A novel shared decision-making (SDM) tool for anticoagulation management in atrial fibrillation: protocol for a prospective, cluster randomized controlled trial.
Trials
; 24(1): 623, 2023 Oct 02.
Article
de En
| MEDLINE
| ID: mdl-37779187
ABSTRACT
BACKGROUND:
Atrial fibrillation (AF) is a common arrhythmia that requires anticoagulation therapy to prevent stroke. However, there is still a significant under-/over-treatment in stroke prevention for patients with AF. The adherence and the risk of bleeding associated with oral anticoagulation therapy (OACs) are major concerns. Shared decision-making (SDM) is an approach that involves patients and healthcare providers in making decisions about treatment options. This study aims to assess the effectiveness of a novel SDM tool for anticoagulation management in AF.METHODS:
The study will be a prospective, cluster randomized controlled trial involving 440 patients with AF in 8 community health service centers (clusters) in Shanghai, China. The SDM group will receive anticoagulation management through the novel SDM tool, while the control group will receive standard care. The follow-up period will be at least 2 years. The primary outcome will be any bleeding event, while secondary outcomes include the accordance of stroke prophylaxis for AF according to the current guidelines, time in therapeutic range (TTR), the occurrences of major bleeding and thrombosis events, and patient knowledge, adherence, and satisfaction.DISCUSSION:
This study will provide evidence of the effectiveness of shared decision-making in improving the appropriateness of OAC use in Chinese AF patients. The findings may inform the development of guidelines and policies for the management of AF and anticoagulation therapy in China and other countries. TRIAL REGISTRATION ChiCTR ChiCTR2200062123. Registered on 23 July 2022.Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Fibrillation auriculaire
/
Accident vasculaire cérébral
Type d'étude:
Clinical_trials
/
Diagnostic_studies
/
Guideline
/
Observational_studies
/
Prognostic_studies
/
Qualitative_research
/
Risk_factors_studies
Limites:
Humans
Pays/Région comme sujet:
Asia
Langue:
En
Journal:
Trials
Sujet du journal:
MEDICINA
/
TERAPEUTICA
Année:
2023
Type de document:
Article
Pays d'affiliation:
Chine