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

Stroke Clinical Trial

— ENHANCE-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096781
• Other study ID #: 50864
• Status: Completed
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: August 17, 2022

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1001
• Est. completion date: August 17, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Cooper University Hospital	Camden	New Jersey
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	East Carolina University	Greenville	North Carolina
United States	Ochsner Medical Center	New Orleans	Louisiana
United States	Stanford University	Palo Alto	California

Sponsors (6)

Lead Sponsor	Collaborator
Stanford University	American Heart Association, East Carolina University, Ochsner Health System, The Cleveland Clinic, The Cooper Health System

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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.

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

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. — View 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 P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Decisional Conflict Scale (16 items)	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 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Secondary	Decision Regret Scale (5 items)	Decision Regret Scale, is scored from 1-5, where 1 indicates they made the right decision and 5 indicates they made the wrong decision. This scale ranges from 5-25	Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Secondary	Weighted composite outcome scale according to patient preference	Patient-selected weighted composite outcome scale is a composite scale to consider both decisional conflict and decisional regret scales simultaneously according to the priority based on the survey of 100 potential participants. The rationale for this endpoint is to consider not only the preference of majority patients (73%) but also the minority (27%) participants who prefer the decisional regret scale	Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Secondary	Preparation for Decision Making Scale (10 items)	Preparation for Decision Making scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision	Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Secondary	Utah-Stanford Atrial Fibrillation Knowledge Assessment	Newly developed assessment for this study to record Atrial Fibrillation Knowledge	Baseline, Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Secondary	Quality of Communication (Based on CAHPS Clinician & Group Survey)	CAHPS 3-item modified version	Visit 1 (Post Clinic Visit)
Secondary	Atrial Fibrillation Severity Scale (AFSS)	The University of Toronto Atrial Fibrillation Severity Scale (AFSS) is a questionnaire designed for patients with AFib. It consists of 19 items combined into 3 parts to capture total AF burden, health care utilization, and the severity of AFib related symptoms	Baseline, Visit 2 (1-month follow up), Visit 3(6-month follow-up)
Secondary	Collaborative Agreement on Decision	Assess the collaborative agreement (1. Patient Reported Outcome 2) Clinician Reported	Visit 1 (Post Clinic Visit)
Secondary	Clinician Satisfaction of the Decision Aid: Physician Survey	Clinician Satisfaction of the Decision Aid as assessed by a physician survey on shared decision making	Visit 1 (Post Clinic Visit)
Secondary	Patient Satisfaction of the Decision Aid: Patient Survey	Patient Satisfaction of the Decision Aid as assessed by Patient survey on shared decision making	Visit 1 (Post Clinic Visit)
Secondary	Length of Visit at visit 1 (clinician)	Compare treatment arm on the length of visit	Visit 1 (Post Clinic Visit)
Secondary	Anticoagulant Choice (Patient follow up questions on Anticoagulant use)	Decision on anticoagulation choice as assessed by patient follow up questions	Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Secondary	Anticoagulation Persistence and adherence (Patient follow up questions on Anticoagulant use)	Persistence and adherence to anticoagulation among participants selecting anticoagulation, as assessed by Patient follow up questions	Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Secondary	Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus	Incidence of Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus	Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled
Secondary	Death	Incidence of Death	Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled