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

NCT ID: NCT03003832

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-07-13

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Change in electronic health record default for new opioid analgesic prescriptions

Intervention Type OTHER

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Change in electronic health record default for new opioid analgesic prescriptions

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Cancer diagnosis code within the past 1 year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Albert Einstein College of Medicine

OTHER

Sponsor Role collaborator

Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Marcus Bachhuber

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 33885773 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29678969 (View on PubMed)

Other Identifiers

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2016-6036

Identifier Type: -

Identifier Source: org_study_id

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