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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01979588
Other study ID # What's Going Around
Secondary ID
Status Completed
Phase N/A
First received October 30, 2013
Last updated March 30, 2016
Start date November 2013
Est. completion date November 2014

Study information

Verified date March 2016
Source NorthShore University HealthSystem
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 206703
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Other:
What's Going Around tool
Provider has access to the What's Going Around tool
Control
Provider does not have access to the What's Going Around tool but received information regarding the tool prior to study initiation

Locations

Country Name City State
United States Northshore University HealthSystem Evanston Illinois

Sponsors (1)

Lead Sponsor Collaborator
NorthShore University HealthSystem

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of visits for pediatric patients with asthma in which asthma counseling performed 1 year No
Other Percent of time a pertussis PCR was sent for patients with a complaint of cough during a period of high pertussis prevalence 1 year No
Other Percent of pharyngitis patients who received a Group A Strep test during a period of high prevalence of group A strep 1 year No
Other 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 1 year No
Other Percent of pharyngitis patients who received a Group A Strep test during a period of low prevalence of group A strep 1 year No
Other Percent of pharyngitis patients who received a Group A strep appropriate antibiotic during a period of high prevalence of group A strep 1 year No
Other Percent of pharyngitis patients who received a Group A Strep appropriate antibiotic during a period of low prevalence of group A strep 1 year No
Other Percent of patients with asthma who have a hospital visit for asthma 1 year No
Other Percentage of days that a physician used the What's Going Around tool of all days he/she worked in a year 1 year No
Primary Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season 1 year No
Secondary Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season 1 year No
Secondary Percent of primary care visits in which a patient received an antibiotic 1 year No
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