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NCT07758439
PROMOTE: A Pilot and Feasibility Study
Conditions: Shared Decision Making
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 58
Sponsor: University of Pittsburgh
Location: Community Medical Services Mesa, AZ on Main Mesa Arizona
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07758439). StuddyBuddy aggregates publicly available trial information.