Translating Individual-level Risks and Preferences Into Personalized Blood Pressure Target Decisions

University Of California At Davis, Davis CA

Investigators

Abstract

PROJECT SUMMARY Simon Ascher, MD, MPH is establishing himself as a clinical investigator in patient-oriented research that focuses on individualizing clinical decision-making in hypertension. This K23 award will provide the necessary training for Dr. Ascher to successfully transition to an independent investigator and achieve the following goals: 1) develop expertise in advanced statistical methods for predicting individualized treatment effects from clinical trials; 2) acquire essential knowledge and skills in using surveys to quantify patient preferences; 3) obtain hands-on experience in developing patient decision aids embedded in the electronic health record (EHR); and 4) gain proficiency in designing and conducting behavioral clinical trials. Dr. Ascher has assembled a mentorship team led by his co-primary mentors, Dr. Richard Kravitz, an established leader in doctor-patient communication and heterogeneous treatment effects; and Dr. Michael Shlipak, an internationally renowned researcher in kidney and cardiovascular disease epidemiology, and comprised of co-mentors and advisors who provide complementary expertise in advanced biostatistics methods, health preferences, digital health, and clinical trials. Hypertension affects nearly half of all U.S. adults, yet optimal blood pressure (BP) targets continue to be heavily debated and poorly implemented. The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated among non-diabetic individuals that intensive BP treatment reduces CVD events and deaths, but also increases serious adverse events. The broad application of SPRINT could have enormous public health impact, but well-documented heterogeneity in risks and preferences requires individualized decision-making. Building on Dr. Ascher's KL2-supported work, the current proposal aims to develop a personalized approach to BP targets by combining several powerful strategies: individualized risk prediction for multiple outcomes, calibration of the benefits and harms from BP treatment according to patient preferences, and use of a BP target decision aid to guide shared decision-making. In Aim 1, he will refine models in SPRINT that predict for each outcome an individual's change in absolute risk with intensive versus standard BP lowering and then seek external validation in the Action to Control Cardiovascular Risk in Diabetes Blood Pressure (ACCORD BP) trial. In Aim 2, he will use an instrument he previously developed to characterize the variation in patient preferences for BP treatment outcomes, and to identify a limited set of patient clusters with similar preferences. In Aim 3, he will first develop an interactive BP target decision aid embedded in the EHR that translates a patient's risks and preferences into a personalized BP target recommendation; he will then evaluate the decision aid's feasibility in a pilot trial. The proposed plans are realistic and feasible within the 5- year award period, and will lay the groundwork to pursue funding to conduct a large-scale trial of the BP target decision aid. In addition, Dr. Ascher will have acquired the skills and experience necessary to achieve his career goal of becoming a leader and innovator in efforts to individualize CVD prevention strategies.