Clinical trial NCT03920501: Comparison of Tele-Critical Care Versus Usual Care On ICU Performance (TELESCOPE)
Official title: Comparison of Tele-Critical Care Versus Usual Care On ICU Performance: A Cluster Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Care
Intensive Care Unit
Keywords: Critical care
Quality improvement
Tele-critical care
Telemedicine
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 19360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria for Clusters:

* Intensive care units from public hospitals and with at least eight beds
* Intensive care units with physician and nurses available 24 hours a day

Exclusion Criteria for Clusters:

* Intensive care units with structured multidisciplinary round more than three times a week based in a formal instrument
* Intensive care units already doing audit \& feedback
* Dedicated coronary care units/cardiac intensive care units or other specialized units
* Step-down units

Inclusion Criteria for Patients:

* Adult patients (\> 18 years old)
* Admitted after the beginning of the study

Exclusion Criteria for Patients:

* Admission for other reasons than medical (e.g., judicial cause)
* Previously included in TELESCOPE (for the primary outcome analysis)

Primary outcomes:
measure: Intensive Care Unit Length of Stay
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Secondary outcomes:
measure: In-Hospital Mortality
timeFrame: From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days
measure: Standardized Resource Use
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Standardized Mortality Rate
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Incidence Density of Central Line-Associated Bloodstream Infection (CLABSI)
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Incidence Density of Ventilator-Associated Pneumonia (VAP)
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Incidence Density of Urinary Tract Infection Associated with Catheter
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Ventilator-Free Days at Day 28
timeFrame: 28 Days
measure: Patient-Days Receiving Oral or Enteral Feeding
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Patient-Days Under Light Sedation or Alert and Calm
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Rate of Patients Under Normoxia
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Other outcomes:
measure: Rate of Patients with Head of the Bed Elevated
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Incidence of Early Reintubation
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Incidence of Accidental Extubation
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Rate of Central-Line Catheter Use
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Rate of Vesical Catheter Use
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Rate of Adequate Prophylaxis for Venous Thromboembolism
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: Rate of Adequate Glycemic Control
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
measure: ICU Readmission
timeFrame: From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days
measure: ICU Mortality
timeFrame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Adriano J Pereira, MD PhD
role: STUDY_DIRECTOR
References:
citation: Ranzani O, Pereira AJ, Santos MCD, Correa TD, Ferraz LJR, Cordioli E, Morbeck RA, Berwanger O, Morais LC, Schettino G, Cavalcanti AB, Rosa RG, Biondi RS, Salluh JIF, Azevedo LCP, Serpa Neto A, Noritomi DT. Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial. Rev Bras Ter Intensiva. 2022 Jan-Mar;34(1):87-95. doi: 10.5935/0103-507x.20220003-pt.
citation: Noritomi DT, Ranzani OT, Ferraz LJR, Dos Santos MC, Cordioli E, Albaladejo R, Serpa Neto A, Correa TD, Berwanger O, de Morais LC, Schettino G, Cavalcanti AB, Rosa RG, Biondi RS, Salluh JI, Azevedo LCP, Pereira AJ; TELESCOPE Trial Investigators. TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE): protocol for a cluster-randomised clinical trial on adult general ICUs in Brazil. BMJ Open. 2021 Jun 21;11(6):e042302. doi: 10.1136/bmjopen-2020-042302.