Clinical Decision Support Tools for Antibiotic Prescribing

May 4, 2021 updated by: Steven Horng, MD, Beth Israel Deaconess Medical Center

The Effect of Data Visualization on Provider Knowledge of Culture Sensitivity Results

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

273

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Steven Horng, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

June 26, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

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)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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