A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU (EXPERT-IS)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

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

Treatments: Other: Telemedicine-based intervention; Other: Standard of care arm

Study type: Interventional

Funder types: Other

Identifiers

NCT05423795

P 150954J

Details and patient eligibility

About

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.

Enrollment: 256 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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256 participants in 2 patient groups

Comparator Arm

Other group

Description:

Classic expertise (as routinely performed in the participating ICU)

Treatment:

Other: Standard of care arm

Telemedicine-based intervention

Experimental group

Description:

Telemedicine-based expert advice.

Treatment:

Other: Telemedicine-based intervention