About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presented for ED care at ARMC
Age 18 or older
Probable OUD diagnosis
Speak and understand English or Spanish
Disqualifiers
None
Trial design
Sequential
Treatments tested in this trial
SUN
BehavioralThe 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.
SUN + Telebridge
BehavioralTeleBridge 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.
ED-ITT
BehavioralEnrolled 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.
ED-ITT + BHS
BehavioralEnrolled 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.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
The number of days a buprenorphine prescription was filled in the 6 months after enrollment
Secondary outcomes
The time to a composite measure of overdose, suicide, self-harm and death
Sponsors and contacts
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RAND
Lead sponsor
Arrowhead Regional Medical Center
Collaborator
Alameda Health System
Collaborator
Stanford University
Collaborator