Active Malignancies, Life Threatening Complication of the Malignancy or Its Treatments
Conditions
Brief 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. 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.
Interventions
OTHERTelemedicine-based intervention
Telemedicine-based intervention Multifaceted intervention including daily videoconferences with audit and feedback, educational interventions, and dissemination of published works
OTHERStandard of care arm
Classic expertise (as routinely performed in the participating ICU)
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Stepped wedge design
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients (\> 18 years old) 2. Active malignancy; 3. ICUs seeking for an advice must admit fewer than 30 patients with active cancer per year; 4. Patients has been urgently admitted in the ICU for a life threatening complication of the malignancy or its treatments.
Exclusion criteria
1. Isolated HIV infection or AIDS; 2. ICU admission complicating scheduled surgery, 3. Treatment-limitation decisions at admission; 4. No coverage by the French statutory health insurance system, 5. Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | at hospital discharge (up to 28 days) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 changes based on expert opinion | 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. | at 28 days | 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. |
| Number of blood transfusions | at 28 days | — |
Contacts
Primary ContactElie AZOULAY, Pr
Backup ContactMatthieu Resche-Rigon, Pr
Outcome results
None listed