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

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 <Can$50,000. This 3-year study is powered to detect a minimal clinically important relative risk reduction of 12 % in the composite clinical outcome of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, need for coronary revascularization, and hospitalizations for chronic disease-related ambulatory care sensitive conditions, each of which will be assessed using healthcare administrative data. Secondary outcomes will include quality of life and healthcare costs.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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-016-0491-6) contains supplementary material, which is available to authorized users.

Insulin resistance, blood glucose and inflammatory cytokine levels are risk factors for cardiovascular events in diabetic patients complicated with coronary heart disease

“…For patients with diabetes mellitus, there is a correlation between the risk of CHD and diabetes-related risk factors such as hyperglycemia, hyperlipidemia, insulin resistance, hyperinsulinemia and other factors ( 8 ), which leads to atherosclerosis and further aggravates the development of the disease ( 9 ). Previous studies have confirmed that the incidence of cardiovascular events in diabetic patients complicated with CHD is related to factors in the patients such as age, obesity, high blood lipids profile, increased blood pressure and other items ( 10 ). However, there is still little known about the association of blood glucose abnormalities, insulin resistance or inflammatory responses of the body with T2DM and CHD.…”

Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis

“…The ACCESS trial is a pragmatic clinical trial in Alberta, Canada, which completed recruitment in August 2018 (ClinicalTrials.gov registration NCT02579655). ACCESS is a factorial (2 × 2) RCT that is evaluating the impact of providing free high-value medications and/or a tailored health education program on patient outcomes and health care costs among seniors at high risk of cardiovascular complications [30]. The free medications intervention involved elimination of patients’ 25% copayments for all medications considered high value in preventing cardiovascular disease (Additional file 1).…”

Exploring patient and pharmacist perspectives on complex interventions for cardiovascular prevention: A qualitative descriptive process evaluation

“…Participants who stated a preference for electronic communication during eligibility screening received regular emails and access to a personalized electronic platform in addition to the mailers. The details of the programme are reported elsewhere, 21 Finally, MOXIE included a facilitated relay intervention whereby patients were sent letters regarding indicated medications, which were tailored based on the information provided at baseline.…”

“…The trial aims to evaluate the impact of two interventions targeting financial barriers and lack of knowledge, among low-income seniors with high CV risk in Alberta, Canada. 21,22 The interventions are as follows: (1) a comprehensive tailored self-management education and support (SMES) programme including facilitated relay of clinical information to participants' health-care providers; and (2) elimination of copayments for select high-value cardioprotective medications (comparing with standard care: copayments of 30% of drug costs, to a maximum of $25/medication/dispensation). We hypothesized that these interventions would result in improved medication adherence and health behaviour changes, ultimately resulting in fewer hospitalizations, CV events and deaths.…”

“…While our interventions were grounded in theory, 21 their successful implementation was essential for changing participant behaviour.…”