Infectious DiseaseNCT03580603
Clinical Decision Support Tools for Antibiotic Prescribing
A study testing Visualization tool in people with Infectious Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Disease
- What is being tested?
- Visualization tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2018to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: 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.
- Conditions
- Infectious Disease
- Being tested
- Visualization tool
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visualization toolOther
Visual representation of past microbiological culture data
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic visualization tool | Experimental | Provider will answer microbiological sensitivity questions using a new antibiotic visualization tool. Receives: Other: Visualization tool |
| Standard practice | No intervention | Provider will answer microbiological sensitivity questions using standard medical record tools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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)
Measured: To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.
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
Measured: To be assessed at the time of patient enrollment + 1 day
Final culture results
Final culture results drawn from that visit will be compared to antibiotic orders for effectiveness
Measured: To be assessed at the time of patient enrollment + 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start5 Mar 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Horng, MD, Beth Israel Deaconess Medical Center
- Investigators
- Steven Horng, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580603
- Sponsor's protocol ID
- 2017P000432
- Other IDs
- 2017P000432
- Status last verified
- May 2021
- First submitted
- 9 Apr 2018
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Data Visualization on Provider Knowledge of Culture Sensitivity Results
- ClinicalTrials.gov ID
- NCT03580603
- Acronym / sponsor ID
- 2017P000432
- Conditions
- Infectious Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 9 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic visualization tool | Experimental | Other: Visualization toolProvider will answer microbiological sensitivity questions using a new antibiotic visualization tool. |
| Standard practice | No intervention | –Provider will answer microbiological sensitivity questions using standard medical record tools. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visualization toolVisual representation of past microbiological culture data | Other | Antibiotic visualization tool |
Primary outcome
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)
3 secondary outcomes
Post-intervention survey
Time frame: 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
Final culture results
Time frame: To be assessed at the time of patient enrollment + 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Horng, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visualization tool in people with Infectious Disease, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provider knowledge (time frame: To be assessed at the time of patient enrollment, up to one day after the initial antibiotic is ordered.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.