Clinical trial NCT05423795: A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU
Official title: A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU : A Stepped Wedge Cluster-randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Active Malignancies
Life Threatening Complication of the Malignancy or Its Treatments
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 256
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge design
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality
timeFrame: at hospital discharge (up to 28 days)
Secondary outcomes:
measure: Number of changes based on expert opinion
timeFrame: at 28 days
measure: Number of invasive diagnostic tests used
timeFrame: at 28 days
measure: Number of non-invasive diagnostic tests used
timeFrame: at 28 days
measure: Proportion of patients with non-invasive ventilation and/or high flow oxygen
timeFrame: at 28 days
measure: Proportion of patients in whom the cause for ICU admission remained undetermined
timeFrame: at 28 days
measure: Number of days without life-supporting interventions
timeFrame: at 28 days
measure: Number of anti-microbial agents
timeFrame: at 28 days
measure: Number of blood transfusions
timeFrame: at 28 days
measure: Number of chemotherapy
timeFrame: at 28 days
measure: Proportion of patients with antibiotic de-escalation
timeFrame: at 28 days
measure: Duration of antibiotic therapy
timeFrame: up to 28 days
measure: Length of ICU stay
timeFrame: at hospital discharge (up to 28 days)
measure: Proportion of ICU-acquired events
timeFrame: at 28 days
measure: Satisfaction of patients, intensivists, primary physicians, and expert.
timeFrame: at 28 days
Other outcomes:
Locations:
Study officials:
References: