A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU

Study Overview
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Brief Summary
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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.

Official Title
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A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU : A Stepped Wedge Cluster-randomised Trial

Conditions
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Active Malignancies, Life Threatening Complication of the Malignancy or Its Treatments

Intervention / Treatment
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* Other: Telemedicine-based intervention
* Other: Standard of care arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped wedge design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Comparator Arm<br>Classic expertise (as routinely performed in the participating ICU) | Other: Standard of care arm<br>* Classic expertise (as routinely performed in the participating ICU)<br>|
| Experimental: Telemedicine-based intervention<br>Telemedicine-based expert advice. | Other: Telemedicine-based intervention<br>* Telemedicine-based intervention Multifaceted intervention including daily videoconferences with audit and feedback, educational interventions, and dissemination of published works<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | at hospital discharge (up to 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of changes based on expert opinion |  | at 28 days | 
| Number of invasive diagnostic tests used |  | at 28 days | 
| Number of non-invasive diagnostic tests used |  | at 28 days | 
| Proportion of patients with non-invasive ventilation and/or high flow oxygen |  | at 28 days | 
| Proportion of patients in whom the cause for ICU admission remained undetermined |  | at 28 days | 
| Number of days without life-supporting interventions |  | at 28 days | 
| Number of anti-microbial agents |  | at 28 days | 
| Number of blood transfusions |  | at 28 days | 
| Number of chemotherapy |  | at 28 days | 
| Proportion of patients with antibiotic de-escalation |  | at 28 days | 
| Duration of antibiotic therapy |  | up to 28 days | 
| Length of ICU stay |  | at hospital discharge (up to 28 days) | 
| Proportion of ICU-acquired events |  | 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. | at 28 days |