Back to resultsElectronic Defaults to Reduce Opioid Prescribing in Emergency Department and Primary Care Settings
Primary Purpose
Acute Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Change in electronic health record default for new opioid analgesic prescriptions
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Clinical Site Inclusion Criteria:
- Primary care clinic (internal medicine, family medicine, or urgent care) or emergency department within Montefiore Medical Center
Patient Inclusion Criteria:
- Received a new opioid analgesic prescription, defined as no opioid analgesic prescription in the preceding 6 months
Patient Exclusion Criteria:
- Cancer diagnosis code within the past 1 year
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Standard of care
Arm Description
The intervention condition consists of a change to the electronic health record so that new opioid analgesic prescriptions automatically default to 10 pills (i.e., the "quantity dispensed" field is pre-populated). This value is modifiable by providers who can tailor the prescription based on clinical factors.
The control condition will be the usual electronic health record interface. The default number of pills varies by medication, most medications currently have either a blank default or a default of 30 pills.
Outcomes
Primary Outcome Measures
Initial prescription <= 10 pills (y/n)
Extracted from the electronic medical record
Secondary Outcome Measures
Initial prescription number of pills
Extracted from the electronic medical record
Initial prescription morphine milligram equivalents
Extracted from the electronic medical record
Opioid analgesic re-order (y/n)
Extracted from the electronic medical record
Total opioid analgesic pills prescribed, including re-orders
Extracted from the electronic medical record
Total morphine milligram equivalents prescribed, including re-orders
Extracted from the electronic medical record
Outpatient visits
Extracted from the electronic medical record
Emergency department visits
Extracted from the electronic medical record
Hospitalizations
Extracted from the electronic medical record
Full Information
NCT ID
NCT03003832
First Posted
December 6, 2016
Last Updated
August 13, 2018
Sponsor
Montefiore Medical Center
Collaborators
Albert Einstein College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03003832
Brief Title
Electronic Defaults to Reduce Opioid Prescribing in Emergency Department and Primary Care Settings
Official Title
A Cluster-randomized Trial of Modifying Electronic Health Record Defaults to Reduce the Prescribed Quantity of Opioid Analgesics in Primary Care and Emergency Department Settings
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
July 13, 2018 (Actual)
Study Completion Date
July 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montefiore Medical Center
Collaborators
Albert Einstein College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this research is to investigate the impact of changing opioid analgesic prescribing defaults on the quantity of opioids prescribed for acute non-cancer pain in adult primary care and emergency department settings. We will change prescribing defaults for select short-acting opioid analgesics including immediate release oxycodone and hydrocodone as well as codeine and tramadol, including their co-formulations with acetaminophen. In a cluster-randomized trial of matched pairs of Montefiore Medical Center clinical sites, stratified by specialty and teaching status, we will evaluate the impact of this intervention on patient-level outcomes using 18 months of data (6 months pre-intervention and 12 months post-intervention).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention condition consists of a change to the electronic health record so that new opioid analgesic prescriptions automatically default to 10 pills (i.e., the "quantity dispensed" field is pre-populated). This value is modifiable by providers who can tailor the prescription based on clinical factors.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
The control condition will be the usual electronic health record interface. The default number of pills varies by medication, most medications currently have either a blank default or a default of 30 pills.
Intervention Type
Other
Intervention Name(s)
Change in electronic health record default for new opioid analgesic prescriptions
Primary Outcome Measure Information:
Title
Initial prescription <= 10 pills (y/n)
Description
Extracted from the electronic medical record
Time Frame
Through study completion (18 months)
Secondary Outcome Measure Information:
Title
Initial prescription number of pills
Description
Extracted from the electronic medical record
Time Frame
Through study completion (18 months)
Title
Initial prescription morphine milligram equivalents
Description
Extracted from the electronic medical record
Time Frame
Through study completion (18 months)
Title
Opioid analgesic re-order (y/n)
Description
Extracted from the electronic medical record
Time Frame
Within 30 days after the initial prescription
Title
Total opioid analgesic pills prescribed, including re-orders
Description
Extracted from the electronic medical record
Time Frame
Within 30 days after the initial prescription
Title
Total morphine milligram equivalents prescribed, including re-orders
Description
Extracted from the electronic medical record
Time Frame
Within 30 days after the initial prescription
Title
Outpatient visits
Description
Extracted from the electronic medical record
Time Frame
Within 30 days after the initial prescription
Title
Emergency department visits
Description
Extracted from the electronic medical record
Time Frame
Within 30 days after the initial prescription
Title
Hospitalizations
Description
Extracted from the electronic medical record
Time Frame
Within 30 days after the initial prescription
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Clinical Site Inclusion Criteria:
Primary care clinic (internal medicine, family medicine, or urgent care) or emergency department within Montefiore Medical Center
Patient Inclusion Criteria:
Received a new opioid analgesic prescription, defined as no opioid analgesic prescription in the preceding 6 months
Patient Exclusion Criteria:
Cancer diagnosis code within the past 1 year
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33885773
Citation
Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Thakral M, Cunningham CO. Effect of Changing Electronic Health Record Opioid Analgesic Dispense Quantity Defaults on the Quantity Prescribed: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2021 Apr 1;4(4):e217481. doi: 10.1001/jamanetworkopen.2021.7481.
Results Reference
derived
PubMed Identifier
29678969
Citation
Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Cunningham CO. Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial. BMJ Open. 2018 Apr 20;8(4):e019559. doi: 10.1136/bmjopen-2017-019559.
Results Reference
derived
Learn more about this trial
Electronic Defaults to Reduce Opioid Prescribing in Emergency Department and Primary Care Settings
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