Assessing outcomes of enhanced chronic disease care through patient education and a value-based formulary study ACCESS—study protocol for a 2×2 factorial randomized trialReportar como inadecuado




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Implementation Science

, 11:131

First Online: 26 September 2016Received: 10 August 2016Accepted: 08 September 2016DOI: 10.1186-s13012-016-0491-6

Cite this article as: Campbell, D.J.T., Tonelli, M., Hemmelgarn, B. et al. Implementation Sci 2015 11: 131. doi:10.1186-s13012-016-0491-6

Abstract

BackgroundChronic diseases result in significant morbidity and costs. Although medications and lifestyle changes are effective for improving outcomes in chronic diseases, many patients do not receive these treatments, in part because of financial barriers, patient and provider-level knowledge gaps, and low patient motivation. The Assessing outcomes of enhanced chronic disease care through patient education and a value-based formulary study ACCESS will determine the impact of two interventions: 1 a value-based formulary which eliminates copayment for high-value preventive medications; and 2 a comprehensive self-management support program aimed at promoting health behavior change and medication adherence, combined with relay of information on medication use to healthcare providers, on cardiovascular events and-or mortality in low-income seniors with elevated cardiovascular risk.

MethodsThe ACCESS study will use a parallel, open label, factorial randomized trial design, with blinded endpoint evaluation in 4714 participants who are over age >65 and therefore have drug insurance provided by Alberta Blue Cross with 30 % co-payment; are at a high risk for cardiovascular events based on a history of any one of the following: coronary heart disease, prior stroke, chronic kidney disease, heart failure, or any two of the following: current cigarette smoking, diabetes mellitus, hypertension, or hypercholesterolemia; and have a household income
DiscussionGiven identified gaps in care in chronic disease, and the frequency of financial and knowledge-related barriers in low-income Albertans, this study will test the impact of providing free high-value preventive medications i.e., value-based insurance and a tailored self-management education and facilitated relay strategy on outcomes and costs. By measuring the impact on both health outcomes and costs, as well as the impact on reducing health inequities in this vulnerable population, our study will facilitate informed policy decisions.

Trial registrationClinicaltrials.gov: NCT02579655. Registered Oct 15, 2015.

KeywordsRandomized clinical trial Chronic disease Cost Education Drug insurance Electronic supplementary materialThe online version of this article doi:10.1186-s13012-016-0491-6 contains supplementary material, which is available to authorized users.

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Autor: David J. T. Campbell - Marcello Tonelli - Brenda Hemmelgarn - Chad Mitchell - Ross Tsuyuki - Noah Ivers - Tavis Campbell

Fuente: https://link.springer.com/







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