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A Study to Quantify Use of Anticoagulation to Improve Management of Atrial Fibrillation (QUANTUM AF)

24 dicembre 2019 aggiornato da: Janssen Scientific Affairs, LLC

Quantify Use of Anticoagulation to Improve Management of AF

The purpose of this study is to evaluate the impact of a hospital quality improvement (QI) program on the use of guideline-recommended oral anticoagulants (OAC) in hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke. Specifically, the study will determine whether the intervention, compared to Usual Care, will result in a greater increase in the proportion of patients with AF at risk for ischemic stroke who are appropriately treated with OAC.

Panoramica dello studio

Stato

Terminato

Condizioni

Fibrillazione atriale

Tipo di studio

Osservativo

Iscrizione (Effettivo)

2000

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Stati Uniti
- Arizona
  - Glendale, Arizona, Stati Uniti, 85306
    - Banner Thunderbird
  - Mesa, Arizona, Stati Uniti, 85206
    - Banner Heart Hospital
  - Mesa, Arizona, Stati Uniti, 85202
    - Banner Desert Medical Center
  - Mesa, Arizona, Stati Uniti, 85206
    - Banner Baywood Medical Center
  - Phoenix, Arizona, Stati Uniti, 85006
    - Banner University Medical Center
  - Phoenix, Arizona, Stati Uniti, 85037
    - Banner Estrella
  - Sun City, Arizona, Stati Uniti, 85351
    - Banner Boswell Medical Center
  - Sun City West, Arizona, Stati Uniti, 85375
    - Banner Del Webb
  - Tucson, Arizona, Stati Uniti, 85713
    - Banner University Medical Center - South (BUMC-S)
  - Tucson, Arizona, Stati Uniti, 85724
    - Banner University Medical Center - Tucson (BUMC-T)
- Colorado
  - Greeley, Colorado, Stati Uniti, 80631
    - Banner North Colorado Medical Center
- Connecticut
  - Hartford, Connecticut, Stati Uniti, 06102
    - Hartford Hospital
  - New Britain, Connecticut, Stati Uniti, 06050
    - The Hospital of Central Connecticut
- Illinois
  - Bolingbrook, Illinois, Stati Uniti, 60440
    - AMITA Adventist Medical Center Bolingbrook
  - Elk Grove Village, Illinois, Stati Uniti, 60007
    - AMITA Alexian Brothers Medical Center
  - Hinsdale, Illinois, Stati Uniti, 60521
    - AMITA Adventist Medical Center Hinsdale
  - Hoffman Estates, Illinois, Stati Uniti, 60169
    - AMITA St. Alexius Medical Center
  - La Grange, Illinois, Stati Uniti, 60525
    - AMITA Adventist Medical Center La Grange
  - Mount Vernon, Illinois, Stati Uniti, 62864
    - SSM Health Good Samaritan Hospital
- Kentucky
  - Danville, Kentucky, Stati Uniti, 40422
    - Ephraim McDowell Regional Medical Center
- Maryland
  - Baltimore, Maryland, Stati Uniti, 21229
    - St. Agnes Hospital
- Michigan
  - Kalamazoo, Michigan, Stati Uniti, 49048
    - Borgess Medical Center
- Nebraska
  - Fremont, Nebraska, Stati Uniti, 68025
    - Fremont Health Medical Center
- New Jersey
  - Plainsboro, New Jersey, Stati Uniti, 08536
    - Penn Medicine - Princeton Health
  - Pomona, New Jersey, Stati Uniti, 08240
    - AtlantiCare
- New York
  - Bay Shore, New York, Stati Uniti, 11706
