Trial Outcomes & Findings for Emergency Department Outcomes for Patients With Opioid Use Disorder (NCT NCT04289363)

Last Updated: 2023-07-06

Results Overview

The outcome will be calculated using the following formula: \[(Candidates who receive ED-initiated BUP with any disposition) + (Candidates who receive ED-expedited BUP and who are discharged)\] / \[(Candidates who are discharged) + (Candidates who receive ED-initiated BUP that are not discharged)\].

Recruitment status

COMPLETED

Target enrollment

53 participants

Primary outcome timeframe

Up to Month 12

Results posted on

2023-07-06

Participant Flow

Certain Outcome Measures of the current study were pre-specified to utilize participants not enrolled in the study. These participants are represented in the "Patients Identified via Chart Review" arm. As these participants were not enrolled in the study, they are not counted in the Protocol Enrollment. Enrolled participants are represented in the "ED Patients" arm.

Participant milestones

Participant milestones
Measure	ED Patients Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc. Clinical program implementation: Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.	Patients Identified Via Chart Review Patients who were identified via retrospective chart review for the purpose of outcome measure analysis.
Overall Study STARTED	53	1489
Overall Study COMPLETED	39	1489
Overall Study NOT COMPLETED	14	0

Reasons for withdrawal

Reasons for withdrawal
Measure	ED Patients Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc. Clinical program implementation: Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.	Patients Identified Via Chart Review Patients who were identified via retrospective chart review for the purpose of outcome measure analysis.
Overall Study Lost to Follow-up	14	0

Baseline Characteristics

Not all participants in the "Patients identified via Chart Review" arm had baseline Sex data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ED Patients n=39 Participants Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc. Clinical program implementation: Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.	Patients Identified Via Chart Review n=1489 Participants Patients who were identified via chart review.	Total n=1528 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 10.72 • n=39 Participants	41.3 years STANDARD_DEVIATION 11.91 • n=1489 Participants	42.25 years STANDARD_DEVIATION 11.315 • n=1528 Participants
Sex: Female, Male Female	10 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline Sex data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	277 Participants n=1488 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline Sex data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	287 Participants n=1527 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline Sex data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Sex: Female, Male Male	29 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline Sex data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	1211 Participants n=1488 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline Sex data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	1240 Participants n=1527 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline Sex data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline ethnicity data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	198 Participants n=1289 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline ethnicity data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	205 Participants n=1328 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline ethnicity data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline ethnicity data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	1044 Participants n=1289 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline ethnicity data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	1076 Participants n=1328 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline ethnicity data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline ethnicity data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	47 Participants n=1289 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline ethnicity data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	47 Participants n=1328 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline ethnicity data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	10 Participants n=1075 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	10 Participants n=1114 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Race (NIH/OMB) Asian	0 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	4 Participants n=1075 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	4 Participants n=1114 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	1 Participants n=1075 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	1 Participants n=1114 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Race (NIH/OMB) Black or African American	8 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	317 Participants n=1075 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	325 Participants n=1114 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Race (NIH/OMB) White	27 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	658 Participants n=1075 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	685 Participants n=1114 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Race (NIH/OMB) More than one race	0 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	35 Participants n=1075 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	35 Participants n=1114 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=39 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	50 Participants n=1075 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.	54 Participants n=1114 Participants • Not all participants in the "Patients identified via Chart Review" arm had baseline race data collected. Thus, the total number of participants analyzed for each of these sections is less than the overall number of baseline participants.
Region of Enrollment United States	39 participants n=39 Participants	1489 participants n=1489 Participants	1528 participants n=1528 Participants

PRIMARY outcome

Timeframe: Up to Month 12

Population: The overall number of participants analyzed for this outcome measure (n=1489) represents individuals identified via retrospective chart review and data matching for all adult emergency department (ED) patients identified to have nonmedical opioid use presenting to the ED during the IF, Post-IF or Maintenance periods. This outcome was not assessed among participants in the ED patients arm.

Outcome measures

Outcome measures
Measure	Patients Identified Via Chart Review n=1489 Participants Patients who were identified via chart review.
Percent of Participants Who Received Emergency Department (ED)-Initiated/Expedited Buprenorphine (BUP)	39.40 Percentage of participants Interval 36.7 to 42.0

PRIMARY outcome

Timeframe: Day 30 Post-Discharge (Up to Month 12)

The outcome will be calculated using the following formula: (participants who are confirmed to be engaged in formal addiction treatment for Opioid Use Disorder (OUD) on the 30th day following discharge / total number of participants who received ED-initiated/expedited BUP).

