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OpenTrials
Completed

NCT Number: NCT03003832

Electronic Defaults to Reduce Opioid Prescribing in Emergency Department and Primary Care Settings

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).

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Change in electronic health record default for new opioid analgesic prescriptions

Other

Primary outcomes

  1. Initial prescription <= 10 pills (y/n)

    Time frame: Through study completion (18 months)

    Extracted from the electronic medical record

Secondary outcomes

  1. Initial prescription number of pills

    Time frame: Through study completion (18 months)

    Extracted from the electronic medical record

  2. Initial prescription morphine milligram equivalents

    Time frame: Through study completion (18 months)

    Extracted from the electronic medical record

  3. Opioid analgesic re-order (y/n)

    Time frame: Within 30 days after the initial prescription

    Extracted from the electronic medical record

  4. Total opioid analgesic pills prescribed, including re-orders

    Time frame: Within 30 days after the initial prescription

    Extracted from the electronic medical record

  5. Total morphine milligram equivalents prescribed, including re-orders

    Time frame: Within 30 days after the initial prescription

    Extracted from the electronic medical record

  6. Outpatient visits

    Time frame: Within 30 days after the initial prescription

    Extracted from the electronic medical record

  7. Emergency department visits

    Time frame: Within 30 days after the initial prescription

    Extracted from the electronic medical record

  8. Hospitalizations

    Time frame: Within 30 days after the initial prescription

    Extracted from the electronic medical record

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Albert Einstein College of Medicine

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2016
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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