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Best Practice Alert for Opioid Prescribing

Best Practice Alert for Post-Surgical Opioid Prescribing At Discharge

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04446975
Enrollment
21689
Registered
2020-06-25
Start date
2020-07-07
Completion date
2021-06-08
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use

Brief summary

The investigators will embed a developed decision support tool into the electronic health record (EHR) to individualize pain therapy in surgical patients after hospital discharge and test its performance in a pragmatic clinical trial. Preliminary data indicate that current opioid prescription practice after surgery follows a one size fits all pattern. In-hospital opioid use prior to discharge serves as a reliable indicator to estimate needs for analgesic medications at home. The investigators will test the hypothesis that the existing tool will enable providers to write need-based prescriptions based on prior-to-discharge opioid use, empower patients to maximize alternatives to opioids (ALTO) therapies at home, while minimizing the need for rescue prescriptions. The investigators will test this tool prospectively in a cohort of \ 1,000 providers (primary subjects) and \ 39,000 surgical patients (secondary subjects) in four University of Colorado Health (UCHealth) hospitals (clusters to be exposed versus (vs.) non-exposed to the intervention).

Detailed description

Converting knowledge on actual need for opioid pain medications after surgery into tangible benefits can prevent over-prescription of opioids that become available for non-medical use. The objective of this aim is to prescribe pain medications after surgery in a patient-centered fashion. The investigators have used the average amount of opioid medications (in milligram morphine equivalents - MME) taken prior to discharge to inform the clinical decision support tool. This tool will reduce the amount of opioid medications prescribed while maintaining patient post-operative pain control. The calculated prior to discharge daily MME dose will be applied to generate a recommendation for the prescription of a cumulative opioid dose that will be displayed when the electronic order entry for the post-discharge pain medication is made in the EHR using a best-practice alert (BPA). In addition, the provider will be prompted to also prescribe non-opioid analgesic medications. This BPA was developed by the Principal Investigator under guidance of the UCHealth System Multidisciplinary Opioid/Pain Management Committee as well as published guidelines. Based on the relationship between opioids taken prior to discharge and post-discharge opioid intake described above as well as published guidelines for post-discharge prescriptions after surgery will use a tiered approach towards determining the total amount of opioids to be prescribed. Accordingly, the investigators have integrated an algorithm into the BPA such that opioid intake from the EHR only triggers the BPA if the total amount of prescribed opioids exceeds the predicted thresholds. The opioid prescribing BPA will be assessed over a 44-week period in all eligible patients. 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 and will be tracked. The investigators will use an all On vs. all Off configuration to answer the questions if the average amount of total opioids per post-discharge prescription is lower with the BPA active. The investigation will commence with two Off periods to assess if reduction in prescribing patterns occurs over time regardless of the intervention. Two On periods at the end of the study will determine if any observed changes in prescribing patterns stabilize or continued changes take place.

Interventions

OTHERBPA

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.

Sponsors

University of Nebraska
CollaboratorOTHER
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Intervention model description

This trial will be designed using a stepped wedge design with randomization occurring based on timing and location of enrollment according to PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary) to maximize applicability. The BPA will be turned OFF vs. ON in the participating hospitals according to each 8-week study interval. OFF and ON periods will be separated by 4-week washout intervals. An 8-week period prior to study start will provide baseline trends in prescription patterns. The investigation will commence with two OFF periods to assess if reduction in prescribing patterns occurs over time regardless of the intervention. Two ON periods at the end of the study will determine if any observed changes in prescribing patterns stabilize or continued changes take place.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Primary subjects: • Credentialed providers (attending, fellow, and resident physicians, advanced practice providers including nurse practitioners and physician assistants) at each UCH (UC Health) site writing a discharge opioid prescription are eligible to receive the intervention. Secondary subjects: • Adult surgical inpatients age 18 and older within the UCHealth system at 4 different hospitals including UCH Metro, UCH Memorial Central, Medical Center of the Rockies, and Poudre Valley Hospital.

Exclusion criteria

Primary subjects: • None Secondary subjects: • Less than 18 years of age.

Design outcomes

Primary

MeasureTime frameDescription
Opioids Prescribed at Discharge1 day, on discharge date from hospitalPrescribed milligram morphine equivalents (MME) discharge opioid dose as recorded in the electronic health record

Secondary

MeasureTime frameDescription
Number of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge1 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
Number of Participants With Opioid Prescriptions After DischargeDay of discharge +1 until 28 days after dischargeNumber of participants with opioid prescriptions after discharge as recorded in the electronic health record

Countries

United States

Participant flow

Participants by arm

ArmCount
BPA Off
No BPA message is displayed to providers.
10,686
BPA On
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.
11,003
Total21,689

Baseline characteristics

CharacteristicBPA OffBPA OnTotal
Age, Continuous56.6 years
STANDARD_DEVIATION 18.2
56.3 years
STANDARD_DEVIATION 18.1
56.5 years
STANDARD_DEVIATION 18.2
Race/Ethnicity, Customized
Ethnicity
Hispanic
1468 Participants1524 Participants2992 Participants
Race/Ethnicity, Customized
Ethnicity
Non-Hispanic
9112 Participants9368 Participants18480 Participants
Race/Ethnicity, Customized
Ethnicity
Unknown
106 Participants111 Participants217 Participants
Region of Enrollment
United States
10686 participants11003 participants21689 participants
Sex/Gender, Customized
Male
4907 Participants5137 Participants10044 Participants
Sex/Gender, Customized
Non Male
5779 Participants5866 Participants11645 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Opioids Prescribed at Discharge

Prescribed milligram morphine equivalents (MME) discharge opioid dose as recorded in the electronic health record

Time frame: 1 day, on discharge date from hospital

ArmMeasureValue (MEDIAN)
BPA OffOpioids Prescribed at Discharge100 miligram morphine equivalents
BPA OnOpioids Prescribed at Discharge75 miligram morphine equivalents
Secondary

Number of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge

Number of Participants prescribed discharge non-opioid analgesic medications (opioid/non-opioid combination formulations) as recorded in the electronic health record

Time frame: 1 day, on discharge date from hospital

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BPA OffNumber of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge1758 Participants
BPA OnNumber of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge1687 Participants
Secondary

Number of Participants With Opioid Prescriptions After Discharge

Number of participants with opioid prescriptions after discharge as recorded in the electronic health record

Time frame: Day of discharge +1 until 28 days after discharge

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
BPA OffNumber of Participants With Opioid Prescriptions After Discharge1870 Participants
BPA OnNumber of Participants With Opioid Prescriptions After Discharge2046 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026