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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Critical Care, Intensive Care Unit

Intervention / Treatment
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* Behavioral: Tele-Critical Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-Critical Care<br>Tele-Critical Care + Audit & Feedback. | Behavioral: Tele-Critical Care<br>* 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.<br>|
| No Intervention: Usual Care<br>Usual Care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-Hospital Mortality | Any death during hospital stay | From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days | 
| Standardized Resource Use | Calculated based on length of stay in the intensive care unit and adjusted for severity of acute illness | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days | 
| Standardized Mortality Rate | Ratio of observed deaths to expected deaths | 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) | Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019 | 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) | Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019 | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days | 
| Incidence Density of Urinary Tract Infection Associated with Catheter | Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019 | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days | 
| Ventilator-Free Days at Day 28 | Survival time free of invasive mechanical ventilation from ICU admission to day 28. | 28 Days | 
| Patient-Days Receiving Oral or Enteral Feeding | Use of enteral or oral feeding | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days | 
| Patient-Days Under Light Sedation or Alert and Calm | Defined as a Richmond Agitation-Sedation Scale (RASS) -3 to +1 | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days | 
| Rate of Patients Under Normoxia | Defined as oxygen saturation (SpO2) between 92% and 96% | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical care, Quality improvement, Tele-critical care, Telemedicine