TelemedicineNCT05260710
Evaluation of the Impact of Telemedicine in Pediatric Intensive Care Units
A study testing Telemedicine Intervention in people with Telemedicine and Critical Care, run by Hospital Moinhos de Vento.
Trial summary
This study will be a cluster randomized controlled trial to assess the impact of telemedicine in Pediatric Intensive Care Units (PICU), through daily tele-rounds with a board certified physician and educational activities, in improving clinical-assistance indicators, as well as reducing the length of stay in the PICU. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Telemedicine, Critical Care, Pediatric
- What is being tested?
- Telemedicine Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,760 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to Dec 2023
- 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 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All children admitted to the pediatric ICU aged ≥29 days and <18 years
- Length of stay of more than 8 hours and, in case of death, with a length of stay of more than 24 hours
Who cannot join
- Patients with incomplete medical records
- Incomplete data in the institution's database
- Patients whose guardians did not accept to participate in the study and/or who did not sign the informed consent form and the image use term.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Impact of Telemedicine Use on Clinical Care Indicators in Pediatric Intensive Care Units: Cluster Randomized Controlled Trial
This study will be a cluster randomized controlled trial to assess the impact of telemedicine in Pediatric Intensive Care Units (PICU), through daily tele-rounds with a board certified physician and educational activities, in improving clinical-assistance indicators, as well as reducing the length of stay in the PICU.
Read the detailed description
This is a parallel cluster randomized controlled trial in pediatric intensive care units in Brazil.
PICUs is the unit of randomization. All patients admitted to the PICUs selected to participate in the project will be included in the study allocated to the control or intervention group as their respective hospitals are randomized.
Intervention group: Tele-rounds are case discussions with remote pediatric intensive care physicians and physicians from other specialties, such as a radiologist, infectious disease specialist, for the debate on conducts based on the best scientific evidence. Additionally, concurrently with the period of application of the intervention, continuing education activities will be made available to all professionals from the teams of the participating centers. Education activities are held monthly and consist of video classes and discussions of complex cases.
Control group: This group will maintain the usual care offered by the participating centers.
- Being tested
- Telemedicine Intervention
- Keywords
- Telemedicine, Pediatric Intensive Care Units, Randomized Controlled Clinical Trial, Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine InterventionBehavioural
Tele-Critical Care: 1) establishing a diagnosis 2) guiding the therapeutic approach and 3) performing clinical follow-up. Physicians will discuss all patients in the unit, bed by bed, evaluating the specific clinical situation of each hospitalized patient, according to the protocol developed by the study.The proposal is to maintain horizontal care (the patient is monitored from the 1st day of hospitalization until discharge) for all patients in the unit.
+
Continuing education activities: video classes and discussions of complex cases.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine intervention | Experimental | Tele-critical care + continuing education activities Receives: Behavioral: Telemedicine Intervention |
| Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lenght of stay
Time until discharge from the Pediatric intensive care unit
Measured: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
Secondary outcomes (5)
To measure PICU mortality
To measure the mortality rate in PICUs
Measured: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
To check the days free from mechanical ventilation
To check the days free from mechanical ventilation of patients hospitalized in PICUs
Measured: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
To measure the time of use of vasoactive drugs
To measure the time of use of vasoactive drugs by patients hospitalized in PICUs
Measured: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
To measure the time of use of broad-spectrum antibiotics
To measure the time of use of broad-spectrum antibiotics in patients hospitalized in PICUs
Measured: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
To measure the time of use of sedation/analgesia
To measure the time of use of sedation/analgesia in patients hospitalized in PICUs
Measured: From PICU admission until the date of PICU 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 posted2 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label)
- Masking
- None (open label)
- Enrolment
- 1,760 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Moinhos de Vento
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Cezar Cabral, Hospital Moinhos de Vento
- Investigators
- Felipe C Cabral, Principal investigator, Hospital Moinhos de Vento
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260710
- Sponsor's protocol ID
- 5.126.122
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With the publication of the main study the IPD will be available to researchers not members of the study.
Publications
Agência IBGE https://agenciadenoticias.ibge.gov.br/agencia-noticias/2012-agencia-de-notíci as/27614-ibge-divulga-distribuicao-de-utis-respiradores-medicos-e-enfermeiros: Acessado em 14 de novembro de 2020.
BRASIL. Ministério da Saúde. Diretrizes Operacionais para o Estabelecimento e o Funcionamento de Comitês de Monitoramento de Dados e de Segurança / Ministério da Saúde, Organização Mundial da Saúde. Brasília : Ministério da Saúde, 2008. 44 p.
Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.
PubMed 22951546Chen J, Sun D, Yang W, Liu M, Zhang S, Peng J, Ren C. Clinical and Economic Outcomes of Telemedicine Programs in the Intensive Care Unit: A Systematic Review and Meta-Analysis. J Intensive Care Med. 2018 Jul;33(7):383-393. doi: 10.1177/0885066617726942. Epub 2017 Aug 22.
PubMed 28826282DE AZEVEDO, Arimatéia Portela et al. Fatores que interferem no desempenho da utilização de leitos de unidade de terapia intensiva (UTI). Brazilian Journal of Health Review, v. 3, n. 4, p. 7421-7438, 2020.
Garingo A, Friedlich P, Chavez T, Tesoriero L, Patil S, Jackson P, Seri I. "Tele-rounding" with a remotely controlled mobile robot in the neonatal intensive care unit. J Telemed Telecare. 2016 Mar;22(2):132-8. doi: 10.1177/1357633X15589478. Epub 2015 Jun 26.
PubMed 26116855Grundy BL, Crawford P, Jones PK, Kiley ML, Reisman A, Pao YH, Wilkerson EL, Gravenstein JS. Telemedicine in critical care: an experiment in health care delivery. JACEP. 1977 Oct;6(10):439-44. doi: 10.1016/s0361-1124(77)80239-6.
PubMed 71365MINISTÉRIO DA SAÚDE. Portaria n. 3.432, de 12 de agosto de 1998. Estabelece Critérios de Classificação de Unidade de Terapia Intensiva (UTI). Diário Oficial da União n. 154; Poder Executivo, 13 ago. 1998. Disponível em: <www.medicinaintensiva.com.br/portaria-3432.htm>. Acesso em: 10 jan. 2010.
Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
PubMed 22036893PATRIDGE, Emily F.; BARDYN, Tania P. Research electronic data capture (REDCap). Journal of the Medical Library Association: JMLA, v. 106, n. 1, p. 142, 2018.
PARK, Heesun. SAS Institute, Inc. Cary, North Carolina. Sign, v. 2, n. 4, p. 1.
Pfrimmer DM, Roslien JJ. The Tele-ICU: a new dimension in critical care nursing education and practice. J Contin Educ Nurs. 2011 Aug;42(8):342-3. doi: 10.3928/00220124-20110722-03.
PubMed 21800788Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG; CONSORT Group. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012 Dec 26;308(24):2594-604. doi: 10.1001/jama.2012.87802.
PubMed 23268518Jacovas VC, Chagas MEV, Constant HMRM, Alves SS, Krauzer JRM, Guerra LR, de Almeida Pires A, Gomes da Cunha L, Matte MCC, de Campos Moreira T, Cabral FC. Telemedicine in Pediatric Intensive Care Units: Perspectives From a Brazilian Experience. Curr Pediatr Rep. 2021;9(3):65-71. doi: 10.1007/s40124-021-00242-z. Epub 2021 Jul 12.
PubMed 34277142de Oliveira Laguna Silva G, Konig Klever E, Castro da Rocha J, da Silva MMD, da Rosa de Amorim J, Cristina Jacovas V, Marina Simionato B, Gomes da Cunha L, Zaupa APB, Mafalda Krauzer JR, de Almeida Pires A, Cezar Cabral F, de Campos Moreira T, Rodrigues Moleda Constant HM. Evaluation of the use of telemedicine in pediatric intensive care units: a cluster-randomized trial. Postgrad Med. 2024 Aug;136(6):633-640. doi: 10.1080/00325481.2024.2388023. Epub 2024 Aug 5.
PubMed 39093639
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Telemedicine Use on Clinical Care Indicators in Pediatric Intensive Care Units: Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05260710
- Acronym / sponsor ID
- 5.126.122
- Keywords
- Telemedicine, Pediatric Intensive Care Units, Randomized Controlled Clinical Trial, Technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,760 participants (estimated)
- Lead sponsor
- Hospital Moinhos de VentoUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Mar 2022 (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.
This study will be a cluster randomized controlled trial to assess the impact of telemedicine in Pediatric Intensive Care Units (PICU), through daily tele-rounds with a board certified physician and educational activities, in improving clinical-assistance indicators, as well as reducing the length of stay in the PICU.
Detailed description
This is a parallel cluster randomized controlled trial in pediatric intensive care units in Brazil.
PICUs is the unit of randomization. All patients admitted to the PICUs selected to participate in the project will be included in the study allocated to the control or intervention group as their respective hospitals are randomized.
Intervention group: Tele-rounds are case discussions with remote pediatric intensive care physicians and physicians from other specialties, such as a radiologist, infectious disease specialist, for the debate on conducts based on the best scientific evidence. Additionally, concurrently with the period of application of the intervention, continuing education activities will be made available to all professionals from the teams of the participating centers. Education activities are held monthly and consist of video classes and discussions of complex cases.
Control group: This group will maintain the usual care offered by the participating centers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label)
| Arm | Type | Receives |
|---|---|---|
| Telemedicine intervention | Experimental | Behavioral: Telemedicine InterventionTele-critical care + continuing education activities |
| Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All children admitted to the pediatric ICU aged ≥29 days and <18 years
- Length of stay of more than 8 hours and, in case of death, with a length of stay of more than 24 hours
Key exclusion criteria (3 listed)
- Patients with incomplete medical records
- Incomplete data in the institution's database
- Patients whose guardians did not accept to participate in the study and/or who did not sign the informed consent form and the image use term.
