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Clinical Trials/NCT03920501
NCT03920501
Unknown
Not Applicable

Comparison of Tele-Critical Care Versus Usual Care On ICU Performance: A Cluster Randomized Clinical Trial

Hospital Israelita Albert Einstein1 site in 1 country19,360 target enrollmentAugust 5, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Care
Sponsor
Hospital Israelita Albert Einstein
Enrollment
19360
Locations
1
Primary Endpoint
Intensive Care Unit Length of Stay
Last Updated
4 years ago

Overview

Brief Summary

TELESCOPE will be a cluster randomized clinical trial to ascertain whether the use of an intervention including multidisciplinary round with a board certified physician through tele-critical care and periodic meetings to discuss strategies to improve quality indicators can reduce ICU length of stay of patients admitted to intensive care units (ICUs).

Detailed Description

Cluster randomized trial involving ICUs in Brazil. ICU is the unit of randomization. The trial will have two stages: Stage I - Baseline data: * Characterize participant ICUs and quality indicators * Characterize patients from each participant ICU to describe baseline outcomes Stage II - Intervention: This is the main stage for data analysis. ICUs will be randomly assigned to an experimental or control group. The experimental group should use a multidisciplinary rounds with a board certified physician through tele-critical care and take part in meetings to discuss how to improve local quality indicators, and the control group will follow the local standard of care.

Registry
clinicaltrials.gov
Start Date
August 5, 2019
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Intensive Care Unit Length of Stay

Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

Time until discharge from the intensive care unit

Secondary Outcomes

  • In-Hospital Mortality(From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days)
  • Incidence Density of Urinary Tract Infection Associated with Catheter(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
  • Patient-Days Receiving Oral or Enteral Feeding(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
  • Patient-Days Under Light Sedation or Alert and Calm(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
  • Standardized Resource Use(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
  • Standardized Mortality Rate(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
  • Incidence Density of Central Line-Associated Bloodstream Infection (CLABSI)(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
  • Incidence Density of Ventilator-Associated Pneumonia (VAP)(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)
  • Ventilator-Free Days at Day 28(28 Days)
  • Rate of Patients Under Normoxia(From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days)

Study Sites (1)

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