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

This study is currently recruiting participants.
Verified April 2014 by NorthShore University HealthSystem
Sponsor:
Information provided by (Responsible Party):
Ari Robiscek, NorthShore University HealthSystem
ClinicalTrials.gov Identifier:
NCT01979588
First received: October 30, 2013
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
Influenza Like Illness
Asthma
Group A Streptococcal Infection
Pertussis
Other: What's Going Around tool

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem:

Primary Outcome Measures:
  • Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Percent of primary care visits in which a patient received an antibiotic [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percentage of visits for pediatric patients with asthma in which asthma counseling performed [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percent of patients with asthma who have a hospital visit for asthma [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15000
Study Start Date: November 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Providers do not have access to What's Going Around Tool but receive an instructional video explaining tool
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
Other: What's Going Around tool
Provider has access to the What's Going Around tool

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01979588

Contacts
Contact: Ari Robicsek, MD 8475702490 Arobicsek@northshore.org
Contact: NIRAV SHAH, MD, MPH 7737025232 Nshah2@northshore.org

Locations
United States, Illinois
Northshore University HealthSystem Recruiting
Evanston, Illinois, United States, 60201
Contact: Ari Robicsek, MD    847-570-2490    Arobicsek@northshore.org   
Contact: Nirav Shah, MD, MPH    7737025232    Nshah2@northshore.org   
Principal Investigator: Ari Robicsek, MD         
Sponsors and Collaborators
NorthShore University HealthSystem
Investigators
Principal Investigator: Ari Robicsek, MD NorthShore University HealthSystem
  More Information

No publications provided

Responsible Party: Ari Robiscek, Vice President for Clinical and Quality Informatics, Associate CMIO, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT01979588     History of Changes
Other Study ID Numbers: What's Going Around
Study First Received: October 30, 2013
Last Updated: April 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Whooping Cough
Asthma
Influenza, Human
Streptococcal Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Infection
Gram-Positive Bacterial Infections

ClinicalTrials.gov processed this record on April 17, 2014