Stroke Clinical Trial
— ENHANCE-AFOfficial title:
Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
NCT number | NCT04096781 |
Other study ID # | 50864 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 18, 2019 |
Est. completion date | August 17, 2022 |
Verified date | April 2024 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Stanford University | American Heart Association, East Carolina University, Ochsner Health System, The Cleveland Clinic, The Cooper Health System |
United States,
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
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 |
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