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Clinical Trials/NCT03003832
NCT03003832
Completed
Not Applicable

A Cluster-randomized Trial of Modifying Electronic Health Record Defaults to Reduce the Prescribed Quantity of Opioid Analgesics in Primary Care and Emergency Department Settings

Montefiore Medical Center0 sites15,000 target enrollmentDecember 2016
ConditionsAcute Pain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Pain
Sponsor
Montefiore Medical Center
Enrollment
15000
Primary Endpoint
Initial prescription <= 10 pills (y/n)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The goal of this research is to investigate the impact of changing opioid analgesic prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult primary care and emergency department settings. We will change prescribing defaults for select short-acting opioid analgesics including immediate release oxycodone and hydrocodone as well as codeine and tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial of matched pairs of Montefiore Medical Center clinical sites, stratified by specialty and teaching status, we will evaluate the impact of this intervention on patient-level outcomes using 18 months of data (6 months pre-intervention and 12 months post-intervention).

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
July 13, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marcus Bachhuber

Assistant Professor

Montefiore Medical Center

Eligibility Criteria

Inclusion Criteria

  • Primary care clinic (internal medicine, family medicine, or urgent care) or emergency department within Montefiore Medical Center
  • Patient Inclusion Criteria:
  • Received a new opioid analgesic prescription, defined as no opioid analgesic prescription in the preceding 6 months

Exclusion Criteria

  • Cancer diagnosis code within the past 1 year

Outcomes

Primary Outcomes

Initial prescription <= 10 pills (y/n)

Time Frame: Through study completion (18 months)

Extracted from the electronic medical record

Secondary Outcomes

  • Initial prescription number of pills(Through study completion (18 months))
  • Initial prescription morphine milligram equivalents(Through study completion (18 months))
  • Total morphine milligram equivalents prescribed, including re-orders(Within 30 days after the initial prescription)
  • Opioid analgesic re-order (y/n)(Within 30 days after the initial prescription)
  • Hospitalizations(Within 30 days after the initial prescription)
  • Outpatient visits(Within 30 days after the initial prescription)
  • Total opioid analgesic pills prescribed, including re-orders(Within 30 days after the initial prescription)
  • Emergency department visits(Within 30 days after the initial prescription)

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