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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).
Cluster randomized trial involving ICUs in Brazil. ICU is the unit of randomization.
The trial will have two stages:
Stage I - Baseline data:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-Critical Care | Experimental | Tele-Critical Care + Audit & Feedback. |
|
| Usual Care | No Intervention | Usual Care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Patients with Head of the Bed Elevated | 30 degrees in patients under mechanical ventilation | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days |
| Incidence of Early Reintubation |
Inclusion Criteria for Clusters:
Exclusion Criteria for Clusters:
Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Adriano J Pereira, MD PhD | Hospital Israelita Albert Einstein | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | São Paulo | 05652-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39382244 | Derived | 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. | |
| 35766658 |
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Data sharing open to researchers not members of the study after two years of the publication of the main study
After two years of the first publication
Data will be acessed through an online repository protected with password and for secondary analyses according to pre-specified plans.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2021 | Sep 9, 2021 | SAP_000.pdf |
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|
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 |
Less than 48 hours after extubation
| From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days |
| Incidence of Accidental Extubation | Rate of accidental extubation | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days |
| Rate of Central-Line Catheter Use | Use of central-line catheter use | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days |
| Rate of Vesical Catheter Use | Use of vesical catheter | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days |
| Rate of Adequate Prophylaxis for Venous Thromboembolism | Adequate prophylaxis for venous thromboembolism | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days |
| Rate of Adequate Glycemic Control | Adequate glycemic control | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days |
| ICU Readmission | Readmission less than 24 hours after discharge | From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days |
| ICU Mortality | ICU mortality rate | From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days |
| 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. |
| 34155070 | 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. |