Clinical Decision Support Tools for Antibiotic Prescribing
Primary Purpose
Infectious Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visualization tool
Sponsored by
About this trial
This is an interventional other trial for Infectious Disease
Eligibility 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
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Antibiotic visualization tool
Standard practice
Arm Description
Provider will answer microbiological sensitivity questions using a new antibiotic visualization tool.
Provider will answer microbiological sensitivity questions using standard medical record tools.
Outcomes
Primary Outcome Measures
Provider knowledge
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
Post-intervention survey
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)
Antibiotic order changes
Antibiotic orders that are not complete by the time of the intervention will be monitored for any cancellation or change in orders
Final culture results
Final culture results drawn from that visit will be compared to antibiotic orders for effectiveness
Full Information
NCT ID
NCT03580603
First Posted
April 9, 2018
Last Updated
May 4, 2021
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03580603
Brief Title
Clinical Decision Support Tools for Antibiotic Prescribing
Official Title
The Effect of Data Visualization on Provider Knowledge of Culture Sensitivity Results
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
273 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antibiotic visualization tool
Arm Type
Experimental
Arm Description
Provider will answer microbiological sensitivity questions using a new antibiotic visualization tool.
Arm Title
Standard practice
Arm Type
No Intervention
Arm Description
Provider will answer microbiological sensitivity questions using standard medical record tools.
Intervention Type
Other
Intervention Name(s)
Visualization tool
Intervention Description
Visual representation of past microbiological culture data
Primary Outcome Measure Information:
Title
Provider knowledge
Description
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)
Time Frame
To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.
Secondary Outcome Measure Information:
Title
Post-intervention survey
Description
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)
Time Frame
To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.
Title
Antibiotic order changes
Description
Antibiotic orders that are not complete by the time of the intervention will be monitored for any cancellation or change in orders
Time Frame
To be assessed at the time of patient enrollment + 1 day
Title
Final culture results
Description
Final culture results drawn from that visit will be compared to antibiotic orders for effectiveness
Time Frame
To be assessed at the time of patient enrollment + 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Horng, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Decision Support Tools for Antibiotic Prescribing
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