Surveillance Monitoring as an Alternative to Telemetry

Not Applicable

Terminated

• Conditions: Patient Monitoring; Telemetry
• Interventions: Device: Telemetry Monitoring; Device: Vital Sync IM & VPMP (Surveillance Monitoring)

• Registration Number: NCT03039738
• Lead Sponsor: Medtronic - MITG

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Study Start: 2017-04-03
• Primary Completion: 2018-01-04
• Study Completion: 2018-01-04
• Results First Submitted: 2018-12-07
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-03
• Results First Posted: 2019-04-29
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 206

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemetry Monitoring Arm	Telemetry Monitoring	The telemetry group will serve as the control group and will be monitored via the site's standard of care telemetry protocols.
Surveillance Monitoring Arm	Vital Sync IM & VPMP (Surveillance Monitoring)	Subjects in the surveillance monitoring group will alternatively be admitted to medical surgical unit and be monitored via the surveillance monitoring platform.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Associated Health Care Costs (HCC) as Determined by Review of Billing Records	Baseline to end of hospital stay (or up to 30 days post enrollment)	Health Care Costs will be determined by comparing HCC between the surveillance monitoring and telemetry monitoring arms
Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records	Baseline to end of hospital stay (or up to 30 days post enrollment)	Hospital Unit Transfers (HUT) will be determined by comparing the number of hospital unit transfers between monitoring arms.
Length of Stay (LOS) in the ICU as Determined by Review of Medical Records	Baseline to end of hospital stay (or up to 30 days post enrollment)	Length of Stay in the ICU will be determined by comparing numbers between monitoring arms.
Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records	Baseline to end of hospital stay (or up to 30 days post enrollment)	CI include Rapid Response Team calls and Code Blue Activations. The Number of Clinical Interventions will be determined by comparing numbers between monitoring arms.
Time of Rapid Response Team Activation to Time of a Threshold Notification as Measured by the Surveillance Monitoring System Only	Baseline to end of hospital stay (or up to 30 days post enrollment)	Time of Rapid Response Team (RRT) will be determined by comparing the number of RRT interventions between monitoring arms (only for surveillance monitoring arm)
Clinical Team and Patient Satisfaction as Measured by Qualitative Questionnaires	Baseline to end of hospital stay (or up to 30 days post enrollment)	Clinical Team and Patient Satisfaction will be determined by comparing the Qualitative Questionnaire response between monitoring arms.
Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires	Baseline to end of hospital stay (or up to 30 days post enrollment)	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.

Trial Locations

Locations (1)

Washington University in Saint Louis; 🇺🇸 Saint Louis, Missouri, United States