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Electronic Defaults to Reduce Opioid Prescribing in Dentistry Practices

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
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    10-pill default

    5-pill default

    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.

    New opioid analgesic prescriptions will automatically default to 5 pills.

    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 number of pills to dispense
    From the electronic health record

    Secondary Outcome Measures

    Initial prescription morphine milligram equivalents to dispense
    From the electronic health record
    Opioid analgesic reorder (y/n)
    From the electronic health record
    Total opioid analgesic pills to dispense, including re-orders
    From the electronic health record
    Total morphine milligram equivalents to dispense, including re-orders
    From the electronic health record
    Outpatient visits
    From the electronic health record
    Emergency department visits
    From the electronic health record
    Hospitalizations
    From the electronic health record

    Full Information

    First Posted
    December 19, 2016
    Last Updated
    August 13, 2018
    Sponsor
    Montefiore Medical Center
    Collaborators
    Albert Einstein College of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03030469
    Brief Title
    Electronic Defaults to Reduce Opioid Prescribing in Dentistry Practices
    Official Title
    A Cluster-randomized Trial of Modifying Electronic Health Record Defaults to Reduce the Prescribed Quantity of Opioid Analgesics in Dentistry Practices
    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 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).

    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
    10000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    10-pill default
    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
    5-pill default
    Arm Type
    Experimental
    Arm Description
    New opioid analgesic prescriptions will automatically default to 5 pills.
    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 number of pills to dispense
    Description
    From the electronic health record
    Time Frame
    Through study completion (18 months)
    Secondary Outcome Measure Information:
    Title
    Initial prescription morphine milligram equivalents to dispense
    Description
    From the electronic health record
    Time Frame
    Through study completion (18 months)
    Title
    Opioid analgesic reorder (y/n)
    Description
    From the electronic health record
    Time Frame
    Within 30 days after the initial prescription
    Title
    Total opioid analgesic pills to dispense, including re-orders
    Description
    From the electronic health record
    Time Frame
    Within 30 days after the initial prescription
    Title
    Total morphine milligram equivalents to dispense, including re-orders
    Description
    From the electronic health record
    Time Frame
    Within 30 days after the initial prescription
    Title
    Outpatient visits
    Description
    From the electronic health record
    Time Frame
    Within 30 days after the index prescription
    Title
    Emergency department visits
    Description
    From the electronic health record
    Time Frame
    Within 30 days after the initial prescription
    Title
    Hospitalizations
    Description
    From the electronic health 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: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcus Bachhuber, MD
    Organizational Affiliation
    Montefiore Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    35792881
    Citation
    Bachhuber MA, Nash D, Southern WN, Heo M, Berger M, Schepis M, Sugarman OK, Cunningham CO. Reducing Opioid Analgesic Prescribing in Dentistry Through Prescribing Defaults: A Cluster-Randomized Controlled Trial. Pain Med. 2023 Jan 4;24(1):1-10. doi: 10.1093/pm/pnac106.
    Results Reference
    derived

    Learn more about this trial

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