Opioid Use Disorder, Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe
Conditions
Keywords
opioid, Opioid Use Disorder, MOUD, buprenorphine, methadone
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTRTME
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.
Sponsors
T. John Winhusen, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outpatient MOUD initiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MOUD knowledge score | 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 |
| MOUD Stigma | 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. |
| Drug Self-efficacy | 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. |
| Opioid-overdose knowledge score | 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. |
Countries
United States
Contacts
CONTACTLindsay Bybee, MS
CONTACTBen Kropp Kropp, MSLS
PRINCIPAL_INVESTIGATORT. John Winhusen, PhD.
University of Cincinnati
Outcome results
None listed