Evaluation of the Clinical Impact of Different Telemedicine Practices in Intensive Care Units

NCT05960994 | Completed

• 1 other identifier: 5535-23
• Study Type: interventional
• Target: 22,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess whether an intervention package via telemedicine consisting of daily multidisciplinary rounds with a specialist in intensive care medicine, an intervention package provided by a specialized multiprofessional team (nursing, physical therapy and clinical pharmacy) and a management intervention package, focused on quality and safety, reduces the length of stay in ICU patients in Brazil. Our hypothesis is that the intervention package via telemedicine has the potential to decrease the length of stay in ICU patients in Brazil. The study provides for the implementation of three interventions in association via telemedicine.

• Daily multidisciplinary rounds conducted by a physician specialized in intensive care medicine
• Intervention package by specialized multidisciplinary team (nursing, physiotherapy and clinical pharmacy).
• Management intervention package (quality and safety). The main questions it aims to answer are:
• Length of stay in ICU
• ICU mortality.
• In-hospital mortality.
• Ventilator-free days during the first 28 days.
• ICU readmission within 48 hours.
• Early reintubation (\<48h after elective extubation).
• Ventilator-associated events.
• Accidental extubation rate.
• Patient Mobilization Density.
• Adherence to maintaining the head-of-bed elevation.
• Adequate prevention of venous thromboembolism.
• Rate of patient-days under adequate sedation.
• Rate of patients-days with oral or enteral nutrition.
• Rate of patients with adequate glycemic control.
• Rate of patients-days within normoxemia.
• Rate of central venous catheter use.
• Central venous catheter dwell time.
• Rate of indwelling urinary catheter use.
• Indwelling urinary catheter dwell time.
• Standard resource use.
• Standardized mortality rate.

Conditions

Telemedicine; Critical Care; Intensive Care Units

Keywords

Telemedicine; Critical care; Intensive care units

Outcome Measures

Primary Outcomes (1)

• Intensive Care Unit Length of Stay

  Defined as the time interval in hours between patients' ICU admission and the moment of ICU physical discharge times (i.e., transfer to another care facility or another hospital) or ICU death, as defined by the hospital's system date and time. Date and time will be entered by the health care worker responsible for data collection. ICU LOS will be derived in 24 hours periods with decimal place.

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

Secondary Outcomes (7)

• ICU mortality

  From date of randomization until the date of ICU death, assessed up to 90 days

• In-hospital mortality

  From date of randomization until the date of hospital discharge, assessed up to 90 days

• Ventilator-free days during the first 28 days

  28 Days

• ICU readmission within 48 hours.

  From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days

• Early reintubation (<48h after elective extubation).

  From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days

Other Outcomes (13)

• Patient mobilization density in the ICU

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

• Adherence to maintaining the head-of-bed elevation (30°-45°).

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

• Adequate prevention of venous thromboembolism.

  From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days

Study Arms (5)

Sequence 1

EXPERIMENTAL

Sequence 1 will consist of a 3-month control period, followed by a 3-month transition period, and finally, a 19-month intervention period. The total duration of sequence 1 will be 25 months.

Other: Intervention period

Sequence 2

EXPERIMENTAL

Sequence 2 will consist of a 7-month control period, followed by a 3-month transition period, and finally, a 15-month intervention period. The total duration of sequence 2 will be 25 months.

Other: Intervention period

Sequence 3

EXPERIMENTAL

Sequence 3 will consist of a 11-month control period, followed by a 3-month transition period, and finally, a 9-month intervention period. The total duration of sequence 3 will be 25 months.

Other: Intervention period

Sequence 4

EXPERIMENTAL

Sequence 4 will consist of a 15-month control period, followed by a 3-month transition period, and finally, a 7-month intervention period. The total duration of sequence 4 will be 25 months.

Other: Intervention period

Sequence 5

EXPERIMENTAL

Sequence 5 will consist of a 19-month control period, followed by a 3-month transition period, and finally, a 3-month intervention period. The total duration of sequence 5 will be 25 months.

Other: Intervention period

Interventions

Intervention period OTHER

During the intervention period, three interventions will be implemented through telemedicine. 1. A daily multidisciplinary round conducted by a physician specialized in intensive care medicine. 2. A intervention package administered by a specialized multidisciplinary team, consisting of nursing, physiotherapy, and clinical pharmacy. 3. A management intervention package will be implemented, with a specific focus on enhancing quality and safety.

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intensive care units from public or philanthropic hospitals.
• ICUs with a minimum of 7 and a maximum of 20 beds.
• Intensive care units with physician and nurses available 24 hours a day and physiotherapist available at least ≥ 18 hours a day.

You may not qualify if:

• Intensive care units with structured multidisciplinary round more than three times a week conducted by an intensive care physician (certified), documented in the medical record, with a fixed duration (\>5 min / patient), using some supporting tool (checklist or standard form), goal oriented, based on established protocols, including all the patients admitted to the ICU.
• Intensive care units already doing audit and feedback with specific planning.
• Dedicated coronary care units/cardiac intensive care units or other specialized units (cardiac surgery, neurological, burned patients).
• Step-down units or semi-intensive cardiac care unit.
• Intensive care units without availability of substitute renal therapy.
• ICU coordinator specialist in intensive care medicine and management training (MBA in Health Management or equivalent).
• Adult patients (≥ 18 years old).
• Admission for other reasons than medical (e.g., judicial cause, legal reasons, safety reasons).
• Previously included in the TELESCOPE II trial (for the primary outcome analysis).

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Einstein Hospital Israelita

São Paulo, São Paulo, 05651-901, Brazil

Location

Study Officials

• Adriano J Pereira, MD, PhD

  Hospital Israelita Albert Einstein

  STUDY DIRECTOR

• Renato CF Chaves, MD, PhD, MBA

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: For technical reasons, it is impossible to perform blinding for patients, health care staff, professionals involved in patient care, and data collectors in the ICUs participating in the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The TELESCOPE II study is an open-label, national, multicenter, stepped-wedge cluster randomized controlled trial. The randomization unit will be the ICU, since the intervention will be applied to the entire multiprofessional team. Therefore, 25 ICUs participating in the study will be allocated and randomized to one of the five sequences. In each sequence, the initial period will serve as the control period without any intervention. Subsequently, as the intervention is stepwise implemented, new control periods will be introduced based on the assigned sequence. Due to the multifaceted nature of the intervention, a delay in onset of effect is expected; thus, the study design contemplates a transition period, which will occur in all sequences, when the intervention will be occurring, but these data will not be used in the main analysis. All groups will receive all interventions, but at different times

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 27, 2023
• Study Start: January 8, 2024
• Primary Completion: January 31, 2026
• Study Completion: May 1, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After two years of the first publication
• Access Criteria: Data will be accessed through an online repository protected with password and for secondary analyses according to pre-specified plans.

Locations

BR (1)