Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation

Abstract

; for the Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators IMPORTANCE Shared decision-making (SDM) about anticoagulant treatment in patients with atrial fibrillation (AF) is widely recommended but its effectiveness is unclear. OBJECTIVE To assess the extent to which the use of an SDM tool affects the quality of SDM and anticoagulant treatment decisions in at-risk patients with AF. DESIGN, SETTING, AND PARTICIPANTS This encounter-randomized trial recruited patients with nonvalvular AF who were considering starting or reviewing anticoagulant treatment and their clinicians at academic, community, and safety-net medical centers between January 30, 2017 and June 27, 2019. Encounters were randomized to either the standard care arm or care that included the use of an SDM tool (intervention arm). Data were analyzed from August 1 to November 30, 2019. INTERVENTIONS Standard care or care using the Anticoagulation Choice Shared Decision Making tool (which presents individualized risk estimates and compares anticoagulant treatment options across issues of importance to patients) during the clinical encounter. MAIN OUTCOMES AND MEASURES Quality of SDM (which included quality of communication, patient knowledge about AF and anticoagulant treatment, accuracy of patient estimates of their own stroke risk [within 30% of their estimate], decisional conflict, and satisfaction), decisions made during the encounter, duration of the encounter, and clinician involvement of patients in the SDM process. RESULTS The clinical trial enrolled 922 patients (559 men [60.6%]; mean [SD] age, 71 [11] years) and 244 clinicians. A total of 463 patients were randomized to the intervention arm and 459 patients to the standard care arm. Participants in both arms reported high communication quality, high knowledge, and low decisional conflict, demonstrated low accuracy in their risk perception, and would similarly recommend the approach used in their encounter. Clinicians were significantly more satisfied after intervention encounters (400 of 453 encounters [88.3%] vs 277 of 448 encounters [61.8%]; adjusted relative risk, 1.49; 95% CI, 1.42-1.53). A total of 747 of 873 patients (85.6%) chose to start or continue receiving an anticoagulant medication. Patient involvement in decision-making (as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale) scores were significantly higher in the intervention arm (mean [SD] score, 33.0 [10.8] points vs 29.1 [13.1] points, respectively; adjusted mean difference, 4.2 points; 95% CI, 2.8-5.6 points). No significant between-arm difference was found in encounter duration (mean [SD] duration, 32 [16] minutes in the intervention arm vs 31 [17] minutes in the standard care arm; adjusted mean between-arm difference, 1.1; 95% CI, −0.3 to 2.5 minutes). CONCLUSION AND RELEVANCE The use of an SDM encounter tool improved several measures of SDM quality and clinician satisfaction, with no significant effect on treatment decisions...

Shared Decision Making Tools for People Facing Stroke Prevention Strategies in Atrial Fibrillation: A Systematic Review and Environmental Scan

“…In summary, knowledge was evaluated and found significantly improved with the use of SDM tools in 5 studies. One of the trials 48 reported minimal change in knowledge probably due to nearly optimal levels at baseline. Five studies reported low decisional conflict immediately postintervention (9–19 out of 100 points).…”

“…Table 1 and Supplementary Material 5 describe the 14 included SDM tools. 31 – 55 All but 2 were in English; the mAF app 42 was in Chinese and MATCh AFib 43 , 44 in Portuguese. When examining their intended use, 3 were patient decision aids, 5 were encounter tools, 4 had features of both, and 2 were not classifiable because of either lack of information or access to the tool itself.…”

“…Six studies, including 2 randomized trials 42 , 48 and 4 nonrandomized studies, 34 , 43 , 53 , 55 at high risk of bias reported the effect of SDM tools on SDM outcomes ( Table 2 and Supplementary Material 6 ).…”

“…Twelve decision aids met more than 50% of the IPDAS items (Figure 2). The top-rated tools were PtDA, [51][52][53] Anticoagulation Choice, [45][46][47][48] Don't Wait to Anticoagulate, 38 and PDA, 55 which met .70% of all IPDAS items. PtDA was the only tool that assessed for readability.…”

“…Five studies reported low decisional conflict immediately postintervention (9-19 out of 100 points). 34,43,48,53,55 The only study that reported preintervention scores demonstrated a large effect associated with the intervention. 34 Quality of life was evaluated in only 1 randomized trial, which had substantial between-arm imbalance at baseline.…”