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PROMOTE: A Pilot and Feasibility Study (PROMOTE)

6. august 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Observationel

Tilmelding (Anslået)

58

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Research Program Manager
  • Telefonnummer: +1-412-624-7263
  • E-mail: dmo36@pitt.edu

Studiesteder

  • Forenede Stater
    • Arizona
      • Mesa, Arizona, Forenede Stater, 85213
        • Community Medical Services Mesa, AZ on Main
        • Kontakt:
          • Clinic Manager
          • Telefonnummer: 480-977-1500

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of client survey recruitment and data collection procedures
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feasibility of healthcare professional survey recruitment and data collection procedures
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6-month implementation period
The number of completed Spanish surveys divided by the total number of client surveys completed.
6-month implementation period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pittsburgh

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)
Yale University
New York University
Berkshire Medical Center
Penn State College of Medicine
Community Medical Services, LLC

Efterforskere

  • Ledende efterforsker: Paul Joudrey, MD, MPH, University of Pittsburgh
  • Ledende efterforsker: Cristina Murray-Krezan, PhD, University of Pittsburgh

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

30. juli 2026

Først indsendt, der opfyldte QC-kriterier

6. august 2026

Først opslået (Faktiske)

11. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STUDY26030108
  • 1R61DA063659 (U.S. NIH-bevilling/kontrakt)

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