Automated Documentation of Vital Parameters Using Mobile Stations and Activation of the Rapid Response Team

Study Overview
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Brief Summary
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The documentation of vital signs is traditionally performed manually when the patient is not admitted in intensive care units, which can lead to documentary errors, long time for data acquisition and, consequently, impairment in the early identification of possible clinical deterioration. In-bed technology solutions are available to automate the collection of vital data and transfer information to a medical record or central electronic monitoring and its role in the health value chain needs further investigation. The investigators propose to evaluate the impact of the Connex Spot Monitor solution Welch Allyn (CSM / Hillrom) in conjunction with the Hillrom Connecta solution in a real world situation, conducting a cluster randomized trilal in wards of a tertiary hospital. In addition, this study aims to estimate the clinical effectiveness of a technological solution that performs an analysis of vital signs and automatically activates the rapid response team (RRT) when the pre-defined criteria are met, comparing it with the traditional manual method. The primary outcome is the number of times that the RRT fires in a timely manner.

Official Title
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Automated Documentation of Vital Parameters in Wards Using Mobile Stations - Effect on the Appropriate Activation of the Rapid Response Team: a Cluster Randomized Clinical Trial

Conditions
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Inpatient Facililty Diagnoses

Intervention / Treatment
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* Device: Hillrom
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All patients with activated RRT during the study recruitment period. Exclusion Criteria: - Individuals who need blood pressure measurement in lower members.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hillrom<br>The intervention involves an automated vital signs document system consisting of a mobile medical device for measuring vital signs (CSM / Hillrom) that collects and analyzes data acquired at the bedside to be sent to a remote data processing point (Digital Control Station), using Hillrom Connecta software. | Device: Hillrom<br>* Hillrom Connecta solution will record vital signs in an automated way, without the need for human intervention, and activate TRR activation when at least one criteria is met. The frequency of monitoring vital signs will be defined based on the MEWS score.<br>|
| Active Comparator: Control<br>Hospital usual care. | Other: Control<br>* Hospital usual care regarding vital signs collection and TRR activation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RRT | Number of rapid response team triggers activated in a timely manner. | 24 hours |