Clinical trial NCT06047600: Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination (UroCCR 126)
Official title: Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Digitizing Perioperative Nursing Coordination
Keywords: Kidney tumor
Digital tool
Care pathways
Cost analysis
Health economic evaluation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 858
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: cross-sectional stepped wedge cluster randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The project proposes to evaluate the interest of the UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination

Detailed description: Kidney cancer represents 2 to 3% of solid cancers in adults. Worldwide, an estimated 431,288 people a year are diagnosed with kidney cancer. Each year, in France, 13,500 patients undergo total or partial nephrectomy. The development of minimally invasive surgical techniques and the structuring of innovative care pathways for the management of renal tumors in Enhanced Rehabilitation After Surgery (RAAC) and even on an outpatient basis have led to a significant reduction in the length of stays. The physiognomy of the course of care for patients operated on for a renal tumor is completely modified and generates for the patient a feeling of deterioration in the quality of care and disruption of medical follow-up.

The objective is to deploy a model for coordinating the perioperative care pathway of patients who have undergone nephrectomy for renal tumor in several French centers in order to assess the impact for patients, caregivers and the health system.

This coordination would lead to the formalization of a nurse coordinator job profile adapted to the specificities of oncological surgery and the tools necessary for its implementation. The UroConnect device has a "patient" interface for presenting self-questionnaires and access to a library of educational content and a "caregiver" interface to rationalize and optimize the nurse's activity of perioperative coordination in his task.

Eligibility criteria: Inclusion Criteria:

* Planned surgical management by total or partial nephrectomy for kidney tumor,
* Affiliation or beneficiary of the French social security
* Expressed consent for integration of the UroCCR cohort,
* Expressed consent to participate in the DiPRU study.

Exclusion Criteria:

* Difficulties understanding and expressing oneself in French
* Participant under guardianship or curatorship
* Pregnancy at the time of surgery
* No internet access

Primary outcomes:
measure: Number of unscheduled and uncoordinated care utilizations
timeFrame: 30 post-operative days
Secondary outcomes:
measure: Patient anxiety evaluation
timeFrame: Day-1
measure: Hospitalised patient satisfaction and experience evaluation
timeFrame: Day-30 post-op
measure: Nature and reasons for seeking care
timeFrame: Day 30
measure: Average length of stay
timeFrame: Day 30
measure: UroConnect usage
timeFrame: Month 24
measure: Nursing coordination activity linked to UroConnect
timeFrame: Month 24
measure: Qualitative analysis of the obstacles and levers to appropriation of UroConnect
timeFrame: Month 24
measure: Differential real cost for the Hospital
timeFrame: Month 24
measure: Differential cost-consequence ratio
timeFrame: Day 30
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Cabestany
country: France
facility: Centre Catalan d'Urologie
city: Caen
country: France
facility: CHU de Caen
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Marseille
country: France
facility: APHM
city: Mont-de-Marsan
country: France
facility: CH de Mont de Marsan
city: Nîmes
country: France
facility: CHU de Nîmes
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHu de Toulouse
Study officials:
References: