Randomized controlled trial of a coordinated care intervention to improve risk factor control after stroke or transient ischemic attack in the safety net: Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities (SUCCEED).

BackgroundRecurrent strokes are preventable through awareness and control of risk factors such as hypertension, and through lifestyle changes such as healthier diets, greater physical activity, and smoking cessation. However, vascular risk factor control is frequently poor among stroke survivors, particularly among socio-economically disadvantaged blacks, Latinos and other people of color. The Chronic Care Model (CCM) is an effective framework for multi-component interventions aimed at improving care processes and outcomes for individuals with chronic disease. In addition, community health workers (CHWs) have played an integral role in reducing health disparities; however, their effectiveness in reducing vascular risk among stroke survivors remains unknown. Our objectives are to develop, test, and assess the economic value of a CCM-based intervention using an Advanced Practice Clinician (APC)-CHW team to improve risk factor control after stroke in an under-resourced, racially/ethnically diverse population.Methods/designIn this single-blind randomized controlled trial, 516 adults (≥40 years) with an ischemic stroke, transient ischemic attack or intracerebral hemorrhage within the prior 90 days are being enrolled at five sites within the Los Angeles County safety-net setting and randomized 1:1 to intervention vs usual care. Participants are excluded if they do not speak English, Spanish, Cantonese, Mandarin, or Korean or if they are unable to consent. The intervention includes a minimum of three clinic visits in the healthcare setting, three home visits, and Chronic Disease Self-Management Program group workshops in community venues. The primary outcome is blood pressure (BP) control (systolic BP <130 mmHg) at 1 year. Secondary outcomes include: (1) mean change in systolic BP; (2) control of other vascular risk factors including lipids and hemoglobin A1c, (3) inflammation (C reactive protein [CRP]), (4) medication adherence, (5) lifestyle factors (smoking, diet, and physical activity), (6) estimated relative reduction in risk for recurrent stroke or myocardial infarction (MI), and (7) cost-effectiveness of the intervention versus usual care.DiscussionIf this multi-component interdisciplinary intervention is shown to be effective in improving risk factor control after stroke, it may serve as a model that can be used internationally to reduce race/ethnic and socioeconomic disparities in stroke in resource-constrained settings.Trial registrationClinicalTrials.gov Identifier NCT01763203

998-119 Should We Worry About the Hypercholesterolemic Effects of Anti-Hypertensive Medications?

Several large studies have demonstrated improved morbidity and mortality with lowering of blood pressure (BP) in hypertension (HTN). The drugs which have been shown to lower BP and cardiovascular (CV) risk are beta blocking agents and thiazide diuretics. In spite of the documented benefit from the use of these agents, there is a tendency among some physicians to avoid these two classes of drugs when treating HTN. One of the reasons quoted is that both of these classes of drugs increase cholesterol levels, which is postulated to negate the CV risk reduction afforded by BP lowering. This study was undertaken to determine the magnitude of benefit from the lowering of BP with these drugs and compare it with the expected loss of benefit due to increased cholesterol levels with these drugs. A decision analysis was constructed utilizing a new life expectancy (LE) function. L1FESPANS (Lagrange Interpolated Functions of Empirical Survival Percentages Approximated by NEVADA Simulations) is designed to individualize mortality prediction utilizing mortality data from the National Center for Health Statistics and numerous large epidemiological studies. Modifiable factors which are included in this model to assist in the survival prediction include: age, sex, race, BP cholesterol level, current smoking history, and body mass index. For the initial analysis, a 10% reduction in BP with a 5% increase in absolute cholesterol level with these agents was assumed. Sensitivity analyses were performed for a wide range of initial BPs, cholesterol levels and smoking history. Reduction of BP with either of these agents resulted in 1–5 years of additional LE depending on baseline conditions. Significant increases in LE were predicted even in the elderly. A 5% rise in cholesterol, in contrast, was associated with a 0.0–0.6 year decrease in LE. The reduction in LE for increased cholesterol was at most 28% of the increase in LE due to BP lowering. Women had a slightly greater reduction of LE from increased cholesterol In conclusion, without taking the other metabolic effects of these agents into consideration, the increase in CV risk due to the small predicted increase in cholesterol only partially negates the benefits of BP lowering. These predictions are based on studies utilizing high dose (50–100mg) diuretics. Lower doses will have even less effect on lipid profiles and the negative LE changes in hypertensive patients

Derivation and Application of a Tool to Estimate Benefits from Multiple Therapies That Reduce Recurrent Stroke Risk

© 2020 BMJ Publishing Group. All rights reserved. Background and Purpose - Lowering blood pressure and cholesterol, antiplatelet/antithrombotic use, and smoking cessation reduce risk of recurrent stroke. However, gaps in risk factor control among stroke survivors warrant development and evaluation of alternative care delivery models that aim to simultaneously improve multiple risk factors. Randomized trials of care delivery models are rarely of sufficient duration or size to be powered for low-frequency outcomes such as observed recurrent stroke. This creates a need for tools to estimate how changes across multiple stroke risk factors reduce risk of recurrent stroke. Methods - We reviewed existing evidence of the efficacy of interventions addressing blood pressure reduction, cholesterol lowering, antiplatelet/antithrombotic use, and smoking cessation and extracted relative risks for each intervention. From this, we developed a tool to estimate reductions in recurrent stroke risk, using bootstrapping and simulation methods. We also calculated a modified Global Outcome Score representing the proportion of potential benefit (relative risk reduction) achieved if all 4 individual risk factors were optimally controlled. We applied the tool to estimate stroke risk reduction among 275 participants with complete 12-month follow-up data from a recently published randomized trial of a healthcare delivery model that targeted multiple stroke risk factors. Results - The recurrent stroke risk tool was feasible to apply, yielding an estimated reduction in the relative risk of ischemic stroke of 0.36 in both the experimental and usual care trial arms. Global Outcome Score results suggest that participants in both arms likely averted, on average, 45% of recurrent stroke events that could possibly have been prevented through maximal implementation of interventions for all 4 individual risk factors. Conclusions - A stroke risk reduction tool facilitates estimation of the combined impact on vascular risk of improvements in multiple stroke risk factors and provides a summary outcome for studies testing alternative care models to prevent recurrent stroke. Registration - URL: https://www.clinicaltrials.gov; Unique identifier: NCT00861081