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

November 2, 2021 updated by: Jordan D. Miller, Ph.D., Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Snap40 Monitor
Patients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital.
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.
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.
Other: No Monitor
Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Algorithms useful in prediction of readmission following cardiac surgery
Time Frame: 48 hours
Measure data collected via machine learning algorithms to predict readmission following cardiac surgery in patients.
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Snap40 Ltd.

Investigators

  • Principal Investigator: Jordan D Miller, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2018

Primary Completion (Actual)

October 26, 2021

Study Completion (Actual)

October 26, 2021

Study Registration Dates

First Submitted

August 14, 2018

First Submitted That Met QC Criteria

January 8, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2021

Last Update Submitted That Met QC Criteria

November 2, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 17-008249

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Remote Monitoring

Clinical Trials on Snap40 Monitor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe