Back to resultsEMR Defaults to Nudge Opioid Prescribing
Primary Purpose
Pain, Acute, Opioid Use, Unspecified
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)
Sponsored by
About this trial
This is an interventional health services research trial for Pain, Acute
Eligibility Criteria
Inclusion Criteria:
- Discharge prescription from emergency for study drug: hydrocodone/acetaminophen, oxycodone, or oxycodone/acetaminophen.
Exclusion Criteria:
- none
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Null setting, forced entry
5 tablet default
10 tablet default
15 tablet default
Status quo default setting
Arm Description
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.
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.
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.
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.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion ≤12
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.
Proportion at default setting
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.
Full Information
NCT ID
NCT04155229
First Posted
October 28, 2019
Last Updated
November 4, 2019
Sponsor
University of California, San Francisco
Collaborators
National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT04155229
Brief Title
EMR Defaults to Nudge Opioid Prescribing
Official Title
Effect of Default Electronic Health Record Settings on Clinician Opioid Prescribing Patterns in Emergency Departments
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 3, 2016 (Actual)
Primary Completion Date
September 3, 2017 (Actual)
Study Completion Date
September 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Opioid Use, Unspecified
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Null setting, forced entry
Arm Type
Experimental
Arm Description
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.
Arm Title
5 tablet default
Arm Type
Experimental
Arm Description
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.
Arm Title
10 tablet default
Arm Type
Experimental
Arm Description
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.
Arm Title
15 tablet default
Arm Type
Experimental
Arm Description
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.
Arm Title
Status quo default setting
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Dispense quantity of prescribed opioids
Description
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.
Time Frame
Through study completion, approximately 340 days
Secondary Outcome Measure Information:
Title
Proportion ≤12
Description
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.
Time Frame
Through study completion, approximately 340 days
Title
Proportion at default setting
Description
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.
Time Frame
Through study completion, approximately 340 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Discharge prescription from emergency for study drug: hydrocodone/acetaminophen, oxycodone, or oxycodone/acetaminophen.
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Montoy, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31961377
Citation
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.
Results Reference
derived
Learn more about this trial
EMR Defaults to Nudge Opioid Prescribing
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