Continuous remote patient monitoring in heart failure patients (CASCADE study): mixed methods feasibility protocol (Preprint)

BACKGROUND Heart failure (HF) is a prevalent chronic disease and is associated with increases in mortality and morbidity. HF is a leading cause of hospitalizations and readmissions in the United States. A potentially promising area for preventing HF readmissions is continuous remote patient monitoring (CRPM). OBJECTIVE The primary aim of this study is to determine the feasibility and preliminary efficacy of a CRPM solution on HF patients at NorthShore University HealthSystem (NSUHS). METHODS This study is a feasibility study and will use a wearable biosensor to continuously, remotely monitor HF patients for 30 days post discharge. Eligible patients admitted with a HF exacerbation at NSUHS will be recruited and the wearable biosensor will be placed prior to discharge. The biosensor will collect physiological ambulatory data, which will be analyzed for signs of patient deterioration. Participants will also complete a daily survey through a dedicated study phone. If prespecified criteria from the physiological data and survey results are met a notification will be triggered and a predetermined EHR-based pathway of telephonic management will be completed. In phase I, which has already been completed, five patients were enrolled and monitored for 30 days post-discharge. The results of phase I were analyzed and modifications to the program were made to optimize it. Following analysis of the results from phase I, 15 patients are being enrolled for phase II, which is a calibration and testing period to enable further adjustments to be made. Following phase II, 45 patients will be enrolled for phase III. These results will be analyzed to determine the feasibility of a CRPM program in HF patients. Semi-structured interviews will also be conducted with key stakeholders, including patients, and these results will be analyzed using the Affective Adaptation of the Technology Acceptance Model (A/TAM). RESULTS Phase I has been completed and results have been published. Phase II and phase III results will be available by the end of 2022. CONCLUSIONS A CRPM program may offer a low-risk solution to improve care of HF patients post hospital discharge and may help decrease readmission of HF patients to the hospital. This protocol may also lay the groundwork for the use of CRPM solutions in other high risk patient groups. CLINICALTRIAL NCT04738279