Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation

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.

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Use of an Atrial Fibrillation Medication Decision Aid Improves Knowledge and Process for Decision Making (Preprint)

10.2196/preprints.12404 ◽

2018 ◽

Author(s):

Molly Beinfeld ◽

Suzanne Brodney ◽

Michael Barry ◽

Erika Poole ◽

Adam Kunin

Keyword(s):

Atrial Fibrillation ◽

Decision Making ◽

Shared Decision Making ◽

Anticoagulant Therapy ◽

Decision Aid ◽

Response Rate ◽

Intervention Group ◽

Shared Decision ◽

Community Based ◽

Baseline Group

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

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Development of a shared decision‐making tool in vitiligo: an international study

British Journal of Dermatology ◽

10.1111/bjd.20137 ◽

2021 ◽

Author(s):

J. Shourick ◽

M. Ahmed ◽

J. Seneschal ◽

T. Passeron ◽

N. Andreux ◽

...

Keyword(s):

Decision Making ◽

Shared Decision Making ◽

International Study ◽

Shared Decision ◽

Decision Making Tool

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“Unreal world” or “real world” data in oral anticoagulant treatment of atrial fibrillation

Thrombosis and Haemostasis ◽

10.1160/th16-08-0658 ◽

2016 ◽

Vol 116 (10) ◽

pp. 587-589 ◽

Cited By ~ 41

Author(s):

Gregory Y. H. Lip ◽

Ben Freedman

Keyword(s):

Atrial Fibrillation ◽

Real World ◽

Oral Anticoagulant ◽

Review Process ◽

Anticoagulant Treatment ◽

Real World Data ◽

Oral Anticoagulant Treatment ◽

World Data

Note: The review process for this manuscript was fully handled by Christian Weber, Editor in Chief.

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P4745Concomitant oral anticoagulant and antidepressant therapy in patients with atrial fibrillation and risk of stroke and bleeding: a population based cohort study

European Heart Journal ◽

10.1093/eurheartj/ehz745.1121 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

J J Komen ◽

P Hjemdahl ◽

A K Mantel - Teeuwisse ◽

O H Klungel ◽

B Wettermark ◽

...

Keyword(s):

Atrial Fibrillation ◽

Propensity Score ◽

Oral Anticoagulant ◽

Cox Regression ◽

Oral Anticoagulants ◽

Anticoagulant Treatment ◽

Oral Anticoagulant Treatment ◽

Increased Risk ◽

Antidepressant Use

Abstract Background Anticoagulation treatment reduces the risk of stroke but increases the risk of bleeding in atrial fibrillation (AF) patients. Antidepressants use is associated with increased risk for stroke and bleeds. Objective To assess the association between antidepressant use in AF patients with oral anticoagulants and bleeding and stroke risk. Methods All AF patients newly prescribed with an oral anticoagulant in the Stockholm Healthcare database (n=2.3 million inhabitants) from July 2011 until 2016 were included and followed for one year or shorter if they stopped claiming oral anticoagulant treatment or had an outcome of interest. Outcomes were severe bleeds and strokes, requiring acute hospital care. During follow-up, patients were considered exposed to antidepressant after claiming a prescription for the duration of the prescription. With a time-varying Cox regression, we assessed the association between antidepressant use and strokes and bleeds, adjusting for confounders (i.e., age, sex, comorbidities, comedication, and year of inclusion). In addition, we performed a propensity score matched analysis to test the robustness of our findings. Results Of the 30,595 patients included after claiming a prescription for a NOAC (n=13,506) or warfarin (n=17,089), 4 303 claimed a prescription for an antidepressant during follow-up. A total of 712 severe bleeds and 551 strokes were recorded in the cohort. Concomitant oral anticoagulant and antidepressant use was associated with increased rates of severe bleeds (4.7 vs 2.7 per 100 person-years) compared to oral anticoagulant treatment without antidepressant use (aHR 1.42, 95% CI: 1.12–1.80), but not significantly associated with increased stroke rates (3.5 vs 2.1 per 100 person-years, aHR 1.23, 95% CI: 0.93–1.62). No significant differences were observed between different oral anticoagulant classes (i.e., warfarin or NOAC) or different antidepressant classes (i.e., SSRI, TCA, or other antidepressant). Additional propensity-score matched analyses yielded similar results but showed a significantly increased risk for stroke (HR: 1.47, 95% CI: 1.08–2.02). Incidence rates of strokes and bleeds Conclusion Concomitant use of an oral anticoagulant and an antidepressant, irrespective of type, is associated with an increased bleeding risk. Increased awareness and a critical consideration for the need of an antidepressant is recommended in this population. Acknowledgement/Funding Swedish Heart Lung Foundation

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Atrial Fibrillation Screen, Management, and Guideline‐Recommended Therapy in the Rural Primary Care Setting: A Cross‐Sectional Study and Cost‐Effectiveness Analysis of eHealth Tools to Support All Stages of Screening

Journal of the American Heart Association ◽

10.1161/jaha.120.017080 ◽

2020 ◽

Vol 9 (18) ◽

Cited By ~ 1

Author(s):

Jessica Orchard ◽

Jialin Li ◽

Ben Freedman ◽

Ruth Webster ◽

Glenn Salkeld ◽

...

