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

Critical Care Clinical Trial

— TELESCOPE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03920501
• Other study ID #: TELESCOPE
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2021
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19360
• Est. completion date: December 31, 2021
• Est. primary completion date: April 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Care
• Intensive Care Unit

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Incidence of Early Reintubation	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Ventilator-Free Days at Day 28	Survival time free of invasive mechanical ventilation from ICU admission to day 28.	28 Days
Secondary	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
Secondary	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
Secondary	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