Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards

Study Overview
=================
Brief Summary
-----------------
The primary aim of the current study is to assess the effect of continuous wireless vital signs monitoring with generation of real-time alerts compared to blinded monitoring without alerts on the cumulative duration of any severely deviating vital signs in patients admitted to general hospital wards with acute medical conditions. Patients admitted with medical conditions represents a large and heterogenous group occupying a substantial part of the total in-patient capacity in the Danish hospitals today. The hypothesize is that continuous vital signs monitoring, and real-time alerts will reduce the cumulative duration of severely deviating vital signs.

Detailed Description
-----------------
Deterioration of patients on general hospital wards often goes unnoticed for prolonged periods of time. This delay can potentially result in severe adverse outcomes such as cardiopulmonary arrest and need for admission to the intensive care unit (ICU). These complications occur despite the fact that, in most cases, measurable changes in physiological vital signs, could identify patients at risk. Moreover, occurrence of complications increase treatment costs considerably underpinning the rationale of early detection of patient deterioration in both human and economic terms. Monitoring of vital signs outside of ICU or telemetry units usually relies on intermittent manual assessments performed by clinical staff at intervals of up to 12 hours with the Early Warning Score (EWS), Tidlig Opsporing af Kritisk Sygdom (TOKS) or similar systems. However, significant deterioration may occur in-between these intervals, which may explain the EWS/TOKS score's proven lack of impact on morbidity and mortality in Danish hospitals. Recent medico-technical advances have allowed for clinical use of small wireless wear-and-forget devices that continuously monitor various indices of cardiopulmonary status, ambulatory activity, temperature etc. Studies suggest that integration of continuous monitoring into automated patient surveillance systems more often detects cardiorespiratory instability and may decrease number of Emergency Response Team activations, ICU transfers, length of hospital stay, morbidity and mortality but further randomized controlled trials (RCTs) are needed to confirm this. Other advantages may be a decrease in the time required for vital signs measurement and recording compared to routine monitoring and overall health care cost savings with return-on-investment estimates ranging from 127%-1739%.

Official Title
-----------------
Continuous Wireless Monitoring of Vital Signs and Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards

Conditions
-----------------
Alert Fatigue, Health Personnel, Deterioration, Clinical

Intervention / Treatment
-----------------
* Device: real time alarm of deviating vital signs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion and randomization possible within 12 hours of fulfilling all other inclusion criteria below. Adult patients (≥18 years). At least one (additional) expected overnight stay. High-risk medical admission, defines as EITHER: one or more of the following symptoms or tentative diagnoses: Pneumonia, dyspnea, acute coronary syndrome, new onset heart failure or sepsis WITH two or more of the following deviations in vital signs recorded at one time point within 48 hours of admission: Respiratory rate ≥ 21 min-1 or ≤ 7 min-1 Oxygen saturation of arterial hemoglobin ≤ 93 % Pulse rate ≥ 111 min-1 or ≤ 40 min-1 Systolic blood pressure ≤ 100 mmHg or > 200 mmHg Temperature > 39 °C or ≤ 35,9 °C Any alteration in mental status Any oxygen supplementation OR ○ Discharged from ICU-stay lasting ≥ 24 hours regardless of cause of ICU-admission. Exclusion Criteria: Patient expected not to cooperate with study procedures. Allergy to plaster or silicone. Patients admitted for palliative care only (i.e. no active treatment). Planned admission to unit using continuous vital sign monitoring (i.e. an intermediary care/telemetry unit). Patients previously enrolled in the studies WARD-COPD (H-18026653) or WARD-Surgery (H-17033535). Patients previously enrolled in the surgical ward RCT A pacemaker or Implantable Cardioverter Defibrillator (ICD) device. Inability to give informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention arm<br>Active alarms | Device: real time alarm of deviating vital signs<br>* Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds<br>|
| No Intervention: no intervention<br>No alarms | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge: | ● SpO2 < 85% | 5 days after inclusion or until discharge | 
| Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge: | Respiratory rate ≤ 5 min-1 Respiratory rate > 24 min-1 | 5 days after inclusion or until discharge | 
| Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge: | Heart rate > 130 min-1 Heart rate ≤ 30 min-1 | 5 days after inclusion or until discharge | 
| Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge: | Systolic blood pressure ≤ 90 mmHg Systolic blood pressure > 220 mmHg | 5 days after inclusion or until discharge | 
| Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge: | ● Atrial fibrillation | 5 days after inclusion or until discharge | 
| Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge: | ● Circulatory failure Systolic blood pressure < 100 mmHg AND Heart rate >110 min-1 (for more than 30 minutes) OR heart rate >130 min-1 (for more than 5 minutes) OR heart rate < 50 (for more than 30 minutes) AND/ | 5 days after inclusion or until discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and duration of deviations in vital signs | Frequency of each of the deviations in vital signs. List of vital signs, and normal limits detailed in protocol | 5 days after inclusion or until discharge |