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

2019년 12월 24일 업데이트: 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.

연구 개요

상태

종료됨

정황

심방세동

연구 유형

관찰

등록 (실제)

2000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

그룹/코호트 수

코호트 및 개입

그룹/코호트
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.

그룹/코호트

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods 기간: 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

2차 결과 측정

결과 측정	측정값 설명	기간
Percentage of Patients Readmitted to the Same Hospital 기간: 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 기간: 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 기간: 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 기간: End of study (Month 20)	A performance dashboard will be implemented to aggregate and display performance data.	End of study (Month 20)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Janssen Scientific Affairs, LLC

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 12월 29일

기본 완료 (실제)

2019년 12월 3일

연구 완료 (실제)

2019년 12월 3일

연구 등록 날짜

최초 제출

2017년 12월 19일

QC 기준을 충족하는 최초 제출