- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979588
How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice (WGA)
Previous work has shown that the epidemiological context of a patient's presentation can provide important information for clinicians to aid in diagnosis and treatment. With current electronic health records, it is increasingly possible to perform syndromic surveillance that is local and specific to a patient's characteristics.
The investigators have developed algorithms for syndromic surveillance for a number of conditions in which contextual information might be of use to treating clinicians. The syndromic surveillance algorithms already developed are for influenza-like-illness, whooping cough, asthma exacerbation, Group A Streptococcal pharyngitis, and gastroenteritis infection.
The investigators plan on studying these tools with a clustered randomized control cohort study evaluating how clinical decision making is affected by use of these tools by outpatient general practitioners. The goal is to incorporate these validated algorithms into a quality improvement tool which will provide point-of-care clinical decision support to clinicians
Study Overview
Status
Intervention / Treatment
Detailed Description
The epidemiological context of a patient's presentation can provide important information for clinicians to aid in diagnosis and treatment. The investigators previously developed and validated a syndromic surveillance tool for detecting influenza-like illness (ILI) encounters. The investigators then evaluated 40,642 outpatient ILI episodes during 'flu seasons' over 6 years. The investigators found that even after controlling for patient presentation and physician factors, the context in which a patient presented was strongly associated with the likelihood that an antimicrobial agent would be prescribed. Specifically, patients were less likely to be prescribed an antibiotic if they presented with ILI during the pandemic influenza period (when awareness of 'flu season' was very high), or after their physician had personally seen many patients with ILI in the prior week.
Currently, most clinicians have only limited access to data regarding the 'context' in which a patient presents. Under such circumstances, physicians are often unaware of local epidemiological information that could help them make optimal treatment decisions. In centers with advanced use of electronic health records (EHRs), it is increasingly possible to perform syndromic surveillance that is local (e.g. specific to a neighborhood or school district), current (e.g. updated daily), and specific to a patient's characteristics (e.g. age, chief complaint).
To that end, the investigators have developed algorithms for syndromic surveillance for a number of syndromes including Asthma, ILI, Pertussis, Group A Streptococcus Pharyngitis, and Gastroenteritis. These algorithms may provide contextual information that might be of use to clinicians.
The purpose of this study is to determine the effect of how a point-of-care clinical decision tool in the form of syndromic surveillance algorithms affect clinical decision making amongst outpatient health care providers and also patient outcomes. We will be using a 2 year look back prior to tool roll out as a comparison.
Specific Aims:
To determine the effect this point-of-care clinical decision tool has on clinical decision making amongst primary care providers.
To determine the clinical outcomes of patients whose physicians had access to these tools
To understand how these point-of-care clinical decision tools are used among healthcare providers in day to day practice
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Evanston, Illinois, United States, 60201
- Northshore University Healthsystem
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All patients seen in a Northshore University HealthSystem outpatient clinic (Family Medicine, Internal Medicine or Pediatric) between the Nov 1 2013 to Oct 31 2014
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control
Providers do not have access to What's Going Around Tool but receive an instructional video explaining tool
|
Provider does not have access to the What's Going Around tool but received information regarding the tool prior to study initiation
|
|
Active Comparator: What's Going Around Tool
Provider has access to What's Going Around Tool.
Provider also shown a video explaining how to use Tool
|
Provider has access to the What's Going Around tool
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season
Time Frame: 1 year
|
1 year
|
|
Percent of primary care visits in which a patient received an antibiotic
Time Frame: 1 year
|
1 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of visits for pediatric patients with asthma in which asthma counseling performed
Time Frame: 1 year
|
1 year
|
|
Percent of time a pertussis PCR was sent for patients with a complaint of cough during a period of high pertussis prevalence
Time Frame: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A Strep test during a period of high prevalence of group A strep
Time Frame: 1 year
|
1 year
|
|
Percent of time that a pertussis active antibiotic was prescribed in a patient with a complaint of a cough during a period of high pertussis prevalence
Time Frame: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A Strep test during a period of low prevalence of group A strep
Time Frame: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A strep appropriate antibiotic during a period of high prevalence of group A strep
Time Frame: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A Strep appropriate antibiotic during a period of low prevalence of group A strep
Time Frame: 1 year
|
1 year
|
|
Percent of patients with asthma who have a hospital visit for asthma
Time Frame: 1 year
|
1 year
|
|
Percentage of days that a physician used the What's Going Around tool of all days he/she worked in a year
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ari Robicsek, MD, Northshore University Healthsystem
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- What's Going Around
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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