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

A

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)

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

Trial contacts and locations

0

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Central trial contact

Elie AZOULAY, Pr; Matthieu Resche-Rigon, Pr

Data sourced from clinicaltrials.gov

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