NCT03003832

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

1.6 years

First QC Date

December 6, 2016

Last Update Submit

August 13, 2018

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • Initial prescription <= 10 pills (y/n)

    Extracted from the electronic medical record

    Through study completion (18 months)

Secondary Outcomes (8)

  • Initial prescription number of pills

    Through study completion (18 months)

  • Initial prescription morphine milligram equivalents

    Through study completion (18 months)

  • Opioid analgesic re-order (y/n)

    Within 30 days after the initial prescription

  • Total opioid analgesic pills prescribed, including re-orders

    Within 30 days after the initial prescription

  • Total morphine milligram equivalents prescribed, including re-orders

    Within 30 days after the initial prescription

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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

Standard of care

NO INTERVENTION

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.

Interventions

Change in electronic health record default for new opioid analgesic prescriptionsOTHER
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cancer diagnosis code within the past 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33885773DERIVED

  • 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.

    PMID: 29678969DERIVED

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 6, 2016

First Posted

December 28, 2016

Study Start

December 1, 2016

Primary Completion

July 13, 2018

Study Completion

July 13, 2018

Last Updated

August 14, 2018

Record last verified: 2018-08