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

24. december 2019 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Atrieflimren

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

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

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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 / kohorte

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	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	Foranstaltningsbeskrivelse	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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Janssen Scientific Affairs, LLC

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 (Faktiske)

29. december 2017

Primær færdiggørelse (Faktiske)

3. december 2019

Studieafslutning (Faktiske)

3. december 2019

Datoer for studieregistrering

Først indsendt

19. december 2017

Først indsendt, der opfyldte QC-kriterier