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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Remote Monitoring

Intervention / Treatment
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* Device: Snap40 Monitor
* Other: No Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Snap40 Monitor<br>Patients randomly assigned to wear the Snap40 monitor will wear the device for 48 hours following discharge from the hospital. | Device: Snap40 Monitor<br>* 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.<br>|
| Placebo Comparator: No Monitor<br>Patients randomly assigned to not wear the Snap40 monitor will continue with their follow-up surgical care in the ordinary fashion. | Other: No Monitor<br>* Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician satisfaction in the use of remote monitoring technology. | 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. | 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 |