- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01979588
How Does the Clinical Tool 'What's Going Around' Affect Clinical Practice (WGA)
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
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Illinois
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Evanston, Illinois, États-Unis, 60201
- Northshore University Healthsystem
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Control
Providers do not have access to What's Going Around Tool but receive an instructional video explaining tool
|
Provider does not have access to the What's Going Around tool but received information regarding the tool prior to study initiation
|
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Comparateur actif: What's Going Around Tool
Provider has access to What's Going Around Tool.
Provider also shown a video explaining how to use Tool
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Provider has access to the What's Going Around tool
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season
Délai: 1 year
|
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season
Délai: 1 year
|
1 year
|
|
Percent of primary care visits in which a patient received an antibiotic
Délai: 1 year
|
1 year
|
Autres mesures de résultats
Mesure des résultats |
Délai |
|---|---|
|
Percentage of visits for pediatric patients with asthma in which asthma counseling performed
Délai: 1 year
|
1 year
|
|
Percent of time a pertussis PCR was sent for patients with a complaint of cough during a period of high pertussis prevalence
Délai: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A Strep test during a period of high prevalence of group A strep
Délai: 1 year
|
1 year
|
|
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
Délai: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A Strep test during a period of low prevalence of group A strep
Délai: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A strep appropriate antibiotic during a period of high prevalence of group A strep
Délai: 1 year
|
1 year
|
|
Percent of pharyngitis patients who received a Group A Strep appropriate antibiotic during a period of low prevalence of group A strep
Délai: 1 year
|
1 year
|
|
Percent of patients with asthma who have a hospital visit for asthma
Délai: 1 year
|
1 year
|
|
Percentage of days that a physician used the What's Going Around tool of all days he/she worked in a year
Délai: 1 year
|
1 year
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ari Robicsek, MD, Northshore University Healthsystem
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- What's Going Around
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