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Using Rapid Cycle Randomized Controlled Trials to Optimize the Influenza Clinical Decision Support Tool

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03415425
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE December 26, 2017
First Posted Date  ICMJE January 30, 2018
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE January 16, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
Alert Cancelation Rate [ Time Frame: 2 months. ]
Number of times alert fires in medical record within 2 Month period
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2018)
Vaccination Rate at Discharge [ Time Frame: 2 months ]
Number of vaccinations recorded in EMR within 2 Month period
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 Using Rapid Cycle Randomized Controlled Trials to Optimize the Influenza Clinical Decision Support Tool
Official Title  ICMJE Using Rapid Cycle Randomized Controlled Trials to Optimize the Influenza Clinical Decision Support Tool
Brief Summary The proposed study aims to examine several iterations of the Influenza Best Practice Alert at NYU Langone Health. The goal is to increase ordering of the influenza vaccine through the alert.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Clinical Decision Support
Intervention  ICMJE
  • Other: Current Version of the Influenza Alert
    Intervention includes the current version of the Influenza Alert that fires in the electronic medical record if the patient has not received the flu vaccination, as part of usual care.
  • Other: Alternate Modifications of the Influenza Alert
    Intervention includes various iterations of the Influenza Alert that fires in the electronic medical record if the patient has not received the flu vaccination.
Study Arms  ICMJE
  • Active Comparator: Usual Care
    The current version of the alert will fire for this arm of the study.
    Intervention: Other: Current Version of the Influenza Alert
  • Active Comparator: Alert Iteration
    A modified version of the alert will fire for this arm of the study.
    Intervention: Other: Alternate Modifications of the Influenza Alert
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2018)
4000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All NYU Langone Health inpatients eligible for the Influenza clinical decision support tool

Exclusion Criteria:

  • N/A
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ashley Bagheri, MS 6465012560 ashley.bagheri@nyumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03415425
Other Study ID Numbers  ICMJE RCT CDS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leora Horwitz, MD, MHS NYU Langone Health
PRS Account NYU Langone Health
Verification Date October 2019

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