- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04155229
EMR Defaults to Nudge Opioid Prescribing
Effect of Default Electronic Health Record Settings on Clinician Opioid Prescribing Patterns in Emergency Departments
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Discharge prescription from emergency for study drug: hydrocodone/acetaminophen, oxycodone, or oxycodone/acetaminophen.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
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. |
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. |
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. |
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). |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion, approximately 340 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion, approximately 340 days
|
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.
|
Through study completion, approximately 340 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Juan Carlos Montoy, MD, PhD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Acute Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antipyretics
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Acetaminophen
- Oxycodone
- Hydrocodone
- Acetaminophen, hydrocodone drug combination
Other Study ID Numbers
- EMRdefaults
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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