july 2020 • JAMA

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

Marleen Kunneman, Megan E. Branda, Ian G. Hargraves, et al.

DOI: 10.1001/jamainternmed.2020.2908

Content curated by:David Rodrigues

Key message

Será que em pessoas com fibrilhação auricular, o uso de ferramentas de decisão compartilhada na escolha de anticoagulação afeta a qualidade da tomada de decisão e a seleção de tratamento anticoagulante? Ensaio clínico aleatorizado de 922 pacientes com fibrilhação auricular e 151 médicos. O uso da ferramenta de consulta para decisão partilhada para decisão de anticoagulação resultou em várias melhorias de indicadores de qualidade de tomada de decisão compartilhada e satisfação do médico sem alterar as taxas de tratamento anticoagulante ou a duração do encontro. Estes resultados indicam que o uso de ferramentas para tomada de decisão partilhada na consulta contribui para a decisão de pacientes com fibrilhação auricular que consideram tratamento anticoagulante.

Analysis

Population

Doentes com FA sem tratamento com NOAC (coorte start) ou com tratamento há mais de 6 meses (coorte review)

Method

Ensaio clinico com aleatorização oculta, grupos semalhantes na baseline, não houve ocultação nem de participantes, nem de clínicos mas mais grave, nem de quem avaliava os outcomes. Potencial viés aqui que poderia favorecer a intervenção.Follow-up adequado, análise ITT, bom esforço para uniformizar medida de resultado.

Results

O ensaio clínico envolveu 922 pacientes (559 homens [60,6%]; idade média [DP], 71 [11] anos) e 244 clínicos. 463 pacientes foram aleatorizados para o braço de intervenção e 459 pacientes para o braço controlo. Os participantes de ambos os grupos relataram alta qualidade da comunicação, alto conhecimento e baixo conflito de decisão, demonstraram baixa precisão na percepção de risco e recomendariam da mesma forma a abordagem usada no encontro. Os médicos ficaram significativamente mais satisfeitos após as consultas no braço intervenção (400 de 453 encontros [88,3%] vs 277 de 448 encontros [61,8%]; risco relativo ajustado, 1,49; IC 95%, 1,42-1,53). 747 dos 873 pacientes (85,6%) optou por iniciar ou continuar um fármaco anticoagulante. O envolvimento do doente na tomada de decisão (avaliado por meio de gravações em vídeo dos encontros usando a escala de 12 itens da escala Observing Patient Involvement in Decision Making foi significativamente maior no grupo de intervenção (pontuação média [DP], 33,0 [10,8] pontos versus 29,1 [13,1] pontos, respectivamente; diferença média ajustada, 4,2 pontos; IC95%, 2,8-5,6 pontos). Não foi encontrada diferença significativa entre os braços na duração da consulta (duração média [DP], 32 [16] minutos no braço de intervenção vs 31 [17] minutos no braço controlo; diferença média ajustada entre os braços, 1,1; 95% IC, -0,3 a 2,5 minutos).

Abstract

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 or encounter duration. These results help to calibrate expectations about the value of implementing SDM tools in the care of patients with AF.