How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice (WGA)
Primary Purpose
Influenza Like Illness, Asthma, Group A Streptococcal Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
What's Going Around tool
Control
Sponsored by
About this trial
This is an interventional diagnostic trial for Influenza Like Illness
Eligibility Criteria
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
Sites / Locations
- Northshore University HealthSystem
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
What's Going Around Tool
Arm Description
Providers do not have access to What's Going Around Tool but receive an instructional video explaining tool
Provider has access to What's Going Around Tool. Provider also shown a video explaining how to use Tool
Outcomes
Primary Outcome Measures
Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season
Secondary Outcome Measures
Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season
Percent of primary care visits in which a patient received an antibiotic
Full Information
NCT ID
NCT01979588
First Posted
October 30, 2013
Last Updated
March 30, 2016
Sponsor
NorthShore University HealthSystem
1. Study Identification
Unique Protocol Identification Number
NCT01979588
Brief Title
How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice
Acronym
WGA
Official Title
How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza Like Illness, Asthma, Group A Streptococcal Infection, Pertussis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206703 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Providers do not have access to What's Going Around Tool but receive an instructional video explaining tool
Arm Title
What's Going Around Tool
Arm Type
Active Comparator
Arm Description
Provider has access to What's Going Around Tool. Provider also shown a video explaining how to use Tool
Intervention Type
Other
Intervention Name(s)
What's Going Around tool
Intervention Description
Provider has access to the What's Going Around tool
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Provider does not have access to the What's Going Around tool but received information regarding the tool prior to study initiation
Primary Outcome Measure Information:
Title
Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season
Time Frame
1 year
Title
Percent of primary care visits in which a patient received an antibiotic
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Percentage of visits for pediatric patients with asthma in which asthma counseling performed
Time Frame
1 year
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Percent of patients with asthma who have a hospital visit for asthma
Time Frame
1 year
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari Robicsek, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northshore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22868833
Citation
Hebert C, Beaumont J, Schwartz G, Robicsek A. The influence of context on antimicrobial prescribing for febrile respiratory illness: a cohort study. Ann Intern Med. 2012 Aug 7;157(3):160-9. doi: 10.7326/0003-4819-157-3-201208070-00005.
Results Reference
background
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How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice
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