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A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial.

Publication ,  Journal Article
Vinereanu, D; Lopes, RD; Bahit, MC; Xavier, D; Jiang, J; Al-Khalidi, HR; He, W; Xian, Y; Ciobanu, AO; Kamath, DY; Fox, KA; Rao, MP; Tajer, C ...
Published in: Lancet
October 14, 2017

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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Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

October 14, 2017

Volume

390

Issue

10104

Start / End Page

1737 / 1746

Location

England

Related Subject Headings

  • Stroke
  • Romania
  • Risk Factors
  • Prospective Studies
  • Patient Education as Topic
  • Middle Aged
  • Medication Adherence
  • Male
  • India
  • Humans
 

Citation

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Vinereanu, D., Lopes, R. D., Bahit, M. C., Xavier, D., Jiang, J., Al-Khalidi, H. R., … IMPACT-AF investigators, . (2017). A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet, 390(10104), 1737–1746. https://doi.org/10.1016/S0140-6736(17)32165-7
Vinereanu, Dragos, Renato D. Lopes, M Cecilia Bahit, Denis Xavier, Jie Jiang, Hussein R. Al-Khalidi, Wensheng He, et al. “A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial.Lancet 390, no. 10104 (October 14, 2017): 1737–46. https://doi.org/10.1016/S0140-6736(17)32165-7.
Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, et al. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Oct 14;390(10104):1737–46.
Vinereanu, Dragos, et al. “A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial.Lancet, vol. 390, no. 10104, Oct. 2017, pp. 1737–46. Pubmed, doi:10.1016/S0140-6736(17)32165-7.
Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, He W, Xian Y, Ciobanu AO, Kamath DY, Fox KA, Rao MP, Pokorney SD, Berwanger O, Tajer C, de Barros E Silva PGM, Roettig ML, Huo Y, Granger CB, IMPACT-AF investigators. A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet. 2017 Oct 14;390(10104):1737–1746.
Journal cover image

Published In

Lancet

DOI

EISSN

1474-547X

Publication Date

October 14, 2017

Volume

390

Issue

10104

Start / End Page

1737 / 1746

Location

England

Related Subject Headings

  • Stroke
  • Romania
  • Risk Factors
  • Prospective Studies
  • Patient Education as Topic
  • Middle Aged
  • Medication Adherence
  • Male
  • India
  • Humans