NCT01979588

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206,703

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

October 30, 2013

Last Update Submit

March 30, 2016

Conditions

Influenza Like IllnessAsthmaGroup A Streptococcal InfectionPertussis

Outcome Measures

Primary Outcomes (1)

  • Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season

    1 year

Secondary Outcomes (2)

  • Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season

    1 year

  • Percent of primary care visits in which a patient received an antibiotic

    1 year

Other Outcomes (9)

  • Percentage of visits for pediatric patients with asthma in which asthma counseling performed

    1 year

  • Percent of time a pertussis PCR was sent for patients with a complaint of cough during a period of high pertussis prevalence

    1 year

  • Percent of pharyngitis patients who received a Group A Strep test during a period of high prevalence of group A strep

    1 year

  • +6 more other outcomes

Study Arms (2)

Control

PLACEBO COMPARATOR

Providers do not have access to What's Going Around Tool but receive an instructional video explaining tool

Other: Control

What's Going Around Tool

ACTIVE COMPARATOR

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

Interventions

What's Going Around toolOTHER

Provider has access to the What's Going Around tool

What's Going Around Tool
ControlOTHER

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

Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northshore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Related 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.

    PMID: 22868833BACKGROUND

MeSH Terms

Conditions

AsthmaStreptococcal InfectionsWhooping Cough

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBordetella InfectionsGram-Negative Bacterial InfectionsRespiratory Tract Infections

Study Officials

  • Ari Robicsek, MD

    Endeavor Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President for Clinical and Quality Informatics, Associate CMIO

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 8, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

US(1)