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

Not Applicable

Not yet recruiting

• Conditions: Life Threatening Complication of the Malignancy or Its Treatments; Active Malignancies
• Interventions: Other: Telemedicine-based intervention; Other: Standard of care arm

• Registration Number: NCT05423795
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Last Update Submitted: 2022-06-14
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 256

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Telemedicine-based intervention	Telemedicine-based intervention	Telemedicine-based expert advice.
Comparator Arm	Standard of care arm	Classic expertise (as routinely performed in the participating ICU)

Primary Outcome Measures

Name	Time	Method
All-cause mortality	at hospital discharge (up to 28 days)

Secondary Outcome Measures

Name	Time	Method
Number of chemotherapy	at 28 days
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 with antibiotic de-escalation	at 28 days
Satisfaction of patients, intensivists, primary physicians, and expert.	at 28 days	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.
Number of days without life-supporting interventions	at 28 days
Duration of antibiotic therapy	up to 28 days
Proportion of patients in whom the cause for ICU admission remained undetermined	at 28 days
Number of anti-microbial agents	at 28 days
Number of blood transfusions	at 28 days
Length of ICU stay	at hospital discharge (up to 28 days)
Proportion of ICU-acquired events	at 28 days