Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое SUN
  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.
• Поведенческое SUN + Telebridge
  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 w
• Поведенческое ED-ITT
  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 c
• Поведенческое ED-ITT + BHS
  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 ps

Первичные конечные точки

• The number of days a buprenorphine prescription was filled in the 6 months after enrollment [Срок оценки: 6 months from date of enrollment]

Вторичные конечные точки (1)

• The time to a composite measure of overdose, suicide, self-harm and death [Срок оценки: 6 months from date of enrollment]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Arrowhead Regional Medical Center — Colton

Идентификаторы

NCT: NCT06827288 · 2022-N0631

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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