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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03580603
Other study ID # 2017P000432
Secondary ID 2017P000432
Status Completed
Phase N/A
First received
Last updated
Start date March 5, 2018
Est. completion date September 30, 2018

Study information

Verified date May 2021
Source Beth Israel Deaconess Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 273
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Visualization tool
Visual representation of past microbiological culture data

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.
Secondary 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)
To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.
Secondary 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 To be assessed at the time of patient enrollment + 1 day
Secondary Final culture results 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
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