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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04155229
Other study ID # EMRdefaults
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2016
Est. completion date September 3, 2017

Study information

Verified date November 2019
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date September 3, 2017
Est. primary completion date September 3, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- none

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco National Center for Advancing Translational Science (NCATS)

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. Through study completion, approximately 340 days
Secondary 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. Through study completion, approximately 340 days
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