scholarly journals Effect of Shared Decision‐Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial

Author(s):  
Peter A. Noseworthy ◽  
Megan E. Branda ◽  
Marleen Kunneman ◽  
Ian G. Hargraves ◽  
Angela L. Sivly ◽  
...  

Background Guidelines promote shared decision‐making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within‐encounter SDM tool to usual care (UC) increases patient involvement in decision‐making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter‐level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow‐up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
P Noseworthy ◽  
M.E Branda ◽  
M Kunneman ◽  
I.G Hargraves ◽  
A.L Sivly ◽  
...  

Abstract Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation (AF). We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision making and clinician satisfaction, without affecting encounter length. Purpose We aimed to estimate the extent to which use of an SDM tool affected patient adherence to the decided care plan and clinical safety endpoints. Methods We conducted a multi-center, encounter-level randomized trial assessing the efficacy of UC with vs. without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice, AC) in patients with non-valvular AF considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months post-enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled [PDC] for DOAC, and as time in therapeutic range (TTR) for warfarin). We also followed for any safety outcomes (stroke [stroke or transient ischemic attack], major bleeding, or death). Results We enrolled 922 evaluable patient encounters (AC=463, UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary (78% of patients in AC filled their first prescription vs. 81% in UC) or secondary adherence to anticoagulation (see Figure, PDCDOAC was 74.1% in AC vs. 71.6% in UC; TTRwarfarin was 66.6% in AC vs. 64.4% in UC). PDCDOAC was better (65%) in AC than in UC (55%) (OR 1.49, CIs 1.00, 2.22). Safety outcomes, mostly bleeds, occurred in 13% (AC) of and 14% (UC) of participants. Conclusions This is the largest reported randomized trial in AF comparing usual care with and without an SDM tool to promote SDM. Although patients were more actively involved in SDM, we found no significant differences between arms in primary or secondary adherence to anticoagulation or clinical safety outcomes. FUNDunding Acknowledgement Type of funding sources: Other. Main funding source(s): The trial was funded by and conducted independently of the National Heart, Lung, and Blood Institute (NHLBI) of the U.S. National Institutes of Health (RO1 HL131535-01). The funding body had no influence on the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Figure 1


2018 ◽  
Author(s):  
Molly Beinfeld ◽  
Suzanne Brodney ◽  
Michael Barry ◽  
Erika Poole ◽  
Adam Kunin

BACKGROUND A rural community-based Cardiology practice implemented shared decision making supported by an evidence-based decision aid booklet to improve the quality of anticoagulant therapy decisions in patients with atrial fibrillation. OBJECTIVE To develop a practical workflow for implementation of an anticoagulant therapy decision aid and to assess the impact on patients’ knowledge and process for anticoagulant medication decision making. METHODS The organization surveyed all patients with atrial fibrillation being seen at Copley Hospital to establish a baseline level of knowledge, certainty about the decision and process for decision making. The intervention surveys included the same knowledge, certainty, process and demographic questions as the baseline surveys, but also included questions asking for feedback on the decision aid booklet. Stroke risk scores (CHA2DS2-VASc score) were calculated by Copley staff for both groups using EMR data. RESULTS We received 46 completed surveys in the baseline group (64% response rate) and 50 surveys in the intervention group (72% response rate). The intervention group had higher knowledge score than the baseline group (3.6 out of 4 correct answers vs 3.1, p=0.036) and Decision Process Score (2.89 out of 4 vs 2.09, p=0.0023) but similar scores on the SURE scale (3.12 out of 4 vs 3.17, p=0.79). Knowledge and Process score differences were sustained even after adjusting for co-variates in stepwise linear regression analyses. Patients with high school or lower education appeared to benefit the most from shared decision making, as demonstrated by their knowledge scores. CONCLUSIONS It is feasible and practical to implement shared decision making supported by decision aids in a community-based Cardiology practice. Shared decision making can improve knowledge and process for decision making for patients with atrial fibrillation. CLINICALTRIAL None


2020 ◽  
Vol 180 (9) ◽  
pp. 1215 ◽  
Author(s):  
Marleen Kunneman ◽  
Megan E. Branda ◽  
Ian G. Hargraves ◽  
Angela L. Sivly ◽  
Alexander T. Lee ◽  
...  

2019 ◽  
Vol 32 (4) ◽  
pp. 765-776 ◽  
Author(s):  
Ulla Hellström Muhli ◽  
Jan Trost ◽  
Eleni Siouta

Purpose The purpose of this paper is to analyse the accounts of Swedish cardiologists concerning patient involvement in consultations for atrial fibrillation (AF). The questions were: how cardiologists handle and provide scope for patient involvement in medical consultations regarding AF treatment and how cardiologists describe their familiarity with shared decision-making. Design/methodology/approach A descriptive study was designed. Ten interviews with cardiologists at four Swedish hospitals were held, and a qualitative content analysis was performed on the collected data. Findings The analysis shows cardiologists’ accounts of persuasive practice, protective practice, professional role and medical craftsmanship when it comes to patient involvement and shared decision-making. The term “shared decision-making” implies a concept of not only making one decision but also ensuring that it is finalised with a satisfactory agreement between both parties involved, the patient as well as the cardiologist. In order for the idea of patient involvement to be fulfilled, the two parties involved must have equal power, which can never actually be guaranteed. Research limitations/implications Methodologically, this paper reflects the special contribution that can be made by the research design of descriptive qualitative content analysis (Krippendorff, 2004) to reveal and understand cardiologists’ perspectives on patient involvement and participation in medical consultation and shared decision-making. The utility of this kind of analysis is to find what cardiologists said and how they arrived at their understanding about patient involvement. Accordingly, there is no quantification in this type of research. Practical implications Cardiologists should prioritise patient involvement and participation in decision-making regarding AF treatment decisions in consultations when trying to meet the request of patient involvement. Originality/value Theoretically, the authors have learned that the patient involvement and shared decision-making requires the ability to see patients as active participants in the medical consultation process.


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