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.

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.

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.

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.

Talking About Type 2 Diabetes: Family Communication From the Perspective of At-Risk Relatives.

PURPOSE: The purpose of this study was to describe type 2 diabetes (T2DM) communication and risk reduction recommendations from the perspective of family members at risk for T2DM based on family history. METHODS: Semistructured qualitative interviews were conducted with 33 individuals with a first-degree relative with T2DM. Participants were recruited from the community and a previous pharmacogenetics study. Deductive and inductive codes were applied to the transcripts. RESULTS: Conversations with family members with and without T2DM focused on symptoms and disease management of the family member with T2DM. With at-risk relatives, conversations also focused on prevention. Lack of perceived relevance to family members without T2DM was a barrier to communication. Recommendations to facilitate communication included education of an at-risk family member to increase awareness of risk, followed by sharing of learned information with others. CONCLUSION: Efforts are needed to increase awareness and improve communication about T2DM risk factors, familial risk, and risk reduction behaviors within families with a family history of T2DM. Family members with and without T2DM should be encouraged to communicate with their relatives about T2DM and the risk to family members. Identification of family members who can facilitate communication, education, and modeling of healthy behaviors may increase awareness and motivate at-risk individuals to engage in risk-reducing behaviors.

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.