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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Deterioration, Clinical; Alert Fatigue, Health Personnel
• Intervention / Treatment: Device: real time alarm of 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%.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katja K Grønbæk, MD; Phone Number: 0045258781188; Email: katja.kjaer.groenbaek.01@regionh.dk
• Study Contact Backup: Name: Christian S Meyhoff, MD, PhD; Phone Number: 004524910542; Email: christian.sylvest.meyhoff@regionh.dk

Study Locations

• Denmark
  • Region H
    • København NV, Region H, Denmark, 2400
      • Recruiting
      • Bispebjerg and Frederiksberg Hospital
      • Contact: Katja Grønbæk, MD; Phone Number: 28781188; Email: katja.kjaer.groenbaek.01@gmail.com
      • Contact: Christian S Meyhoff, MD, PhD; Phone Number: 24910542; Email: christian.sylvest.meyhoff@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with any adverse clinical outcomes	Any adverse events. Criteria for each defined in protocol. Adverse events will be manually categorised as a 'Severe adverse event' (SAE), or simple 'adverse event' (AE).	30 days after inclusion
Length of hospital stay (LOS)	Lenght of hospital stay	6 months after inclusion
Total patient-related healthcare expenses in patients experiencing adverse clinical outcomes compared to patients without such outcomes and the effect of the study intervention on expenses	Total patient-related healthcare expenses in patients experiencing adverse clinical outcomes compared to patients without such outcomes and the effect of the study intervention on expenses	2 years
Staff response time (interventions group only)	Time from the staff is notified by app, until they respond by selecting 'check on patient' in app Stratified according to time of day	5 days after inclusion

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: Odense University Hospital; Rigshospitalet, Denmark; Hvidovre University Hospital; Aalborg University Hospital
• Investigators: Principal Investigator: Katja K Grønbæk, MD, Bispebjerg Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 29, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Mental Fatigue; Fatigue; Disease Progression; Clinical Deterioration; Alert Fatigue, Health Personnel
• Other Study ID Numbers: H-20033246

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No