Electronic Defaults to Reduce Opioid Prescribing in Emergency Department and Primary Care Settings

Acute Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03003832
• Other study ID #: 2016-6036
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: July 13, 2018

Study information

• Verified date: August 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15000
• Est. completion date: July 13, 2018
• Est. primary completion date: July 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Clinical Site 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

Patient Exclusion Criteria:

• Cancer diagnosis code within the past 1 year

Related Conditions & MeSH terms

• Acute Pain
• Emergencies

Intervention

Other:
• Change in electronic health record default for new opioid analgesic prescriptions

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	Albert Einstein College of Medicine, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Initial prescription <= 10 pills (y/n)	Extracted from the electronic medical record	Through study completion (18 months)
Secondary	Initial prescription number of pills	Extracted from the electronic medical record	Through study completion (18 months)
Secondary	Initial prescription morphine milligram equivalents	Extracted from the electronic medical record	Through study completion (18 months)
Secondary	Opioid analgesic re-order (y/n)	Extracted from the electronic medical record	Within 30 days after the initial prescription
Secondary	Total opioid analgesic pills prescribed, including re-orders	Extracted from the electronic medical record	Within 30 days after the initial prescription
Secondary	Total morphine milligram equivalents prescribed, including re-orders	Extracted from the electronic medical record	Within 30 days after the initial prescription
Secondary	Outpatient visits	Extracted from the electronic medical record	Within 30 days after the initial prescription
Secondary	Emergency department visits	Extracted from the electronic medical record	Within 30 days after the initial prescription
Secondary	Hospitalizations	Extracted from the electronic medical record	Within 30 days after the initial prescription