Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
NCT ID: NCT04096781
Last Updated: 2024-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1001 participants
INTERVENTIONAL
2019-12-18
2022-08-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Shared Decision Making Tool (SDMT)
SDMT
The intervention involves a clear pathway centered on the use of a web-based decision tool. This tool aims to support the shared decision-making process for anticoagulation for stroke prevention in atrial fibrillation. This web-based tool will be used both by the participants as well the physician responsible for atrial fibrillation decision making.
Usual Care
Usual Care
The participants will receive usual care.
Interventions
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SDMT
The intervention involves a clear pathway centered on the use of a web-based decision tool. This tool aims to support the shared decision-making process for anticoagulation for stroke prevention in atrial fibrillation. This web-based tool will be used both by the participants as well the physician responsible for atrial fibrillation decision making.
Usual Care
The participants will receive usual care.
Eligibility Criteria
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Inclusion Criteria
* Non-valvular atrial fibrillation or atrial flutter (AFib)
* CHA2DS2-VASc stroke score of:
* Men: 1 or more
* Women: 2 or more
* Able to consent in English or Spanish (if resources allow) and follow study instructions
Exclusion Criteria
* Mechanical valve replacement
* Absolute contraindication to anticoagulation (Based on clinician judgment)
* Indication for anticoagulation therapy for a condition other than atrial fibrillation
* Left atrial appendage exclusion (by surgery or device placement)
* At the clinical discretion of the investigator
18 Years
ALL
No
Sponsors
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American Heart Association
OTHER
East Carolina University
OTHER
Ochsner Health System
OTHER
The Cleveland Clinic
OTHER
The Cooper Health System
OTHER
Stanford University
OTHER
Responsible Party
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Paul Wang
Professor of Medicine (Cardiovascular Medicine), Stanford University Medical Center
Principal Investigators
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Paul J Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Randall S Stafford, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Palo Alto, California, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Cooper University Hospital
Camden, New Jersey, United States
East Carolina University
Greenville, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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References
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Baykaner T, Pundi K, Lin B, Lu Y, DeSutter K, Lhamo K, Garay G, Nunes JC, Morin DP, Sears SF, Chung MK, Paasche-Orlow MK, Sanders LM, Bunch TJ, Hills MT, Mahaffey KW, Stafford RS, Wang PJ. The ENHANCE-AF clinical trial to evaluate an atrial fibrillation shared decision-making pathway: Rationale and study design. Am Heart J. 2022 May;247:68-75. doi: 10.1016/j.ahj.2022.01.013. Epub 2022 Jan 28.
Nunes JC, Baykaner T, Pundi K, DeSutter K, True Hills M, Mahaffey KW, Sears SF, Morin DP, Lin B, Wang PJ, Stafford RS. Design and development of a digital shared decision-making tool for stroke prevention in atrial fibrillation. JAMIA Open. 2023 Feb 2;6(1):ooad003. doi: 10.1093/jamiaopen/ooad003. eCollection 2023 Apr.
Chung MK, Fagerlin A, Wang PJ, Ajayi TB, Allen LA, Baykaner T, Benjamin EJ, Branda M, Cavanaugh KL, Chen LY, Crossley GH, Delaney RK, Eckhardt LL, Grady KL, Hargraves IG, True Hills M, Kalscheur MM, Kramer DB, Kunneman M, Lampert R, Langford AT, Lewis KB, Lu Y, Mandrola JM, Martinez K, Matlock DD, McCarthy SR, Montori VM, Noseworthy PA, Orland KM, Ozanne E, Passman R, Pundi K, Roden DM, Saarel EV, Schmidt MM, Sears SF, Stacey D, Stafford RS, Steinberg BA, Youn Wass S, Wright JM. Shared Decision Making in Cardiac Electrophysiology Procedures and Arrhythmia Management. Circ Arrhythm Electrophysiol. 2021 Dec;14(12):e007958. doi: 10.1161/CIRCEP.121.007958. Epub 2021 Dec 6.
Pundi K, Baykaner T, True Hills M, Lin B, Morin DP, Sears SF, Wang PJ, Stafford RS. Blood Thinners for Atrial Fibrillation Stroke Prevention. Circ Arrhythm Electrophysiol. 2021 Jun;14(6):e009389. doi: 10.1161/CIRCEP.120.009389. Epub 2021 Jun 11. No abstract available.
Ajayi TB, Remein CD, Stafford RS, Fagerlin A, Chung MK, Childs E, Benjamin EJ. Cross-Center Virtual Education Fellowship Program for Early-Career Researchers in Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008552. doi: 10.1161/CIRCEP.120.008552. Epub 2020 Oct 8.
Nunes, J.C., Shah, S., Fazal, M. et al. Patient Education Strategies to Improve Risk of Stroke in Patients with Atrial Fibrillation. Curr Cardiovasc Risk Rep 16, 249-258 (2022). https://doi.org/10.1007/s12170-022-00709-8.
Pourshams I, Lin B, Wang PJ, Stafford RS. Decision-Making Experiences and Decisional Regret in Patients Receiving Implanted Cardioverter-Defibrillators. Heart Mind 2022; 6(1): 32-5. doi: 10.4103/hm.hm_51_21
Wang PJ, Lu Y, Mahaffey KW, Lin A, Morin DP, Sears SF, Chung MK, Russo AM, Lin B, Piccini J, Hills MT, Berube C, Pundi K, Baykaner T, Garay G, Lhamo K, Rice E, Pourshams IA, Shah R, Newswanger P, DeSutter K, Nunes JC, Albert MA, Schulman KA, Heidenreich PA, Bunch TJ, Sanders LM, Turakhia M, Verghese A, Stafford RS. Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway. J Am Heart Assoc. 2023 Feb 7;12(3):e028562. doi: 10.1161/JAHA.122.028562. Epub 2023 Feb 7.
Other Identifiers
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50864
Identifier Type: -
Identifier Source: org_study_id
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