Trial Outcomes & Findings for Clinical Decision Support to Implement ED-initiated Buprenorphine for OUD (NCT NCT03658642)
NCT ID: NCT03658642
Last Updated: 2022-06-28
Results Overview
The primary outcome will be Buprenorphine (BUP) initiation in the Emergency Department (ED), defined as whether or not an eligible patient is administered BUP in the ED and/or prescribed BUP upon discharge from the ED. Although this is not a patient-centered outcome, it is a pragmatic and meaningful surrogate that will serve as a lead indicator of the CDS intervention's effect on engaging more OUD patients in treatment. Medications for Opioid Use Disorder (MOUD)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5047 participants
Primary outcome timeframe
Upon discharge (Up to 1 day)
Results posted on
2022-06-28
Participant Flow
Physicians in the study were not "enrolled" but rather were found in the electronic health record data used in the study.
Participant milestones
| Measure |
Clinical Decision Support for BUP
The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score\>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score \>12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.
Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)
|
Usual Care
The CDS will not be activated and patients will receive care as usual.
|
|---|---|---|
|
Patients
STARTED
|
2787
|
2260
|
|
Patients
COMPLETED
|
2787
|
2260
|
|
Patients
NOT COMPLETED
|
0
|
0
|
|
Physicians
STARTED
|
340
|
259
|
|
Physicians
COMPLETED
|
340
|
259
|
|
Physicians
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were 599 physicians included in the study, 524 physicians (75 missing) had demographic information.
Baseline characteristics by cohort
| Measure |
Clinical Decision Support for BUP
n=2787 Participants
The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score\>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score \>12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.
Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)
|
Usual Care
n=2260 Participants
The CDS will not be activated and patients will receive care as usual.
|
Total
n=5047 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=314 Participants • There were 599 physicians included in the study, 524 physicians (75 missing) had demographic information.
|
0 Participants
n=210 Participants • There were 599 physicians included in the study, 524 physicians (75 missing) had demographic information.
|
0 Participants
n=524 Participants • There were 599 physicians included in the study, 524 physicians (75 missing) had demographic information.
|
|
Age, Categorical
Between 18 and 65 years
|
305 Participants
n=314 Participants • There were 599 physicians included in the study, 524 physicians (75 missing) had demographic information.
|
203 Participants
n=210 Participants • There were 599 physicians included in the study, 524 physicians (75 missing) had demographic information.
|
508 Participants
n=524 Participants • There were 599 physicians included in the study, 524 physicians (75 missing) had demographic information.
|
|
Age, Categorical
>=65 years
|
9 Participants
n=314 Participants • There were 599 physicians included in the study, 524 physicians (75 missing) had demographic information.
|
7 Participants
n=210 Participants • There were 599 physicians included in the study, 524 physicians (75 missing) had demographic information.
|
16 Participants
n=524 Participants • There were 599 physicians included in the study, 524 physicians (75 missing) had demographic information.
|
|
Age, Continuous
|
36 years
n=2787 Participants
|
36 years
n=2260 Participants
|
36 years
n=5047 Participants
|
|
Sex: Female, Male
Patients · Female
|
917 Participants
n=2787 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
813 Participants
n=2260 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
1730 Participants
n=5047 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
|
Sex: Female, Male
Patients · Male
|
1870 Participants
n=2787 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
1447 Participants
n=2260 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
3317 Participants
n=5047 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
|
Sex: Female, Male
Physician · Female
|
104 Participants
n=314 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
69 Participants
n=210 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
173 Participants
n=524 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
|
Sex: Female, Male
Physician · Male
|
210 Participants
n=314 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
141 Participants
n=210 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
351 Participants
n=524 Participants • 5047 patients had demographic information, 524 physicians (75 missing) had demographic information.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
505 Participants
n=2787 Participants
|
196 Participants
n=2260 Participants
|
701 Participants
n=5047 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2166 Participants
n=2787 Participants
|
1934 Participants
n=2260 Participants
|
4100 Participants
n=5047 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
116 Participants
n=2787 Participants
|
130 Participants
n=2260 Participants
|
246 Participants
n=5047 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2787 Participants
|
0 Participants
n=2260 Participants
|
0 Participants
n=5047 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2787 Participants
|
0 Participants
n=2260 Participants
|
0 Participants
n=5047 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2787 Participants
|
0 Participants
n=2260 Participants
|
0 Participants
n=5047 Participants
|
|
Race (NIH/OMB)
Black or African American
|
452 Participants
n=2787 Participants
|
406 Participants
n=2260 Participants
|
858 Participants
n=5047 Participants
|
|
Race (NIH/OMB)
White
|
2048 Participants
n=2787 Participants
|
1565 Participants
n=2260 Participants
|
3613 Participants
n=5047 Participants
|
|
Race (NIH/OMB)
More than one race
|
196 Participants
n=2787 Participants
|
219 Participants
n=2260 Participants
|
415 Participants
n=5047 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
91 Participants
n=2787 Participants
|
70 Participants
n=2260 Participants
|
161 Participants
n=5047 Participants
|
|
Region of Enrollment
United States
|
3127 participants
n=2787 Participants
|
2519 participants
n=2260 Participants
|
5646 participants
n=5047 Participants
|
PRIMARY outcome
Timeframe: Upon discharge (Up to 1 day)The primary outcome will be Buprenorphine (BUP) initiation in the Emergency Department (ED), defined as whether or not an eligible patient is administered BUP in the ED and/or prescribed BUP upon discharge from the ED. Although this is not a patient-centered outcome, it is a pragmatic and meaningful surrogate that will serve as a lead indicator of the CDS intervention's effect on engaging more OUD patients in treatment. Medications for Opioid Use Disorder (MOUD)
Outcome measures
| Measure |
Clinical Decision Support for BUP
n=2787 Participants
The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score\>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score \>12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.
Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)
|
Usual Care
n=2260 Participants
The CDS will not be activated and patients will receive care as usual.
|
|---|---|---|
|
Count of Initiating BUP in the ED With Referral for Ongoing MOUD With User-centered CDS Compared With Usual Care
|
347 Participants
|
271 Participants
|
SECONDARY outcome
Timeframe: Upon discharge (Up to 1 day)The count of enrolled patients who receive an Medication Assisted Therapy (MAT) appointment. Medications for Opioid Use Disorder (MOUD)
Outcome measures
| Measure |
Clinical Decision Support for BUP
n=2787 Participants
The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score\>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score \>12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.
Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)
|
Usual Care
n=2260 Participants
The CDS will not be activated and patients will receive care as usual.
|
|---|---|---|
|
Count of Those With Referral to Follow-up for Ongoing MOUD Treatment (Patient Level)
|
367 Participants
|
226 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: These data were not able to be obtained.
Data will be collected in the aggregate for the percentage of patients that attended the referral MAT appointment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Clinicians participating in the study.
Number of clinicians providing ED-initiated BUP regardless of CDS
Outcome measures
| Measure |
Clinical Decision Support for BUP
n=340 Participants
The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score\>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score \>12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.
Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)
|
Usual Care
n=259 Participants
The CDS will not be activated and patients will receive care as usual.
|
|---|---|---|
|
Number of Clinicians Providing ED-initiated BUP
|
151 Participants
|
88 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Clinicians participating in the study.
Number of clinicians that refer patients with OUD regardless of CDS
Outcome measures
| Measure |
Clinical Decision Support for BUP
n=340 Participants
The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score\>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score \>12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.
Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)
|
Usual Care
n=259 Participants
The CDS will not be activated and patients will receive care as usual.
|
|---|---|---|
|
Number of Clinicians Providing Referral of Any Ongoing MOUD Treatment
|
141 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Clinicians participating in the study.
Number of clinicians that obtained DATA waiver
Outcome measures
| Measure |
Clinical Decision Support for BUP
n=340 Participants
The Clinical Decision Support (CDS) will be available for clinician use for Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) with referral for ongoing medication assisted treatment (MAT) if: ED chief complaint or urine drug screen indicate opioid use. The clinician will then be prompted to complete DSM-5 checklist for OUD. If DSM-5 OUD Score\>5 and urine drug screen is positive for opioids, then the clinician is prompted to complete COWS scale. If COWS score \>12, then the clinician is prompted to order BUP. Regardless of COWS score, the clinician will be prompted to schedule an MAT appointment with BUP provider. The CDS will interface with outside MAT facilities so that making an appointment is easy and to capture data on whether an appointment has been scheduled.
Clinical Decision Support (CDS): This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)
|
Usual Care
n=259 Participants
The CDS will not be activated and patients will receive care as usual.
|
|---|---|---|
|
Number of Clinicians Who Have Received Drug Addiction Treatment Act (DATA) of 2000 Training
|
50 Participants
|
30 Participants
|
Adverse Events
Clinical Decision Support for BUP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Ted Melnick, MD, MHS Associate Professor of Emergency Medicine and of Biostatistics (Health Informat
Yale School of Medicine
Phone: (203) 785-5174
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place