Fagerlin, Angie

Background: Deciding to use oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF) is complex. For many, the decision between treatment and non-treatment requires a primary tradeoff between the risks of potential stroke and increased bleeding. Hypothesis: We hypothesized that patient values and empiric stroke risk measured by CHA 2 DS 2 -VASc score would influence OAC decisions. Methods: We conducted a secondary analysis of a randomized clinical trial where eligible clinicians and patients were independently randomized to one of two decision aids (DAs) – a patient decision aid and/or an encounter decision aid. Eligible patients were adults with AF with CHA 2 DS 2 -VASc≥1 for men or ≥2 for women. Patients newly prescribed (OAC-naive subgroup) or already taking OAC (OAC-experienced subgroup) were included. We assessed patient values using a 5-point Likert scale between stroke prevention and bleeding risk after SDM during a clinical encounter. We report preliminary results using descriptive statistics and adjusted analysis to investigate the effects of CHA 2 DS 2 -VASc and expressed values on OAC use. Results: 1005 patients were included in the analysis. 828 (82%) patients valued stroke prevention over bleeding risk. Among the OAC-naive group, 175 (63%) valued stroke prevention more than bleed avoidance, 58 (20%) valued bleed avoidance more than stroke prevention, and 47 (17%) were neutral. In the unadjusted analysis, patients were more likely to value stroke prevention if they were OAC-experienced (p<0.001), older (p<0.001), female (p< 0.001), had patient-reported bleeding (p=0.003), or if CHA 2 DS 2 -VASc ≥ 2 if male, ≥3 if female (p<0.001) Table 1 . After adjustments, there were significant associations for OAC use among patients who valued stroke prevention (OR 5.35, 95%CI 3.13-9.13, p<0.001) or had higher CHA 2 DS 2 -VASc (OR 2.03, 95%CI 1.26-3.27, p=0.004). Patients who valued bleed avoidance had an opposing association not to use OAC (OR 0.23, 95%CI 0.11-0.48, p<0.001). Conclusions: Patients with elevated risk (CHA 2 DS 2 -VASc score, age, and female), and those who reported a prior bleeding event valued stroke prevention more than bleeding avoidance. Both empiric stroke risk and patient values were associated with the decision to use OAC. While the tradeoff between stroke prevention and bleeding risk is only one aspect of the decision-making process, these results indicate variability in patient values may influence OAC use.

Introduction: It is unknown how comorbid diagnoses affect patients’ disease-specific knowledge or how patients’ health literacy or numeracy affects this relationship. In patients with atrial fibrillation (AF), comorbidities can be quantified by the CHA 2 DS 2 -VASc score. We explore the association of AF/stroke knowledge with CHA 2 DS 2 -VASc score, health literacy, and numeracy for usual care participants in the multi-center Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation (RED-AF) trial evaluating decision aids to initiate (initiation cohort) or continue (monitor cohort) oral anticoagulation (OAC) in AF patients. Methods: This study was conducted at six academic medical centers in the United States. Participants were aged ≥18, diagnosed with non-valvular AF, and at risk for stroke (CHA 2 DS 2 -VASc ≥1 for men, ≥2 for women). Patient demographics were obtained via questionnaires after a baseline clinical encounter; knowledge was evaluated by patient responses to 7 questions about OAC and AF. Health literacy was measured by a validated self-reported screening tool; numeracy by a validated subjective numeracy scale; CHA 2 DS 2 -VASc was calculated from medical records. We applied generalized estimating equations for a binomial outcome to jointly relate patient knowledge to CHA 2 DS 2 -VASc score, health literacy and numeracy, controlling for 5 additional patient factors and accounting for clustering by clinician. Results: We report on 306 patients randomized to the usual care group across six participating sites. Average age 68.7 9, 61.6% male, mean CHA 2 DS 2 -VASc 2 1.5. Patient knowledge was independently associated with numeracy (5% higher odds of correct response per 1 unit increase in numeracy, 95% CI 0-10%, p=0.05) and membership in the monitor cohort (40% odds of correct response, 4-89%, p=0.03) but not health literacy or increased stroke risk. Conclusion: In the RED-AF study , although health literacy and increasing stroke risk were not independently associated with patient knowledge about AF, numeracy had a minimal positive association. Those already on OAC had greater disease knowledge than patients newly starting OAC. These results suggest a need to broadly increase patient education regardless of baseline comorbidity burden and degree of health literacy. Future studies should be performed to better understand other factors that drive patient knowledge regarding AF and stroke.

Background: Guidelines recommend shared decision-making (SDM) for patients with atrial fibrillation (AF) making decisions regarding anticoagulation for stroke prevention. Decision support tools (e.g., Decision Aids [DAs]) facilitate SDM. However, little research has compared the effectiveness of the two most common types of DAs: (1) encounter decision aid (EDA) and (2) pre-encounter patient decision aid (PDA). Our study assessed the comparative effectiveness of PDAs and EDAs on SDM during AF clinical encounters where stroke prevention strategies were discussed. Research Question: Do decision aids (PDA or EDA), alone or in combination, improve patients’ AF decision-making experience compared to usual care? Methods: A cluster randomized multi-center trial in patients with AF comparing usual care (no DA) vs. one DA (EDA or PDA) or both DAs. Clinicians and patients were randomized independently into 4 study arms. Clinicians were randomized to use or not use the EDA for all study visits, and patients were randomized to use or not use the PDA. Co-primary outcome domains were: (1) quality of SDM (2) patient knowledge, and (3) decisional conflict. Secondary outcomes included: (1) treatment choice, (2) treatment initiation, and (3) treatment persistence. Patient characteristics were assessed. We will present comparisons of the randomized DAs on the co-primary and secondary outcomes and subgroup analyses. Results: Between December 2020-July 2023, investigators in 6 U.S. healthcare systems enrolled 1117 patients (mean (M) age 69, 63% male, 89% White) and 107 clinicians. Compared to usual care (no DA, M=31.6), SDM was better in patients receiving PDA (M=35.4) and EDA (44.5) alone or together (M=43.7; p’s<0.001). Knowledge about AF was greatest for those receiving both DAs or the PDA alone (84% accurate responses for PDA and both vs 76% with no DA, p<0.001), followed closely by the EDA alone (82%, p=0.003). Finally, both DAs (M=19.5) and EDA alone (M=20.0) had better decisional conflict scores compared to usual care (M=25.8; p’s<0.001). We will present analyses that assess the impact of DAs on secondary outcomes and interactions with DA, patient, and clinical characteristics across each outcome. Conclusions: In one of the first randomized trials examining the comparative effectiveness of EDAs and PDAs on SDM in clinical medicine, both PDAs and EDAs improved shared decision-making, decisional conflict, and knowledge compared to patients receiving usual care.