Telehealth vs In-Person Evaluation of Addiction Treatment After Visiting the Emergency Department
- Conditions
- Opioid Use Disorder
- Registration Number
- NCT06961058
- Lead Sponsor
- University of California, Davis
- Brief Summary
Main study objective: compare long-term buprenorphine treatment outcomes for patients who start buprenorphine for opioid use disorder (OUD) in the emergency department and are then referred to get outpatient buprenorphine treatment either via telehealth or at an in-person clinic.
Researchers will:
Compare rates of establishing outpatient OUD treatment, how long patients stay on buprenorphine, and patients' experience with care to determine whether patient experiences and outcomes are better for patients referred to telehealth treatment versus patients patients referred to in-person treatment after they leave the emergency department.
Participants will:
Be recruited from 3 different hospital emergency departments.
Answer questionnaires at baseline and then 1, 3, 6, and 9 months after their initial emergency department visit.
- Detailed Description
Buprenorphine is a lifesaving but underused medication for treating opioid use disorder (OUD). Providing buprenorphine for OUD in hospital emergency departments is an evidence-based practice that reduces patients' risk of overdose. Most people with OUD need to stay on buprenorphine for years, yet median buprenorphine adherence is typically less than six months. There is thus a clear need for strategies to increase long term buprenorphine retention, particularly among patients prescribed buprenorphine in emergency departments, who often face barriers when transitioning to outpatient OUD treatment after they leave the emergency department. The practice of providing outpatient OUD treatment via telehealth (e.g., through video or phone visits) was developed years ago to serve rural areas, but it has become much more widely used and accepted across the US since the COVID-19 pandemic. Telehealth OUD treatment may also reduce logistical barriers to treatment (e.g., transportation) and reduce impacts of patient-reported OUD stigma (by reducing in-person visits to addiction clinics). This proposed study will address the following research question: For patients prescribed buprenorphine for OUD in hospital emergency departments and then referred for outpatient buprenorphine treatment, how do rates of establishing outpatient treatment and long-term retention in treatment compare for patients referred to treatment in person (at outpatient clinics or opioid treatment programs) versus treatment via telehealth? The study hypothesis is that rates of engaging with outpatient treatment, long-term buprenorphine retention, and patients' experience with care will be greater for patients referred to telehealth compared to in-person OUD treatment. To test this hypothesis, this project will conduct a pragmatic clinical trial at three emergency departments that participate in "CA Bridge," a statewide California program to encourage substance use treatment in emergency departments. Patients started on buprenorphine for OUD in the emergency department will be recruited and randomized 3:1 to either a random assignment group or a group where patients can choose their outpatient arm assignment. Patients in the random assignment group will be further randomized 1:1 to be referred to either in-person or telehealth outpatient treatment. This 2-step study design allows researchers to estimate both traditional effect sizes and the impact of patient preference on outcomes. Buprenorphine prescribing will be measured using prescription records from California's prescription drug monitoring program; patient questionnaires will be administered at baseline and 1, 3, 6, and 9 months after patients' emergency department visit. Treatment outcomes will be the proportion of patients establishing outpatient OUD treatment (i.e., filling at least one outpatient buprenorphine prescription within 30 days of their emergency department) and cumulative days with an active buprenorphine prescription six months after their emergency department visit (primary outcome). Drug related fatal overdose will be measured using California death certificate data. Subsequent emergency department visits and hospitalizations will be assessed from electronic health records. Patients' experience with care will be measured using AHRQ's Consumer Assessment of Health Providers and Systems Clinician and Group survey version 4.0, which includes questions specific to telehealth encounters. Finally, this study will examine associations between patients' baseline reports of OUD stigma and subsequent treatment outcomes as well as how arm assignment effects this association. Study findings will fill key evidence gaps and directly inform decisions by clinicians and patients about where patients should be referred for outpatient buprenorphine treatment after they leave the emergency department. Compared to the general population with OUD, patients who seek OUD care in the emergency department have higher overdose risk and are disproportionately low-income, non-white, and unstably housed. Thus, improving buprenorphine retention among patients who start treatment in the emergency department also has potential to reduce socioeconomic disparities in OUD treatment and, ultimately, overdose rates. Findings from our study will be immediately applicable to clinicians and patients in the nearly 300 hospital emergency departments across California that participate in the CA Bridge program as well as to hospitals across the country that have implemented emergency department-based OUD treatment programs.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 528
- Adult patients who present to the emergency department and receive buprenorphine (either administered or prescribed) to treat OUD
- do not have an established outpatient clinic where they will get buprenorphine when they leave the emergency department
- inability to give consent
- patients living in institutions (e.g., nursing homes, prisons)
- unable to complete questionnaires in either English or Spanish
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method buprenorphine retention 6 months cumulative days with an active buprenorphine prescription
- Secondary Outcome Measures
Name Time Method past 30-day opioid use 1, 3, 6, 9 months patient-reported number of days patient used opioids (illicit opioids or prescription opioids for non-medical reasons) during past 30 days
patient experience with care 1, 3, 6, 9 months Access and visit rating subscales of AHRQ CAHPS clinician and group survey
non-fatal overdose 1, 3, 6, 9 months non-fatal overdose related to drug use, assessed from a combination of patient report and hospital electronic health records
establishing outpatient treatment 1 month patients filling at least 1 outpatient buprenorphine prescription within 30 days of their emergency department visit
buprenorphine retention 3 months, 9 months cumulative days with an active buprenorphine prescription
buprenorphine retention (binary) 3, 6, 9 months active buprenorphine prescription with no gap in coverage \>7 days
drug overdose death 1, 3, 6, 9 months death related to overdose
Trial Locations
- Locations (3)
El Centro Regional Medical Center Emergency Department
🇺🇸El Centro, California, United States
University of California Davis Emergency Department
🇺🇸Sacramento, California, United States
Olive View - UCLA Medical Center Emegency Department
🇺🇸Sylmar, California, United States