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Telehealth vs In-Person Evaluation of Addiction Treatment After Visiting the Emergency Department

In Person vs Telehealth Opioid Use Disorder Treatment After Patients Leave the Emergency Department

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06961058
Acronym
TREATED
Enrollment
528
Registered
2025-05-07
Start date
2025-06-03
Completion date
2029-09-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder

Keywords

emergency department, buprenorphine, telehealth, comparative effectiveness

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.

Interventions

OTHERreferral to telehealth treatment

the intervention tested will be referral to get outpatient treatment via telehealth. Participants in the telehealth arm will receive the intervention.

OTHERreferral to in person treatment

participants in the in person arm will be referred to in person OUD treatment after they leave the ED

Sponsors

University of California, Davis
Lead SponsorOTHER
Patient-Centered Outcomes Research Institute
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

Research staff will be unaware of participant arm assignment until after the participant has enrolled.

Intervention model description

Our study will use a two-stage randomization procedure. Patients will first be randomized 3:1 to either a "random assignment" group, which will then be further randomized 1:1 to one of the two arms, or a "patient choice" group. Patients in the "patient choice" group will be assigned to their preferred arm. If patients in this group have no preference, we will randomize them 1:1 to one of the arms. This approach allows estimation of both treatment effects and effects of patient preference on outcomes.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* inability to give consent * patients living in institutions (e.g., nursing homes, prisons) * unable to complete questionnaires in either English or Spanish

Design outcomes

Primary

MeasureTime frameDescription
buprenorphine retention6 monthscumulative days with an active buprenorphine prescription

Secondary

MeasureTime frameDescription
buprenorphine retention3 months, 9 monthscumulative days with an active buprenorphine prescription
buprenorphine retention (binary)3, 6, 9 monthsactive buprenorphine prescription with no gap in coverage \>7 days
drug overdose death1, 3, 6, 9 monthsdeath related to overdose
past 30-day opioid use1, 3, 6, 9 monthspatient-reported number of days patient used opioids (illicit opioids or prescription opioids for non-medical reasons) during past 30 days
patient experience with care1, 3, 6, 9 monthsAccess and visit rating subscales of AHRQ CAHPS clinician and group survey
non-fatal overdose1, 3, 6, 9 monthsnon-fatal overdose related to drug use, assessed from a combination of patient report and hospital electronic health records
establishing outpatient treatment1 monthpatients filling at least 1 outpatient buprenorphine prescription within 30 days of their emergency department visit

Countries

United States

Contacts

CONTACTMeghan Weyrich, MPH
masoulsby@health.ucdavis.edu916-734-7391
CONTACTStephen Henry, MD MSc
sghenry@ucdavis.edu916-734-7391
PRINCIPAL_INVESTIGATORAimee Moulin, MD MAS

University of California, Davis

PRINCIPAL_INVESTIGATORStephen G Henry, MD MSc

University of California, Davis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026