Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention (ENHANCE-AF)

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Stroke; Atrial Fibrillation; Arrhythmia; Atrial Flutter; Cardiac
• Intervention / Treatment: Behavioral: SDMT; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 1001
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford University
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Cooper University Hospital
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • East Carolina University
  • Ohio
    • Cleveland, Ohio, United States, 931562
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Behavioral: Usual Care; The participants will receive usual care.
Experimental: Shared Decision Making Tool (SDMT)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
Quality of Communication (Based on CAHPS Clinician & Group Survey)	CAHPS 3-item modified version	Visit 1 (Post Clinic Visit)
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)
Collaborative Agreement on Decision	Assess the collaborative agreement (1. Patient Reported Outcome 2) Clinician Reported	Visit 1 (Post Clinic Visit)
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)
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)
Length of Visit at visit 1 (clinician)	Compare treatment arm on the length of visit	Visit 1 (Post Clinic Visit)
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)
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)
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
Death	Incidence of Death	Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: The Cleveland Clinic; American Heart Association; The Cooper Health System; East Carolina University; Ochsner Health System
• Investigators: Principal Investigator: Paul J Wang, MD, Stanford University; Principal Investigator: Randall S Stafford, MD, Stanford University

Publications and helpful links

General Publications

• 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. Erratum In: J Am Heart Assoc. 2023 Oct 3;12(19):e027740.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): June 23, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: 50864

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No