Outcome measures

Outcome measures
Measure	Patients Identified Via Chart Review n=38 Participants Patients who were identified via chart review.
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 Percentage of participants Interval 33.2 to 63.5

SECONDARY outcome

Timeframe: Up to Month 12

Population: The overall number of participants analyzed for this outcome measure (n=1281) represents individuals identified via retrospective chart review and data matching for all adult emergency department (ED) patients identified to have nonmedical opioid use presenting to the ED during the IF, Post-IF or Maintenance periods. This outcome was not assessed among participants in the ED patients arm.

The outcome will be calculated using the following formula: \[(ED-initiated, discharged) + (ED-expedited, discharged)\] / All candidates who were discharged

Outcome measures

Outcome measures
Measure	Patients Identified Via Chart Review n=1281 Participants Patients who were identified via chart review.
Percent of Discharged Participants Who Received ED-Initiated BUP	32.10 Percentage of participants Interval 29.1 to 35.0

SECONDARY outcome

Timeframe: Up to Month 12

Population: The overall number of participants analyzed for this outcome measure (n=1317) represents individuals identified via retrospective chart review and data matching for all adult emergency department (ED) patients identified to have nonmedical opioid use presenting to the ED during the IF, Post-IF or Maintenance periods. This outcome was not assessed among participants in the ED patients arm.

The outcome will be calculated using the following formula: (ED-initiated, not admitted) /All candidates who were not admitted

Outcome measures

Outcome measures
Measure	Patients Identified Via Chart Review n=1317 Participants Patients who were identified via chart review.
Percent of Not-Admitted Participants Who Received ED-Initiated BUP	28.10 Percentage of participants Interval 25.3 to 30.9

SECONDARY outcome

Timeframe: Up to Month 12

Population: The overall number of participants analyzed for this outcome measure (n=1310) represents individuals identified via retrospective chart review and data matching for all adult emergency department (ED) patients identified to have nonmedical opioid use presenting to the ED during the IF, Post-IF or Maintenance periods. This outcome was not assessed among participants in the ED patients arm.

The outcome will be calculated using the following formula: (ED-initiated, all) / \[All discharged candidates + (ED-initiated, not discharged)\]

Outcome measures

Outcome measures
Measure	Patients Identified Via Chart Review n=1310 Participants Patients who were identified via chart review.
Percent of Participants Who Received ED-Initiated BUP	30.7 Percentage of participants Interval 27.8 to 33.5

SECONDARY outcome

Timeframe: Up to Month 12

The outcome will be calculated using the following formula: (ED-initiated/expedited, all) / \[All discharged candidates + (ED-initiated/expedited, not discharged)\]

Outcome measures

Outcome measures
Measure	Patients Identified Via Chart Review n=1489 Participants Patients who were identified via chart review.
Percent of Participants Who Received ED-Initiated/Expedited BUP	25.4 Percentage of participants Interval 22.9 to 27.9

SECONDARY outcome

Timeframe: Baseline, Day 30

The TLFB assessment will elicit the participant's self-reported use of illicit substances over the previous 7 days. At the Day 30 follow-up visit the assessment period will be the 7 days preceding the Day 30 post index ED visit.

Outcome measures

Outcome measures
Measure	Patients Identified Via Chart Review n=30 Participants Patients who were identified via chart review.
Change in Number of Days of Opioid and/or Other Drug Use as Assessed by Timeline Followback (TLFB) Assessment	-2.3 Days Interval -3.7 to -0.9

SECONDARY outcome

Timeframe: Baseline, Day 30

Participants will be asked to report the number of opioid-related overdose events experienced in the past 30 days through a self-report form.

Outcome measures

Outcome measures
Measure	Patients Identified Via Chart Review n=30 Participants Patients who were identified via chart review.
Change in Number of Self-Reported Opioid-Related Overdose Events	1.78 Overdose events Interval 0.44 to 7.24

Adverse Events

ED Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients Identified Via Chart Review

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ryan McCormack

NYU Langone Health

Phone: 2122632862

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place