PROMOTE: A Pilot and Feasibility Study
ConditionShared Decision Making
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Do not meet client inclusion criteria
For the client survey, each client may complete the survey only once during the 6-month implementation period.
The investigators will exclude healthcare professionals who do not meet inclusion criteria
The investigators will exclude clients who do not meet inclusion criteria
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Implementation facilitation for shared decision making
BehavioralImplementation 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.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: Patient Implementation Intervention1 intervention
Group B: Health Care Provider Implementation Intervention1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
6-month implementation period2
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.
Time frame
6-month implementation period3
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.
Time frame
6-month period preceding the implementation period4
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).
Time frame
6-month implementation periodSecondary outcomes
1
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.
Time frame
6-month implementation period2
Acceptability of the Spanish version of client survey
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.
Time frame
6-month implementation period3
Utilization of Spanish version of client survey
The number of completed Spanish surveys divided by the total number of client surveys completed.
Time frame
6-month implementation periodSponsors and contacts
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University of Pittsburgh
Lead sponsor
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
Source ClinicalTrials.gov
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