Clinical trial NCT04661748: Automated Alerts of Patient Deterioration vs. Routine Monitoring of High-risk Patients Admitted to Medical Wards
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alert Fatigue, Health Personnel
Deterioration, Clinical
Lead sponsor: University Hospital Bispebjerg and Frederiksberg
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Odense University Hospital
name: Aalborg University Hospital
name: Hvidovre University Hospital
First posted: 2020-12-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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%.

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.

Primary outcomes:
measure: Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
timeFrame: 5 days after inclusion or until discharge
measure: Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
timeFrame: 5 days after inclusion or until discharge
measure: Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
timeFrame: 5 days after inclusion or until discharge
measure: Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
timeFrame: 5 days after inclusion or until discharge
measure: Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
timeFrame: 5 days after inclusion or until discharge
measure: Cumulative duration of one or more of the following deviations in vital signs during the first five days of admission or until discharge:
timeFrame: 5 days after inclusion or until discharge
Secondary outcomes:
measure: Frequency and duration of deviations in vital signs
timeFrame: 5 days after inclusion or until discharge
Other outcomes:
measure: Number of patients with any adverse clinical outcomes
timeFrame: 30 days after inclusion
measure: Length of hospital stay (LOS)
timeFrame: 6 months after inclusion
measure: 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
timeFrame: 2 years
measure: Staff response time (interventions group only)
timeFrame: 5 days after inclusion
Locations:
city: København NV
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital
state: Region H
Study officials:
affiliation: Bispebjerg Hospital
name: Katja K Grønbæk, MD
role: PRINCIPAL_INVESTIGATOR
References: