- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580603
Clinical Decision Support Tools for Antibiotic Prescribing
The Effect of Data Visualization on Provider Knowledge of Culture Sensitivity Results
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Antibiotic visualization tool
Provider will answer microbiological sensitivity questions using a new antibiotic visualization tool.
|
Visual representation of past microbiological culture data
|
|
No Intervention: Standard practice
Provider will answer microbiological sensitivity questions using standard medical record tools.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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) |
To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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) |
To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.
|
|
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
|
To be assessed at the time of patient enrollment + 1 day
|
|
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
|
To be assessed at the time of patient enrollment + 1 week
|
Collaborators and Investigators
Investigators
- Principal Investigator: Steven Horng, MD, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P000432 (Other Identifier: Committee on Clinical Investigations Beth Israel Deaconess Medical Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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