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

NCT05423795 | Unknown

• 1 other identifier: P 150954J
• Study Type: interventional
• Target: 256
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  at hospital discharge (up to 28 days)

Secondary Outcomes (14)

• Number of changes based on expert opinion

  at 28 days

• 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

Study Arms (2)

Comparator Arm

OTHER

Classic expertise (as routinely performed in the participating ICU)

Other: Standard of care arm

Telemedicine-based intervention

EXPERIMENTAL

Telemedicine-based expert advice.

Other: Telemedicine-based intervention

Interventions

Telemedicine-based intervention OTHER

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

Telemedicine-based intervention

Standard of care arm OTHER

Classic expertise (as routinely performed in the participating ICU)

Comparator Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\> 18 years old)
• Active malignancy;
• ICUs seeking for an advice must admit fewer than 30 patients with active cancer per year;
• Patients has been urgently admitted in the ICU for a life threatening complication of the malignancy or its treatments.

You may not qualify if:

• Isolated HIV infection or AIDS;
• ICU admission complicating scheduled surgery,
• Treatment-limitation decisions at admission;
• No coverage by the French statutory health insurance system,
• Pregnant or breastfeeding

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Central Study Contacts

Elie AZOULAY, Pr

CONTACT

+33142499421; elie.azoulay@aphp.fr

Matthieu Resche-Rigon, Pr

CONTACT

+33142499742; matthieu.resche-rigon@u-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge design

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 21, 2022
• Study Start: June 1, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 21, 2022

Record last verified: 2022-06