Opioid Use
Conditions
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
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
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| Opioids Prescribed at Discharge | 1 day, on discharge date from hospital | Prescribed milligram morphine equivalents (MME) discharge opioid dose as recorded in the electronic health record |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge | 1 day, on discharge date from hospital | Number 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 Discharge | Day of discharge +1 until 28 days after discharge | Number of participants with opioid prescriptions after discharge as recorded in the electronic health record |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 21,689 |
Baseline characteristics
| Characteristic | BPA Off | BPA On | Total |
|---|---|---|---|
| Age, Continuous | 56.6 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 Participants | 1524 Participants | 2992 Participants |
| Race/Ethnicity, Customized Ethnicity Non-Hispanic | 9112 Participants | 9368 Participants | 18480 Participants |
| Race/Ethnicity, Customized Ethnicity Unknown | 106 Participants | 111 Participants | 217 Participants |
| Region of Enrollment United States | 10686 participants | 11003 participants | 21689 participants |
| Sex/Gender, Customized Male | 4907 Participants | 5137 Participants | 10044 Participants |
| Sex/Gender, Customized Non Male | 5779 Participants | 5866 Participants | 11645 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BPA Off | Opioids Prescribed at Discharge | 100 miligram morphine equivalents |
| BPA On | Opioids Prescribed at Discharge | 75 miligram morphine equivalents |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BPA Off | Number of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge | 1758 Participants |
| BPA On | Number of Participants With Opioid/Non-opioid Combination Medications Prescribed on Day of Discharge | 1687 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BPA Off | Number of Participants With Opioid Prescriptions After Discharge | 1870 Participants |
| BPA On | Number of Participants With Opioid Prescriptions After Discharge | 2046 Participants |