Jackson, Elizabeth A.

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.

Abstract Objective To evaluate the effectiveness of multiple decision aid strategies in promoting high quality shared decision making for prevention of stroke in patients with non-valvular atrial fibrillation. Design Cluster randomized controlled trial. Setting Six academic medical centers in the United States. Participants Patient participants were aged ≥18 with a diagnosis of non-valvular atrial fibrillation, at risk for stroke (CHA 2 DS 2 -VASc ≥1 for men, ≥2 for women), and scheduled for a clinical appointment to discuss stroke prevention strategies. Participating clinicians were those who manage stroke prevention strategies for participating patients. Intervention Patients were randomized to use a patient decision aid or usual care; clinicians were randomized to use an encounter decision aid or usual care with all participating patients. Main outcome measures Primary outcome measures were quality of shared decision making measured by OPTION12, knowledge of atrial fibrillation and its management, and decisional conflict. Results 1117 participants across six sites were included in the analysis. Compared with usual care, the combined use of both the patient decision aid and the encounter decision aid improved the quality of shared decision making (adjusted mean difference 12.1 (95% confidence interval (CI) 8.0 to 16.2; P<0.001), improved patients’ knowledge (odds ratio 1.68 (95% CI 1.35 to 2.09; P<0.001), and reduced patients’ decisional conflict (adjusted mean difference −6.3 (95% CI −9.6 to −3.1; P<0.001). Statistically significant improvements were also observed with the encounter decision aid alone versus usual care for all three outcomes and with the patient decision aid alone versus usual care for quality of shared decision making and knowledge. No important differences were observed in treatment choices for stroke prevention or in participants’ satisfaction. No statistically significant difference in the length of visit across study groups was detected. Conclusion Patients who received any decision aid (encounter decision aid, patient decision aid, or both) had lower decisional conflict, better shared decision making, and greater knowledge than those receiving no decision aid, except for the effect of the patient decision aid on decisional conflict, which did not reach statistical significance. The study establishes that use of either pre-visit or in-visit decision aids individually or in combination is advantageous compared with usual care. Trial registration ClinicalTrials.gov NCT04357288 .

Introduction: Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear. We assessed the extent to which using an SDM tool promotes high-quality SDM. Hypothesis: SDM will improve communication quality, knowledge, and decisional conflict and will translate to improved medication adherence and outcomes. Methods: In this multicentre encounter-randomized trial, we included patients with nonvalvular AF considering starting/reviewing anticoagulation, and their clinicians. We compared usual care with or without ANTICOAGULATION CHOICE, an SDM conversation tool for use during the clinical encounter that presents individualized risk estimates and compares anticoagulation options across patient important issues. Results: We enrolled and video-recorded 922 patient-clinician encounters. So far, our data have shown that participants in both arms reported near-optimal communication quality, knowledge, and decisional conflict (JAMA IM-2020). Patients in intervention-arm estimated their stroke risks more accurately and were more involved in decision-making (JAMA IM-2020), clinicians were more satisfied (JAMA IM-2020), and cost conversation were more common (JAMA NO-2021). Use of the intervention had no effect on treatment decisions, encounter duration (JAMA IM-2020), treatment adherence, clinical outcomes (JAHA-epub) or patient-perceived sense of the care plan (PEC-epub). New analyses have shown that compared to eligible white participants, black participants more frequently did not enrol to the study. Enrolment of Black, indigenous, and people of colour benefited most form including and prioritizing practices most likely to care for them. We found no evidence of contamination (tool use, functional, or learned) between study arms. Conclusions: Use of an SDM tool improved some measures of SDM quality, without affecting treatment decisions and their sensibility, encounter duration, patient adherence, or clinical outcomes. Our results should calibrate expectations as to what could be accomplished by implementing SDM tools about anticoagulation in the care of patients with AF

Abstract Background: Trial recruitment of Black, indigenous, and people of color (BIPOC) is key for interventions that interact with socioeconomic factors and cultural norms, preferences, and values. We report on our experience enrolling BIPOC participants into a multicenter trial of a shared decision-making intervention about anticoagulation to prevent strokes, in patients with atrial fibrillation (AF). Methods: We enrolled patients with AF and their clinicians in 5 healthcare systems (three academic medical centers, an urban/suburban community medical center, and a safety-net inner-city medical center) located in three states (Minnesota, Alabama, and Mississippi) in the United States. Clinical encounters were randomized to usual care with or without a shared decision-making tool about anticoagulation. Analysis: We analyzed BIPOC patient enrollment by site, categorized reasons for non-enrollment, and examined how enrollment of BIPOC patients was promoted across sites.Results: Of 2247 patients assessed, 922 were enrolled of which 147 (16%) were BIPOC patients. In comparison to trial-eligible White participants, eligible Black participants more frequently did not enroll (102 (11%) vs. 185 (15%); p <.001). The rate of BIPOC patients enrollment varied substantially by site and was generally reflective of the population served at each participating site. Enrollment of BIPOC patients benefited most from including and prioritizing practices most likely to care for BIPOC patients, with lower yield from specific efforts to reach BIPOC clinic attendees and enrolling BIPOC patients first when possible. Conclusions: Enrollment from practices that have implemented policies that favor the care of BIPOC patients can contribute to generate trustworthy estimates of the effect of these interventions in clinical practice that are applicable to BIPOC populations. Best practices to optimize the enrollment of BIPOC participants into trials that examined complex and culturally sensitive interventions remain to be developed.Clinical trial registration: ClinicalTrials.gov (NCT02905032)

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.

Abstract Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation (AF). 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. Purpose We aimed to estimate the extent to which use of an SDM tool affected patient adherence to the decided care plan and clinical safety endpoints. Methods We conducted a multi-center, encounter-level randomized trial assessing the efficacy of UC with vs. without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice, AC) in patients with non-valvular AF considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months post-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 [PDC] for DOAC, and as time in therapeutic range (TTR) for warfarin). We also followed for any safety outcomes (stroke [stroke or transient ischemic attack], major bleeding, or death). Results We enrolled 922 evaluable patient encounters (AC=463, UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary (78% of patients in AC filled their first prescription vs. 81% in UC) or secondary adherence to anticoagulation (see Figure, PDCDOAC was 74.1% in AC vs. 71.6% in UC; TTRwarfarin was 66.6% in AC vs. 64.4% in UC). PDCDOAC was better (65%) in AC than in UC (55%) (OR 1.49, CIs 1.00, 2.22). Safety outcomes, mostly bleeds, occurred in 13% (AC) of and 14% (UC) of participants. Conclusions This is the largest reported randomized trial in AF comparing usual care with and without an SDM tool to promote SDM. Although patients were more actively involved in SDM, we found no significant differences between arms in primary or secondary adherence to anticoagulation or clinical safety outcomes. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The trial was funded by and conducted independently of the National Heart, Lung, and Blood Institute (NHLBI) of the U.S. National Institutes of Health (RO1 HL131535-01). The funding body had no influence on the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Figure 1