Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder
ADAPT-ED
1 other identifier
interventional
500
1 country
1
Brief Summary
The ADAPT-ED study is a two-stage, sequential multiple assignment randomized trial (SMART) to inform the development of an adaptive intervention that is optimally effective in increasing long-term buprenorphine use for adults presenting to the ED with probable opioid use disorder (OUD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2024
CompletedFirst Submitted
Initial submission to the registry
February 10, 2025
CompletedFirst Posted
Study publicly available on registry
February 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2028
February 19, 2026
February 1, 2026
2.7 years
February 10, 2025
February 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The number of days a buprenorphine prescription was filled in the 6 months after enrollment
6 months from date of enrollment
Secondary Outcomes (1)
The time to a composite measure of overdose, suicide, self-harm and death
6 months from date of enrollment
Study Arms (6)
SUN with no follow up
ACTIVE COMPARATORIn Arm A, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be responders by 90 days and therefore receive no active follow up.
SUN followed by ED-ITT
ACTIVE COMPARATORIn Arm B, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team.
SUN followed by ED-ITT + BHS
ACTIVE COMPARATORIn Arm C, participants are randomized to receive SUN-assisted treatment initiation and linkage to care. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT + BHS condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team augmented with a behavioral health consultant who will provide behavioral health support for up to 3 months.
SUN + Telebridge with no follow up
ACTIVE COMPARATORIn Arm D, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be responders by 90 days and therefore receive no active follow up.
SUN + Telebridge followed by ED-ITT
ACTIVE COMPARATORIn Arm E, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team.
SUN + Telebridge followed by ED-ITT + BHS
ACTIVE COMPARATORIn Arm F, participants are randomized to receive SUN-assisted treatment initiation and linkage to care plus SUN-assisted immediate telehealth connection to an outpatient provider. The patients are determined to be non-responders within 90 days and are subsequently randomized into the ED-ITT + BHS condition to receive ongoing buprenorphine treatment by an ED-based interim treatment team augmented with a behavioral health consultant who will provide behavioral health support for up to 3 months.
Interventions
The SUN helps patients initiate buprenorphine treatment in the hospital, connects patients to follow-up care by facilitating appointments at outpatient clinics, addresses barriers to care, and serves as a resource for patients and clinicians. The SUN also advocates for a harm-reduction culture, models respectful interactions with people who use drugs and provides technical assistance to hospital staff to reduce stigma and discrimination.
TeleBridge consists of an immediate telehealth connection to a buprenorphine provider affiliated with the CA Bridge program who has expertise facilitating pharmacotherapy with individuals with OUD. TeleBridge addresses barriers to initiation of buprenorphine by reducing long wait times and the inability of the outpatient setting to initiate treatment on demand. TeleBridge also eliminates the need for patients to meet system-level requirements (e.g. on time for appointments during working hours while wearing appropriate attire) to obtain follow-up care. TeleBridge is a more resource-intensive form of care because it involves developing formalized relationships with outpatient providers and implementing telehealth protocols. TeleBridge is feasible based on the increased use of telehealth to expand post-ED care pathways.
Enrolled patients who have not filled an outpatient buprenorphine (BUP) prescription at 30 days, return to the ED with an OUD-related event, or self-report nonadherence to the prescribed BUP are considered non-responders, and randomly assigned to a second stage intervention. For non-responders randomized to receive ongoing BUP treatment by an ED-based interim treatment team (ED-ITT), the SUN and Site PI (an ED physician with expertise in addiction medicine) will meet weekly to review the SUN's caseload, using a patient registry that has been modified for the trial. The registry: 1) prompts/documents proactive SUN outreach up to 3 additional months for non-responders, with an emphasis on prioritizing subsequent outreach to patients who have not yet engaged with outpatient care, or who are at risk of dropping out if the patient have transitioned; and 2) documents when the ED provider prescribes transitional BUP and when the patient would be due for a new prescription.
Enrolled patients who have not filled an outpatient buprenorphine (BUP) prescription at 30 days, return to the ED with an OUD-related event, or self-report to the SUN nonadherence to the prescribed BUP will be considered non-responders, and randomly assigned to a second stage intervention. For non-responders randomized to receive ongoing BUP treatment from the ED-ITT+BHS, Behavioral Health Support (BHS) will be added to ED-ITT and include a weekly caseload review with an externally-affiliated psychiatrist with expertise in addiction medicine who will make mental health and substance use treatment recommendations, both pharmacological and behavioral, to the ED provider and SUN for up to 3 months. The consultant may also ask the SUN to do a more detailed behavioral health assessment, if insufficient information is available to make treatment recommendations. All prescriptions will be written by the ED provider.
Eligibility Criteria
You may qualify if:
- Presented for ED care at ARMC
- Age 18 or older
- Probable OUD diagnosis
- Speak and understand English or Spanish
- Have capacity to give informed consent
- Provide a signed and dated informed consent form
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RANDlead
- Alameda Health Systemcollaborator
- Stanford Universitycollaborator
- Arrowhead Regional Medical Centercollaborator
Study Sites (1)
Arrowhead Regional Medical Center
Colton, California, 92324, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Katherine Watkins, MD
Study Record Dates
First Submitted
February 10, 2025
First Posted
February 14, 2025
Study Start
October 4, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
March 31, 2028
Last Updated
February 19, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
All participant data will be destroyed in accordance with RAND Survey Research Group institutional policies (RAND SRG follows Federal guidelines, currently 7 years following study completion).