    - Southside Hospital
  - Binghamton, New York, Stati Uniti, 13905
    - Our Lady of Lourdes Hospital
  - Forest Hills, New York, Stati Uniti, 11375
    - Long Island Jewish Forest Hills
  - Huntington, New York, Stati Uniti, 11743
    - Huntington Hospital
  - Manhasset, New York, Stati Uniti, 11030
    - North Shore University Hospital
  - New Hyde Park, New York, Stati Uniti, 11040
    - Long Island Jewish Med Ctr
  - New York, New York, Stati Uniti, 10021
    - Lenox Hill Hospital
  - Valley Stream, New York, Stati Uniti, 11580
    - Long Island Jewish Valley Stream
  - Watertown, New York, Stati Uniti, 13601
    - Samaritan Medical Center
- Ohio
  - Cincinnati, Ohio, Stati Uniti, 45236
    - The Jewish Hospital - Mercy
  - Cincinnati, Ohio, Stati Uniti, 45255
    - Mercy Anderson Hospital
  - Cleveland, Ohio, Stati Uniti, 44106
    - University Hospitals Cleveland Medical Center
  - Lima, Ohio, Stati Uniti, 45801
    - Mercy St. Rita's Medical Center
  - Lorain, Ohio, Stati Uniti, 44053
    - Mercy Lorain Regional Medical Center
  - Oregon, Ohio, Stati Uniti, 43616
    - Mercy St. Charles Hospital
  - Richmond Heights, Ohio, Stati Uniti, 44143
    - University Hospitals Regional Hospitals
  - Toledo, Ohio, Stati Uniti, 43608
    - Mercy Health St Vincent Medical Center
  - Toledo, Ohio, Stati Uniti, 43623
    - Mercy St. Anne Hospital
- Oklahoma
  - Oklahoma City, Oklahoma, Stati Uniti, 73104
    - Oklahoma Health Science Center
  - Tulsa, Oklahoma, Stati Uniti, 74136
    - Saint Francis Hospital
- Pennsylvania
  - Allentown, Pennsylvania, Stati Uniti, 18102
    - St. Luke's University Health Network
  - Bethlehem, Pennsylvania, Stati Uniti, 18015
    - St.Luke's University Health Network - St.Luke's Cardiology Associates
  - Danville, Pennsylvania, Stati Uniti, 17822
    - Geisinger Medical Center
  - Scranton, Pennsylvania, Stati Uniti, 18510
    - Geisinger Medical Center
  - Wilkes-Barre, Pennsylvania, Stati Uniti, 18711
    - Geisinger Wyoming Valley
- South Carolina
  - Anderson, South Carolina, Stati Uniti, 29621
    - AnMed Health
- South Dakota
  - Sioux Falls, South Dakota, Stati Uniti, 57105
    - Avera McKennan Hospital
- Texas
  - Abilene, Texas, Stati Uniti, 79601
    - Hendrick Medical Center
  - Dallas, Texas, Stati Uniti, 75203
    - Methodist Dallas Medical Center
  - Dallas, Texas, Stati Uniti, 75237
    - Methodist Charlton Medical Center
  - Mansfield, Texas, Stati Uniti, 76063
    - Methodist Mansfield Medical Center
  - Richardson, Texas, Stati Uniti, 75082
    - Methodist Richardson Medical Center
- Virginia
  - Alexandria, Virginia, Stati Uniti, 22304
    - Inova Alexandria Hospital
  - Falls Church, Virginia, Stati Uniti, 22042
    - Inova Health Care Services
  - Newport News, Virginia, Stati Uniti, 23601
    - Riverside Regional Medical Center
- West Virginia
  - Huntington, West Virginia, Stati Uniti, 25702
    - St Marys Medical Center
  - Morgantown, West Virginia, Stati Uniti, 26505
    - Monongalia County General Hospital Company

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke will be included.

