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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03920501

Recruitment Status Recruiting

First Posted April 19, 2019

Last update posted July 29, 2020

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:Critical Care
    Intensive Care Unit
  • Intervention/Treatment: Behavioral: Tele-Critical Care
  • Phase: N/A
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
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: November 2020
  • Estimated Study Completion Date: December 2020
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.
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
  • 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
Contacts

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

Brazil
Hospital Israelita Albert Einstein
São Paulo

Sponsors and Collaborators

Hospital Israelita Albert Einstein

More Information
  • Responsible Party: Hospital Israelita Albert Einstein
  • ClinicalTrials.gov Identifier: NCT03920501 History of Changes
  • 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
  • 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