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出境医 / 临床实验 / Comparison of Tele-Critical Care Versus Usual Care On ICU Performance (TELESCOPE) (TELESCOPE)

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

Study Description
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).

Condition or disease Intervention/treatment Phase
Critical Care Intensive Care Unit Behavioral: Tele-Critical Care Not Applicable

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Tele-Critical Care Versus Usual Care On ICU Performance: A Cluster Randomized Clinical Trial
Actual Study Start Date : August 5, 2019
Actual Primary Completion Date : April 7, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. 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 100 weeks ]
    Time until discharge from the intensive care unit


Secondary Outcome Measures :
  1. In-Hospital Mortality [ Time Frame: From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 100 weeks ]
    Any death during hospital stay

  2. Standardized Resource Use [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Calculated based on length of stay in the intensive care unit and adjusted for severity of acute illness

  3. Standardized Mortality Rate [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Ratio of observed deaths to expected deaths

  4. Incidence Density of Central Line-Associated Bloodstream Infection (CLABSI) [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019

  5. Incidence Density of Ventilator-Associated Pneumonia (VAP) [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019

  6. Incidence Density of Urinary Tract Infection Associated with Catheter [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019

  7. Ventilator-Free Days at Day 28 [ Time Frame: 28 Days ]
    Survival time free of invasive mechanical ventilation from ICU admission to day 28.

  8. Patient-Days Receiving Oral or Enteral Feeding [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Use of enteral or oral feeding

  9. Patient-Days Under Light Sedation or Alert and Calm [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Defined as a Richmond Agitation-Sedation Scale (RASS) -3 to +1

  10. Rate of Patients Under Normoxia [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Defined as oxygen saturation (SpO2) between 92% and 96%


Other Outcome Measures:
  1. Rate of Patients with Head of the Bed Elevated [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    30 degrees in patients under mechanical ventilation

  2. Incidence of Early Reintubation [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Less than 48 hours after extubation

  3. Incidence of Accidental Extubation [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Rate of accidental extubation

  4. Rate of Central-Line Catheter Use [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Use of central-line catheter use

  5. Rate of Vesical Catheter Use [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Use of vesical catheter

  6. Rate of Adequate Prophylaxis for Venous Thromboembolism [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Adequate prophylaxis for venous thromboembolism

  7. Rate of Adequate Glycemic Control [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Adequate glycemic control

  8. ICU Readmission [ Time Frame: From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 100 weeks ]
    Readmission less than 24 hours after discharge

  9. ICU Mortality [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    ICU mortality rate


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Locations
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Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil, 05652-900
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE April 19, 2019
Last Update Posted Date May 6, 2021
Actual Study Start Date  ICMJE August 5, 2019
Actual Primary Completion Date April 7, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019) 		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 100 weeks ]
Time until discharge from the intensive care unit
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
  • In-Hospital Mortality [ Time Frame: From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 100 weeks ]
    Any death during hospital stay
  • Standardized Resource Use [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Calculated based on length of stay in the intensive care unit and adjusted for severity of acute illness
  • Standardized Mortality Rate [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Ratio of observed deaths to expected deaths
  • Incidence Density of Central Line-Associated Bloodstream Infection (CLABSI) [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    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) [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019
  • Incidence Density of Urinary Tract Infection Associated with Catheter [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    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 [ Time Frame: 28 Days ]
    Survival time free of invasive mechanical ventilation from ICU admission to day 28.
  • Patient-Days Receiving Oral or Enteral Feeding [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Use of enteral or oral feeding
  • Patient-Days Under Light Sedation or Alert and Calm [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Defined as a Richmond Agitation-Sedation Scale (RASS) -3 to +1
  • Rate of Patients Under Normoxia [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Defined as oxygen saturation (SpO2) between 92% and 96%
Original Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • In-Hospital Mortality [ Time Frame: From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 100 weeks ]
    Any death during hospital stay
  • Standardized Resource Use [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Calculated based on length of stay in the intensive care unit and adjusted for severity of acute illness
  • Standardized Mortality Rate [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Ratio of observed deaths to expected deaths
  • Incidence Density of Central Line-Associated Bloodstream Infection (CLABSI) [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    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) [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019
  • Incidence Density of Urinary Tract Infection Associated with Catheter [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    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 [ Time Frame: 28 Days ]
    Survival time free of invasive mechanical ventilation from ICU admission to day 28.
  • Patient-Days Receiving Oral or Enteral Feeding [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Use of enteral or oral feeding
  • Patient-Days Under Light Sedation or Alert and Calm [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Defined as a Richmond Agitation-Sedation Scale (RASS) -3 to 0
  • Rate of Patients Under Normoxia [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Defined as oxygen saturation (SpO2) between 92% and 96%
Current Other Pre-specified Outcome Measures
 (submitted: April 16, 2019)
  • Rate of Patients with Head of the Bed Elevated [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    30 degrees in patients under mechanical ventilation
  • Incidence of Early Reintubation [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Less than 48 hours after extubation
  • Incidence of Accidental Extubation [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Rate of accidental extubation
  • Rate of Central-Line Catheter Use [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Use of central-line catheter use
  • Rate of Vesical Catheter Use [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Use of vesical catheter
  • Rate of Adequate Prophylaxis for Venous Thromboembolism [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Adequate prophylaxis for venous thromboembolism
  • Rate of Adequate Glycemic Control [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    Adequate glycemic control
  • ICU Readmission [ Time Frame: From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 100 weeks ]
    Readmission less than 24 hours after discharge
  • ICU Mortality [ Time Frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 100 weeks ]
    ICU mortality rate
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comparison of Tele-Critical Care Versus Usual Care On ICU Performance (TELESCOPE)
Official Title  ICMJE Comparison of Tele-Critical Care Versus Usual Care On ICU Performance: A Cluster Randomized Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Care
  • Intensive Care Unit
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Tele-Critical Care
    Tele-Critical Care + Audit & Feedback.
    Intervention: Behavioral: Tele-Critical Care
  • No Intervention: Usual Care
    Usual Care.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 5, 2021) 		19360
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2019) 		15000
Estimated Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date April 7, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03920501
Other Study ID Numbers  ICMJE TELESCOPE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data sharing open to researchers not members of the study after two years of the publication of the main study
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: After two years of the first publication
Responsible Party Hospital Israelita Albert Einstein
Study Sponsor  ICMJE Hospital Israelita Albert Einstein
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospital Israelita Albert Einstein
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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