NCT04446975

Best Practice Alert for Opioid Prescribing

Completed NA Results posted Last updated 4 March 2024

What this trial tests

NA trial testing BPA in Opioid Use in 21,689 participants. Completed in 8 June 2021.

Timeline

7 July 2020

Primary endpoint
8 June 2021

8 June 2021

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	single
Primary purpose	other
Enrollment	21,689
Start date	7 July 2020
Primary completion	8 June 2021
Estimated completion	8 June 2021
Sites	1 location across United States

Drugs / interventions tested

• BPA — full drug profile →

Conditions studied

• Opioid Use — all drugs for Opioid Use →

Sponsor

University of Colorado, Denver

Who can join

18 and older, any sex, with Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioids Prescribed at Discharge Primary · 1 day, on discharge date from hospital

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

Group	Value	95% CI
BPA Off	100	0 – 225
BPA On	75	0 – 225

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

Group	Value	95% CI
BPA Off	1758
BPA On	1687

Number of Participants With Opioid Prescriptions After Discharge Secondary · "Day of discharge +1" until 28 days after discharge

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

Group	Value	95% CI
BPA Off	1870
BPA On	2046

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Best Practice Alerts Informed by Inpatient Opioid Intake to Reduce Opioid Prescribing after Surgery (PRIOR): A Cluster Randomized Multiple Crossover Trial.
   Rolfzen ML, Wick A, Mascha EJ, Shah K, et al · · 2023 · cited 10× · PMID 37155372 · DOI 10.1097/aln.0000000000004607