Keyword(s):

Atrial Fibrillation ◽

Cost Effectiveness ◽

Incremental Cost ◽

Oral Anticoagulant ◽

Population Based ◽

Incremental Cost Effectiveness Ratio ◽

Anticoagulant Treatment ◽

Cost Effectiveness Ratio ◽

Oral Anticoagulant Treatment ◽

Effectiveness Analysis

BACKGROUND Internationally, most atrial fibrillation (AF) management guidelines recommend opportunistic screening for AF in people ≥65 years of age and oral anticoagulant treatment for those at high stroke risk (CHA₂DS₂‐VA≥2). However, gaps remain in screening and treatment. METHODS AND RESULTS General practitioners/nurses at practices in rural Australia (n=8) screened eligible patients (≥65 years of age without AF) using a smartphone ECG during practice visits. eHealth tools included electronic prompts, guideline‐based electronic decision support, and regular data reports. Clinical audit tools extracted de‐identified data. Results were compared with an earlier study in metropolitan practices (n=8) and nonrandomized control practices (n=69). Cost‐effectiveness analysis compared population‐based screening with no screening and included screening, treatment, and hospitalization costs for stroke and serious bleeding events. Patients (n=3103, 34%) were screened (mean age, 75.1±6.8 years; 47% men) and 36 (1.2%) new AF cases were confirmed (mean age, 77.0 years; 64% men; mean CHA₂DS₂‐VA, 3.2). Oral anticoagulant treatment rates for patients with CHA₂DS₂‐VA≥2 were 82% (screen detected) versus 74% (preexisting AF)( P =NS), similar to metropolitan and nonrandomized control practices. The incremental cost‐effectiveness ratio for population‐based screening was AU$16 578 per quality‐adjusted life year gained and AU$84 383 per stroke prevented compared with no screening. National implementation would prevent 147 strokes per year. Increasing the proportion screened to 75% would prevent 177 additional strokes per year. CONCLUSIONS An AF screening program in rural practices, supported by eHealth tools, screened 34% of eligible patients and was cost‐effective. Oral anticoagulant treatment rates were relatively high at baseline, trending upward during the study. Increasing the proportion screened would prevent many more strokes with minimal incremental cost‐effectiveness ratio change. eHealth tools, including data reports, may be a valuable addition to future programs. REGISTRATION URL: https://www.anzctr.org.au . Unique identifier: ACTRN12618000004268.

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Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation

JAMA Internal Medicine ◽

10.1001/jamainternmed.2020.2908 ◽

2020 ◽

Vol 180 (9) ◽

pp. 1215 ◽

Cited By ~ 1

Author(s):

Marleen Kunneman ◽

Megan E. Branda ◽

Ian G. Hargraves ◽

Angela L. Sivly ◽

Alexander T. Lee ◽

...

Keyword(s):

Atrial Fibrillation ◽

Decision Making ◽

Shared Decision Making ◽

Stroke Prevention ◽

Shared Decision

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Stepwise mass screening for atrial fibrillation using N-terminal B-type natriuretic peptide: the STROKESTOP II study

EP Europace ◽

10.1093/europace/euz255 ◽

2019 ◽

Vol 22 (1) ◽

pp. 24-32 ◽

Cited By ~ 12

Author(s):

Katrin Kemp Gudmundsdottir ◽

Tove Fredriksson ◽

Emma Svennberg ◽

Faris Al-Khalili ◽

Leif Friberg ◽

...

Keyword(s):

Atrial Fibrillation ◽

High Risk ◽

Natriuretic Peptide ◽

Oral Anticoagulant ◽

Risk Group ◽

High Risk Group ◽

Low Risk ◽

Screening Procedure ◽

Anticoagulant Treatment ◽

Oral Anticoagulant Treatment

Abstract Aims To study the prevalence of unknown atrial fibrillation (AF) in a high-risk, 75/76-year-old, population using N-terminal B-type natriuretic peptide (NT-proBNP) and handheld electrocardiogram (ECG) recordings in a stepwise screening procedure. Methods and results The STROKESTOP II study is a population-based cohort study in which all 75/76-year-old in the Stockholm region (n = 28 712) were randomized 1:1 to be invited to an AF screening programme or to serve as the control group. Participants without known AF had NT-proBNP analysed and were stratified into low-risk (NT-proBNP <125 ng/L) and high-risk (NT-proBNP ≥125 ng/L) groups. The high-risk group was offered extended ECG-screening, whereas the low-risk group performed only one single-lead ECG recording. In total, 6868 individuals accepted the screening invitation of which 6315 (91.9%) did not have previously known AF. New AF was detected in 2.6% [95% confidence interval (CI) 2.2–3.0] of all participants without previous AF. In the high-risk group (n = 3766/6315, 59.6%), AF was diagnosed in 4.4% (95% CI 3.7–5.1) of the participants. Out of these, 18% had AF on their index-ECG. In the low-risk group, one participant was diagnosed with AF on index-ECG. The screening procedure resulted in an increase in known prevalence from 8.1% to 10.5% among participants. Oral anticoagulant treatment was initiated in 94.5% of the participants with newly diagnosed AF. Conclusion N-terminal B-type natriuretic peptide-stratified systematic screening for AF identified 4.4% of the high-risk participants with new AF. Oral anticoagulant treatment initiation was well accepted in the group diagnosed with new AF.

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