Electronic Defaults to Reduce Opioid Prescribing in Dentistry Practices

A Cluster-randomized Trial of Modifying Electronic Health Record Defaults to Reduce the Prescribed Quantity of Opioid Analgesics in Dentistry Practices

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 dentistry 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 three Montefiore Medical Center dentistry sites, 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): 10000
• 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:

• Dentistry clinic 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:

• None

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10-pill default; 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
Experimental: 5-pill default; New opioid analgesic prescriptions will automatically default to 5 pills.	Other: Change in electronic health record default for new opioid analgesic prescriptions
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial prescription number of pills to dispense	From the electronic health record	Through study completion (18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial prescription morphine milligram equivalents to dispense	From the electronic health record	Through study completion (18 months)
Opioid analgesic reorder (y/n)	From the electronic health record	Within 30 days after the initial prescription
Total opioid analgesic pills to dispense, including re-orders	From the electronic health record	Within 30 days after the initial prescription
Total morphine milligram equivalents to dispense, including re-orders	From the electronic health record	Within 30 days after the initial prescription
Outpatient visits	From the electronic health record	Within 30 days after the index prescription
Emergency department visits	From the electronic health record	Within 30 days after the initial prescription
Hospitalizations	From the electronic health record	Within 30 days after the initial prescription

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: Albert Einstein College of Medicine
• Investigators: Principal Investigator: Marcus Bachhuber, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Sugarman OK, Cunningham CO. Reducing opioid analgesic prescribing in dentistry through prescribing defaults: a cluster randomized controlled trial. Pain Med. 2022 Jul 6:pnac106. doi: 10.1093/pm/pnac106. Online ahead of print.

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 19, 2016
• First Submitted That Met QC Criteria: January 22, 2017
• First Posted (Estimate): January 25, 2017

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: Pain; Neurologic Manifestations; 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: 2016-7373

Plan for Individual participant data (IPD)

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