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

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ClinicalTrials.gov Identifier: NCT03920501
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
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).

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 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
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care

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.



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



Information from the National Library of Medicine

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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920501


Contacts
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Contact: Adriano J Pereira, MD PhD +55 11 2151 1521 adriano.pereira2@einstein.br
Contact: Danilo T Noritomi, MD PhD +55 11 2151 1521 danilo.noritomi@einstein.br

Locations
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Brazil
Hospital Israelita Albert Einstein Recruiting
São Paulo, Brazil, 05652-900
Contact: Danilo T Noritomi    +55 11 2151 1521    danilo.noritomi@einstein.br   
Sponsors and Collaborators
Hospital Israelita Albert Einstein
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Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT03920501    
Other Study ID Numbers: TELESCOPE
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: After two years of the first publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Israelita Albert Einstein:
Critical care
Quality improvement
Tele-critical care
Telemedicine