Trial Outcomes & Findings for Best Practice Alert for Opioid Prescribing (NCT NCT04446975)
NCT ID: NCT04446975
Last Updated: 2024-03-04
Results Overview
Prescribed milligram morphine equivalents (MME) discharge opioid dose as recorded in the electronic health record
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21689 participants
Primary outcome timeframe
1 day, on discharge date from hospital
Results posted on
2024-03-04
Participant Flow
Participant milestones
| Measure |
Site 1, BPA Off First
Treatment sequence:
* BPA Off
* Washout period
* BPA On
* Washout period
* BPA Off
* Washout period
* BPA On
|
Site 2, BPA On First
Treatment sequence:
* BPA On
* Washout period
* BPA Off
* Washout period
* BPA On
* Washout period
* BPA Off
|
Site 3, BPA On First
Treatment sequence:
* BPA On
* Washout period
* BPA Off
* Washout period
* BPA On
* Washout period
* BPA Off
|
Site 4, BPA Off First
Treatment sequence:
* BPA Off
* Washout period
* BPA On
* Washout period
* BPA Off
* Washout period
* BPA On
|
|---|---|---|---|---|
|
Randomization Period 1 (8 Weeks)
STARTED
|
2435
|
1295
|
883
|
833
|
|
Randomization Period 1 (8 Weeks)
COMPLETED
|
2435
|
1295
|
883
|
833
|
|
Randomization Period 1 (8 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (4 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (4 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 1 (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Randomization Period 2 (8 Weeks)
STARTED
|
2527
|
1285
|
927
|
936
|
|
Randomization Period 2 (8 Weeks)
COMPLETED
|
2527
|
1285
|
927
|
936
|
|
Randomization Period 2 (8 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (4 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (4 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 2 (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Randomization Period 3 (8 Weeks)
STARTED
|
2174
|
1105
|
818
|
821
|
|
Randomization Period 3 (8 Weeks)
COMPLETED
|
2174
|
1105
|
818
|
821
|
|
Randomization Period 3 (8 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 3 (4 Weeks)
STARTED
|
0
|
0
|
0
|
0
|
|
Washout Period 3 (4 Weeks)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period 3 (4 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Randomization Period 4 (8 Weeks)
STARTED
|
2607
|
1248
|
963
|
832
|
|
Randomization Period 4 (8 Weeks)
COMPLETED
|
2607
|
1248
|
963
|
832
|
|
Randomization Period 4 (8 Weeks)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Best Practice Alert for Opioid Prescribing
Baseline characteristics by cohort
| Measure |
BPA Off
n=10686 Participants
No BPA message is displayed to providers.
|
BPA On
n=11003 Participants
BPA message is displayed to providers based on patient opioid intake as reported in the EHR.
BPA: At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider.
|
Total
n=21689 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 18.2 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 18.1 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 18.2 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
4907 Participants
n=5 Participants
|
5137 Participants
n=7 Participants
|
10044 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non Male
|
5779 Participants
n=5 Participants
|
5866 Participants
n=7 Participants
|
11645 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
1468 Participants
n=5 Participants
|
1524 Participants
n=7 Participants
|
2992 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Non-Hispanic
|
9112 Participants
n=5 Participants
|
9368 Participants
n=7 Participants
|
18480 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown
|
106 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10686 participants
n=5 Participants
|
11003 participants
n=7 Participants
|
21689 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day, on discharge date from hospitalPrescribed milligram morphine equivalents (MME) discharge opioid dose as recorded in the electronic health record
Outcome measures
| Measure |
BPA Off
n=10686 Participants
No BPA message is displayed to providers.
|
BPA On
n=11003 Participants
BPA message is displayed to providers based on patient opioid intake as reported in the EHR.
BPA: At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider.
|
|---|---|---|
|
Opioids Prescribed at Discharge
|
100 miligram morphine equivalents
Interval 0.0 to 225.0
|
75 miligram morphine equivalents
Interval 0.0 to 225.0
|
SECONDARY outcome
Timeframe: 1 day, on discharge date from hospitalNumber of Participants prescribed discharge non-opioid analgesic medications (opioid/non-opioid combination formulations) as recorded in the electronic health record
Outcome measures
| Measure |
BPA Off
n=10686 Participants
No BPA message is displayed to providers.
|
BPA On
n=11003 Participants
BPA message is displayed to providers based on patient opioid intake as reported in the EHR.
BPA: At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider.
|
|---|---|---|
|
Number of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge
|
1758 Participants
|
1687 Participants
|
SECONDARY outcome
Timeframe: "Day of discharge +1" until 28 days after dischargeNumber of participants with opioid prescriptions after discharge as recorded in the electronic health record
Outcome measures
| Measure |
BPA Off
n=10686 Participants
No BPA message is displayed to providers.
|
BPA On
n=11003 Participants
BPA message is displayed to providers based on patient opioid intake as reported in the EHR.
BPA: At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider.
|
|---|---|---|
|
Number of Participants With Opioid Prescriptions After Discharge
|
1870 Participants
|
2046 Participants
|
Adverse Events
BPA Off
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BPA On
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place