Influenza Like IllnessWGANCT01979588
How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice
A study testing What's Going Around tool in people with Influenza Like Illness and Asthma, run by Endeavor Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza Like Illness, Asthma, Group A Streptococcal Infection
- What is being tested?
- What's Going Around tool
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206,703 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Northshore University HealthSystem
Evanston, Illinois, 60201
About this study
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
Read the 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
- Being tested
- What's Going Around tool, Control
- Medical subject headings
- Asthma, Streptococcal Infections, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What's Going Around toolOther
Provider has access to the 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
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Providers do not have access to What's Going Around Tool but receive an instructional video explaining tool Receives: 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 Receives: Other: What's Going Around tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season
Measured: 1 year
Secondary outcomes (2)
Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season
Measured: 1 year
Percent of primary care visits in which a patient received an antibiotic
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza Like IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206,703 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ari Robiscek, Endeavor Health
- Investigators
- Ari Robicsek, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979588
- Sponsor's protocol ID
- What's Going Around
- Acronym
- WGA
- Status last verified
- Mar 2016
- First submitted
- 30 Oct 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22868833
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice
- ClinicalTrials.gov ID
- NCT01979588
- Acronym / sponsor ID
- WGA / What's Going Around
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206,703 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: ControlProviders do not have access to What's Going Around Tool but receive an instructional video explaining tool |
| What's Going Around Tool | Active comparator | Other: What's Going Around toolProvider has access to What's Going Around Tool. Provider also shown a video explaining how to use Tool |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| What's Going Around toolProvider has access to the What's Going Around tool | Other | What's Going Around Tool |
| ControlProvider does not have access to the What's Going Around tool but received information regarding the tool prior to study initiation | Other | Control |
Primary outcome
Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season
Time frame: 1 year
2 secondary outcomes
Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season
Time frame: 1 year
Percent of primary care visits in which a patient received an antibiotic
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Background: PubMed 22868833Hebert 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.
Related trials for Influenza Like Illness
RecruitingObservational study
Mucosal and Systemic Immunity Correlates of Protection Against Influenza in Young Children, Aged 2-5 Years (MUSIC-Flu)
Influenza -Like Illness, Influenza (Healthy Volunteers)
Recruiting
Abbott ID NOW Point-of-Care Testing
Influenza, Influenza-like Illness
RecruitingPhase 3
A Study on the Efficacy of a Vaccine Against Influenza in Adults ≥65 Years of Age
Influenza, Human
RecruitingObservational study
Virological Surveillance of Acute Respiratory Infection in Primary Health Care in Metropolitan France
Respiratory Tract Infections (RTI), Influenza -Like Illness
Recruiting
Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care
Acute Respiratory Infection, Influenza-like Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ari Robicsek, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing What's Going Around tool in people with Influenza Like Illness and Asthma, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01979588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.