Comparison of Tele-Critical Care Versus Usual Care On ICU Performance (TELESCOPE)
Study Details
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 |
|---|---|---|
|
N/A |
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
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
- Intensive Care Unit Length of Stay [From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days]
Time until discharge from the intensive care unit
Secondary Outcome Measures
- In-Hospital Mortality [From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days]
Any death during hospital stay
- Standardized Resource Use [From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days]
Calculated based on length of stay in the intensive care unit and adjusted for severity of acute illness
- Standardized Mortality Rate [From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days]
Ratio 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 days]
Following 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 days]
Following 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 Catheter [From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days]
Following the Centers for Disease Control/National Healthcare Safety Network (CDC/NHSN) Surveillance Definition of Healthcare-Associated Infection 2019
- Ventilator-Free Days at Day 28 [28 Days]
Survival time free of invasive mechanical ventilation from ICU admission to day 28.
- Patient-Days Receiving Oral or Enteral Feeding [From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days]
Use of enteral or oral feeding
- Patient-Days Under Light Sedation or Alert and Calm [From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days]
Defined as a Richmond Agitation-Sedation Scale (RASS) -3 to +1
- Rate of Patients Under Normoxia [From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days]
Defined as oxygen saturation (SpO2) between 92% and 96%
Other Outcome Measures
- 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]
30 degrees in patients under mechanical ventilation
- Incidence of Early Reintubation [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
- Incidence 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 accidental extubation
- Rate 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]
Use of central-line catheter use
- Rate of Vesical Catheter Use [From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days]
Use of vesical catheter
- Rate of 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]
Adequate prophylaxis for venous thromboembolism
- Rate of Adequate Glycemic Control [From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days]
Adequate glycemic control
- ICU Readmission [From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days]
Readmission less than 24 hours after discharge
- ICU Mortality [From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days]
ICU mortality rate
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Israelita Albert Einstein | São Paulo | Brazil | 05652-900 |
Sponsors and Collaborators
- Hospital Israelita Albert Einstein
Investigators
- Study Director: Adriano J Pereira, MD PhD, Hospital Israelita Albert Einstein
Study Documents (Full-Text)
More Information
Publications
None provided.- TELESCOPE