Patient Monitoring, Telemetry
Conditions
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
Interventions
DEVICEVital 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.
DEVICETelemetry Monitoring
Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.
Sponsors
Medtronic - MITG
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Telemetry Monitoring: Continuous ECG monitoring for hospitalized patients at-risk for cardiac events. | 206 |
| 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.
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. | 0 |
| Total | 206 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incomplete data sets | 54 | 0 |
Baseline characteristics
| Characteristic | Telemetry Monitoring Arm | Total |
|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 15.6 | 55.3 years STANDARD_DEVIATION 15.7 |
| Body Mass Index (BMI) | 28.8 kg/m^2 STANDARD_DEVIATION 9.2 | 28.8 kg/m^2 STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 202 Participants | 202 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Region of Enrollment United States | 152 participants | 134 participants |
| Sex: Female, Male Female | 107 Participants | 107 Participants |
| Sex: Female, Male Male | 99 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 206 | 0 / 0 |
| other Total, other adverse events | 8 / 206 | 0 / 0 |
| serious Total, serious adverse events | 40 / 206 | 0 / 0 |
Outcome results
Primary
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.
Time frame: Baseline to end of hospital stay (or up to 30 day post enrollment)
Population: The study was prematurely terminated; no conclusion should be drawn from the reported data. Data for SM arm were not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemetry Monitoring (TM) Arm | Hospital Length of Stay (LOS) as Assessed by Review of Medical Records | 79.9 hrs | Standard Deviation 73 |
Secondary
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
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Population: The study was prematurely terminated; the billing data for both TM and SM arms were not collected, and outcome measure analysis was not performed.
Secondary
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.
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Population: The patient and clinical team satisfaction questionnaires were designed to be collected for the SM arm only. The study enrolled control arm only prior to termination. The questionnaires were not collected, and no outcome measure analyses were performed.
Secondary
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.
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Population: All clinicians (e.g. ED physicians, nurses, critical care nurses) involved in the care of study participants at each hospital (not study subjects.) The study was prematurely terminated; no conclusion should be drawn from the reported data. The data for SM Arm were not collected, and no outcome measure analyses were performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telemetry Monitoring (TM) Arm | Clinicians Familiarity With AHA Guidelines and Telemetry Utilization as Measured by Qualitative Questionnaires | 118 Participants |
Secondary
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.
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Population: The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data. Only participants who were admitted to ICU, were assessed for this Outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telemetry Monitoring (TM) Arm | Length of Stay (LOS) in the ICU as Determined by Review of Medical Records | 4.4 hrs | Standard Deviation 4.9 |
Secondary
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.
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Population: The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telemetry Monitoring (TM) Arm | Number of Participants With Clinical Interventions (CI) as Determined by Review of Medical Records | 14 Participants |
Secondary
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.
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Population: The study was prematurely terminated; the data for SM Arm were not collected, and no outcome measure analyses were performed. No conclusion should be drawn from the reported data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telemetry Monitoring (TM) Arm | Number of Participants With Hospital Unit Transfers (HUT) as Determined by Review of Medical Records | 143 Participants |
Secondary
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)
Time frame: Baseline to end of hospital stay (or up to 30 days post enrollment)
Population: The study was prematurely terminated; this outcome was for Surveillance Monitoring arm only. The data were not collected, and no outcome measure analysis was performed.