Clinical trial NCT06827288: Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder
Official title: Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Arrowhead Regional Medical Center
name: Alameda Health System
name: Stanford University
First posted: 2025-02-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A two-stage Sequential Multiple Assignment Randomized Trial (SMART).
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Detailed description: 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 OUD. The trial includes (1) two first stage components: the CA Bridge Model with Substance Use Navigator assisted treatment initiation and linkage to care (SUN) or CA Bridge plus immediate telehealth connection to an outpatient provider (SUN+TeleBridge); (2) a dynamic tailoring variable describing (non) response to the first stage: whether the patient has not filled an outpatient buprenorphine prescription at 30 days or whether the patient returns to the ED with an OUD-related event or self-reports non-adherence to buprenorphine within the first 90 days; (3) two second-stage components for non-responders; either ongoing buprenorphine treatment by an ED-based interim treatment team (ED-ITT) or ED-ITT augmented with behavioral health support (ED-ITT+BHS). First-stage responders will receive no further active intervention unless the participant returns to the ED or notifies the SUN about no longer taking buprenorphine within 90 days of study enrollment.

Hypothesis 1: The investigators hypothesize that the most intensive Adaptive Treatment Strategy (ATS) will lead to (a) more days of buprenorphine use and (b) a longer time to overdose, self-harm, or death compared to the least intensive ATS.

Hypothesis 2: The investigators hypothesize that (a) SUN+TeleBridge in the first stage of the ATS and (b) ED-ITT+BHS in the second stage of the ATS will each lead to more days of buprenorphine use and a longer time to overdose, self-harm, or death within the first 12 months compared to SUN and ED-ITT, respectively, and (c) there is a synergistic positive effect of receiving both SUN+TeleBridge and ED-ITT+BHS on days of buprenorphine use.

Hypothesis 3: The investigators hypothesize that the effect of SUN+TeleBridge versus SUN and the effect of ED-ITT+BHS versus ED-ITT among first stage non-responders will be larger among those with (a) a history of overdose at baseline and (b) co-occurring depression or PTSD at baseline relative to those who do not have either or those conditions.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: The number of days a buprenorphine prescription was filled in the 6 months after enrollment
timeFrame: 6 months from date of enrollment
Secondary outcomes:
measure: The time to a composite measure of overdose, suicide, self-harm and death
timeFrame: 6 months from date of enrollment
Other outcomes:
Locations:
city: Colton
country: United States
facility: Arrowhead Regional Medical Center
state: California
Study officials:
References: