The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON)

Official title

The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery

Overview

The goal of this clinical trial is to demonstrate that simulation training for paramedical staff in neurosurgery departments, in announcing and accompanying patients with a brain tumor, improves patient satisfaction when a (potentially malignant) brain tumor is discovered, compared with usual care. The main question it aims to answer is: \- Are patients more satisfied (as measured by scores on the EORCT IN-PATSAT32 questionnaire) with their neurosurgical hospitalization following the discovery of a brain tumor in centers where paramedics have been trained by simulation? Researchers will compare the results of the EORTC IN-PATSAT32 questionnaire to determine whether paramedic training improves patient satisfaction between simulation-trained and untrained centers. Participants will be asked to complete the EORT IN-PATSAT32 questionnaire at the end of their hospital stay.

Interventions

• Other Paramedic training
  Nurses and care assistants at the centers randomized to the "with training" arm will undergo a day-and-a-half of training to help them support patients diagnosed with brain tumors. Training consists of half a day of theory, followed by a day of simulation.

Primary outcome measures

• Measuring patient satisfaction following the discovery of a brain tumor. [Time frame: The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)]

Secondary outcome measures (6)

• Measurement of patients' experiences following the discovery of a brain tumor via scores obtained (other questionnaire items) [Time frame: The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)]
• Measuring patients' feelings [Time frame: The day of discharge from neurosurgery, on average 8 days (between 1 days and 15 days)]
• Measuring Caregivers' Experiences/Quality of Life at Work [Time frame: Day 0 and Month 6]
• Measurement of caregivers' listening skills. [Time frame: Day 0, after training and Month 6]
• Measuring communication within the paramedical team [Time frame: Day 0 and Month 6]
• Measuring communication between paramedical and medical teams. [Time frame: Day 0 and Month 6]

Eligibility criteria

Inclusion criteria

• Patient over 18 years of age
• Patient covered by a social security scheme
• Patient signed informed consent form
• Patient found to have a brain tumor (potentially malignant, primary or secondary if this is the mode of entry into the disease)
• Hospitalization in the Neurosurgery Department at the time of tumor discovery, before the histological diagnosis is announced.

Exclusion criteria

• Patients with a personal history of cancer
• Patient without family AND unable to receive information

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

France · 11 centers

• CHU Brest — Brest
• CHU Amiens — Amiens
• CHU Angers — Angers
• CHU Bordeaux — Bordeaux
• APHM Nord — Marseille
• CHU Nantes — Nantes
• CHU Nice — Nice
• CHU Rouen — Rouen
• … and 3 more centers

Identifiers

NCT: NCT06962215 · 29BRC24.0039 - IPSIMANON · 2024-A00353-44

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