Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Surgery

Overview

This study is designed to determine the perceived value of continuous remote monitoring to surgeons and surgical patients at Mayo Clinic in Rochester, MN, and determine whether algorithms can be generated to predict risk of readmission following discharge. This initial study will be conducted through the Department of Cardiovascular Surgery.

Full Title of Study: “Use of Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Cardiac Surgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 26, 2021

Detailed Description

The overall aim of this project is to determine the perceived utility and benefit to use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN. The investigators also aim to determine whether machine learning algorithms can predict readmission following cardiac surgery in these patients, which the investigators believe will benefit patients in future studies.

Interventions

  • Device: Snap40 Monitor
    • Non-invasive, wearable armband device used to measure change in systolic blood pressure, respiratory rate, heart rate, body temperature, movement, and oxyhemoglobin saturation and streams this information to a cloud-based storage system. Patients will complete a questionnaire.
  • Other: No Monitor
    • Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire.

Arms, Groups and Cohorts

  • Active Comparator: Snap40 Monitor
    • Patients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital.
  • Placebo Comparator: No Monitor
    • Patients randomly assigned to not wear the Snap40 monitor will continue with their follow-up surgical care in the ordinary fashion.

Clinical Trial Outcome Measures

Primary Measures

  • Physician satisfaction in the use of remote monitoring technology.
    • Time Frame: 48 hours
    • Physician satisfaction survey measure the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN.

Secondary Measures

  • Patient satisfaction in the use of remote monitoring technology.
    • Time Frame: 48 hours
    • Patient satisfaction survey measures the utility and benefit to the use of remote monitoring technology in patients being discharged following cardiac surgery at Mayo Clinic in Rochester, MN.

Participating in This Clinical Trial

Target accrual: 100 patients Subject population (children, adults, groups): adults undergoing coronary bypass surgery at Mayo Clinic in Rochester, MN Inclusion Criteria:

  • Patients undergoing isolated coronary artery bypass graft (CABG) surgery – Must be undergoing the procedure at Mayo Clinic in Rochester, MN – Must be greater than or equal to 40 years of age Exclusion Criteria:

  • Under 40 years of age – Concomitant additional surgical procedure (e.g., CABG + valve replacement) – Patients with implantable pacemakers/defibrillators – Patients that find the device too uncomfortable to wear for 48 hours

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • Snap40 Ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jordan D. Miller, Ph.D., Principal Investigator – Mayo Clinic
  • Overall Official(s)
    • Jordan D Miller, Principal Investigator, Mayo Clinic

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