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Trial record 1 of 1 for:    NCT04155229
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EMR Defaults to Nudge Opioid Prescribing

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ClinicalTrials.gov Identifier: NCT04155229
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Collaborator:
National Center for Advancing Translational Sciences (NCATS)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
The investigators conducted a prospective, block-randomized study to determine whether and to what extent changes in the default settings in the electronic medical record (EMR) affect opioid prescriptions for patients discharged from emergency departments (EDs).

Condition or disease Intervention/treatment Phase
Pain, Acute Opioid Use, Unspecified Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone) Not Applicable

Detailed Description:
In two large, urban emergency departments, we randomly altered the pre-populated dispense quantities of discharge prescriptions for commonly-prescribed opioids over a series of five 4-week blocks. These changes were made without announcement, and providers were not informed of the study itself.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Each of two sites underwent block randomization of four treatment assignments.
Masking: None (Open Label)
Masking Description: The investigators did not mask the changes to the electronic medical record, but note that they also did not announce them.
Primary Purpose: Health Services Research
Official Title: Effect of Default Electronic Health Record Settings on Clinician Opioid Prescribing Patterns in Emergency Departments
Actual Study Start Date : October 3, 2016
Actual Primary Completion Date : September 3, 2017
Actual Study Completion Date : September 3, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Null setting, forced entry

Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.

This arm has a default setting for opioid quantity set at -blank-. This setting required the prescriber to enter a quantity in order to write a prescription.

 Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)

For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.

Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.
Experimental: 5 tablet default

Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.

This arm has a default setting for opioid quantity set at 5.

 Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)

For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.

Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.
Experimental: 10 tablet default

Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.

This arm has a default setting for opioid quantity set at 10.

 Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)

For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.

Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.
Experimental: 15 tablet default

Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.

This arm has a default setting for opioid quantity set at 15.

 Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)

For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.

Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.
Active Comparator: Status quo default setting

Each arm sets the default quantity (preset quantity) embedded in the electronic medical record for study opioids.

This arm has a default setting for opioid quantity set at the status quo value for each site (20 for site 1, 12 for site 2).

 Other: Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)

For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.

Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg.


Outcome Measures
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Primary Outcome Measures :
  1. Dispense quantity of prescribed opioids [ Time Frame: Through study completion, approximately 340 days ]
    The dispense quantity of prescribed study drugs was collected from the electronic medical record at each site. The mean and median quantities per prescription according to each study arm were compared.


Secondary Outcome Measures :
  1. Proportion ≤12 [ Time Frame: Through study completion, approximately 340 days ]
    The dispense quantity of study drugs was collected from the electronic medical record at each site. The proportion of prescriptions at 12 or fewer tablets was compared across study arms.

  2. Proportion at default setting [ Time Frame: Through study completion, approximately 340 days ]
    The dispense quantity of study drugs was collected from the electronic medical record at each site. The proportion of prescriptions written for the given default setting was compared across treatment arms.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Discharge prescription from emergency for study drug: hydrocodone/acetaminophen, oxycodone, or oxycodone/acetaminophen.

Exclusion Criteria:

  • none
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155229


Sponsors and Collaborators
University of California, San Francisco
National Center for Advancing Translational Sciences (NCATS)
Investigators
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Principal Investigator: Juan Carlos Montoy, MD, PhD University of California, San Francisco
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04155229    
Other Study ID Numbers: EMRdefaults
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Acetaminophen
Acetaminophen, hydrocodone drug combination
Oxycodone
Hydrocodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents