- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Illinois
-
Evanston, Illinois, Forenede Stater, 60201
- NorthShore University HealthSystem
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: 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
|
Aktiv komparator: What's Going Around Tool
Provider has access to What's Going Around Tool.
Provider also shown a video explaining how to use Tool
|
Provider has access to the What's Going Around tool
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage of visits for ILI in which a patient was prescribed an antibacterial agent during the seasonal flu season
Tidsramme: 1 year
|
1 year
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage of visits for ILI in which a patient was prescribed an antiviral agent during the seasonal flu season
Tidsramme: 1 year
|
1 year
|
Percent of primary care visits in which a patient received an antibiotic
Tidsramme: 1 year
|
1 year
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage of visits for pediatric patients with asthma in which asthma counseling performed
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year
|
1 year
|
Percent of patients with asthma who have a hospital visit for asthma
Tidsramme: 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
Tidsramme: 1 year
|
1 year
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Ari Robicsek, MD, NorthShore University HealthSystem
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- What's Going Around
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Pertussis
-
Sanofi Pasteur, a Sanofi CompanyAfsluttetPertussis (kighoste)Frankrig
-
Institut PasteurHopital Universitaire Robert-Debre; Hospices Civils de Lyon; Centre Hospitalier... og andre samarbejdspartnereIkke rekrutterer endnuIndvirkning af bakteriel ekspression og immunrespons i sværhedsgraden af pertussis (PERT-SEVEREII)Bordetella Pertussis, kighosteFrankrig
-
ILiAD BiotechnologiesAktiv, ikke rekrutterendeBordetella Pertussis, kighosteDet Forenede Kongerige, Australien, Costa Rica
-
University of TurkuGlaxoSmithKline; Sanofi Pasteur, a Sanofi CompanyAfsluttet
-
Institut PasteurAgence de Médecine Préventive, France; Institut Pasteur de Madagascar; Institut...AfsluttetBordetella Pertussis, kighosteCambodja, Madagaskar, At gå
-
Institut PasteurSanofi Pasteur, a Sanofi Company; Institut Pasteur of Cote d'IvoireAfsluttetBordetella Pertussis, kighosteCôte D'Ivoire
-
University of SouthamptonRekrutteringPertussis/kighosteDet Forenede Kongerige
-
Association Clinique Thérapeutique Infantile du...Sanofi; GlaxoSmithKline; Merck Sharp & Dohme LLCRekrutteringBørn, kun | Ambulant | Pertussis/kighosteFrankrig
-
University Hospital, GhentGlaxoSmithKline; Sanofi Pasteur, a Sanofi Company; Novartis Vaccines; University... og andre samarbejdspartnereAfsluttetForebyggelse af infektioner med Bordetella PertussisBelgien
-
University of VirginiaUkendtTransport af Bordetella PertussisForenede Stater
Kliniske forsøg med Control
-
Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutteringSvangerskabsforebyggelse | Udnyttelse af sundhedsvæsenet | PræventionsbrugForenede Stater
-
University of California, San FranciscoTrukket tilbage
-
Essilor InternationalAktiv, ikke rekrutterende
-
Singapore General HospitalDuke-NUS Graduate Medical SchoolUkendtFjern iskæmisk konditionering på blodtrykskontrol hos patienter med kronisk nyresygdom (ERIC-BP-CKD)Hjerte-kar-sygdomme | Forhøjet blodtryk | Kroniske nyresygdommeSingapore
-
University of UtahJohns Hopkins University; Arizona State University; National Multiple Sclerosis...AfsluttetMultipel sclerose | Svimmelhed | Svimmelhed | FaldskadeForenede Stater
-
University Hospital, BrestRekruttering
-
University of California, San FranciscoUniversity of California, BerkeleyAfsluttet
-
Istanbul Medipol University HospitalAktiv, ikke rekrutterende
-
Instituto Sexológico MurcianoHospital Virgen del Alcazar de LorcaAfsluttetFor tidlig ejakulation | Medicinsk udstyr | OnaniSpanien
-
AllerganAfsluttet