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

Mayo Clinic

Status: Completed

Conditions: Remote Monitoring

Treatments: Other: No Monitor; Device: Snap40 Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03800329

17-008249

Details and patient eligibility

About

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 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.

Enrollment: 50 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Snap40 Monitor

Active Comparator group

Description:

Patients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital.

Treatment:

Device: Snap40 Monitor

No Monitor

Placebo Comparator group

Description:

Patients randomly assigned to not wear the Snap40 monitor will continue with their follow-up surgical care in the ordinary fashion.

Treatment:

Other: No Monitor