Descrizione

Inclusion Criteria:

Inpatient hospitalization
Primary or secondary discharge International Classification of Diseases (ICD)-9/10 diagnosis code for AF paroxysmal (I48.0), persistent (I48.1), chronic (I48.2), or unspecified (427.31, I48.91)
Proxied Congestive Heart failure (CHA2DS2-VASC) score greater than or equal to (>=) 2 using ICD-9 diagnosis scoring algorithm developed previously. The scoring algorithm will be expanded to include ICD-10 codes
Discharged to home, skilled nursing facility, inpatient rehabilitation, or nursing home

Exclusion Criteria:

Presence of artificial mechanical heart valve by ICD-9/10 diagnosis or procedure code during comorbid identification period or current hospitalization
Surgical procedure during hospitalization for open heart surgery, brain, or spine
Intravenous heparin given on the day of discharge without warfarin/oral anticoagulant (OAC), antiplatelets, and/or aspirin
History of left atrial appendage occlusion, including the Watchman device
Any in-hospital (current hospitalization) bleeding identified by ICD-9/10 diagnosis codes

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
Quality Improvement (QI) Program Hospitals assigned to the QI program arm will begin the 4-month Preparatory Phase which is designed to introduce the institutional baseline reporting tools and materials related to performance improvement, and gain insight into their gaps in treatment, followed by 15 month Implementation Phase, which will consist of education, process, and engagement activities that are targeted at the hospital and healthcare provider level and then the Measurement Period at which time hospitals will complete a final survey to document specific interventions that were successfully implemented and perform a final retrospective chart review on selected patients.
Usual Care Hospitals assigned to the Usual Care arm will not participate in the structured QI program but will continue with their standard hospital practice in treating patients with atrial fibrillation (AF) at risk for ischemic stroke. Hospitals will also complete a final survey and final retrospective chart reviews during the Measurement Period.

Gruppo / Coorte

Quality Improvement (QI) Program

Hospitals assigned to the QI program arm will begin the 4-month Preparatory Phase which is designed to introduce the institutional baseline reporting tools and materials related to performance improvement, and gain insight into their gaps in treatment, followed by 15 month Implementation Phase, which will consist of education, process, and engagement activities that are targeted at the hospital and healthcare provider level and then the Measurement Period at which time hospitals will complete a final survey to document specific interventions that were successfully implemented and perform a final retrospective chart review on selected patients.

Usual Care

Hospitals assigned to the Usual Care arm will not participate in the structured QI program but will continue with their standard hospital practice in treating patients with atrial fibrillation (AF) at risk for ischemic stroke. Hospitals will also complete a final survey and final retrospective chart reviews during the Measurement Period.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods Lasso di tempo: Baseline up to 20 months	The impact of a hospital quality improvement (QI) program on the use of guideline-recommended oral anticoagulants (OAC) in hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke will be evaluated by measuring change in the percentage of patients treated with OAC, from baseline to Final Collection Periods.	Baseline up to 20 months

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Percentage of Patients Readmitted to the Same Hospital Lasso di tempo: Up to 20 months	Percentage of patients readmitted to the same hospital for all-cause readmissions, stroke-related readmissions, cardiovascular (CV)-related readmissions, and bleeding- related readmissions will be evaluated.	Up to 20 months
Percentage of Patients who Received OAC by Hospital Characteristics Subgroups Lasso di tempo: End of study (Month 20)	Use of OAC at the end of study by hospital characteristics subgroups (that is, patients care mix, infrastructure-bed size, staffing, academic status, location, urban/rural, provider) will be determined.	End of study (Month 20)
Effect of Tools Components of the QI Program on the use of OAC Lasso di tempo: End of study (Month 20)	The effect of the educational process-based components of the QI program relative to the Usual Care arm on the use of OAC will be evaluated.	End of study (Month 20)
Effect of Degree of Engagement in the QI Program Lasso di tempo: End of study (Month 20)	A performance dashboard will be implemented to aggregate and display performance data.	End of study (Month 20)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Janssen Scientific Affairs, LLC

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

29 dicembre 2017

Completamento primario (Effettivo)

3 dicembre 2019

Completamento dello studio (Effettivo)

3 dicembre 2019

Date di iscrizione allo studio

Primo inviato

19 dicembre 2017

Primo inviato che soddisfa i criteri di controllo qualità