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

24. desember 2019 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Atrieflimmer

Studietype

Observasjonsmessig

Registrering (Faktiske)

2000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Gruppe / Kohort

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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods Tidsramme: 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

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Percentage of Patients Readmitted to the Same Hospital Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: End of study (Month 20)	A performance dashboard will be implemented to aggregate and display performance data.	End of study (Month 20)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Janssen Scientific Affairs, LLC

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. desember 2017

Primær fullføring (Faktiske)

3. desember 2019

Studiet fullført (Faktiske)

3. desember 2019

Datoer for studieregistrering

Først innsendt

19. desember 2017

Først innsendt som oppfylte QC-kriteriene