Integrated Proactive Wireless Monitoring for Clinical Deterioration: A Stepped Wedge Randomized Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Inpatient Facililty Diagnoses
- Sponsor
- King Abdullah International Medical Research Center
- Enrollment
- 13160
- Primary Endpoint
- Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation
- Status
- Not Yet Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The study evaluates whether implementing a wireless monitoring system for patients admitted to hospital wards reduces mortality and cardiopulmonary failure.
Detailed Description
The trial is designed as a stepped-wedge cluster RCT. Hospital wards (which constitute clusters in this design) will be randomized to have wireless monitoring, 7 wards at a time, with each 7 wards constituting a sequence. The study consists of 5 periods of two-month sequences followed by a one-month transition time with a phased introduction of the intervention. In the first period, all wards will have no wireless monitoring. After a baseline period of 2 (+1 washout) months, the intervention (monitoring system) will be implemented in a randomly selected new sequence every 3-month period until the intervention is implemented in all sequences.
Investigators
Dr Yaseen Arabi
Chairman intensive care unit
King Saud Bin Abdulaziz University for Health Sciences
Eligibility Criteria
Inclusion Criteria
- •Ward level Inpatient wards, defined as wards used to manage adult inpatients.
- •Patient level
- •Aged 14 years or older
- •Checked in as inpatient status to one of the study wards
Exclusion Criteria
- •Cardiology, pediatric, obstetric wards
- •ICUs and emergency departments
- •Operating rooms
- •Outpatient clinics
- •Daycare wards, endoscopy, outpatient procedure areas, hemodialysis units
- •Patient level No commitment for full life support at the time of arrival to the study ward (designated as Do-Not-Resuscitate status)
Outcomes
Primary Outcomes
Composite endpoint of 30-day in-hospital mortality, cardiac arrest, requirement of vasopressor or intubation
Time Frame: 30 days
After hospital admission within 30 days
Secondary Outcomes
- Cardiac arrest(30 days)
- Requirement of vasopressors(within 30 days of hospital admission)
- Requirement of intubation(30 days)
- Hospital length of stay(90 days)
- Transfer to ICU(30 days)
- ICU- free days(30 days)
- CCRT activation(30 days)