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Trial record 38 of 74 for:    Codeine AND Acetaminophen

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

Tracking Information
First Submitted Date  ICMJE December 19, 2016
First Posted Date  ICMJE January 25, 2017
Last Update Posted Date August 14, 2018
Study Start Date  ICMJE December 2016
Actual Primary Completion Date July 13, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2017)
Initial prescription number of pills to dispense [ Time Frame: Through study completion (18 months) ]
From the electronic health record
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03030469 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2017)
  • Initial prescription morphine milligram equivalents to dispense [ Time Frame: Through study completion (18 months) ]
    From the electronic health record
  • Opioid analgesic reorder (y/n) [ Time Frame: Within 30 days after the initial prescription ]
    From the electronic health record
  • Total opioid analgesic pills to dispense, including re-orders [ Time Frame: Within 30 days after the initial prescription ]
    From the electronic health record
  • Total morphine milligram equivalents to dispense, including re-orders [ Time Frame: Within 30 days after the initial prescription ]
    From the electronic health record
  • Outpatient visits [ Time Frame: Within 30 days after the index prescription ]
    From the electronic health record
  • Emergency department visits [ Time Frame: Within 30 days after the initial prescription ]
    From the electronic health record
  • Hospitalizations [ Time Frame: Within 30 days after the initial prescription ]
    From the electronic health record
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Electronic Defaults to Reduce Opioid Prescribing in Dentistry Practices
Official Title  ICMJE A Cluster-randomized Trial of Modifying Electronic Health Record Defaults to Reduce the Prescribed Quantity of Opioid Analgesics in Dentistry Practices
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Acute Pain
Intervention  ICMJE Other: Change in electronic health record default for new opioid analgesic prescriptions
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 22, 2017)
10000
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 13, 2018
Actual Primary Completion Date July 13, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03030469
Other Study ID Numbers  ICMJE 2016-7373
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marcus Bachhuber, Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Albert Einstein College of Medicine
Investigators  ICMJE
Principal Investigator: Marcus Bachhuber, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP