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

Comparison of Tele-Critical Care Versus Usual Care On ICU Performance: A Cluster Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03920501
Acronym
TELESCOPE
Enrollment
19360
Registered
2019-04-19
Start date
2019-08-05
Completion date
2021-12-31
Last updated
2021-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Intensive Care Unit

Keywords

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

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).

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.

Interventions

BEHAVIORALTele-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.

Sponsors

Hospital Israelita Albert Einstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intensive Care Unit Length of StayFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysTime until discharge from the intensive care unit

Secondary

MeasureTime frameDescription
In-Hospital MortalityFrom date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 daysAny death during hospital stay
Patient-Days Under Light Sedation or Alert and CalmFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysDefined as a Richmond Agitation-Sedation Scale (RASS) -3 to +1
Standardized Resource UseFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysCalculated based on length of stay in the intensive care unit and adjusted for severity of acute illness
Standardized Mortality RateFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysRatio of observed deaths to expected deaths
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 daysFollowing the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019
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 daysFollowing the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019
Incidence Density of Urinary Tract Infection Associated with CatheterFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysFollowing the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019
Ventilator-Free Days at Day 2828 DaysSurvival time free of invasive mechanical ventilation from ICU admission to day 28.
Patient-Days Receiving Oral or Enteral FeedingFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysUse of enteral or oral feeding
Rate of Patients Under NormoxiaFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysDefined as oxygen saturation (SpO2) between 92% and 96%

Other

MeasureTime frameDescription
Incidence of Accidental ExtubationFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysRate of accidental extubation
Rate of Central-Line Catheter UseFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysUse of central-line catheter use
Rate of Vesical Catheter UseFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysUse of vesical catheter
Rate of Adequate Prophylaxis for Venous ThromboembolismFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysAdequate prophylaxis for venous thromboembolism
Rate of Adequate Glycemic ControlFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysAdequate glycemic control
ICU ReadmissionFrom date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 daysReadmission less than 24 hours after discharge
ICU MortalityFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysICU mortality rate
Incidence of Early ReintubationFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 daysLess than 48 hours after extubation
Rate of Patients with Head of the Bed ElevatedFrom date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days30 degrees in patients under mechanical ventilation

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026