NCT03580603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 9, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

April 9, 2018

Last Update Submit

May 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Post-intervention survey

    To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.

  • Antibiotic order changes

    To be assessed at the time of patient enrollment + 1 day

  • Final culture results

    To be assessed at the time of patient enrollment + 1 week

Study Arms (2)

Antibiotic visualization tool

EXPERIMENTAL

Provider will answer microbiological sensitivity questions using a new antibiotic visualization tool.

Other: Visualization tool

Standard practice

NO INTERVENTION

Provider will answer microbiological sensitivity questions using standard medical record tools.

Interventions

Visual representation of past microbiological culture data

Antibiotic visualization tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Horng, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 9, 2018

First Posted

July 9, 2018

Study Start

March 5, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

May 6, 2021

Record last verified: 2021-05

Locations