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Clinical Decision Support Tools for Antibiotic Prescribing

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ClinicalTrials.gov Identifier: NCT03580603
Recruitment Status : Enrolling by invitation
First Posted : July 9, 2018
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
Steven Horng, MD, Beth Israel Deaconess Medical Center

Brief Summary:
The goal of this study is to assess the utility of a data visualization tool for providers' understanding patients' past microbiological culture sensitivities. Providers that are ordering antibiotics for patients with previous culture data in the medical record will be asked to answer questions regarding past sensitivity results. They will be randomized to either using the visualization tool before answering the questions or using the standard medical record tools. They will then be surveyed about their decision-making, knowledge, and the usefulness of the tool.

Condition or disease Intervention/treatment Phase
Infectious Disease Other: Visualization tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Data Visualization on Provider Knowledge of Culture Sensitivity Results
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Antibiotic visualization tool
Provider will answer microbiological sensitivity questions using a new antibiotic visualization tool.
Other: Visualization tool
Visual representation of past microbiological culture data

No Intervention: Standard practice
Provider will answer microbiological sensitivity questions using standard medical record tools.



Primary Outcome Measures :
  1. Provider knowledge [ Time Frame: To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered. ]

    Provider knowledge of patients' previous culture sensitivity results as determined by the proportion of correct answers on a questionnaire:

    Do you think this patient has had previous resistance to each of these antibiotics at BIDMC (Beth Israel Deaconess Medical Center)?

    [List of the top 4 antibiotic classes to which resistance is seen at BIDMC that the patient has previously had tested for antibiotic sensitivities]

    Yes (previous organisms resistant or with intermediate resistance)

    No (no previous resistance noted)



Secondary Outcome Measures :
  1. Post-intervention survey [ Time Frame: To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered. ]

    Providers will be asked survey questions regarding their decision-making and the usability and usefulness of the tool using a 5 point Likert scale:

    I understand the previous culture data for this patient (Strongly disagree) 1 2 3 4 5 (Strongly agree)

    I feel like I made an informed antibiotic choice (Strongly disagree) 1 2 3 4 5 (Strongly agree)

    The tool provided new information that you were not previously aware of (Strongly disagree) 1 2 3 4 5 (Strongly agree)

    The tool enabled you to more quickly understand this patient's microbiological data (Strongly disagree) 1 2 3 4 5 (Strongly agree)

    The tool was easy to use (Strongly disagree) 1 2 3 4 5 (Strongly agree)


  2. Antibiotic order changes [ Time Frame: To be assessed at the time of patient enrollment + 1 day ]
    Antibiotic orders that are not complete by the time of the intervention will be monitored for any cancellation or change in orders

  3. Final culture results [ Time Frame: To be assessed at the time of patient enrollment + 1 week ]
    Final culture results drawn from that visit will be compared to antibiotic orders for effectiveness



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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

Inclusion Criteria:

  • provider is caring for a patient with a previous positive urine or blood cultures
  • provider is caring for a patient currently in a clinical location being investigated
  • provider is caring for a patient with orders placed for an intravenous, intramuscular, oral antibiotics

Exclusion Criteria:

  • the patient has already received the antibiotic by the time of the intervention
  • the antibiotic has been cancelled by the time of intervention
  • the research assistant is unable to reach the ordering provider before the visit is completed
  • participation by the clinician in the study would impede clinical care
  • age < 18

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): NCT03580603


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Steven Horng, MD Beth Israel Deaconess Medical Center

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Responsible Party: Steven Horng, MD, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03580603     History of Changes
Other Study ID Numbers: 2017P000432
2017P000432 ( Other Identifier: Committee on Clinical Investigations Beth Israel Deaconess Medical Center )
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents