Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-06 @ 8:28 PM
Study NCT ID:
NCT06961058
Status:
RECRUITING
Last Update Posted:
2025-10-22
First Post:
2025-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telehealth vs In-Person Evaluation of Addiction Treatment After Visiting the Emergency Department
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
In Person vs Telehealth Opioid Use Disorder Treatment After Patients Leave the Emergency Department
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREATED
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BPS-2023C3-35503 | OTHER_GRANT | Patient-Centered Outcomes Research Institute | View |