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

Primary Purpose

Digitizing Perioperative Nursing Coordination

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Uroconnect Follow Up Group
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Digitizing Perioperative Nursing Coordination focused on measuring Kidney tumor, Digital tool, Care pathways, Cost analysis, Health economic evaluation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU d'Angers
  • CHU de Bordeaux
  • Centre Catalan d'Urologie
  • CHU de Caen
  • Hôpital Henri Mondor
  • APHM
  • CH de Mont de Marsan
  • CHU de Nîmes
  • CHU de Rennes
  • CHU de Strasbourg
  • CHu de Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Uroconnect Follow Up Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of unscheduled and uncoordinated care utilizations
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

Patient anxiety evaluation
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.
Hospitalised patient satisfaction and experience evaluation
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).
Nature and reasons for seeking care
Nature and reasons for seeking care declared by the patient and confirmed by the doctor who treated him/her
Average length of stay
Number of re-hospitalizations for complications at D30, use of medical care (medical consultations and hospitalizations) in the 30 days following surgery (SNDS).
UroConnect usage
Number of alerts generated by UroConnect.
Nursing coordination activity linked to UroConnect
Evaluation of nurse activity due to patient requests on UroConnect
Qualitative analysis of the obstacles and levers to appropriation of UroConnect
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.
Differential real cost for the Hospital
Difference in actual costs (€), from the hospital's point of view, between phases with and without the digital tool .
Differential cost-consequence ratio
Difference in inpatient and outpatient costs (€) between the 2 strategies

Full Information

First Posted
September 6, 2023
Last Updated
September 14, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT06047600
Brief Title
Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination (UroCCR 126)
Acronym
DiPRU
Official Title
Optimization of the Surgical Care Pathway for Kidney Tumors by Digitizing Perioperative Nursing Coordination
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digitizing Perioperative Nursing Coordination
Keywords
Kidney tumor, Digital tool, Care pathways, Cost analysis, Health economic evaluation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
cross-sectional stepped wedge cluster randomized controlled trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
858 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group is based on the pre-existing organization, with no digital patient follow-up tools.
Arm Title
Uroconnect Follow Up Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Uroconnect Follow Up Group
Intervention Description
Inplementation of UroConnect remote monitoring Medical Device (DM) to optimize patient support and nursing coordination.
Primary Outcome Measure Information:
Title
Number of unscheduled and uncoordinated care utilizations
Description
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.
Time Frame
30 post-operative days
Secondary Outcome Measure Information:
Title
Patient anxiety evaluation
Description
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.
Time Frame
Day-1
Title
Hospitalised patient satisfaction and experience evaluation
Description
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).
Time Frame
Day-30 post-op
Title
Nature and reasons for seeking care
Description
Nature and reasons for seeking care declared by the patient and confirmed by the doctor who treated him/her
Time Frame
Day 30
Title
Average length of stay
Description
Number of re-hospitalizations for complications at D30, use of medical care (medical consultations and hospitalizations) in the 30 days following surgery (SNDS).
Time Frame
Day 30
Title
UroConnect usage
Description
Number of alerts generated by UroConnect.
Time Frame
Month 24
Title
Nursing coordination activity linked to UroConnect
Description
Evaluation of nurse activity due to patient requests on UroConnect
Time Frame
Month 24
Title
Qualitative analysis of the obstacles and levers to appropriation of UroConnect
Description
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.
Time Frame
Month 24
Title
Differential real cost for the Hospital
Description
Difference in actual costs (€), from the hospital's point of view, between phases with and without the digital tool .
Time Frame
Month 24
Title
Differential cost-consequence ratio
Description
Difference in inpatient and outpatient costs (€) between the 2 strategies
Time Frame
Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Christophe Bernhard, MD, PhD
Phone
05.57.82.06.87
Email
Jean-christophe.bernhard@chu-bordeaux.fr
Facility Information:
Facility Name
CHU d'Angers
City
Angers
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Bigot, Pr
Email
PiBigot@chu-angers.fr
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Bernhard, MD,PhD
Email
Jean-christophe.bernhard@chu-bordeaux.fr
Facility Name
Centre Catalan d'Urologie
City
Cabestany
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Gimel, Dr
Email
gimel@urologie66.fr
Facility Name
CHU de Caen
City
Caen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaut Waeckel, Dr
Phone
02.31.06.49.47
Facility Name
Hôpital Henri Mondor
City
Créteil
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Ingels, Dr
Email
alexandre.ingels@aphp.fr
Facility Name
APHM
City
Marseille
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Boissier, Pr
Email
romain.boissier@ap-hm.fr
Facility Name
CH de Mont de Marsan
City
Mont-de-Marsan
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Patard, Pr
Email
jean-jacques.patard@ch-mdm.fr
Facility Name
CHU de Nîmes
City
Nîmes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis Fontenil, Dr
Email
alexis.fontenil@chu-nimes.fr
Facility Name
CHU de Rennes
City
Rennes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim BENSALAH, Pr
Email
karim.bensalah@chu-rennes.fr
Facility Name
CHU de Strasbourg
City
Strasbourg
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé LANG, Pr.
Email
herve.lang@chru-strasbourg.fr
Facility Name
CHu de Toulouse
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Doumerc, Dr
Email
doumerc.n@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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