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 |
|---|---|---|
| Telemedicine InterventionTele-Critical Care: 1) establishing a diagnosis 2) guiding the therapeutic approach and 3) performing clinical follow-up. Physicians will discuss all patients in the unit, bed by bed, evaluating the specific clinical situation of each hospitalized patient, according to the protocol developed by the study.The proposal is to maintain horizontal care (the patient is monitored from the 1st day of hospitalization until discharge) for all patients in the unit. + Continuing education activities: video classes and discussions of complex cases. | Behavioural | Telemedicine intervention |
Primary outcome
Lenght of stay
Time frame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
Time until discharge from the Pediatric intensive care unit
5 secondary outcomes
To measure PICU mortality
Time frame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
To check the days free from mechanical ventilation
Time frame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
To measure the time of use of vasoactive drugs
Time frame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
To measure the time of use of broad-spectrum antibiotics
Time frame: From PICU admission until the date of PICU discharge or death, whichever comes first, assessed up to 90 days
To measure the time of use of sedation/analgesia
Time frame: From PICU admission until the date of PICU 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 29 Mar 2022.
- BackgroundAgência IBGE https://agenciadenoticias.ibge.gov.br/agencia-noticias/2012-agencia-de-notíci as/27614-ibge-divulga-distribuicao-de-utis-respiradores-medicos-e-enfermeiros: Acessado em 14 de novembro de 2020.
- BackgroundBRASIL. Ministério da Saúde. Diretrizes Operacionais para o Estabelecimento e o Funcionamento de Comitês de Monitoramento de Dados e de Segurança / Ministério da Saúde, Organização Mundial da Saúde. Brasília : Ministério da Saúde, 2008. 44 p.
- Background: PubMed 22951546Campbell MK, Piaggio G, Elbourne DR, Altman DG; CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012 Sep 4;345:e5661. doi: 10.1136/bmj.e5661. No abstract available.
- Background: PubMed 28826282Chen J, Sun D, Yang W, Liu M, Zhang S, Peng J, Ren C. Clinical and Economic Outcomes of Telemedicine Programs in the Intensive Care Unit: A Systematic Review and Meta-Analysis. J Intensive Care Med. 2018 Jul;33(7):383-393. doi: 10.1177/0885066617726942. Epub 2017 Aug 22.
- BackgroundDE AZEVEDO, Arimatéia Portela et al. Fatores que interferem no desempenho da utilização de leitos de unidade de terapia intensiva (UTI). Brazilian Journal of Health Review, v. 3, n. 4, p. 7421-7438, 2020.
- Background: PubMed 26116855Garingo A, Friedlich P, Chavez T, Tesoriero L, Patil S, Jackson P, Seri I. "Tele-rounding" with a remotely controlled mobile robot in the neonatal intensive care unit. J Telemed Telecare. 2016 Mar;22(2):132-8. doi: 10.1177/1357633X15589478. Epub 2015 Jun 26.
- Background: PubMed 71365Grundy BL, Crawford P, Jones PK, Kiley ML, Reisman A, Pao YH, Wilkerson EL, Gravenstein JS. Telemedicine in critical care: an experiment in health care delivery. JACEP. 1977 Oct;6(10):439-44. doi: 10.1016/s0361-1124(77)80239-6.
- BackgroundMINISTÉRIO DA SAÚDE. Portaria n. 3.432, de 12 de agosto de 1998. Estabelece Critérios de Classificação de Unidade de Terapia Intensiva (UTI). Diário Oficial da União n. 154; Poder Executivo, 13 ago. 1998. Disponível em: <www.medicinaintensiva.com.br/portaria-3432.htm>. Acesso em: 10 jan. 2010.
- Background: PubMed 22036893Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.
- BackgroundPATRIDGE, Emily F.; BARDYN, Tania P. Research electronic data capture (REDCap). Journal of the Medical Library Association: JMLA, v. 106, n. 1, p. 142, 2018.
- BackgroundPARK, Heesun. SAS Institute, Inc. Cary, North Carolina. Sign, v. 2, n. 4, p. 1.
- Background: PubMed 21800788Pfrimmer DM, Roslien JJ. The Tele-ICU: a new dimension in critical care nursing education and practice. J Contin Educ Nurs. 2011 Aug;42(8):342-3. doi: 10.3928/00220124-20110722-03.
- Individual participant dataSharing planned: Yes. With the publication of the main study the IPD will be available to researchers not members of the 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.
Felipe C Cabral principal investigator
Hospital Moinhos de Vento
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine Intervention in people with Telemedicine and Critical Care, run by Hospital Moinhos de Vento.
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 2 inclusion and 3 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 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Felipe C Cabral (+55 (51) 98464-4901, felipe.cabral@hmv.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lenght of stay (time frame: From PICU admission until the date of PICU 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 NCT05260710, which also lists 16 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 29 Mar 2022.