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

A Multifaceted Telemedicine-Based Intervention to Improve Outcomes of Cancer Patients Admitted to the ICU : A Stepped Wedge Cluster-randomised Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Active Malignancies; Life Threatening Complication of the Malignancy or Its Treatments
• Intervention / Treatment: Other: Standard of care arm; Other: Telemedicine-based intervention

• Study Type: Interventional
• Enrollment (Anticipated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elie AZOULAY, Pr; Phone Number: +33142499421; Email: elie.azoulay@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Comparator Arm; Classic expertise (as routinely performed in the participating ICU)	Other: Standard of care arm; Classic expertise (as routinely performed in the participating ICU)
Experimental: Telemedicine-based intervention; Telemedicine-based expert advice.	Other: Telemedicine-based intervention; Telemedicine-based intervention Multifaceted intervention including daily videoconferences with audit and feedback, educational interventions, and dissemination of published works

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	at hospital discharge (up to 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of days without life-supporting interventions		at 28 days
Number of anti-microbial agents		at 28 days
Number of blood transfusions		at 28 days
Number of chemotherapy		at 28 days
Proportion of patients with antibiotic de-escalation		at 28 days
Duration of antibiotic therapy		up to 28 days
Length of ICU stay		at hospital discharge (up to 28 days)
Proportion of ICU-acquired events		at 28 days
Satisfaction of patients, intensivists, primary physicians, and expert.	Satisfaction will be assessed using a visual analog scale (VAS). The VAS is a scale ranging from 0 to 10, with a higher score indicating greater satisfaction.	at 28 days

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): July 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: P 150954J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No