- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01927445
Improving Stroke Prevention Therapy for Patients With Atrial Fibrillation in Primary Care
3. oktober 2017 opdateret af: Sunnybrook Health Sciences Centre
Improving Stroke Prevention Therapy for Patients With Atrial Fibrillation in Primary Care: Protocol for a Pragmatic, Cluster-randomized Trial
The objective of this project is to increase the proportion of patients with AF that receive adequate stroke prevention therapy.
Over half of patients with AF who suffer strokes are permanently disabled.
Yet there remains a large portion of patients who do not receive appropriate stroke prevention therapy.
The investigators hypothesize that a toolkit of quality improvement strategies in primary care could increase the proportion of patients with atrial fibrillation appropriately treated with stroke prevention therapy.
The investigators' goal is to ensure the toolkit of interventions can be easily incorporated into day-to-day practice in primary care and can be readily and broadly disseminated if successful.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The prevalence of atrial fibrillation (AF) is growing as the population ages and 15% of all strokes are already attributed to AF.
Unfortunately, half of patients with AF do not receive prescriptions for anticoagulation to prevent stroke due to a variety of system, provider, and patient-level barriers.
The investigators will conduct a pragmatic, cluster-randomized controlled trial to test a 'toolkit' of quality improvement interventions in primary care.
In keeping with the recommendations of the chronic care model to simultaneously facilitate proactive care by providers and activate patients, the toolkit includes provider- focused strategies (education, audit and feedback, electronic medical record-based tools including decision support and reminders) plus patient-directed strategies (educational letters and reminders).
Thirty three primary care clinics will be randomized to the intervention or usual care.
The trial will last 12 months and will be powered to show a difference of 10% in the primary outcome of proportion of patients receiving guideline-concordant care for stroke prevention.
Analysis will be blind to allocation.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
5000
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Institute for Clinical Evaluative Sciences
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Physicians are participants in the Electronic Medical Record Administrative-data Linked Database (EMRALD).
- Patients are rostered to participating physicians, with a diagnosis in the chart of atrial fibrillation
Exclusion Criteria:
- Physicians who do not consent to data sharing
- Patients who change physicians during the course of the study
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Usual care
No standardized intervention for management of patients with atrial fibrillation.
Instead participants receive interventions for management of chronic kidney disease.
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Eksperimentel: quality improvement toolkit
The toolkit includes provider-focused strategies (education, audit and feedback, electronic decision support and reminders) plus patient-directed strategies (educational letters and reminders).
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educational and informatics-based interventions, including brief guideline summary, decision support and audit and feedback
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Proportion of patients with AF receiving guideline-concordant stroke prevention therapy
Tidsramme: one year
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Patients with risk factors for stroke (ie.
CHADS2 >1 or age >65) who are prescribed anticoagulants and patients with no risk factors for stroke (ie.
CHADS2 = 0 and age <65) who are not prescribed anticoagulants will be considered to be receiving guideline concordant therapy.
(For patients with CHADS2 = 1 but aged < 65 the guideline recommendations are unclear, so these patients will not be considered in the primary analysis.
For example, in patients with AF and hypertension at a younger age, anticoagulation or aspirin or no treatment would each be reasonable.)
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one year
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
proportion of patients taking warfarin in therapeutic range
Tidsramme: one year
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patients must have INR measured 8 times during the year and therapeutic range assessed using Rosendaal method
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one year
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proportion of patients taking a novel anticoagulant with appropriate dosing
Tidsramme: one year
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Dabigatran, rivaroxaban and apixaban should be dose-adjusted in renal failure and avoided if estimated creatinine clearance is <30.
Lower dose dabigatran is recommended for patients over 80.
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one year
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proportion receiving aspirin
Tidsramme: one year
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one year
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proportion receiving clopidogrel
Tidsramme: one year
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one year
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proportion achieving target blood pressure
Tidsramme: one year
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target defined as <130/80 for patients with diabetes, <150/80 for patients over 80, and <140/90 for all others
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one year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Karen Tu, MD, ICES
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. august 2014
Primær færdiggørelse (Faktiske)
1. april 2017
Studieafslutning (Faktiske)
1. juni 2017
Datoer for studieregistrering
Først indsendt
14. august 2013
Først indsendt, der opfyldte QC-kriterier
19. august 2013
Først opslået (Skøn)
22. august 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. oktober 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. oktober 2017
Sidst verificeret
1. oktober 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- G-13-0001873
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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 Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Pusan National University HospitalIkke rekrutterer endnuHjerteimplanterbar elektronisk enhed | Atrial High Rate EpisodeKorea, Republikken
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Academisch Medisch Centrum - Universiteit van Amsterdam...Tilmelding efter invitationKortkoblet idiopatisk ventrikulær fibrillationHolland
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Assiut UniversityTrukket tilbageASD2 (Secundum atrial septal defekt)
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Henry Ford Health SystemTrukket tilbage
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Nobles Medical Technologies II IncTilmelding efter invitationForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater, Italien
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HeartStitch.ComUkendtForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater
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Occlutech International ABAfsluttetSecundum atrial septal defekter
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University Hospital, Basel, SwitzerlandUniversity Hospital GreifswaldAfsluttetAtrium; Fibrillering | Arytmi AtrialTyskland, Schweiz
Kliniske forsøg med quality improvement toolkit
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VA Office of Research and DevelopmentAktiv, ikke rekrutterendeIskæmisk slagtilfælde | Obstruktiv søvnapnø | Forbigående iskæmisk angreb (TIA)Forenede Stater
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University of BirminghamEthicon, Inc.; European Society of ColoproctologyRekrutteringAnastomotisk lækage | Anastomose; KomplikationerDen Russiske Føderation
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University of OxfordUniversity of Michigan; University of Southern California; Chelsea and Westminster... og andre samarbejdspartnereRekrutteringNødsituationer | Undladelse af redningDet Forenede Kongerige
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University of California, San FranciscoPopulation Services InternationalAfsluttet
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ViiV HealthcareJanssen PharmaceuticalsAfsluttetHIV-infektionerTyskland, Holland, Frankrig, Belgien, Spanien
-
University of MichiganAfsluttetKvinder med BRCA 1 eller BRCA 2 mutation | Ikke-testede kvindelige familiemedlemmerForenede Stater
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Fisher and Paykel HealthcareNorth Texas Lung & Sleep ClinicAfsluttetObstruktiv søvnapnøForenede Stater
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University of TorontoUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; McMaster... og andre samarbejdspartnereAfsluttet
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Yale UniversityNational Institutes of Health (NIH); National Institute on Aging (NIA); Trinity...AfsluttetDiabetes mellitus | DiabetesForenede Stater
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University of MichiganThe Craig H. Neilsen FoundationRekrutteringAccept- og forpligtelsesterapi for kronisk smerte ved SCI: Udvikling og test af et e-sundhedsprogramRygmarvsskaderForenede Stater