How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice (WGA)

March 30, 2016 updated by: Ari Robiscek, NorthShore University HealthSystem

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

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

Interventional

Enrollment (Actual)

206703

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

    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: 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

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

Investigators

  • Principal Investigator: Ari Robicsek, MD, Northshore University Healthsystem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

November 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

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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