Trial Outcomes & Findings for Opioid Use Disorder in the Emergency Department: CTN 0069 (NCT NCT03023930)

Last Updated: 2023-12-18

Results Overview

The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT

Recruitment status

COMPLETED

Study phase

Target enrollment

1731 participants

Primary outcome timeframe

12 months

Results posted on

2023-12-18

Participant Flow

A total of 27,748 patients were screened during the baseline evaluation period and 394 were enrolled and analyzed. During the IF evaluation period, 26,456 were screened and 362 enrolled and analyzed. The study was originally conceived as a "modified step wedge" but not designed or implemented as such, as there was no substantial overlap of the baseline evaluation and IF evaluation periods. A total of 975 unique providers were assessed across the study periods via survey.

Participant milestones

Participant milestones
Measure	Baseline Evaluation Period Cohort Evaluating standard dissemination practice compared with implementation facilitation Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP. Implementation Facilitation (IF): IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.	IF Evaluation Period Evaluating standard dissemination practice compared with implementation facilitation Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP. Implementation Facilitation (IF): IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.	Providers - Baseline Period Unique total number of providers added during Baseline Period	Providers - 6 Month Period Unique total number of providers added at 6 Month Period	Providers - 12 Month Period Unique total number of providers added at the 12 Month Period
Overall Study STARTED	394	362	706	92	177
Overall Study COMPLETED	394	362	706	92	177
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline Evaluation Period Cohort n=394 Participants Evaluating standard dissemination practice compared with implementation facilitation Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP. Implementation Facilitation (IF): IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.	IF Evaluation Period Cohort n=362 Participants Evaluating standard dissemination practice compared with implementation facilitation Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP. Implementation Facilitation (IF): IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.	Total n=756 Participants Total of all reporting groups
Age, Continuous	38.9 years STANDARD_DEVIATION 11.7 • n=394 Participants	39.7 years STANDARD_DEVIATION 11.7 • n=362 Participants	39.3 years STANDARD_DEVIATION 11.7 • n=756 Participants
Sex: Female, Male Female	121 Participants n=394 Participants	95 Participants n=362 Participants	216 Participants n=756 Participants
Sex: Female, Male Male	273 Participants n=394 Participants	267 Participants n=362 Participants	540 Participants n=756 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	49 Participants n=394 Participants	39 Participants n=362 Participants	88 Participants n=756 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	345 Participants n=394 Participants	323 Participants n=362 Participants	668 Participants n=756 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=394 Participants	0 Participants n=362 Participants	0 Participants n=756 Participants
Race (NIH/OMB) American Indian or Alaska Native	12 Participants n=394 Participants	15 Participants n=362 Participants	27 Participants n=756 Participants
Race (NIH/OMB) Asian	3 Participants n=394 Participants	4 Participants n=362 Participants	7 Participants n=756 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=394 Participants	2 Participants n=362 Participants	4 Participants n=756 Participants
Race (NIH/OMB) Black or African American	110 Participants n=394 Participants	113 Participants n=362 Participants	223 Participants n=756 Participants
Race (NIH/OMB) White	206 Participants n=394 Participants	188 Participants n=362 Participants	394 Participants n=756 Participants
Race (NIH/OMB) More than one race	14 Participants n=394 Participants	16 Participants n=362 Participants	30 Participants n=756 Participants
Race (NIH/OMB) Unknown or Not Reported	47 Participants n=394 Participants	24 Participants n=362 Participants	71 Participants n=756 Participants
Region of Enrollment United States	394 participants n=394 Participants	362 participants n=362 Participants	756 participants n=756 Participants
Education Less than high school diploma	140 Participants n=394 Participants	126 Participants n=362 Participants	266 Participants n=756 Participants
Education High school graduate or equivalent (GED)	130 Participants n=394 Participants	146 Participants n=362 Participants	276 Participants n=756 Participants
Education Some college, no degree	74 Participants n=394 Participants	62 Participants n=362 Participants	136 Participants n=756 Participants
Education ≥ College degree	50 Participants n=394 Participants	28 Participants n=362 Participants	78 Participants n=756 Participants
Employment Working	63 Participants n=394 Participants	66 Participants n=362 Participants	129 Participants n=756 Participants
Employment Unemployed	228 Participants n=394 Participants	192 Participants n=362 Participants	420 Participants n=756 Participants
Employment Disabled permanently or temporarily	80 Participants n=394 Participants	62 Participants n=362 Participants	142 Participants n=756 Participants
Unstable Housing Shelter for homeless persons	102 Participants n=394 Participants	108 Participants n=362 Participants	210 Participants n=756 Participants
Unstable Housing On the street/public place not intended for sleeping	191 Participants n=394 Participants	192 Participants n=362 Participants	383 Participants n=756 Participants
Unstable Housing Doubled up in someone else's house apartment	190 Participants n=394 Participants	135 Participants n=362 Participants	325 Participants n=756 Participants
Currently living in any of the following places Shelter for homeless persons	41 Participants n=394 Participants	41 Participants n=362 Participants	82 Participants n=756 Participants
Currently living in any of the following places On the street or public place not intended for sleeping	94 Participants n=394 Participants	98 Participants n=362 Participants	192 Participants n=756 Participants
Currently living in any of the following places Welfare hotel or SRO	3 Participants n=394 Participants	6 Participants n=362 Participants	9 Participants n=756 Participants
Currently living in any of the following places Emergency, temporary, transitional or halfway house	4 Participants n=394 Participants	9 Participants n=362 Participants	13 Participants n=756 Participants
Health insurance Private/commercial	45 Participants n=394 Participants	24 Participants n=362 Participants	69 Participants n=756 Participants
Health insurance Medicare	31 Participants n=394 Participants	37 Participants n=362 Participants	68 Participants n=756 Participants
Health insurance Medicaid	287 Participants n=394 Participants	254 Participants n=362 Participants	541 Participants n=756 Participants
Health insurance Unknown	50 Participants n=394 Participants	66 Participants n=362 Participants	116 Participants n=756 Participants
Primary Medical Provider Private physician office	57 Participants n=393 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period	59 Participants n=361 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period	116 Participants n=754 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period
Primary Medical Provider Clinic	116 Participants n=393 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period	96 Participants n=361 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period	212 Participants n=754 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period
Primary Medical Provider Emergency Department or none	217 Participants n=393 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period	204 Participants n=361 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period	421 Participants n=754 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period
Primary Medical Provider Not reported	3 Participants n=393 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period	2 Participants n=361 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period	5 Participants n=754 Participants • 393 out of 394 reported for Baseline Evaluation Period and 361 out of 362 reported for IF Evaluation Period
Number of Positive UDS results by substance Benzodiazepines	101 Participants n=394 Participants	126 Participants n=362 Participants	227 Participants n=756 Participants
Number of Positive UDS results by substance Amphetamine	114 Participants n=394 Participants	102 Participants n=362 Participants	216 Participants n=756 Participants
Number of Positive UDS results by substance Marijuana	153 Participants n=394 Participants	128 Participants n=362 Participants	281 Participants n=756 Participants
Number of Positive UDS results by substance Methamphetamine	146 Participants n=394 Participants	141 Participants n=362 Participants	287 Participants n=756 Participants
Number of Positive UDS results by substance Opiates (300 ng)	328 Participants n=394 Participants	283 Participants n=362 Participants	611 Participants n=756 Participants
Number of Positive UDS results by substance Cocaine	177 Participants n=394 Participants	165 Participants n=362 Participants	342 Participants n=756 Participants
Number of Positive UDS results by substance Ecstasy	21 Participants n=394 Participants	26 Participants n=362 Participants	47 Participants n=756 Participants
Number of Positive UDS results by substance Oxycodone	159 Participants n=394 Participants	139 Participants n=362 Participants	298 Participants n=756 Participants
Number of Positive UDS results by substance Methadone	43 Participants n=394 Participants	56 Participants n=362 Participants	99 Participants n=756 Participants
Number of Positive UDS results by substance Barbiturates	7 Participants n=394 Participants	1 Participants n=362 Participants	8 Participants n=756 Participants
Number of Positive UDS results by substance Buprenorphine	144 Participants n=394 Participants	169 Participants n=362 Participants	313 Participants n=756 Participants
Number of Positive UDS results by substance Fentanyl	200 Participants n=394 Participants	216 Participants n=362 Participants	416 Participants n=756 Participants
Overdose History Overdosed at least once in the past 30 days	108 Participants n=394 Participants	106 Participants n=362 Participants	214 Participants n=756 Participants
Overdose History Report a medical intervention overdose	84 Participants n=394 Participants	79 Participants n=362 Participants	163 Participants n=756 Participants
Overdose History Injection drug use past month	232 Participants n=394 Participants	185 Participants n=362 Participants	417 Participants n=756 Participants
Mental Health History Psych eval during the ED visit?	11 Participants n=394 Participants	15 Participants n=362 Participants	26 Participants n=756 Participants
Mental Health History Lifetime psychiatric treatment: Inpatient	161 Participants n=394 Participants	116 Participants n=362 Participants	277 Participants n=756 Participants
Mental Health History Lifetime psychiatric treatment: Outpatient	185 Participants n=394 Participants	150 Participants n=362 Participants	335 Participants n=756 Participants
Mental Health History Any psychiatric treatment, past 30 day	60 Participants n=394 Participants	42 Participants n=362 Participants	102 Participants n=756 Participants

