study period and retrospective (Electronic Health Record data) following the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Implementation Intervention | – | Behavioral: Implementation facilitation for shared decision makingImplementation 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. |
| Health Care Provider Implementation Intervention | – | Behavioral: Implementation facilitation for shared decision makingImplementation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation facilitation for shared decision makingImplementation 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. | Behavioural | Health Care Provider Implementation Intervention, Patient Implementation Intervention |
Primary outcome
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.
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.
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.
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).
3 secondary outcomes
Feasibility of healthcare professional survey recruitment and data collection procedures
Time frame: 6-month implementation period
Acceptability of the Spanish version of client survey
Time frame: 6-month implementation period
Utilization of Spanish version of client survey
Time frame: 6-month implementation period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Joudrey, MD, MPH principal investigator
University of Pittsburgh
Cristina Murray-Krezan, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shared Decision Making, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research Program Manager (+1-412-624-7263, dmo36@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of client survey recruitment and data collection procedures (time frame: 6-month implementation period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.