Shared decision-making tool for thromboprophylaxis in atrial fibrillation - A feasibility study.

BACKGROUND: Appropriate thromboprophylaxis for patients with atrial fibrillation or atrial flutter (AF) remains a national challenge. METHODS: We hypothesized that a shared decision-making interaction facilitated by an Atrial Fibrillation Shared Decision Making Tool (AFSDM) would improve patient knowledge about atrial fibrillation, and the risks and benefits of various treatment options for stroke prevention; increase satisfaction with the decision-making process; improve the therapeutic alliance between patient and the clinical care team; and increase medication adherence. Using a pre- and post-visit study design, we enrolled 76 patients and completed 2 office visits and 1-month telephone follow-up for 65 patients being seen in our Arrhythmia Clinic over the 1-year period (July 2016 through June 2017). Our primary outcome measure was change in decisional conflict between the first and second clinical visit. RESULTS: Decisional conflict decreased from an average of 31 to 9. Mean change was 22.3 (95% CI, 25.7 - 37.1), corresponding to an effect size of 0.94 standard deviations. Satisfaction with decision increased from 4.0 to 4.5, measures of therapeutic alliance with the care team (Kim Alliance scale) increased from 100.1 to 103.1, and satisfaction with provider increased from 4.2 to 4.5 (P < .0001 for all measures). AF knowledge assessment scores increased from 8.4 to 9.1, and knowledge about personal stroke and bleeding risk increased from 1 to 1.5 (P < .0001). Finally, medication adherence improved as reflected by an increase in the Morisky Medication Adherence scale from 5.9 to 6.4 (P < .0001). CONCLUSIONS: A shared decision-making interaction, facilitated by an AFSDM can significantly improve multiple measures of decision-making quality, leading to improved medication adherence and patient satisfaction.

Atrial fibrillation decision support tool: Population perspective.

BACKGROUND: Appropriate thromboprophylaxis for patients with atrial fibrillation or atrial flutter (AF) remains a national challenge. The recent availability of direct oral anticoagulants (DOACs) with comparable efficacy and improved safety compared with warfarin alters the balance between risk factors for stroke and benefit of anticoagulation. Our objective was to examine the impact of DOACs as an alternative to warfarin on the net benefit of oral anticoagulant therapy (OAT) in a real-world population of AF patients. METHODS: This is a retrospective cohort study of patients with paroxysmal or persistent nonvalvular AF. We updated an Atrial Fibrillation Decision Support Tool (AFDST) to include DOACs as treatment options. The tool generates patient-specific recommendations based upon individual patient risk factor profiles for stroke and major bleeding using quality-adjusted life-years (QALYs) calculated for each treatment strategy by a decision analytic model. The setting included inpatient and ambulatory sites in an academic health center in the midwestern United States. The study involved 5,121 adults with nonvalvular AF seen for any ambulatory visit or inpatient hospitalization over the 1-year period (January through December 2016). Outcome measure was net clinical benefit in QALYs. RESULTS: When DOACs are a therapeutic option, the AFDST recommends OAT for 4,134 (81%) patients and no antithrombotic therapy or aspirin for 489 (9%). A strong recommendation for OAT could not be made in 498 (10%) patients. When warfarin is the only option, OAT is recommended for 3,228 (63%) patients and no antithrombotic therapy or aspirin for 973 (19%). A strong recommendation for OAT could not be made in 920 (18%) patients. In total, 1,508 QALYs could be gained if treatment were changed to that recommended by the AFDST. CONCLUSIONS: Availability of DOACs increases the proportion of patients for whom oral anticoagulation therapy is recommended in a real-world cohort of AF patients and increased projected QALYs by more than 1,500 when all patients are receiving thromboprophylaxis as recommended by the AFDST compared with current treatment.

Impact of an Atrial Fibrillation Decision Support Tool on thromboprophylaxis for atrial fibrillation.

