Atrial FibrillationQUANTUM AFNCT03382613
A Study to Quantify Use of Anticoagulation to Improve Management of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 62 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 2,000 participants
- Where
- 62 sitesUnited States
- Study dates
- 29 Dec 2017to 3 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke will be included.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
62 sites in 1 country.
62 sites in 1 country
United States62 sites
Hendrick Medical Center
Abilene, Texas, 79601
Inova Alexandria Hospital
Alexandria, Virginia, 22304
St. Luke's University Health Network
Allentown, Pennsylvania, 18102
AnMed Health
Anderson, South Carolina, 29621
St. Agnes Hospital
Baltimore, Maryland, 21229
Southside Hospital
Bay Shore, New York, 11706
St.Luke's University Health Network - St.Luke's Cardiology Associates
Bethlehem, Pennsylvania, 18015
Our Lady of Lourdes Hospital
Binghamton, New York, 13905
AMITA Adventist Medical Center Bolingbrook
Bolingbrook, Illinois, 60440
The Jewish Hospital - Mercy
Cincinnati, Ohio, 45236
Mercy Anderson Hospital
Cincinnati, Ohio, 45255
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Methodist Dallas Medical Center
Dallas, Texas, 75203
Methodist Charlton Medical Center
Dallas, Texas, 75237
Ephraim McDowell Regional Medical Center
Danville, Kentucky, 40422
Geisinger Medical Center
Danville, Pennsylvania, 17822
AMITA Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
Inova Health Care Services
Falls Church, Virginia, 22042
Long Island Jewish Forest Hills
Forest Hills, New York, 11375
Fremont Health Medical Center
Fremont, Nebraska, 68025
Banner Thunderbird
Glendale, Arizona, 85306
Banner North Colorado Medical Center
Greeley, Colorado, 80631
Hartford Hospital
Hartford, Connecticut, 06102
AMITA Adventist Medical Center Hinsdale
Hinsdale, Illinois, 60521
AMITA St. Alexius Medical Center
Hoffman Estates, Illinois, 60169
Huntington Hospital
Huntington, New York, 11743
St Marys Medical Center
Huntington, West Virginia, 25702
Borgess Medical Center
Kalamazoo, Michigan, 49048
AMITA Adventist Medical Center La Grange
La Grange, Illinois, 60525
Mercy St. Rita's Medical Center
Lima, Ohio, 45801
Mercy Lorain Regional Medical Center
Lorain, Ohio, 44053
North Shore University Hospital
Manhasset, New York, 11030
Methodist Mansfield Medical Center
Mansfield, Texas, 76063
Banner Desert Medical Center
Mesa, Arizona, 85202
Banner Baywood Medical Center
Mesa, Arizona, 85206
Banner Heart Hospital
Mesa, Arizona, 85206
Monongalia County General Hospital Company
Morgantown, West Virginia, 26505
SSM Health Good Samaritan Hospital
Mount Vernon, Illinois, 62864
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Long Island Jewish Med Ctr
New Hyde Park, New York, 11040
Lenox Hill Hospital
New York, New York, 10021
Riverside Regional Medical Center
Newport News, Virginia, 23601
Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
Mercy St. Charles Hospital
Oregon, Ohio, 43616
Banner University Medical Center
Phoenix, Arizona, 85006
Banner Estrella
Phoenix, Arizona, 85037
Penn Medicine - Princeton Health
Plainsboro, New Jersey, 08536
AtlantiCare
Pomona, New Jersey, 08240
Methodist Richardson Medical Center
Richardson, Texas, 75082
University Hospitals Regional Hospitals
Richmond Heights, Ohio, 44143
Geisinger Medical Center
Scranton, Pennsylvania, 18510
Avera McKennan Hospital
Sioux Falls, South Dakota, 57105
Banner Boswell Medical Center
Sun City, Arizona, 85351
Banner Del Webb
Sun City West, Arizona, 85375
Mercy Health St Vincent Medical Center
Toledo, Ohio, 43608
Mercy St. Anne Hospital
Toledo, Ohio, 43623
Banner University Medical Center - South (BUMC-S)
Tucson, Arizona, 85713
Banner University Medical Center - Tucson (BUMC-T)
Tucson, Arizona, 85724
Saint Francis Hospital
Tulsa, Oklahoma, 74136
Long Island Jewish Valley Stream
Valley Stream, New York, 11580
Samaritan Medical Center
Watertown, New York, 13601
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, 18711
About this study
Official title: 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.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods
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.
Measured: Baseline up to 20 months
Secondary outcomes (4)
Percentage of Patients Readmitted to the Same Hospital
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.
Measured: Up to 20 months
Percentage of Patients who Received OAC by Hospital Characteristics Subgroups
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.
Measured: End of study (Month 20)
Effect of Tools Components of the QI Program on the use of OAC
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.
Measured: End of study (Month 20)
Effect of Degree of Engagement in the QI Program
A performance dashboard will be implemented to aggregate and display performance data.
Measured: End of study (Month 20)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start29 Dec 2017
- Primary completion3 Dec 2019
- Study completion3 Dec 2019
Why it stopped: Operating Company decided to stop study due to strategic realignment and budgetary reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Scientific Affairs, LLC Clinical Trial, Study director, Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382613
- Sponsor's protocol ID
- CR108407
- Other IDs
- NOPRODAFL0001
- Acronym
- QUANTUM AF
- Status last verified
- Dec 2019
- First submitted
- 19 Dec 2017
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantify Use of Anticoagulation to Improve Management of AF
- ClinicalTrials.gov ID
- NCT03382613
- Acronym / sponsor ID
- QUANTUM AF / CR108407
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Operating Company decided to stop study due to strategic realignment and budgetary reasons
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 3 Dec 2019 (actual)
- Study completion
- 3 Dec 2019 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with atrial fibrillation (AF) at risk for ischemic stroke will be included.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods
Time frame: 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.
4 secondary outcomes
Percentage of Patients Readmitted to the Same Hospital
Time frame: Up to 20 months
Percentage of Patients who Received OAC by Hospital Characteristics Subgroups
Time frame: End of study (Month 20)
Effect of Tools Components of the QI Program on the use of OAC
Time frame: End of study (Month 20)
Effect of Degree of Engagement in the QI Program
Time frame: End of study (Month 20)
Results and safety
The study was stopped early (reason given: Operating Company decided to stop study due to strategic realignment and budgetary reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Scientific Affairs, LLC Clinical Trial study director
Janssen Scientific Affairs, LLC
62 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Janssen Scientific Affairs, LLC at 62 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Operating Company decided to stop study due to strategic realignment and budgetary reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Percentage of Patients Treated With OAC From Baseline to Final Collection Periods (time frame: Baseline up to 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.