1. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial
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Dragos Vinereanu, Renato D Lopes, M Cecilia Bahit, Denis Xavier, Jie Jiang, Hussein R Al-Khalidi, Wensheng He, Ying Xian, Andrea O Ciobanu, Deepak Y Kamath, Kathleen A Fox, Meena P Rao, Sean D Pokorney, Otavio Berwanger, Carlos Tajer, Pedro G M de Barros e Silva, Mayme L Roettig, Yong Huo, Christopher B Granger, Justo Carbajales, Javier Neri Ceferino Gómez, Mario Bruno Principato, María Alejandra Von Wulffen, Jorge Galperín Rafael Salvador Acunzo, Ricardo Renato Bonato, Natalia Ciampi, Alberto Babil Marani, Cristian Gustavo Panigadi, Silvia Gabriela Pastura, Leonardo Martín Onetto, Cecilia Rafaela Moya, Nadia Budassi, Marisol Valle, Daniel Camerini, Enrique Monjes, Federico Zabala, Juan Pablo Ricart, Luis Medesani, Eduardo Noe Ortuño Campos, Fabián Ferroni, Mariana Foa Torres, Daniel Omar Fassi, Fernando Javier Díaz Bosio, Gabriel Edgardo Pérez Baztarrica, Teresa Zúñiga Infantas, Daniela Perlo, Celso Fernando García, Rubén García Durán, Luisina García Durán, Cecilia Alejandra Pettinari, Marisa Liliana Vico, Paulina Virginia Lanchiotti, Mariela Soledad Gómez, Carlos Alberto Poy, Franco Sebastián Grazziani, Marcela Julieta Laspina, María Laura Poy, María Cecilia Bahit, Marilia García, Renato D. Lopes, Pedro Gabriel Melo de Barros e Silva, Flávia Egydio, Elissa Restelli, Anelise Kawakami, Tamara Colaiácovo Soares, Mayara Vioto Valois, Tauane Bello Duarte, Lilian Mazza Barbosa, Angelo Amato Vicenzo de Paola, Thiago Librelon Pimenta, Gabriela Dal Moro Jeronimo, Bruna S. Fernandes da Costa, Enia Lucia Coutinho, Andressa Zulmira A. Guerrero, Lilia Nigro Maia, Marcelo Arruda Nakazone, Maria Angelica Teixeira Lemos, Osana Maria Coelho Costa, Ana Paula Demore, Roberta Parra Brito, Camila Dal Bon Melo, Nadielly Codonho Góes, Osvaldo Lorenço, Luiz Otavio Maia Gonçalves, Kátia Nishiama, Tiago Aparecido Maschio de Lima, Luciano Marcelo Backes, Keyla Liliana Alves de Lima Deucher, Milena Pozzatto Rodrigues, Dunnia Monisa Baldissera, José Basileu Caos Reolão, Tais Alves dos Santos, Fernanda Michel Birck Freisleben, Níncia Lucca da Silveira Kaross, Jéssika Tzervieczenski Montovani, Maiara Cantarelli, Aline Lucion, Luciano do Amarante, Priscila Foscarini, Claudia de Mello Perez, Fernanda Ribeiro França, Lisa Fialho, Helena Cramer Veiga Rey, Epotamenides Maria Good God, Estêvão Lanna Figueiredo, Gustavo Fonseca Werner, Jose Carlos de Faria Garcia, Bruna Azevedo, Luiz Carlos Vianna Barbosa, Ernaldo Pardi, Márcia Domingos Oliveira, Toshie Martinelli, Roseli Gomes Cavalini, Michele Santos Montoni de Moraes, Adalberto Menezes Lorga Filho, Eduardo Palmegiani, Thiago Baccilli Cury Megid, Clotildes S.P. Queirantes, Thamyres Santini Arroyo Cruz, Pengkang He, Xiaolan Zhou, Na Zhou, Mingzhong Zhao, Juan Yu, Yong Cheng, Lijun Wang, Lili Liu, Shuwang Liu, Lei Li, Aihua Li, Xiaochen Yuan, Guangwei Xia, Zhirong Wang, Chengzong Li, Wensu Chen, Qiang Tang, Qunzhong Tang, Weiting Xu, Xinyi Zhu, Bin Hou, Wenjian Ma, Chongquan Wang, Qiaoyun Jin, Jianan Wang, Xiaojie Xie, Johny Joseph, Deepak Davidson, Joby K. Thomas, Tony V. Kunjumon, Tibin Stephen, Kamlesh Fatania, Gaurav Rathi, Kinjal Garala, Dhruval Doshi, Kiron Varghese, Srilakshmi MA, Lumin Sheeba, Shantha Kumar, Malipeddi Bhaskara Rao, Kodem Damodara Rao, Anjan Kumar Vuriya, Mandula Padma Kumari, Bidita Khandelwal, Mona Dhakal, Nitin Srivastava, Dheeraj Khatri, Shova Moktan, Rajeev Gupta, Sanjeeb Roy, Kapil Kumawat, Mukesh Sharma, K.K. Sharma, Narendra Jathappa, B.H. Lokesh, Shilpa Kariyappa, A.C. Leela, K.C. Someshwara, Soaham Desai, Devangi Desai, Kunj Patel, Sujal Patel, Maulik Bhartiya, Bhupendra Narayan Mahanta, Dibya Jyoti Dutta, Ghanashyam Rajkonwer, Sandeep Kumar Gupta, Ashok Kumar Mishra, Akansha Singh, Naveen Kesarwani, Shivendra Kumar, Ovidiu Chioncel, Adriana Balan, Nicolae Carstea, Gabriel Tatu Chitoiu, Stelian Cornaciu, Mircea Cinteza, Roxana C. Rimbas, Doina Dimulescu, Luminita Ionescu, Ana Fruntelata, Nicoleta Dumitru, Dan Gaita, Roxana Pleava, Adriana Iliesiu, Gabriela Uscoiu, Daniel Lighezan, Roxana Buzas, Crina J. Sinescu, Ana-Maria Avram, Sorina Baldea, Ruxandra Dragoi Galrinho, Stefania L. Magda, and Lavinia Matei
