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

NCT ID: NCT06961058

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 528 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-03
• Study Completion Date: 2029-09-01

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.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

in person

Participants will get treatment via CA Bridge, California's statewide program to provide Emergency Department (ED)-based OUD treatment. When clinicians or staff suspect an ED patient may have OUD, they refer the patient to an ED-based counselor who assesses the patient and engages them in OUD care. All patients with OUD get brief counseling and take-home naloxone. Patients willing to start treatment get buprenorphine (via either ED- or home-based induction), a referral for in-person outpatient OUD treatment at a local outpatient clinic or opioid treatment program, and a "bridge" prescription of buprenorphine to last until their first outpatient appointment. CA Bridge counselors maintain contact with patients for up to 30 days to help them establish outpatient care. This is usual care in study hospitals and in the \>80% of California hospitals that participate in CA Bridge.

Group Type: ACTIVE_COMPARATOR

referral to in person treatment

Intervention Type: OTHER

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

telehealth

This arm will comprise the same elements as the "in person" arm except that patients will be referred to get outpatient OUD treatment via telehealth (i.e. phone or video visits). Depending on study site and patient insurance, participants will be referred to get treatment at either a clinic associated with their hospital that offers telehealth OUD treatment or from a digital health company that provides on-demand telehealth OUD treatment and support services via video and phone visits.

Group Type: EXPERIMENTAL

referral to telehealth treatment

Intervention Type: OTHER

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

Interventions

referral to telehealth treatment

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

Intervention Type: OTHER

referral to in person treatment

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aimee Moulin, MD MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Stephen G Henry, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

El Centro Regional Medical Center Emergency Department

El Centro, California, United States

Site Status: RECRUITING

University of California Davis Emergency Department

Sacramento, California, United States

Site Status: RECRUITING

Olive View - UCLA Medical Center Emegency Department

Sylmar, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dominique Ritley, MPH

Role: CONTACT

dritley@ucdavis.edu

916-734-7391

Stephen Henry, MD MSc

Role: CONTACT

sghenry@ucdavis.edu

916-734-7391

Facility Contacts

Rahul Nene, MD PhD

Role: primary

rnene@health.ucsd.edu

760-339-7100

Dominique Ritley, MPH

Role: primary

dritley@ucdavis.edu

916-734-7391

Breena Taira, MD MPH

Role: primary

btaira@dhs.lacounty.gov

844-804-0055

References

D'Onofrio G, Chawarski MC, O'Connor PG, Pantalon MV, Busch SH, Owens PH, Hawk K, Bernstein SL, Fiellin DA. Emergency Department-Initiated Buprenorphine for Opioid Dependence with Continuation in Primary Care: Outcomes During and After Intervention. J Gen Intern Med. 2017 Jun;32(6):660-666. doi: 10.1007/s11606-017-3993-2. Epub 2017 Feb 13.

Reference Type: BACKGROUND

PMID: 28194688 (View on PubMed)

Related Links

https://www.pcori.org/research-results/2024/person-versus-telehealth-opioid-use-disorder-treatment-after-patients-leave-emergency-department

PCORI (funder) website for this study

Other Identifiers

BPS-2023C3-35503

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2262435

Identifier Type: -

Identifier Source: org_study_id