Shared Decision Making
Conditions
Keywords
shared decision making, opioid treatment program, implementation facilitation
Brief 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.
Detailed description
A combination of cross-sectional (surveys) during the study period and retrospective (Electronic Health Record data) following the study period.
Interventions
BEHAVIORALImplementation 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.
Sponsors
University of Pittsburgh
National Institute on Drug Abuse (NIDA)
Yale University
New York University
Berkshire Medical Center
Community Medical Services, LLC
Penn State College of Medicine
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of client survey recruitment and data collection procedures | 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 | 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 | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of healthcare professional survey recruitment and data collection procedures | 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. |
| Acceptability of the Spanish version of client survey | 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. |
| Utilization of Spanish version of client survey | 6-month implementation period | The number of completed Spanish surveys divided by the total number of client surveys completed. |
Countries
United States
Contacts
CONTACTResearch Program Manager
PRINCIPAL_INVESTIGATORPaul Joudrey, MD, MPH
University of Pittsburgh
PRINCIPAL_INVESTIGATORCristina Murray-Krezan, PhD
University of Pittsburgh
Outcome results
None listed