Comparison of Tele-Critical Care Versus Usual Care On ICU Performance (TELESCOPE)

Not Applicable

• Conditions: Critical Care; Intensive Care Unit
• Interventions: Behavioral: Tele-Critical Care

• Registration Number: NCT03920501
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

Study Timeline

• Study First Submitted: 2019-04-10
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-19
• Study Start: 2019-08-05
• Primary Completion: 2021-04-07
• Status Verified: 2021-08
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-28
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 19360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tele-Critical Care	Tele-Critical Care	Tele-Critical Care + Audit \& Feedback.

Primary Outcome Measures

Name	Time	Method
Intensive Care Unit Length of Stay	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 Outcome Measures

Name	Time	Method
In-Hospital Mortality	From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days	Any death during hospital stay
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	Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019
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	Use of enteral or oral feeding
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	Defined as a Richmond Agitation-Sedation Scale (RASS) -3 to +1
Standardized Resource Use	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days	Calculated based on length of stay in the intensive care unit and adjusted for severity of acute illness
Standardized Mortality Rate	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days	Ratio of observed deaths to expected deaths
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	Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019
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	Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019
Ventilator-Free Days at Day 28	28 Days	Survival time free of invasive mechanical ventilation from ICU admission to day 28.
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	Defined as oxygen saturation (SpO2) between 92% and 96%

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil