An International Multicenter cluster randomized controlled trial to imProve treatment with AntiCoagulanTs in patients with atrial fibrillation.
a) Background
IMPACT AF is an international quality improvement cluster randomized trial to improve the care of patients with atrial fibrillation to prevent strokes. The goals are to improve the knowledge of care providers and patients, to increase the proportion of eligible patients who receive oral anticoagulation (any oral anticoagulant prescribed by the treating physician), and to increase the proportion of patients who remain on treatment for at least one year. These quality improvement interventions will be directed at the system level, physician and patient.
Atrial fibrillation is an important cause of stroke in India and the ReLY AF registry demonstrated poor rates of INR control in South Asian patients, increasing the risk of stroke. Quality improvement interventions optimizing oral anticoagulation in atrial fibrillation patients may reduce the risk of stroke. These interventions if proven useful in this study, can be scaled up for nationwide use. Such a quality improvement study to prevent strokes in atrial fibrillation patients has not been done in India.
b) Objectives:
• To assess country specific perceptions, system challenges and barriers to the use of oral anticoagulants in patients with atrial fibrillation.
• To determine if an educational intervention aimed at health systems, physicians treating atrial fibrillation and patients with atrial fibrillation will increase the proportion of eligible patients who are treated with oral anticoagulation and increase patient adherence to oral anticoagulants for 1 year.
c) Methods
This is a two arm, prospective matched pair cluster-randomized controlled trial. The cluster will be a secondary or tertiary care hospital that manages patients with atrial fibrillation. The outcomes will be recorded and adjudicated in a blinded fashion. All analysis will be on an intention-to-treat basis.
Number of Clusters – 10-12 tertiary and secondary care centres. 5-6 of these hospitals will receive multilevel quality of care improvement interventions and 5-6 hospitals will be control sites.
d) Results
The primary outcome, change in the proportion of patients treated with oral anticoagulants from baseline to 1 year, was 12% in the educational group versus 3% in the control group (p = 0.0002).
Secondary outcomes:
Deaths: 5% in the educational group vs. 5% in the control group (p = 0.88)
Strokes: 1% in the educational group vs. 2% in the control group (p = 0.043)
Clinically relevant no major bleeding: 3% in the educational group vs. 3% in the control group (p = 0.43)
e) Total recruitment & no. of sites
Globally 2281 patients were randomised from 6 participating countries to a multifaceted and multilevel educational intervention (n = 1,187) versus usual care (n = 1,094).
494 patients were recruited in India from 10 sites.
f) Conclusion
The IMPACT-AF trial showed that an educational intervention was superior at improving the use of oral anticoagulation therapy.
Among patients with atrial fibrillation, the use of an educational intervention increased the proportion of patients treated with oral anticoagulation therapy. Although not powered for clinical events, the educational group was associated with a reduction in total strokes. This educational program needs to be considered as a mechanism to increase the use of oral anticoagulation therapy.
g) Publication status (Name & year):
American Heart Journal: 2016, The Lancet: 2017
h) Publication link
https://www.sciencedirect.com/science/article/pii/S0002870316000934?via=ihub
https://www.sciencedirect.com/science/article/abs/pii/S0140673617321657
Updated as on: 18 Jul 2022