The Cascade Feasibility Pilot (HF) Phase 3
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The study proposal is to deploy a wearable solution that predicts physiological perturbation
      comparable to invasive devices and to perform continuous remote patient monitoring; this will
      be connected to a structured, cascading, escalation pathway involving home health nurses,
      advanced practitioner providers, and heart failure specialists, and has the potential to
      transform heart failure management in the post-discharge period, where patients are the most
      vulnerable for readmission. This feasibility study will contribute to the understanding of
      post-discharge heart failure continuous remote patient monitoring, promote patient self-care,
      and has the potential of improving patient outcomes.
    

Detailed description: 
      Heart failure is a leading cause of hospital readmission. It results in significant
      mortality, morbidity, and health care utilization. Effective continuous remote patient
      monitoring (CRPM) can reduce readmissions, but it has only been realized via invasive
      monitoring. The study will focus on non-invasive heart failure CRPM through a structured
      cascading and escalating alert system. In this feasibility study, the study team will use a
      wearable biosensor and collect ambulatory physiological data that are analyzed by machine
      learning algorithms, potentially identifying physiological perturbation in heart failure
      patients. Alerts from this algorithm may be cascaded with other patient status data to inform
      management by the home health team via a structured protocol. The escalation pathway will
      engage home health, advanced practitioner providers, and heart failure specialists. In the
      first aim, the study team will perform a soft launch on five patients with an extensive
      evaluation to assess feasibility for the pilot trial. In aim 2, the study team will implement
      the feasibility pilot study. In aim 2a, the study team will conduct surveys and
      semi-structured interviews with both providers and patients. The surveys and interviews will
      be applied at three time points (initiation, maintenance, and post-study) to evaluate
      perceptions, acceptance, and experience of this CRPM solution. In aim 2b, the investigators
      will leverage temporal data mining, feature extraction, and patient clustering methods to
      identify valid patterns associated with the pathophysiological events of interest, using
      continuous physiological data, patient reports, and electronic health record data. The study
      team will also compare outcome and process measures from our pilot study to a retrospective
      cohort matched for key demographics and disease severity. This feasibility study will provide
      key learning for a larger efficacy clinical trial to evaluate if this non-invasive
      telemonitoring solution tied to structured patient management via cascading and escalating
      alert pathways can improve outcomes and reduce heart failure readmission.
    

Intervention name(s): Non-invasive continuous remote monitoring with structured escalation pathway; Affective Analysis of Participant Response to Continuous Remote Patient Monitoring
Intervention type(s): Other; Other
Intervention description(s): Continuous patient monitoring through non-invasive biosensors coupled with machine learning algorithms, with a structured escalation and communication pathway for home health providers and HF care team; Surveys and interviews with enrolled participants
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research