Best Practice Alert for Opioid Prescribing

NCT04446975 | Completed Results

• 1 other identifier: 19-3095
• Study Type: interventional
• Target: 21,689
• Locations: 1 country
• Sites: 1

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).

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Opioids Prescribed at Discharge

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

  1 day, on discharge date from hospital

Secondary Outcomes (2)

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

  1 day, on discharge date from hospital

• Number of Participants With Opioid Prescriptions After Discharge

  "Day of discharge +1" until 28 days after discharge

Study Arms (2)

BPA Off

NO INTERVENTION

No best-practice alert (BPA) message is displayed to providers.

BPA On

EXPERIMENTAL

BPA message is displayed to providers based on patient opioid intake as reported in the electronic health record (EHR).

Other: BPA

Interventions

BPA OTHER

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.

BPA On

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• University of Nebraska: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (4)

• Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.

  PMID: 26824844 BACKGROUND

• Loudon K, Treweek S, Sullivan F, Donnan P, Thorpe KE, Zwarenstein M. The PRECIS-2 tool: designing trials that are fit for purpose. BMJ. 2015 May 8;350:h2147. doi: 10.1136/bmj.h2147. No abstract available.

  PMID: 25956159 BACKGROUND

• Bartels K, Fernandez-Bustamante A, McWilliams SK, Hopfer CJ, Mikulich-Gilbertson SK. Long-term opioid use after inpatient surgery - A retrospective cohort study. Drug Alcohol Depend. 2018 Jun 1;187:61-65. doi: 10.1016/j.drugalcdep.2018.02.013. Epub 2018 Mar 27.

  PMID: 29627407 BACKGROUND

• Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.

  PMID: 29238810 BACKGROUND

Results Point of Contact

• Title: Dr. Karsten Bartels
• Organization: UNMC

anesthesiology.research@unmc.edu

(402) 559-4081

Study Officials

• Karsten Bartels, MD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: July 7, 2020
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)