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Male ,medicine.medical_specialty ,China ,MEDLINE ,Argentina ,Administration, Oral ,India ,Hemorrhage ,030204 cardiovascular system & hematology ,law.invention ,Feedback ,Medication Adherence ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Patient Education as Topic ,law ,Risk Factors ,Internal medicine ,Intervention (counseling) ,Atrial Fibrillation ,medicine ,Humans ,030212 general & internal medicine ,Prospective Studies ,Prospective cohort study ,Stroke ,Aged ,business.industry ,Romania ,Anticoagulants ,Atrial fibrillation ,General Medicine ,Odds ratio ,Middle Aged ,medicine.disease ,Drug Utilization ,Stroke prevention ,Physical therapy ,Education, Medical, Continuing ,Female ,business ,Brazil - Abstract
Summary Background Oral anticoagulation is underused in patients with atrial fibrillation. We assessed the impact of a multifaceted educational intervention, versus usual care, on oral anticoagulant use in patients with atrial fibrillation. Methods This study was a two-arm, prospective, international, cluster-randomised, controlled trial. Patients were included who had atrial fibrillation and an indication for oral anticoagulation. Clusters were randomised (1:1) to receive a quality improvement educational intervention (intervention group) or usual care (control group). Randomisation was carried out centrally, using the eClinicalOS electronic data capture system. The intervention involved education of providers and patients, with regular monitoring and feedback. The primary outcome was the change in the proportion of patients treated with oral anticoagulants from baseline assessment to evaluation at 1 year. The trial is registered at ClinicalTrials.gov, number NCT02082548. Findings 2281 patients from five countries (Argentina, n=343; Brazil, n=360; China, n=586; India, n=493; and Romania, n=499) were enrolled from 48 clusters between June 11, 2014, and Nov 13, 2016. Follow-up was at a median of 12·0 months (IQR 11·8–12·2). Oral anticoagulant use increased in the intervention group from 68% (804 of 1184 patients) at baseline to 80% (943 of 1184 patients) at 1 year (difference 12%), whereas in the control group it increased from 64% (703 of 1092 patients) at baseline to 67% (732 of 1092 patients) at 1 year (difference 3%). Absolute difference in the change between groups was 9·1% (95% CI 3·8–14·4); odds ratio of change in the use of oral anticoagulation between groups was 3·28 (95% CI 1·67–6·44; adjusted p value=0·0002). Kaplan-Meier estimates showed a reduction in the secondary outcome of stroke in the intervention versus control groups (HR 0·48, 95% CI 0·23–0·99; log-rank p value=0·0434). Interpretation A multifaceted and multilevel educational intervention, aimed to improve use of oral anticoagulation in patients with atrial fibrillation and at risk for stroke, resulted in a significant increase in the proportion of patients treated with oral anticoagulants. Such an intervention has the potential to improve stroke prevention around the world for patients with atrial fibrillation. Funding Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, and Pfizer.
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- 2017