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

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

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.

Study Overview

• Status: Completed
• Conditions: Inpatient Facililty Diagnoses
• Intervention / Treatment: Device: Hillrom; Other: Control

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil
      • Hospital do Coracao

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

- All patients with activated RRT during the study recruitment period.

Exclusion Criteria:

- Individuals who need blood pressure measurement in lower members.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hillrom; 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; 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.
Active Comparator: Control; Hospital usual care.	Other: Control; Hospital usual care regarding vital signs collection and TRR activation.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital do Coracao
• Investigators: Principal Investigator: José César Ribeiro, RN, Hospital do Coracao

Publications and helpful links

General Publications

• Ribeiro JC, Sgorbissa C, Silva KA, Braz MLD, Horak ACP, Nicola ML, Gurgel RM, Tokunaga SM, Negrelli KL, Murizine GS, Medrado Junior F, Coli RCP, Cavalcanti AB, Marcadenti A. Automated documentation of vital parameters in wards using portable stations - Effect on proper triggering of the rapid response team: a study protocol of a cluster randomized clinical trial. Rev Bras Ter Intensiva. 2022 Nov 4;34(3):319-326. doi: 10.5935/0103-507X.20220101-pt. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: HILLROM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data will be available upon reasonable request including a short study protocol. Both sponsor and funders will evaluate all requests. Brazilian regulatory agencies approval will be also required.
• IPD Sharing Time Frame: After main paper publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No