Critical CareTELESCOPENCT03920501
Comparison of Tele-Critical Care Versus Usual Care On ICU Performance (TELESCOPE)
A study testing Tele-Critical Care in people with Critical Care and Intensive Care Unit, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Intensive Care Unit
- What is being tested?
- Tele-Critical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,360 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intensive care units from public hospitals and with at least eight beds
- Intensive care units with physician and nurses available 24 hours a day
- Adult patients (> 18 years old)
- Admitted after the beginning of the study
Who cannot join
- 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
- Admission for other reasons than medical (e.g., judicial cause)
- Previously included in TELESCOPE (for the primary outcome analysis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Tele-Critical Care Versus Usual Care On ICU Performance: A Cluster Randomized Clinical Trial
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).
Read the 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.
- Conditions
- Critical Care, Intensive Care Unit
- Being tested
- Tele-Critical Care
- Keywords
- Critical care, Quality improvement, Tele-critical care, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Critical CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Tele-Critical Care | Experimental | Tele-Critical Care + Audit \& Feedback. Receives: Behavioral: Tele-Critical Care |
| Usual Care | No intervention | Usual Care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive Care Unit Length of Stay
Time until discharge from the intensive care unit
Measured: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Secondary outcomes (10)
In-Hospital Mortality
Any death during hospital stay
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 28 Days
Patient-Days Receiving Oral or Enteral Feeding
Use of enteral or oral feeding
Measured: 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
Measured: 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%
Measured: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start5 Aug 2019
- Primary completion7 Apr 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19,360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriano J Pereira, MD PhD, Study director, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920501
- Sponsor's protocol ID
- TELESCOPE
- Acronym
- TELESCOPE
- Status last verified
- Aug 2021
- First submitted
- 10 Apr 2019
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing open to researchers not members of the study after two years of the publication of the main study
Publications
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.
PubMed 39382244Ranzani 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.
PubMed 35766658Noritomi 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.
PubMed 34155070
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tele-Critical Care Versus Usual Care On ICU Performance: A Cluster Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03920501
- Acronym / sponsor ID
- TELESCOPE / TELESCOPE
- Conditions
- Critical Care, Intensive Care Unit
- Keywords
- Critical care, Quality improvement, Tele-critical care, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19,360 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 7 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 19 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-Critical Care | Experimental | Behavioral: Tele-Critical CareTele-Critical Care + Audit \& Feedback. |
| Usual Care | No intervention | –Usual Care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Intensive care units from public hospitals and with at least eight beds
- Intensive care units with physician and nurses available 24 hours a day
- Adult patients (> 18 years old)
- Admitted after the beginning of the study
Key exclusion criteria (6 listed)
- 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
- Admission for other reasons than medical (e.g., judicial cause)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-Critical CareDaily 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. | Behavioural | Tele-Critical Care |
Primary outcome
Intensive Care Unit Length of Stay
Time frame: 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
10 secondary outcomes
In-Hospital Mortality
Time frame: From date of randomization until the date of hospital discharge or death, whichever comes first, assessed up to 90 days
Standardized Resource Use
Time frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Standardized Mortality Rate
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 28 Days
Patient-Days Receiving Oral or Enteral Feeding
Time frame: 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
Time frame: 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
Time frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 39382244Pereira 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.
- Derived from this study: PubMed 35766658Ranzani 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.
- Derived from this study: PubMed 34155070Noritomi 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.
- Individual participant dataSharing planned: Yes. Data sharing open to researchers not members of the study after two years of the publication of the main study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriano J Pereira, MD PhD study director
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Critical Care in people with Critical Care and Intensive Care Unit, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Care Unit Length of Stay (time frame: From date of randomization until the date of ICU discharge or death, whichever comes first, assessed up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03920501, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.