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 trial

Abstract

Background: Chronic 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. Methods: The 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