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Electronic Defaults to Reduce Opioid Prescribing in Dentistry Practices

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ClinicalTrials.gov Identifier: NCT03030469
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : August 14, 2018
Sponsor:
Collaborator:
Albert Einstein College of Medicine
Information provided by (Responsible Party):
Marcus Bachhuber, Montefiore Medical Center

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 dentistry 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 three Montefiore Medical Center dentistry sites, 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).

Condition or disease Intervention/treatment Phase
Acute Pain Other: Change in electronic health record default for new opioid analgesic prescriptions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Cluster-randomized Trial of Modifying Electronic Health Record Defaults to Reduce the Prescribed Quantity of Opioid Analgesics in Dentistry Practices
Study Start Date : December 2016
Actual Primary Completion Date : July 13, 2018
Actual Study Completion Date : July 13, 2018

Arm Intervention/treatment
Experimental: 10-pill default
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.
Other: Change in electronic health record default for new opioid analgesic prescriptions
Experimental: 5-pill default
New opioid analgesic prescriptions will automatically default to 5 pills.
Other: Change in electronic health record default for new opioid analgesic prescriptions
No Intervention: Standard of care
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.



Primary Outcome Measures :
  1. Initial prescription number of pills to dispense [ Time Frame: Through study completion (18 months) ]
    From the electronic health record


Secondary Outcome Measures :
  1. Initial prescription morphine milligram equivalents to dispense [ Time Frame: Through study completion (18 months) ]
    From the electronic health record

  2. Opioid analgesic reorder (y/n) [ Time Frame: Within 30 days after the initial prescription ]
    From the electronic health record

  3. Total opioid analgesic pills to dispense, including re-orders [ Time Frame: Within 30 days after the initial prescription ]
    From the electronic health record

  4. Total morphine milligram equivalents to dispense, including re-orders [ Time Frame: Within 30 days after the initial prescription ]
    From the electronic health record

  5. Outpatient visits [ Time Frame: Within 30 days after the index prescription ]
    From the electronic health record

  6. Emergency department visits [ Time Frame: Within 30 days after the initial prescription ]
    From the electronic health record

  7. Hospitalizations [ Time Frame: Within 30 days after the initial prescription ]
    From the electronic health record



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Clinical Site Inclusion Criteria:

  • Dentistry clinic within Montefiore Medical Center

Patient Inclusion Criteria:

  • Received a new opioid analgesic prescription, defined as no opioid analgesic prescription in the preceding 6 months

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030469


Sponsors and Collaborators
Montefiore Medical Center
Albert Einstein College of Medicine
Investigators
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Principal Investigator: Marcus Bachhuber, MD Montefiore Medical Center

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Responsible Party: Marcus Bachhuber, Assistant Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03030469     History of Changes
Other Study ID Numbers: 2016-7373
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Analgesics
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents