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

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

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

• 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

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

• 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; 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

More Information

• Responsible Party: Hospital Israelita Albert Einstein
• ClinicalTrials.gov Identifier: NCT03920501
• Other Study ID Numbers: TELESCOPE
• First Posted: April 19, 2019
• 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