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N/A N=1,542

Emergency Department Outcomes for Patients With Opioid Use Disorder

Opioid-use Disorder

Enrolled (actual)
1,542
Serious AEs
Results posted
Jul 2023
Primary outcome: Primary: Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP) — 39.40 Percentage of participants

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Clinical program implementation (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
NYU Langone Health
Primary completion
Jan 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP)
39.40
PRIMARY
Percent of Participants Who Received ED-Initiated/Expedited BUP Who Were Confirmed to be Engaged in Formal Addiction Treatment for Opioid Use Disorder (OUD) on the 30th Day Following Discharge
48.3
SECONDARY
Percent of Discharged Participants Who Received ED-Initiated BUP
32.10
SECONDARY
Percent of Not-Admitted Participants Who Received ED-Initiated BUP
28.10
SECONDARY
Percent of Participants Who Received ED-Initiated BUP
30.7
SECONDARY
Percent of Participants Who Received ED-Initiated/Expedited BUP
25.4
SECONDARY
Change in Number of Days of Opioid and/or Other Drug Use as Assessed by Timeline Followback (TLFB) Assessment
-2.3
SECONDARY
Change in Number of Self-Reported Opioid-Related Overdose Events
1.78

Summary

Using mixed methods and triangulating multiples sources of data collected over the course of the parent (CTN-0079 - NCT03544112) and the ancillary studies to evaluate the feasibility, acceptability, sustainability and impact of the emergency department (ED)-initiated Buprenorphine (BUP) clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness.

Eligibility Criteria

Inclusion Criteria

Qualitative Population:

  • Key stakeholder or opinion leader for ED-initiated BUP
  • 18 years of age or older

Full Study Population & Limited Study Population:

  • Be able to speak English sufficiently to understand study procedures
  • Be a potential candidate for ED-initiated BUP by meeting either of the 2 criteria:
  • Clinical determination: patient is a willing and eligible candidate for ED-initiated BUP or for whom this can be reasonably inferred, including any patient who is administered and/or prescribed BUP as part of the index ED visit.
  • Research determination: Both a and b below must be true at the time of study enrollment:

a) Assessment conducted by an RA indicates that the patient- (all must be true): i. has had nonmedical opioid use within the last 7 days, ii. meets DSM-5 criteria for moderate or severe opioid use disorder (OUD), iii. denies methadone use within 72 hours of ED visit registration, iv. is not engaged in formal medications for opioid use disorder (MOUD) treatment, v. is not prescribed opioids for chronic pain management, vi. reports being interested or "not sure" if interested in receiving BUP as elicited on the ED Health Survey during the index ED visit.

b) Absence of clinical documentation associated with the ED visit indicating that the patient is not a candidate for ED-initiated BUP.

Exclusion Criteria

Qualitative Population:

  • Unwilling or unable to provide consent
  • currently in jail, prison, or any inpatient overnight facility

Full Study Population:

  • Unwilling or unable to provide written/electronic informed consent
  • Currently engaged in formal MOUD treatment at the time of index ED visit
  • Currently in jail, prison or any inpatient overnight facility as required by court of law
  • Previous participation as a patient- participant in CTN-0079 or previous participation as a Full Study participant in the current study
  • Presents from a medical-based extended care facility
  • Current research participant in a substance use intervention study
  • Inadequate locator information (unable or unwilling to provide 2 unique means of contact)
  • Unable or unwilling to complete research visits at baseline and Day 30.

Limited Study Population:

  • Unwilling or unable to provide written/electronic informed consent
  • Currently engaged in formal MOUD treatment at the time of index ED visit
  • Currently in jail, prison or any inpatient overnight facility as required by court of law
  • Previous participation in the current study as a Limited study or Full study participant
  • Presents from a medical-based extended care facility
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04289363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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