Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRAND

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 volunteers

Qualifiers

Presented for ED care at ARMC

Age 18 or older

Probable OUD diagnosis

Speak and understand English or Spanish

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • SUN

    Behavioral

    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.

  • SUN + Telebridge

    Behavioral

    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.

  • ED-ITT

    Behavioral

    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.

  • ED-ITT + BHS

    Behavioral

    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.

Treatment groups

500 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: SUN with no follow upActive comparator 1 intervention
Group B: SUN followed by ED-ITTActive comparator 2 interventions
Group C: SUN followed by ED-ITT + BHSActive comparator 2 interventions
Group D: SUN + Telebridge with no follow upActive comparator 1 intervention
Group E: SUN + Telebridge followed by ED-ITTActive comparator 2 interventions
Group F: SUN + Telebridge followed by ED-ITT + BHSActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

The number of days a buprenorphine prescription was filled in the 6 months after enrollment

Time frame
6 months from date of enrollment

Secondary outcomes

1

The time to a composite measure of overdose, suicide, self-harm and death

Time frame
6 months from date of enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RAND

Lead sponsor

Arrowhead Regional Medical Center

Collaborator

Alameda Health System

Collaborator

Stanford University

Collaborator