Clinical trial NCT04096781: Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
Official title: Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Stroke
Cardiac
Heart Failure
Arrhythmia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: East Carolina University
name: Ochsner Health System
name: The Cleveland Clinic
name: The Cooper Health System
First posted: 2019-09-20
Enrollment: 1001
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Shared Decision-Making pathway focused on a digital shared decision-making tool (SDMT) that is augmented by a clinician tool and an optional lay coach
Primary purpose: PREVENTION

Brief summary: A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention

Detailed description: This study will test to see if a new type of decision-making process tool, called a Shared Decision Making Pathway, can make a difference in decreasing the risk of stroke due to a condition called Atrial Fibrillation (AFib.) This online tool is designed to help doctors and patients decide together on treatment options for AFib.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 y/o
* 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:

* Moderate to severe mitral stenosis
* 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

Primary outcomes:
measure: Decisional Conflict Scale
timeFrame: Visit 2 (1-month follow-up)
Secondary outcomes:
measure: Decisional Conflict Scale (16 items)
timeFrame: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
measure: Decision Regret Scale (5 items)
timeFrame: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
measure: Weighted composite outcome scale according to patient preference
timeFrame: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
measure: Preparation for Decision Making Scale (10 items)
timeFrame: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
measure: Utah-Stanford Atrial Fibrillation Knowledge Assessment
timeFrame: Baseline, Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
measure: Quality of Communication (Based on CAHPS Clinician & Group Survey)
timeFrame: Visit 1 (Post Clinic Visit)
measure: Atrial Fibrillation Severity Scale (AFSS)
timeFrame: Baseline, Visit 2 (1-month follow up), Visit 3(6-month follow-up)
measure: Collaborative Agreement on Decision
timeFrame: Visit 1 (Post Clinic Visit)
measure: Clinician Satisfaction of the Decision Aid: Physician Survey
timeFrame: Visit 1 (Post Clinic Visit)
measure: Patient Satisfaction of the Decision Aid: Patient Survey
timeFrame: Visit 1 (Post Clinic Visit)
measure: Length of Visit at visit 1 (clinician)
timeFrame: Visit 1 (Post Clinic Visit)
measure: Anticoagulant Choice (Patient follow up questions on Anticoagulant use)
timeFrame: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
measure: Anticoagulation Persistence and adherence (Patient follow up questions on Anticoagulant use)
timeFrame: Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
measure: Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus
timeFrame: Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled
measure: Death
timeFrame: Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Stanford University
name: Paul J Wang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Randall S Stafford, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.