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

NCT06961058 | Recruiting DMC

• 2 other identifiers: 2262435BPS-2023C3-35503
• Study Type: interventional
• Target: 528
• Locations: 1 country
• Sites: 3

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.

Conditions

Opioid Use Disorder

Keywords

emergency department; buprenorphine; telehealth; comparative effectiveness

Outcome Measures

Primary Outcomes (1)

• buprenorphine retention

  cumulative days with an active buprenorphine prescription

  6 months

Secondary Outcomes (7)

• buprenorphine retention

  3 months, 9 months

• buprenorphine retention (binary)

  3, 6, 9 months

• drug overdose death

  1, 3, 6, 9 months

• past 30-day opioid use

  1, 3, 6, 9 months

• patient experience with care

  1, 3, 6, 9 months

Other Outcomes (1)

• health care utilization

  1, 3, 6, 9 months

Study Arms (2)

in person

ACTIVE COMPARATOR

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.

Other: referral to in person treatment

telehealth

EXPERIMENTAL

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.

Other: referral to telehealth treatment

Interventions

referral to telehealth treatment OTHER

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

telehealth

referral to in person treatment OTHER

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

in person

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

El Centro Regional Medical Center Emergency Department

El Centro, California, 92243, United States

RECRUITING

University of California Davis Emergency Department

Sacramento, California, 95817, United States

RECRUITING

Olive View - UCLA Medical Center Emegency Department

Sylmar, California, 91342, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 28194688 BACKGROUND

Related Links

• PCORI (funder) website for this study

MeSH Terms

Conditions

Opioid-Related Disorders; Emergencies

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aimee Moulin, MD MAS

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Stephen G Henry, MD MSc

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique Ritley, MPH

CONTACT

916-734-7391; dritley@ucdavis.edu

Stephen Henry, MD MSc

CONTACT

916-734-7391; sghenry@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Research staff will be unaware of participant arm assignment until after the participant has enrolled.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 7, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)