Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

TRTME: Improving Outpatient Initiation of Medication for Opioid Use Disorder Following Hospitalization (TRTME)

18 augustus 2026 bijgewerkt door: T. John Winhusen, PhD

A Pilot Randomized Controlled Trial to Improve Outpatient Initiation of Medication for Opioid Use Disorder (MOUD) Following Hospitalization: The TRTME (Tailored Overdose Risk Feedback, Testimonials for MOUD Treatment, and Education on MOUD and Opioid Overdose) Trial

The primary objective of this study is to evaluate the ability of TRTME to increase initiation of MOUD outpatient treatment and MOUD knowledge in hospitalized patients with OUD deemed to be good candidates for MOUD by the UCMC Addiction Consult Team (ACT). The secondary objective is to evaluate the ability of TRTME to decrease stigma and increase drug self-efficacy.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is an intent-to-treat, two-arm, open-label, pragmatic randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to TRTME or Control. Participants will receive the assigned intervention following randomization, will complete a post-assessment following treatment receipt, and will complete a follow-up phone call at approximately one month posthospital discharge.

All participants will complete assessments of their opioid-overdose and MOUD knowledge and their risk for experiencing an opioid-overdose during baseline. TRTME participants will be offered a 15-minute intervention in which a trained research staff member reviews personal feedback reports with the recipient to provide information on: 1) the items missed on the knowledge assessment; and 2) their personal overdose risk factors. TRTME participants will also have the opportunity to view short videos from patients talking about their experiences with methadone or buprenorphine treatment. Control participants will be offered two SAMHSA handouts.

Enrollment is expected to take place over a period of approximately 7.5 months. Duration of study participation will be approximately 5 weeks.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Lindsay Bybee, MS
  • Telefoonnummer: 5135858282
  • E-mail: saskowld@uc.edu

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Ohio
      • Cincinnati, Ohio, Verenigde Staten, 45229
        • Werving
        • University of Cincinnati Addiction Sciences Division

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. 18 years of age or older;
  2. A good candidate for methadone or buprenorphine treatment according to a member of the UCMC Addiction Consult Team

Exclusion Criteria:

  1. Have a current planned discharge to a nursing facility
  2. be currently in jail, prison, or any inpatient overnight facility as required by court of law or have pending legal action with high probability of incarceration or court-mandated inpatient treatment
  3. Unable to demonstrate adequate understanding of study procedures during the consent process

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Control
Control participants will be offered two SAMHSA handouts: 1) "Opioid Overdose Prevention Toolkit: Safety Advice for Patients and Family Members"; and 2) "Medication-Assisted Treatment for Opioid Addiction: Facts for Families and Friends". These handouts can be offered as physical copies or electronically.
Experimenteel: TRTME
TRTME participants will be offered a 15-minute intervention in which a trained research staff member reviews personal feedback reports with the recipient to provide information on: 1) the items missed on the knowledge assessment; and 2) their personal overdose risk factors. TRTME participants will also have the opportunity to view short videos from patients talking about their experiences with methadone or buprenorphine treatment.
Gedragsmatig: TRTME
The TRTME intervention includes three elements that have all been previously studied by our research team: 1) brief, personally-tailored education to correct inaccurate, common misconceptions about MOUD and to address knowledge gaps about opioid-overdose; 2) with personally-tailored feedback on the individual's risk factors for experiencing an opioid-overdose; and 3) review of MOUD testimonial videos.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Outpatient MOUD initiation
Tijdsspanne: 30 days

The primary outcome is verified enrollment in outpatient MOUD within 30 days post-discharge.

Participants will be asked about their enrollment in MOUD approximately 30 days after their discharge from the hospital. Participants reporting having enrolled in treatment will be asked to provide a release of information for the treatment program to verify date of treatment enrollment.
30 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
MOUD knowledge score
Tijdsspanne: Immediately after the intervention
The key secondary outcome is MOUD knowledge as measured by the Opioid Overdose and Treatment Awareness Survey (OOTAS) knowledge evaluation. The OOTAS is comprised of 4 sections: 1) opioid-overdose risk factors; 2) signs of an opioid-overdose; 3) how to respond to an opioid-overdose; and 4) misconceptions about MOUD. The OOTAS has been successfully used to measure MOUD knowledge and knowledge change in three studies. The OOTAS includes 10 true-false questions to assess MOUD knowledge, yielding a potential score of 0-10.Secondary Outcome Measures
Immediately after the intervention
MOUD Stigma
Tijdsspanne: Immediately after the intervention

There are no existing validated measures for assessing MOUD stigma in patients who are good candidates for MOUD but have not yet entered treatment. The Medication for Opioid Use Disorder Attitudes Scale (MOUD-AS) was created by OpenEvidence based on stigmatizing beliefs about MOUD among patients considering treatment. The MOUD-AS includes 16 items scored from

1 (strongly disagree) to 5 (strongly agree). The total score, which has a potential range of 16-80, is the outcome of interest.
Immediately after the intervention
Drug Self-efficacy
Tijdsspanne: Immediately after the intervention
Self-efficacy in quitting drug use will be assessed with the Thoughts about abstinence (TAA) instrument. This measure assesses the participant's desire to quit, expected success in quitting and estimated difficulty in avoiding drug use. Our MOUD education intervention has been found to increase expected success in quitting drug use as measured by the TAA.
Immediately after the intervention
Opioid-overdose knowledge score
Tijdsspanne: Immediately after the intervention
Opioid-overdose knowledge will be measured by the first three sections of the OOTAS. The OOTAS has been successfully used to measure opioid-overdose knowledge and knowledge change in three prior studies conducted with individuals with OUD. The OOTAS includes 31 true-false questions to assess opioid-overdose knowledge, yielding a potential score of 0-31.
Immediately after the intervention

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

T. John Winhusen, PhD

Onderzoekers

  • Hoofdonderzoeker: T. John Winhusen, PhD., University of Cincinnati

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

12 augustus 2026

Primaire voltooiing (Geschat)

28 februari 2027

Studie voltooiing (Geschat)

28 februari 2027

Studieregistratiedata

Eerst ingediend

11 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 augustus 2026

Eerst geplaatst (Werkelijk)

21 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

18 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-0331

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren