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

24 december 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Boezemfibrilleren

Studietype

Observationeel

Inschrijving (Werkelijk)

2000

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
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.

Groep / Cohort

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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Percentage of Patients Readmitted to the Same Hospital Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: End of study (Month 20)	A performance dashboard will be implemented to aggregate and display performance data.	End of study (Month 20)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Scientific Affairs, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 december 2017

Primaire voltooiing (Werkelijk)

3 december 2019

Studie voltooiing (Werkelijk)

3 december 2019

Studieregistratiedata

Eerst ingediend

19 december 2017

Eerst ingediend dat voldeed aan de QC-criteria