PRIMARY outcome

Timeframe: 12 months

The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT

Outcome measures

Outcome measures
Measure	Baseline Evaluation Period Cohort n=394 Participants Evaluating standard dissemination practice compared with implementation facilitation Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP. Implementation Facilitation (IF): IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.	IF Evaluation Period Cohort n=362 Participants Evaluating standard dissemination practice compared with implementation facilitation Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP. Implementation Facilitation (IF): IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.
Implementation (Considered the Primary Outcome)	2 Participants	53 Participants

PRIMARY outcome

Timeframe: 30 Days Post Enrollment

The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.

Outcome measures

Outcome measures
Measure	Baseline Evaluation Period Cohort n=394 Participants Evaluating standard dissemination practice compared with implementation facilitation Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP. Implementation Facilitation (IF): IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.	IF Evaluation Period Cohort n=362 Participants Evaluating standard dissemination practice compared with implementation facilitation Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP. Implementation Facilitation (IF): IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.
Effectiveness	40 Participants	59 Participants

SECONDARY outcome

Timeframe: Pre IF (Baseline)

Population: Clinicians assessed at baseline.

ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT. Scores are dichotomized as less ready (scores 0-6) or most ready (scores 7-10).

Outcome measures

Outcome measures
Measure	Baseline Evaluation Period Cohort n=268 Participants Evaluating standard dissemination practice compared with implementation facilitation Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP. Implementation Facilitation (IF): IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.	IF Evaluation Period Cohort Evaluating standard dissemination practice compared with implementation facilitation Standard Dissemination Practice: Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP. Implementation Facilitation (IF): IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.
Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score Most Ready	56 Participants	—
Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score Less Ready	212 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre IF (Baseline)

ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: post IF Evaluation Period (12 months)

ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Post IF (6 months)

ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT