Surveillance Monitoring as an Alternative to Telemetry

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

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.

Study Overview

• Status: Terminated
• Conditions: Patient Monitoring; Telemetry
• Intervention / Treatment: Device: Telemetry Monitoring; Device: Vital Sync IM & VPMP (Surveillance Monitoring)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University in Saint Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Signed and dated informed consent by subject
2. Male or female 18 years of age or older
3. Expected hospitalized admission on the general care floor or medical surgical unit for at least one overnight stay and/or > 12 hours
4. Scheduled for telemetry monitoring
5. Diagnosis indicates American Heart Association (AHA) telemetry Class III or none and therefore not indicated for telemetry monitoring
6. For surveillance monitoring group subjects, treating provider who scheduled subject for telemetry agrees to alternative monitoring plan of surveillance monitoring
7. Willingness to have study devices attached and hair shaved at sensor location as needed during study participation
8. Willingness to participate in all aspects of the study

Exclusion Criteria:

1. Implanted pacemaker or atrial defibrillator
2. Allergy or sensitivity to ECG leads or adhesives that are similar to ECG leads
3. Current AHA Class I or II indication/prescription for telemetry monitoring
4. Prescription for other continuous condition monitoring such as capnography or pulse oximetry
5. Ongoing opioid therapy by patient-controlled analgesia (PCA), by epidural or intrathecal infusions or by intravenous analgesia, per Investigator discretion
6. Ventilated or intubated patients at the time of enrollment
7. Female subject is pregnant, lactating, trying to get pregnant, or has a positive pregnancy test for women with childbearing potential
8. Condition that, in the opinion of the investigator, may prevent completion of the study or protocol requirements
9. Subject is considered as being morbidly obese (defined as BMI >50.0)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Telemetry Monitoring Arm; 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; Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.
EXPERIMENTAL: Surveillance Monitoring Arm; 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); The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Stacey House, MD, PhD, Washington University in Saint Louis

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 3, 2017
• Primary Completion (ACTUAL): January 4, 2018
• Study Completion (ACTUAL): January 4, 2018

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (ESTIMATE): February 1, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: COVMOPO0561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No