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

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03800329
Collaborator
Snap40 Ltd. (Other)
50
1
2
43.7
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Snap40 Monitor
  • Other: No Monitor
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Use of Remote Monitoring to Improve Physician Monitoring, Patient Satisfaction, and Predict Readmissions Following Cardiac Surgery
Actual Study Start Date :
Mar 7, 2018
Actual Primary Completion Date :
Oct 26, 2021
Actual Study Completion Date :
Oct 26, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Physician satisfaction in the use of remote monitoring technology. [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 Outcome Measures

  1. Patient satisfaction in the use of remote monitoring technology. [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.

Other Outcome Measures

  1. Algorithms useful in prediction of readmission following cardiac surgery [48 hours]

    Measure data collected via machine learning algorithms to predict readmission following cardiac surgery in patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • Snap40 Ltd.

Investigators

  • Principal Investigator: Jordan D Miller, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Jordan D. Miller, Ph.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03800329
Other Study ID Numbers:
  • 17-008249
First Posted:
Jan 11, 2019
Last Update Posted:
Nov 3, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 3, 2021