Clinical trial NCT03003832: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
First posted: 2016-12-28
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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 outcomes:
measure: Initial prescription <= 10 pills (y/n)
timeFrame: Through study completion (18 months)
Secondary outcomes:
measure: Initial prescription number of pills
timeFrame: Through study completion (18 months)
measure: Initial prescription morphine milligram equivalents
timeFrame: Through study completion (18 months)
measure: Opioid analgesic re-order (y/n)
timeFrame: Within 30 days after the initial prescription
measure: Total opioid analgesic pills prescribed, including re-orders
timeFrame: Within 30 days after the initial prescription
measure: Total morphine milligram equivalents prescribed, including re-orders
timeFrame: Within 30 days after the initial prescription
measure: Outpatient visits
timeFrame: Within 30 days after the initial prescription
measure: Emergency department visits
timeFrame: Within 30 days after the initial prescription
measure: Hospitalizations
timeFrame: Within 30 days after the initial prescription
Other outcomes:
Locations:
Study officials:
References:
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.
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.