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).
Brief Title
Electronic Defaults to Reduce Opioid Prescribing in Emergency Department and Primary Care Settings
Categories
Completion Date
Completion Date Type
Actual
Conditions
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03003832
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2016-6036
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Extracted from the electronic medical record
Outcome Measure
Initial prescription <= 10 pills (y/n)
Outcome Time Frame
Through study completion (18 months)
Secondary Outcomes
Outcome Description
Extracted from the electronic medical record
Outcome Time Frame
Through study completion (18 months)
Outcome Measure
Initial prescription number of pills
Outcome Description
Extracted from the electronic medical record
Outcome Time Frame
Through study completion (18 months)
Outcome Measure
Initial prescription morphine milligram equivalents
Outcome Description
Extracted from the electronic medical record
Outcome Time Frame
Within 30 days after the initial prescription
Outcome Measure
Opioid analgesic re-order (y/n)
Outcome Description
Extracted from the electronic medical record
Outcome Time Frame
Within 30 days after the initial prescription
Outcome Measure
Total opioid analgesic pills prescribed, including re-orders
Outcome Description
Extracted from the electronic medical record
Outcome Time Frame
Within 30 days after the initial prescription
Outcome Measure
Total morphine milligram equivalents prescribed, including re-orders
Outcome Description
Extracted from the electronic medical record
Outcome Time Frame
Within 30 days after the initial prescription
Outcome Measure
Outpatient visits
Outcome Description
Extracted from the electronic medical record
Outcome Time Frame
Within 30 days after the initial prescription
Outcome Measure
Emergency department visits
Outcome Description
Extracted from the electronic medical record
Outcome Time Frame
Within 30 days after the initial prescription
Outcome Measure
Hospitalizations
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Chinazo Cunningham
Investigator Email
chinazo.cunningham@einsteinmed.org
Investigator Phone