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PROMOTE: A Pilot and Feasibility Study (PROMOTE)

6 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Osservativo

Iscrizione (Stimato)

58

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Research Program Manager
  • Numero di telefono: +1-412-624-7263
  • Email: dmo36@pitt.edu

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Mesa, Arizona, Stati Uniti, 85213
        • Community Medical Services Mesa, AZ on Main
        • Contatto:
          • Clinic Manager
          • Numero di telefono: 480-977-1500

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Comportamentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of client survey recruitment and data collection procedures
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of healthcare professional survey recruitment and data collection procedures
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 6-month implementation period
The number of completed Spanish surveys divided by the total number of client surveys completed.
6-month implementation period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pittsburgh

Collaboratori

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

Investigatori

  • Investigatore principale: Paul Joudrey, MD, MPH, University of Pittsburgh
  • Investigatore principale: Cristina Murray-Krezan, PhD, University of Pittsburgh

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 maggio 2027

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

30 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 agosto 2026

Primo Inserito (Effettivo)

11 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • STUDY26030108
  • 1R61DA063659 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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