Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention

NCT04096781 | Completed DMC

• 1 other identifier: 50864
• Study Type: interventional
• Target: 1,001
• Locations: 1 country
• Sites: 5

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

Conditions

Atrial Fibrillation; Atrial Flutter; Stroke; Cardiac; Heart Failure; Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale

  The Decisional Conflict Scale is a 16 Item scale on whether the participants have enough information to make a clear decision. Each item scored from 1-5, where 1 indicates clarity and 5 indicates confusion, with total score ranging from 16-80

  Visit 2 (1-month follow-up)

Secondary Outcomes (15)

• Decisional Conflict Scale (16 items)

  Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)

• Decision Regret Scale (5 items)

  Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)

• Weighted composite outcome scale according to patient preference

  Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)

• Preparation for Decision Making Scale (10 items)

  Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)

• Utah-Stanford Atrial Fibrillation Knowledge Assessment

  Baseline, Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)

Study Arms (2)

Shared Decision Making Tool (SDMT)

EXPERIMENTAL

Behavioral: SDMT

Usual Care

ACTIVE COMPARATOR

Behavioral: Usual Care

Interventions

SDMT BEHAVIORAL

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.

Shared Decision Making Tool (SDMT)

Usual Care BEHAVIORAL

The participants will receive usual care.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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
• At the clinical discretion of the investigator

Sponsors & Collaborators

• Stanford University: lead
• American Heart Association: collaborator
• East Carolina University: collaborator
• Ochsner Health System: collaborator
• The Cleveland Clinic: collaborator
• The Cooper Health System: collaborator

Study Sites (5)

Stanford University

Palo Alto, California, 94305, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

East Carolina University

Greenville, North Carolina, 27858, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 931562, United States

Location

Related Publications (8)

• 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.

  PMID: 35092723 BACKGROUND

• 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.

  PMID: 36751465 BACKGROUND

• 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.

  PMID: 34865518 BACKGROUND

• 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.

  PMID: 34111936 BACKGROUND

• 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.

  PMID: 33031707 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 36342828 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Stroke; Heart Failure; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Paul J Wang, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Randall S Stafford, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine (Cardiovascular Medicine), Stanford University Medical Center

Model Details: 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

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 20, 2019
• Study Start: December 18, 2019
• Primary Completion: June 23, 2022
• Study Completion: August 17, 2022
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)