BACKGROUND: Appropriate thromboprophylaxis for patients with atrial fibrillation (AF) remains a national challenge. METHODS: We hypothesized that provision of decision support in the form of an Atrial Fibrillation Decision Support Tool (AFDST) would improve thromboprophylaxis for AF patients. We conducted a cluster randomized trial involving 15 primary care practices and 1,493 adults with nonvalvular AF in an integrated health care system between April 2014 and February 2015. Physicians in the intervention group received patient-level treatment recommendations made by the AFDST. Our primary outcome was the proportion of patients with antithrombotic therapy that was discordant from AFDST recommendation. RESULTS: Treatment was discordant in 42% of 801 patients in the intervention group. Physicians reviewed reports for 240 patients. Among these patients, thromboprophylaxis was discordant in 63%, decreasing to 59% 1 year later (P = .02). In nonstratified analyses, changes in discordant care were not significantly different between the intervention group and control groups. In multivariate regression models, assignment to the intervention group resulted in a nonsignificant trend toward decreased discordance (P = .29), and being a patient of a resident physician (P = .02) and a higher HAS-BLED score predicted decreased discordance (P = .03), whereas female gender (P = .01) and a higher CHADSVASc score (P = .10) predicted increased discordance. CONCLUSIONS: Among patients whose physicians reviewed recommendations of the decision support tool discordant therapy decreased significantly over 1 year. However, in nonstratified analyses, the intervention did not result in significant improvements in discordant antithrombotic therapy.

Change in predicted 10-year cardiovascular risk following laparoscopic Roux-en-Y gastric bypass surgery.

BACKGROUND: Bariatric surgery is being conducted more often for morbid obesity, but little evidence exists about how it affects the risk of future cardiovascular events. The goal of this study was to quantify the change in predicted 10-year cardiovascular risk following laparoscopic Roux-en-Y gastric bypass (LRYGBP). METHODS: We conducted a prospective clinical study of morbidly obese adults undergoing LRYGBP at a university hospital in the USA. Our primary outcome measure was mean change in 10-year cardiovascular risk at 12 months. We estimated cardiovascular risk by using the Framingham risk equation, which calculates the absolute risk of cardiovascular events for patients with no known history of heart disease, stroke, or peripheral vascular disease by using information on age, sex, blood pressure, total and high-density lipoprotein cholesterol levels, smoking status, and history of diabetes. RESULTS: Ninety-two participants underwent LRYGBP between December 2004 and October 2005. Their predicted baseline 10-year cardiovascular risk was 6.7%. At 6 and 12 months, their predicted risk had decreased to 5.2% and 5.4%, respectively. Assuming no change in risk among untreated patients, this represents an absolute risk reduction of 1.3%; which suggests that 77 morbidly obese patients would have to undergo LRYGBP to avert one new case of cardiovascular disease over the ensuing 10 years (number needed to treat = 77). CONCLUSION: Our findings indicate that LRYGBP is associated with improvements in cardiovascular risk factors and a corresponding decrease in predicted 10-year risk of cardiovascular disease.

Using an Atrial Fibrillation Decision Support Tool for Thromboprophylaxis in Atrial Fibrillation: Effect of Sex and Age.

OBJECTIVES: To assess the appropriateness of oral anticoagulant therapy (OAT) in women and elderly adults, looking for patterns of undertreatment or unnecessary treatment. DESIGN: Retrospective cohort study. SETTING: Primary care practices of an academic healthcare system. PARTICIPANTS: Adults (aged 28-93) with nonvalvular atrial fibrillation (AF) seen between March 2013 and February 2014 (N = 1,585). MEASUREMENTS: Treatment recommendations were made using an AF decision support tool (AFDST) based on projections of quality-adjusted life expectancy calculated using a decision analytical model that integrates individual-specific risk factors for stroke and hemorrhage. RESULTS: Treatment was discordant from AFDST-recommended treatment in 45% (326/725) of women and 39% (338/860) of men (P = .02). Although current treatment was discordant from recommended in 35% (89/258) of participants aged 85 and older and in 43% (575/1,328) of those younger than 85 (P = .01), many undertreated elderly adults were receiving aspirin as the sole antithrombotic agent. CONCLUSION: Physicians should understand that female sex is a significant risk factor for AF-related stroke and incorporate this into decision-making about thromboprophylaxis. Treating older adults with aspirin instead of OAT exposes them to significant risk of bleeding with little to no reduction in AF-related stroke risk.

Developing an Atrial Fibrillation Guideline Support Tool (AFGuST) for shared decision making.

