This website is for US healthcare professionals

close-icon

Log In to Bolder Science

or

Don't have an account? Sign Up

close-icon

Please enter your email address.

You will receive a link to create a new password via email.

Log In

close-icon

Create an Account

or
  • 8 characters minimum
  • First character may not be a number
  • Last character may not be a number
close-icon

Welcome and thank you for creating an account!

At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

Condition Categories

Condition categories are pulled directly from ClinicalTrials.gov. Choose 1 or more condition categories that you are interested in:

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

Set a default location

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

  • Clinicaltrials.gov identifier

    NCT03920501

  • Recruitment Status

    Active, not recruiting

  • First Posted

    April 19, 2019

  • Last update posted

    May 6, 2021

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
  • 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 2019
  • Estimated Primary Completion Date: April 2021
  • Actual Study Completion Date: December 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.

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

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: May 6, 2021
  • 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