Electronic health record-embedded decision support to reduce stroke risk in patients with atrial fibrillation - Study protocol.

BACKGROUND: Atrial fibrillation (AF) is the most common significant cardiac rhythm disorder and is a powerful common risk factor for stroke. Randomized trials have demonstrated that anticoagulation can reduce the risk of stroke in patients with AF. Yet, there continues to be widespread underutilization of this therapy. To address this practice gap locally and improve efforts to reduce the risk of stroke for patients with AF in our health system, we have designed a study to implement and evaluate the effectiveness of an Atrial Fibrillation Decision Support Tool (AFDST) embedded within our electronic health record. METHODS: Our intervention is provider-facing and focused on decision support. The clinical setting is ambulatory patients being seen by primary care physicians. Patients include those with both incident and prevalent AF. This randomized, prospective trial will enroll 800 patients in our University of Cincinnati Health System who are currently receiving less than optimal anticoagulation therapy as determined by the AFDST. Patients will be randomized to one of two arms - 1) usual care, in which the AFDST is available for use; 2) addition of a best practice advisory (BPA) to the AFDST notifying the clinician that their patient stands to gain a significant benefit from a change in their current thromboprophylactic therapy. RESULTS: The primary outcome is effectiveness of the BPA measured by change to "appropriate thromboprophylaxis" based on the AFDST recommendation at 3 months post randomization. Secondary endpoints include Reach and Adoption, from the RE-AIM framework for implementation studies. Sample size is based upon an improvement from inappropriate to appropriate anticoagulation therapy estimated at 4% in the usual care arm and ≥10% in the experimental arm. CONCLUSION: Our goal is to examine whether addition of a BPA to an AFDST focused on primary care physicians in an ambulatory care setting will improve "appropriate thromboprophylaxis" compared with usual care. Results will be examined at 3 months post randomization and at the end of the study to evaluate durability of changes. We expect to complete patient enrollment by the end of June 2022. TRIAL REGISTRATION: Clinicaltrials.gov NCT04099485.

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.

Can a best practice advisory improve anticoagulation prescribing to reduce stroke risk in patients with atrial fibrillation?

BACKGROUND: Atrial fibrillation (AF) is the most common cardiac rhythm disorder and a risk factor for stroke. Randomized trials have demonstrated that anticoagulation can reduce strokes in AF patients. Yet, widespread underutilization of this therapy continues. To address this practice gap, we designed a study to implement and evaluate the effectiveness of a best practice advisory (BPA) for an Atrial Fibrillation Decision Support Tool (AFDST) embedded within our electronic health record. METHODS: Our intervention is provider-facing, focused on decision support. Clinical setting is ambulatory patients being seen by primary care physicians. We prospectively enrolled 608 patients in our health system who are currently receiving less than optimal anticoagulation therapy as determined by the AFDST and randomized them to one of two arms - 1) usual care, in which the AFDST is available for use; or 2) addition of a BPA to the AFDST notifying clinicians that their patient stands to gain significant benefit from a change in current therapy. Primary outcome was effectiveness of the BPA measured by change to "appropriate thromboprophylaxis" based on the AFDST recommendation at 3 months post-enrollment. Secondary endpoints included Reach and Adoption from the RE-AIM (Reach, Effectiveness, Adoption, Implementation, & Maintenance) framework for implementation studies. RESULTS: Among 562 patients with a minimum follow-up of 3 months, addition of a BPA to the AFDST resulted in significant improvement in anticoagulation therapy, 5 % (12/248) versus 11 % (33/314) p = 0.02, odds ratio 2.31 (95 % CI, 1.17-4.87). CONCLUSIONS: A BPA added to an AF decision support tool improved anticoagulation therapy among AF patients in a primary care academic health system setting.

Introduction to the Special Issue on "Building Institutions for Priority Setting in Health".

In the pursuit of universal health coverage, countries are invariably confronted with questions about which services to pay with public funds, to whom, and at what cost. Such priority-setting processes have major ramifications for the costs and benefits of care delivered. These processes are not just technical, but also highly political and organizational in nature and expressions of social values. This special issue focuses on building institutions for priority setting in health. These institutions serve a public purpose and are primarily concerned with conducting or using health technology assessment (HTA) to inform resource allocation decisions. We first define the concept of institutions for priority setting in health and the methodological considerations of assessing and evaluating these institutions. Next, we present key common themes and summarize key messages across the articles, including lessons learned and future challenges in building these institutions.

Racial and sex differences in optimizing anticoagulation therapy for patients with atrial fibrillation.

Study objective: Atrial fibrillation (AF) is the most common cardiac rhythm disorder, responsible for 15 % of strokes in the United States. Studies continue to document underuse of anticoagulation therapy in minority populations and women. Our objective was to compare the proportion of AF patients by race and sex who were receiving non-optimal anticoagulation as determined by an Atrial Fibrillation Decision Support Tool (AFDST). Design setting and participants: Retrospective cohort study including 14,942 patients within University of Cincinnati Health Care system. Data were analyzed between November 18, 2020, and November 20, 2021. Main outcomes and measures: Discordance between current therapy and that recommended by the AFDST. Results: In our two-category analysis 6107 (41 %) received non-optimal anticoagulation therapy, defined as current treatment category ≠ AFDST-recommended treatment category. Non-optimal therapy was highest in Black (42 % [n = 712]) and women (42 % [n = 2668]) and lower in White (39 % [n = 4748]) and male (40 % [n = 3439]) patients. Compared with White patients, unadjusted and adjusted odds ratios of receiving non-optimal anticoagulant therapy for Black patients were 1.13; 95 % CI, 1.02-1.30, p = 0.02; and 1.17; 95%CI, 1.04-1.31, p = 0.01; respectively, and 1.10; 95 % CI 1.03-1.18, p = 0.005; and 1.36; 95 % CI, 1.25-1.47, p < 0.001; for females compared with males. Conclusions and relevance: In patients with atrial fibrillation in the University of Cincinnati Health system, Black race and female sex were independently associated with an increased odds of receiving non-optimal anticoagulant therapy.