Evaluating the Impact of a Web-Based Risk Assessment System (CareSage) and Tailored Interventions on Health Care Utilization: Protocol for a Randomized Controlled Trial.

Background: Soaring health care costs and a rapidly aging population, with multiple comorbidities, necessitates the development of innovative strategies to deliver high-quality, value-based care.

Objective: The goal of this study is to evaluate the impact of a risk assessment system (CareSage) and targeted interventions on health care utilization.

Methods: This is a two-arm randomized controlled trial recruiting 370 participants from a pool of high-risk patients receiving care at a home health agency. CareSage is a risk assessment system that utilizes both real-time data collected via a Personal Emergency Response Service and historical patient data collected from the electronic medical records. All patients will first be observed for 3 months (observation period) to allow the CareSage algorithm to calibrate based on patient data. During the next 6 months (intervention period), CareSage will use a predictive algorithm to classify patients in the intervention group as "high" or "low" risk for emergency transport every 30 days. All patients flagged as "high risk" by CareSage will receive nurse triage calls to assess their needs and personalized interventions including patient education, home visits, and tele-monitoring. The primary outcome is the number of 180-day emergency department visits. Secondary outcomes include the number of 90-day emergency department visits, total medical expenses, 180-day mortality rates, time to first readmission, total number of readmissions and avoidable readmissions, 30-, 90-, and 180-day readmission rates, as well as cost of intervention per patient. The two study groups will be compared using the Student t test (two-tailed) for normally distributed and Mann Whitney U test for skewed continuous variables, respectively. The chi-square test will be used for categorical variables. Time to event (readmission) and 180-day mortality between the two study groups will be compared by using the Kaplan-Meier survival plots and the log-rank test. Cox proportional hazard regression will be used to compute hazard ratio and compare outcomes between the two groups.

Results: We are actively enrolling participants and the study is expected to be completed by end of 2018; results are expected to be published in early 2019.

Conclusions: Innovative solutions for identifying high-risk patients and personalizing interventions based on individual risk and needs may help facilitate the delivery of value-based care, improve long-term patient health outcomes and decrease health care costs.

Trial Registration: ClinicalTrials.gov NCT03126565; https://clinicaltrials.gov/ct2/show/NCT03126565 (Archived by WebCite at http://www.webcitation.org/6ymDuAwQA).