Active MalignanciesEXPERT-ISNCT05423795
A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU
A study testing Telemedicine-based intervention in people with Active Malignancies and Life Threatening Complication of the Malignancy or Its Treatments, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Admission to the intensive care unit (ICU) is a common event in patients treated for solid tumors or hematologic malignancies. A volume-outcome relationship has been shown in these patients, with a mortality rate decreasing from 70% in low-volume centres to 30-40% in high-volume centres. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Active Malignancies, Life Threatening Complication of the Malignancy or Its Treatments
- What is being tested?
- Telemedicine-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- Jun 2022to Dec 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (> 18 years old)
- Active malignancy;
- ICUs seeking for an advice must admit fewer than 30 patients with active cancer per year;
- Patients has been urgently admitted in the ICU for a life threatening complication of the malignancy or its treatments.
Who cannot join
- Isolated HIV infection or AIDS;
- ICU admission complicating scheduled surgery,
- Treatment-limitation decisions at admission;
- No coverage by the French statutory health insurance system,
- Pregnant or breastfeeding
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU : A Stepped Wedge Cluster-randomised Trial
Admission to the intensive care unit (ICU) is a common event in patients treated for solid tumors or hematologic malignancies. A volume-outcome relationship has been shown in these patients, with a mortality rate decreasing from 70% in low-volume centres to 30-40% in high-volume centres.
We hypothesize that providing the low-volume centres with assistance from experts working in high-volume centres for the management of critically-ill cancer patients can bring down mortality to the values seen in high-volume centres.
Read more
The main objective of this study is to evaluate whether combining three knowledge-transfer methods (videoconference-based forum, educational sessions, and dissemination of published work) increases the survival of cancer patients managed in low-volume centres to the values seen in high-volume centres.
The main endpoint is all-cause mortality at hospital discharge.
- Being tested
- Telemedicine-based intervention, Standard of care arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine-based interventionOther
Telemedicine-based intervention Multifaceted intervention including daily videoconferences with audit and feedback, educational interventions, and dissemination of published works
Standard of care armOther
Classic expertise (as routinely performed in the participating ICU)
| Study group | Role | What they receive |
|---|---|---|
| Comparator Arm | Other | Classic expertise (as routinely performed in the participating ICU) Receives: Other: Standard of care arm |
| Telemedicine-based intervention | Experimental | Telemedicine-based expert advice. Receives: Other: Telemedicine-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: at hospital discharge (up to 28 days)
Secondary outcomes (14)
Number of changes based on expert opinion
Measured: at 28 days
Number of invasive diagnostic tests used
Measured: at 28 days
Number of non-invasive diagnostic tests used
Measured: at 28 days
Proportion of patients with non-invasive ventilation and/or high flow oxygen
Measured: at 28 days
Proportion of patients in whom the cause for ICU admission remained undetermined
Measured: at 28 days
Number of days without life-supporting interventions
Measured: at 28 days
Number of anti-microbial agents
Measured: at 28 days
Number of blood transfusions
Measured: at 28 days
Number of chemotherapy
Measured: at 28 days
Proportion of patients with antibiotic de-escalation
Measured: at 28 days
Duration of antibiotic therapy
Measured: up to 28 days
Length of ICU stay
Measured: at hospital discharge (up to 28 days)
Proportion of ICU-acquired events
Measured: at 28 days
Satisfaction of patients, intensivists, primary physicians, and expert.
Satisfaction will be assessed using a visual analog scale (VAS). The VAS is a scale ranging from 0 to 10, with a higher score indicating greater satisfaction.
Measured: at 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active MalignanciesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge design
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423795
- Sponsor's protocol ID
- P 150954J
- Acronym
- EXPERT-IS
- Status last verified
- Jun 2022
- First submitted
- 14 Jun 2022
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU : A Stepped Wedge Cluster-randomised Trial
- ClinicalTrials.gov ID
- NCT05423795
- Acronym / sponsor ID
- EXPERT-IS / P 150954J
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Jun 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.
Admission to the intensive care unit (ICU) is a common event in patients treated for solid tumors or hematologic malignancies. A volume-outcome relationship has been shown in these patients, with a mortality rate decreasing from 70% in low-volume centres to 30-40% in high-volume centres.
We hypothesize that providing the low-volume centres with assistance from experts working in high-volume centres for the management of critically-ill cancer patients can bring down mortality to the values seen in high-volume centres.
The main objective of this study is to evaluate whether combining three knowledge-transfer methods (videoconference-based forum, educational sessions, and dissemination of published work) increases the survival of cancer patients managed in low-volume centres to the values seen in high-volume centres.
The main endpoint is all-cause mortality at hospital discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge design
| Arm | Type | Receives |
|---|---|---|
| Comparator Arm | Other | Other: Standard of care armClassic expertise (as routinely performed in the participating ICU) |
| Telemedicine-based intervention | Experimental | Other: Telemedicine-based interventionTelemedicine-based expert advice. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (> 18 years old)
- Active malignancy;
- ICUs seeking for an advice must admit fewer than 30 patients with active cancer per year;
- Patients has been urgently admitted in the ICU for a life threatening complication of the malignancy or its treatments.
Key exclusion criteria (5 listed)
- Isolated HIV infection or AIDS;
- ICU admission complicating scheduled surgery,
- Treatment-limitation decisions at admission;
- No coverage by the French statutory health insurance system,
- Pregnant or breastfeeding
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-based interventionTelemedicine-based intervention Multifaceted intervention including daily videoconferences with audit and feedback, educational interventions, and dissemination of published works | Other | Telemedicine-based intervention |
| Standard of care armClassic expertise (as routinely performed in the participating ICU) | Other | Comparator Arm |
Primary outcome
All-cause mortality
Time frame: at hospital discharge (up to 28 days)
14 secondary outcomes
Number of changes based on expert opinion
Time frame: at 28 days
Number of invasive diagnostic tests used
Time frame: at 28 days
Number of non-invasive diagnostic tests used
Time frame: at 28 days
Proportion of patients with non-invasive ventilation and/or high flow oxygen
Time frame: at 28 days
Proportion of patients in whom the cause for ICU admission remained undetermined
Time frame: at 28 days
Number of days without life-supporting interventions
Time frame: at 28 days
Number of anti-microbial agents
Time frame: at 28 days
Number of blood transfusions
Time frame: at 28 days
Number of chemotherapy
Time frame: at 28 days
Proportion of patients with antibiotic de-escalation
Time frame: at 28 days
Duration of antibiotic therapy
Time frame: up to 28 days
Length of ICU stay
Time frame: at hospital discharge (up to 28 days)
Proportion of ICU-acquired events
Time frame: at 28 days
Satisfaction of patients, intensivists, primary physicians, and expert.
Time frame: at 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine-based intervention in people with Active Malignancies and Life Threatening Complication of the Malignancy or Its Treatments, run by Assistance Publique - Hôpitaux de Paris.
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 5 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 21 Jun 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 Elie AZOULAY, Pr (+33142499421, elie.azoulay@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: at hospital discharge (up to 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2022.