Surveillance Monitoring as an Alternative to Telemetry

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the impact of surveillance monitoring versus telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative outcomes.

Detailed Description
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This will be single-center, prospective, pilot, pre/post implementation study to collect post-market data on hospitalized subjects monitored via telemetry and surveillance monitoring

Official Title
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A Prospective Evaluation of Surveillance Monitoring as an Alternative to Telemetry in Patients Scheduled for Telemetry Without American Heart Association (AHA) Indication

Conditions
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Telemetry, Patient Monitoring

Intervention / Treatment
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* Device: Vital Sync IM & VPMP (Surveillance Monitoring)
* Device: Telemetry Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent by subject Male or female 18 years of age or older Expected hospitalized admission on the general care floor or medical surgical unit for at least one overnight stay and/or > 12 hours Scheduled for telemetry monitoring Diagnosis indicates American Heart Association (AHA) telemetry Class III or none and therefore not indicated for telemetry monitoring For surveillance monitoring group subjects, treating provider who scheduled subject for telemetry agrees to alternative monitoring plan of surveillance monitoring Willingness to have study devices attached and hair shaved at sensor location as needed during study participation Willingness to participate in all aspects of the study Exclusion Criteria: Implanted pacemaker or atrial defibrillator Allergy or sensitivity to ECG leads or adhesives that are similar to ECG leads Current AHA Class I or II indication/prescription for telemetry monitoring Prescription for other continuous condition monitoring such as capnography or pulse oximetry Ongoing opioid therapy by patient-controlled analgesia (PCA), by epidural or intrathecal infusions or by intravenous analgesia, per Investigator discretion Ventilated or intubated patients at the time of enrollment Female subject is pregnant, lactating, trying to get pregnant, or has a positive pregnancy test for women with childbearing potential Condition that, in the opinion of the investigator, may prevent completion of the study or protocol requirements Subject is considered as being morbidly obese (defined as BMI >50.0)

Ages Eligible for Study
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Minimum Age: 18 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Telemetry Monitoring Arm<br>The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols. | Device: Telemetry Monitoring<br>* Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.<br>|
| Experimental: Surveillance Monitoring Arm<br>Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform. | Device: Vital Sync IM & VPMP (Surveillance Monitoring)<br>* The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay (LOS) as Assessed by Review of Medical Records | LOS will be determined by comparing LOS Between the Surveillance Monitoring and Telemetry Monitoring Period Arms. | Baseline to end of hospital stay (or up to 30 day post enrollment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associated Health Care Costs (HCC) as Determined by Review of Billing Records | Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms | Baseline to end of hospital stay (or up to 30 days post enrollment) | 
| Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records | Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms. | Baseline to end of hospital stay (or up to 30 days post enrollment) | 
| Length of Stay (LOS) in the ICU as Determined by Review of Medical Records | Length of Stay in the ICU will be determined by comparing numbers between monitoring arms. | Baseline to end of hospital stay (or up to 30 days post enrollment) | 
| Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records | CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms. | Baseline to end of hospital stay (or up to 30 days post enrollment) | 
| Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only | Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm) | Baseline to end of hospital stay (or up to 30 days post enrollment) | 
| Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires | Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms. | Baseline to end of hospital stay (or up to 30 days post enrollment) | 
| Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires | Number of clinicians very familiar and somewhat familiar with AHA guidelines was reported. The questionnaire was administered to all clinicians (e.g. ED physicians, nurses, critical care nurses, intensivists, and hospitalists) involved in the care of study participants at each hospital; it was not administered to study subjects. | Baseline to end of hospital stay (or up to 30 days post enrollment) |