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

NCT ID: NCT05423795

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Comparator Arm

Classic expertise (as routinely performed in the participating ICU)

Group Type: OTHER

Standard of care arm

Intervention Type: OTHER

Classic expertise (as routinely performed in the participating ICU)

Telemedicine-based intervention

Telemedicine-based expert advice.

Group Type: EXPERIMENTAL

Telemedicine-based intervention

Intervention Type: OTHER

Telemedicine-based intervention Multifaceted intervention including daily videoconferences with audit and feedback, educational interventions, and dissemination of published works

Interventions

Telemedicine-based intervention

Telemedicine-based intervention Multifaceted intervention including daily videoconferences with audit and feedback, educational interventions, and dissemination of published works

Intervention Type: OTHER

Standard of care arm

Classic expertise (as routinely performed in the participating ICU)

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Elie AZOULAY, Pr

Role: CONTACT

elie.azoulay@aphp.fr

+33142499421

Matthieu Resche-Rigon, Pr

Role: CONTACT

matthieu.resche-rigon@u-paris.fr

+33142499742

Other Identifiers

P 150954J

Identifier Type: -

Identifier Source: org_study_id