Adaptive Interventions for Emergency Department Patients With Opioid Use Disorder
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Arrowhead Regional Medical Center
RECRUITING
Colton
Contact Information
Primary
Mariah Kalmin, PhD
mariahk@rand.org
310-393-0411
Backup
P'trice Jones, MS
ptricej@rand.org
310-393-0411
Time Frame
Start Date: 2024-10-04
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 500
Treatments
Active_comparator: SUN with no follow up
In 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.
Active_comparator: SUN followed by ED-ITT
In 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.
Active_comparator: SUN followed by ED-ITT + BHS
In 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.
Active_comparator: SUN + Telebridge with no follow up
In 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.
Active_comparator: SUN + Telebridge followed by ED-ITT
In 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.
Active_comparator: SUN + Telebridge followed by ED-ITT + BHS
In 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.
Related Therapeutic Areas
Sponsors
Leads: RAND
Collaborators: Stanford University, Arrowhead Regional Medical Center, Alameda Health System