DiPRU: Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination (UroCCR 126)

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06047600
Collaborator
(none)
858
11
2
26
78
3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Uroconnect Follow Up Group
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
858 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
cross-sectional stepped wedge cluster randomized controlled trialcross-sectional stepped wedge cluster randomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

The control group is based on the pre-existing organization, with no digital patient follow-up tools.

Experimental: Uroconnect Follow Up Group

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

Other: Uroconnect Follow Up Group
Inplementation of UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination.

Outcome Measures

Primary Outcome Measures

  1. Number of unscheduled and uncoordinated care utilizations [30 post-operative days]

    In the 30 post-operative days, number of unscheduled and uncoordinated care utilizations (emergency visits, re-hospitalizations in urology, general medicine or urology consultations) corresponding to the difference between the use of care identified in the National health data system (SNDS) and scheduled and coordinated care, identified in the patient file of the initial hospitalization for scheduled care and by the coordinating nurse for coordinated care.

Secondary Outcome Measures

  1. Patient anxiety evaluation [Day-1]

    Patient anxiety measured by the State-Trait Anxiety Inventory STAI, The STAI questionnaire assesses anxiety as a personality trait and an emotional state and comprised 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: "I am tense; I am worried" and "I feel calm; I feel secure." Trait anxiety items include: "I worry too much over something that really doesn't matter" and "I am content; I am a steady person." All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

  2. Hospitalised patient satisfaction and experience evaluation [Day-30 post-op]

    Patient satisfaction and experience measured by the e-Satis questionnaire .The e-satis questionnaire was created and validated in French by the Haute Autorité de Santé (HAS). It is used as a continuous measure of inpatient satisfaction and experience. It is therefore routinely collected by the HAS. the e-Satis questionnaires are divided into "dimensions" of the patient pathway (from admission to discharge). Patients respond on a scale ranging from "poor" to "excellent" or from "never" to "always". For each dimension, an overall patient experience and satisfaction score is calculated (A score calculation guide is available on the HAS website).

  3. Nature and reasons for seeking care [Day 30]

    Nature and reasons for seeking care declared by the patient and confirmed by the doctor who treated him/her

  4. Average length of stay [Day 30]

    Number of re-hospitalizations for complications at D30, use of medical care (medical consultations and hospitalizations) in the 30 days following surgery (SNDS).

  5. UroConnect usage [Month 24]

    Number of alerts generated by UroConnect.

  6. Nursing coordination activity linked to UroConnect [Month 24]

    Evaluation of nurse activity due to patient requests on UroConnect

  7. Qualitative analysis of the obstacles and levers to appropriation of UroConnect [Month 24]

    In each center, professionals and patients will be asked to take part in an individual interviews. This interview will focus on understanding the determining factors in the appropriation of the system and its impact from the point of view of professionals and patients, by identifying 1/ the factors that hinder and encourage appropriation of the system, 2/ the nature of the changes brought about in professional practice and in the patient's care pathway, the patient's feelings in terms of effects on his or her quality of life, disease management and relationship with carers, 3/ the individual, contextual, sociocultural and technical factors in the effectiveness of the intervention.Interview guides will be drawn up in advance, in line with the objectives and hypotheses of the research, and based on the findings of existing literature, such as theoretical models of behavioral and organizational change.

  8. Differential real cost for the Hospital [Month 24]

    Difference in actual costs (€), from the hospital's point of view, between phases with and without the digital tool .

  9. Differential cost-consequence ratio [Day 30]

    Difference in inpatient and outpatient costs (€) between the 2 strategies

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU d'Angers Angers France
2 CHU de Bordeaux Bordeaux France
3 Centre Catalan d'Urologie Cabestany France
4 CHU de Caen Caen France
5 Hôpital Henri Mondor Créteil France
6 APHM Marseille France
7 CH de Mont de Marsan Mont-de-Marsan France
8 CHU de Nîmes Nîmes France
9 CHU de Rennes Rennes France
10 CHU de Strasbourg Strasbourg France
11 CHu de Toulouse Toulouse France

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT06047600
Other Study ID Numbers:
  • CHUBX2022/77
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023