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

NCT03920501 | Unknown DMC

• 1 other identifier: TELESCOPE
• Study Type: interventional
• Target: 19,360
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Care; Intensive Care Unit

Keywords

Critical care; Quality improvement; Tele-critical care; Telemedicine

Outcome Measures

Primary Outcomes (1)

• Intensive Care Unit Length of Stay

  Time until discharge from the intensive care unit

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

Secondary Outcomes (10)

• In-Hospital Mortality

  From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days

• Standardized Resource Use

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

• Standardized Mortality Rate

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

• Incidence Density of Central Line-Associated Bloodstream Infection (CLABSI)

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

• Incidence Density of Ventilator-Associated Pneumonia (VAP)

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

Other Outcomes (9)

• Rate of Patients with Head of the Bed Elevated

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

• Incidence of Early Reintubation

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

• Incidence of Accidental Extubation

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

Study Arms (2)

Tele-Critical Care

EXPERIMENTAL

Tele-Critical Care + Audit \& Feedback.

Behavioral: Tele-Critical Care

Usual Care

NO INTERVENTION

Usual Care.

Interventions

Tele-Critical Care BEHAVIORAL

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.

Tele-Critical Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intensive care units from public hospitals and with at least eight beds
• Intensive care units with physician and nurses available 24 hours a day

You may not qualify if:

• 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
• Adult patients (\> 18 years old)
• Admitted after the beginning of the study
• Admission for other reasons than medical (e.g., judicial cause)
• Previously included in TELESCOPE (for the primary outcome analysis)

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

Location

Related Publications (3)

• Pereira AJ, Noritomi DT, Dos Santos MC, Correa TD, Ferraz LJR, Schettino GPP, Cordioli E, Morbeck RA, Morais LC, Salluh JIF, Azevedo LCP, Biondi RS, Rosa RG, Cavalcanti AB, Berwanger O, Serpa Neto A, Ranzani OT. Effect of Tele-ICU on Clinical Outcomes of Critically Ill Patients: The TELESCOPE Randomized Clinical Trial. JAMA. 2024 Dec 3;332(21):1798-1807. doi: 10.1001/jama.2024.20651.

  PMID: 39382244 DERIVED

• Ranzani O, Pereira AJ, Santos MCD, Correa TD, Ferraz LJR, Cordioli E, Morbeck RA, Berwanger O, Morais LC, Schettino G, Cavalcanti AB, Rosa RG, Biondi RS, Salluh JIF, Azevedo LCP, Serpa Neto A, Noritomi DT. Statistical analysis of a cluster-randomized clinical trial on adult general intensive care units in Brazil: TELE-critical care verSus usual Care On ICU PErformance (TELESCOPE) trial. Rev Bras Ter Intensiva. 2022 Jan-Mar;34(1):87-95. doi: 10.5935/0103-507x.20220003-pt.

  PMID: 35766658 DERIVED

• Noritomi DT, Ranzani OT, Ferraz LJR, Dos Santos MC, Cordioli E, Albaladejo R, Serpa Neto A, Correa TD, Berwanger O, de Morais LC, Schettino G, Cavalcanti AB, Rosa RG, Biondi RS, Salluh JI, Azevedo LCP, Pereira AJ; TELESCOPE Trial Investigators. TELE-critical Care verSus usual Care On ICU PErformance (TELESCOPE): protocol for a cluster-randomised clinical trial on adult general ICUs in Brazil. BMJ Open. 2021 Jun 21;11(6):e042302. doi: 10.1136/bmjopen-2020-042302.

  PMID: 34155070 DERIVED

Study Officials

• Adriano J Pereira, MD PhD

  Hospital Israelita Albert Einstein

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 19, 2019
• Study Start: August 5, 2019
• Primary Completion: April 7, 2021
• Study Completion: December 31, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: After two years of the first publication
• Access Criteria: Data will be acessed through an online repository protected with password and for secondary analyses according to pre-specified plans.

Locations

BR (1)