NCT04155229

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 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

October 3, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

11 months

First QC Date

October 28, 2019

Last Update Submit

November 4, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dispense quantity of prescribed opioids

    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.

    Through study completion, approximately 340 days

Secondary Outcomes (2)

  • Proportion ≤12

    Through study completion, approximately 340 days

  • Proportion at default setting

    Through study completion, approximately 340 days

Study Arms (5)

Null setting, forced entry

EXPERIMENTAL

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)

5 tablet default

EXPERIMENTAL

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)

10 tablet default

EXPERIMENTAL

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)

15 tablet default

EXPERIMENTAL

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)

Status quo default setting

ACTIVE COMPARATOR

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)

Interventions

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.

10 tablet default15 tablet default5 tablet defaultNull setting, forced entryStatus quo default setting

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Montoy JCC, Coralic Z, Herring AA, Clattenburg EJ, Raven MC. Association of Default Electronic Medical Record Settings With Health Care Professional Patterns of Opioid Prescribing in Emergency Departments: A Randomized Quality Improvement Study. JAMA Intern Med. 2020 Apr 1;180(4):487-493. doi: 10.1001/jamainternmed.2019.6544.

MeSH Terms

Conditions

Acute Pain

Interventions

AcetaminophenHydrocodoneOxycodoneoxycodone-acetaminophen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Juan Carlos Montoy, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The investigators did not mask the changes to the electronic medical record, but note that they also did not announce them.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Each of two sites underwent block randomization of four treatment assignments.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

November 7, 2019

Study Start

October 3, 2016

Primary Completion

September 3, 2017

Study Completion

September 3, 2017

Last Updated

November 7, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share