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Trial record 39 of 74 for:    Codeine AND Acetaminophen

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

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ClinicalTrials.gov Identifier: NCT03003832
Recruitment Status : Completed
First Posted : December 28, 2016
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 6, 2016
First Posted Date  ICMJE December 28, 2016
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: December 22, 2016)
Initial prescription <= 10 pills (y/n) [ Time Frame: Through study completion (18 months) ]
Extracted from the electronic medical record
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03003832 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2017)
  • Initial prescription number of pills [ Time Frame: Through study completion (18 months) ]
    Extracted from the electronic medical record
  • Initial prescription morphine milligram equivalents [ Time Frame: Through study completion (18 months) ]
    Extracted from the electronic medical record
  • Opioid analgesic re-order (y/n) [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
  • Total opioid analgesic pills prescribed, including re-orders [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
  • Total morphine milligram equivalents prescribed, including re-orders [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
  • Outpatient visits [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
  • Emergency department visits [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
  • Hospitalizations [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2016)
  • Initial prescription number of pills [ Time Frame: Through study completion (18 months) ]
    Extracted from the electronic medical record
  • Initial prescription morphine milligram equivalents [ Time Frame: Through study completion (18 months) ]
    Extracted from the electronic medical record
  • Opioid analgesic re-order (y/n) [ Time Frame: Within 30 days after the initial prescripiton ]
    Extracted from the electronic medical record
  • Total opioid analgesic pills prescribed, including re-orders [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
  • Total morphine milligram equivalents prescribed, including re-orders [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
  • Outpatient visits [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
  • Emergency department visits [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
  • Hospitalizations [ Time Frame: Within 30 days after the initial prescription ]
    Extracted from the electronic medical record
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 Emergency Department and Primary Care Settings
Official Title  ICMJE 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
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).
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: Intervention
    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
  • 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 * 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.

*   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: December 22, 2016)
15000
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:

  • 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
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 NCT03003832
Other Study ID Numbers  ICMJE 2016-6036
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 Not Provided
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