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

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

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).

Study Overview

• Status: Completed
• Conditions: Acute Pain
• Intervention / Treatment: Other: Change in electronic health record default for new opioid analgesic prescriptions

• Study Type: Interventional
• Enrollment (Anticipated): 15000
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; The control condition will be the usual electronic health record interface. The default number of pills varies by medication, most medications currently have either a blank default or a default of 30 pills.
Experimental: Intervention; The intervention condition consists of a change to the electronic health record so that new opioid analgesic prescriptions automatically default to 10 pills (i.e., the "quantity dispensed" field is pre-populated). This value is modifiable by providers who can tailor the prescription based on clinical factors.	Other: Change in electronic health record default for new opioid analgesic prescriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial prescription <= 10 pills (y/n)	Extracted from the electronic medical record	Through study completion (18 months)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Albert Einstein College of Medicine

Publications and helpful links

General Publications

• Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Thakral M, Cunningham CO. Effect of Changing Electronic Health Record Opioid Analgesic Dispense Quantity Defaults on the Quantity Prescribed: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e217481. doi: 10.1001/jamanetworkopen.2021.7481.
• Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Cunningham CO. Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial. BMJ Open. 2018 Apr 20;8(4):e019559. doi: 10.1136/bmjopen-2017-019559.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): July 13, 2018
• Study Completion (Actual): July 13, 2018

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (Estimate): December 28, 2016

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Emergencies; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Narcotics; Analgesics, Opioid; Analgesics
• Other Study ID Numbers: 2016-6036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED