Comparing high and low intensity strategies for opioid use disorder treatment in hospitals
Exemplar Hospital Initiation Trial to Enhance Treatment Engagement - Implementation Trial of High Intensity Versus Low Intensity Strategy for Supporting Hospital-Based Opioid Use Disorder Treatment
This study is trying to see if a more intense approach to treating opioid use disorder in hospitals helps patients stay engaged with their treatment after they leave compared to a less intense approach.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Sex | All |
| Sponsor | Hennepin Healthcare Research Institute Academic / other |
| Locations | 4 sites (Boston, Massachusetts and 3 other locations) |
| Trial ID | NCT04921787 on ClinicalTrials.gov |
What this trial studies
This implementation trial evaluates the effectiveness of high-intensity versus low-intensity strategies for supporting hospital-based opioid use disorder treatment in community hospitals that have not previously implemented medication for opioid use disorder (MOUD). Approximately 24 community hospitals will be randomized to either strategy, with oversight from 3-4 academic medical centers that have expertise in this area. The primary outcome will measure the engagement of discharged patients with MOUD within 34 days post-discharge, assessed over a four-year period. The study aims to enhance the treatment of opioid use disorder among hospitalized patients.
Who should consider this trial
Good fit: Ideal candidates for this study are community hospitals willing to implement MOUD for inpatients with opioid use disorder.
Not a fit: Patients in hospitals that are not interested in or unable to implement MOUD will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the rates of engagement with opioid use disorder treatment for patients discharged from community hospitals.
How similar studies have performed: Other studies have shown promising results with similar implementation strategies for opioid use disorder treatment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Be a community hospital deemed by the lead investigators to be in the region of a site/hub. Region will usually be defined as state unless a compelling case can be made as to geographic feasibility of implementing the intervention and access to relevant Medicaid data. 2. Be willing to identify a site champion to promote and adopt change that can address OUD in hospitalized patients. 3. Have hospital personnel who state that their institution is interested in and would be willing to work to implement MOUD prior to hospital discharge. 4. Commit to having buprenorphine-waivered prescribers willing and able to write prescriptions to bridge discharged patients to post-discharge OUD treatment, or available direct entry into outpatient MOUD with methadone or buprenorphine. 5. Have hospital staff who express willingness to engage with a site/hub team for training and for data collection. 6. Be willing to be randomized to low-intensity or high-intensity implementation support. 7. Provide inpatient general medical care. 8. Have sufficient numbers of Medicaid OUD discharges (any listed diagnosis; sufficient is defined as at least enough such that when added to the other hospitals in the region there are on average 100 discharges per year). Medicaid data must capture at least 3 discharge diagnoses, outpatient MOUD, and be available within no more than 12 months of discharge. Exclusion Criteria: 1. Have an ACS routinely prescribing MOUD at discharge. 2. Have an existing, functioning HBOT program or be imminently starting an HBOT initiative, as confirmed by the investigator team. 3. Be a Veterans Affairs hospital.
Where this trial is running
Boston, Massachusetts and 3 other locations
- Boston University — Boston, Massachusetts, United States (Recruiting)
- Hennepin Healthcare Research Institute — Minneapolis, Minnesota, United States (Recruiting)
- New York University — New York, New York, United States (Recruiting)
- Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Paulette Baukol
- Email: pbaukol@bermancenter.org
- Phone: 612-873-6993
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.