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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Critical Care; Intensive Care Unit
• Intervention / Treatment: Behavioral: Tele-Critical Care

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 Type: Interventional
• Enrollment (Actual): 19360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05652-900
    • Hospital Israelita Albert Einstein

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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tele-Critical Care; Tele-Critical Care + Audit & Feedback.	Behavioral: Tele-Critical Care; Daily multidisciplinary rounds with a board certified physician through tele-critical care focusing on: 1) diagnosis; 2) active problems; and 3) therapeutic goals. In addition, the management of health care quality indicators will be conducted by a specially trained (Science of Improvement) board-certified intensive care physician.
NO_INTERVENTION: Usual Care; Usual Care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive Care Unit Length of Stay	Time until discharge from the intensive care unit	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Patients with Head of the Bed Elevated	30 degrees in patients under mechanical ventilation	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Incidence of Early Reintubation	Less than 48 hours after extubation	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Incidence of Accidental Extubation	Rate of accidental extubation	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Rate of Central-Line Catheter Use	Use of central-line catheter use	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Rate of Vesical Catheter Use	Use of vesical catheter	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Rate of Adequate Prophylaxis for Venous Thromboembolism	Adequate prophylaxis for venous thromboembolism	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Rate of Adequate Glycemic Control	Adequate glycemic control	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
ICU Readmission	Readmission less than 24 hours after discharge	From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days
ICU Mortality	ICU mortality rate	From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Study Director: Adriano J Pereira, MD PhD, Hospital Israelita Albert Einstein

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 5, 2019
• Primary Completion (ACTUAL): April 7, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (ACTUAL): April 19, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Telemedicine; Critical care; Quality improvement; Tele-critical care
• Other Study ID Numbers: TELESCOPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing open to researchers not members of the study after two years of the publication of the main study
• IPD Sharing Time Frame: After two years of the first publication
• IPD Sharing Access Criteria: Data will be acessed through an online repository protected with password and for secondary analyses according to pre-specified plans.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No