OBJECTIVE: Patient values and preferences are an important component to decision making when tradeoffs exist that impact quality of life, such as tradeoffs between stroke prevention and hemorrhage in patients with atrial fibrillation (AF) contemplating anticoagulant therapy. Our objective is to describe the development of an Atrial Fibrillation Guideline Support Tool (AFGuST) to assist the process of integrating patients' preferences into this decision. MATERIALS AND METHODS: CHA2DS2VASc and HAS-BLED were used to calculate risks for stroke and hemorrhage. We developed a Markov decision analytic model as a computational engine to integrate patient-specific risk for stroke and hemorrhage and individual patient values for relevant outcomes in decisions about anticoagulant therapy. RESULTS: Individual patient preferences for health-related outcomes may have greater or lesser impact on the choice of optimal antithrombotic therapy, depending upon the balance of patient-specific risks for ischemic stroke and major bleeding. These factors have been incorporated into patient-tailored booklets which, along with an informational video, were developed through an iterative process with clinicians and patient focus groups. KEY LIMITATIONS: Current risk prediction models for hemorrhage, such as the HAS-BLED, used in the AFGuST, do not incorporate all potentially significant risk factors. Novel oral anticoagulant agents recently approved for use in the United States, Canada, and Europe have not been included in the AFGuST. Rather, warfarin has been used as a conservative proxy for all oral anticoagulant therapy. CONCLUSIONS: We present a proof of concept that a patient-tailored decision-support tool could bridge the gap between guidelines and practice by incorporating individual patient's stroke and bleeding risks and their values for major bleeding events and stroke to facilitate a shared decision making process. If effective, the AFGuST could be used as an adjunct to published guidelines to enhance patient-centered conversations about the anticoagulation management.

Integrating real-time clinical information to provide estimates of net clinical benefit of antithrombotic therapy for patients with atrial fibrillation.

BACKGROUND: Guidelines for anticoagulant therapy in patients with atrial fibrillation are based on stroke risk as calculated by either the CHADS2 or the CHA2DS2VASc scores and do not integrate bleeding risk in an explicit, quantitative manner. Our objective was to quantify the net clinical benefit resulting from improved decision making about antithrombotic therapy. METHODS AND RESULTS: This study is a retrospective cohort study of 1876 adults with nonvalvular atrial fibrillation or flutter seen in primary care settings of an integrated healthcare delivery system between December 2012 and January 2014. Projections for quality-adjusted life expectancy reported as quality-adjusted life-years were calculated by a decision analytic model that integrates patient-specific risk factors for stroke and hemorrhage and examines strategies of no antithrombotic therapy, aspirin, or oral anticoagulation with warfarin. Net clinical benefit was defined by the gain or loss in quality-adjusted life expectancy between current treatment and treatment recommended by an Atrial Fibrillation Decision Support Tool. Current treatment was discordant from treatment recommended by the Atrial Fibrillation Decision Support Tool in 931 patients. A clinically significant gain in quality-adjusted life expectancy (defined as ≥0.1 quality-adjusted life-years) was projected in 832 patients. Subgroups were examined. For example, oral anticoagulant therapy was recommended for 188 who currently were receiving no antithrombotic therapy. For the entire cohort, a total of 736 quality-adjusted life-years could be gained were treatment changed to that recommended by the Atrial Fibrillation Decision Support Tool. CONCLUSIONS: Use of a decision support tool that integrates patient-specific stroke and bleeding risk could result in significant gains in quality-adjusted life expectancy for a primary care population of patients with atrial fibrillation.

Usability of an atrial fibrillation anticoagulation decision-support tool.

INTRODUCTION: In individuals with nonvalvular atrial fibrillation, anticoagulant therapy with warfarin reduces the rate of thromboembolic events but increases the risk of bleeding. Treatment decisions frequently are inconsistent with guidelines. A new web-based atrial fibrillation decision-support tool (AF-DST) provides patient-specific information on the risk-benefit tradeoff of anticoagulation. METHODS: The authors performed a pilot usability testing study of the AF-DST with 4 medical house officers and 4 attending physicians by simulating 9 outpatient clinical encounters involving tradeoffs between risks and benefits of anticoagulation. They recorded positive and negative critical incidents in the simulations and assessed satisfaction with use of the AF-DST by the Computer System Usability Questionnaire (CSUQ; score range on each item: 1 = strongly disagree to 7 = strongly agree). RESULTS: Users found the AF-DST to be helpful and had high CSUQ scores (mean item score, 6.3). Usability testing identified 6 positive and 14 negative critical incidents. Participants felt that the AF-DST guided them toward the correct decision. Nevertheless, they desired more information on the "black box" calculations and ignored alerts. Training level appeared to affect how the AF-DST was used, in particular, how users interacted with the AF-DST. CONCLUSIONS: Overall satisfaction with the AF-DST was high and the tool effectively communicated recommendations and uncertainty. Usability testing identified design issues and potential errors caused by decision-support tool use; these gaps should be addressed prior to clinical implementation.