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Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial.
Abstract IMPACT-AFib was an 80,000-patient randomized clinical trial implemented by five US insurance companies (health plans) aimed at increasing the use of oral anticoagulants by individuals with atrial fibrillation who were at high risk of stroke and not on treatment. The underlying thesis was that patients could be change agents to initiate prescribing discussions with their providers. We tested the effect of mailing information to both patients and their providers. We used administrative medical claims and pharmacy dispensing data to identify eligible patients, to randomize them to an early or delayed interve...
Source: Clinical Trials - June 25, 2020 Category: Research Authors: Garcia CJ, Haynes K, Pokorney SD, Lin ND, McMahill-Walraven C, Nair V, Parlett L, Martin D, Al-Khalidi HR, McCall D, Granger CB, Platt R, Cocoros NM Tags: Clin Trials Source Type: research

Early Adoption of Dabigatran and Its Dosing in US Patients With Atrial Fibrillation: Results From the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation Health Services and Outcomes Research
Conclusions Patients receiving dabigatran were younger and at a lower risk of stroke and bleeding. Patients appeared to drive switching from warfarin, whereas clinical characteristics influenced de novo start of dabigatran. These data suggest cautious early uptake of dabigatran, and more careful attention to dosing adjustments is warranted. Clinical Trial Registration URL: Clinicaltrials.gov. Unique identifier: NCT01165710.
Source: JAHA:Journal of the American Heart Association - November 25, 2013 Category: Cardiology Authors: Steinberg, B. A., Holmes, D. N., Piccini, J. P., Ansell, J., Chang, P., Fonarow, G. C., Gersh, B., Mahaffey, K. W., Kowey, P. R., Ezekowitz, M. D., Singer, D. E., Thomas, L., Peterson, E. D., Hylek, E. M., The Outcomes Registry for Better Informed Treatme Tags: Health Services and Outcomes Research Source Type: research