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Randomized Controlled Trial
. 2016 May 26;11(5):e0154832.
doi: 10.1371/journal.pone.0154832. eCollection 2016.

Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial

Pierre-Marie Roy  1 , Antoine Rachas  2 , Guy Meyer  3 , Grégoire Le Gal  4 , Pierre Durieux  5 , Dominique El Kouri  6 , Didier Honnart  7 , Jeannot Schmidt  8 , Catherine Legall  9 , Pierre Hausfater  10 , Jean-Marie Chrétien  11 , Dominique Mottier  4 ; PREVENU study group
Affiliations
Randomized Controlled Trial

Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial

Pierre-Marie Roy et al. PLoS One. .

Abstract

Background: Misuse of thromboprophylaxis may increase preventable complications for hospitalized medical patients.

Objectives: To assess the net clinical benefit of a multifaceted intervention in emergency wards (educational lectures, posters, pocket cards, computerized clinical decision support systems and, where feasible, electronic reminders) for the prevention of venous thromboembolism.

Patients/methods: Prospective cluster-randomized trial in 27 hospitals. After a pre-intervention period, centers were randomized as either intervention (n = 13) or control (n = 14). All patients over 40 years old, admitted to the emergency room, and hospitalized in a medical ward were included, totaling 1,402 (712 intervention and 690 control) and 15,351 (8,359 intervention and 6,992 control) in the pre-intervention and intervention periods, respectively.

Results: Symptomatic venous thromboembolism or major bleeding (primary outcome) occurred at 3 months in 3.1% and 3.2% of patients in the intervention and control groups, respectively (adjusted odds ratio: 1.02 [95% confidence interval: 0.78-1.34]). The rates of thromboembolism (1.9% vs. 1.9%), major bleedings (1.2% vs. 1.3%), and mortality (11.3% vs. 11.1%) did not differ between the groups. Between the pre-intervention and intervention periods, the proportion of patients who received prophylactic anticoagulant treatment more steeply increased in the intervention group (from 35.0% to 48.2%: +13.2%) than the control (40.7% to 44.1%: +3.4%), while the rate of adequate thromboprophylaxis remained stable in both groups (52.4% to 50.9%: -1.5%; 49.1% to 48.8%: -0.3%).

Conclusions: Our intervention neither improved adequate prophylaxis nor reduced the rates of clinical events. New strategies are required to improve thromboembolism prevention for hospitalized medical patients.

Trial registration: ClinicalTrials.gov NCT01212393.

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Conflict of interest statement

Competing Interests: The authors declare having received research grant support from Bayer HealthCare SAS, France and Sanofi SAS, France to perform this study. They declare to have no other support from any organisation for the submitted work; no other financial relationships with any organisations that might have an interest in the submitted work in the previous three years, no other relationships or activities that could appear to have influenced the submitted work. This does not alter the authors’ adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Flow chart.
See this image and copyright information in PMC

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