Impact of PREMs in the Shared Decision Process for Renal Replacement Treatment Methods.

Active, not recruiting

• Conditions: Chronic Kidney Disease, Stage 4 (Severe); Chronic Kidney Disease, Stage 5

• Registration Number: NCT06819345
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The French "my health 2022" plan is the first bundled payment initiative for stage 4 and 5 chronic kidney disease (CKD) pathway with the aim to improve the quality of care and promote a multi professional collaboration for a more holistic approach of healthcare. Renal Replacement therapies (RRT) have a significant impact on the quality of life and autonomy of patients and their caregivers. The transition to these treatments is a critical point in the pathway, involving a complex choice for patients that cannot be based solely on medical considerations but requires to assess the needs and preferences of patients and their caregivers in order to improve their experience and the quality of care. The investigators propose to conduct a prospective cohort study aimed at 1/ describing the patient and caregiver experience, patient related outcome measures (PROM) and the quality of life in relation to the decision-making process 2/ identifying the individual factors (socio-cultural, health literacy) associated with the patient experience, 3/ assessing the expectations and needs of patients regarding the information and support received during the process, and 4/ describing the perceptions of caregivers and professionals regarding the information provided and the decision-making process. The assessments will be conducted by questionnaires before, 3 months after the information on RRT and 3 months after the initiation of RRT or 24 months after the initial information for patients and caregivers and at the time of information on RRT for professionals. The data from the questionnaires will be further explored by a qualitative survey in a subgroup of patients and caregivers. The results of this study will help identify the factors determining the choice and satisfaction of patients and their caregivers in order to adapt the decision making support and thus have a patient-centered approach.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-01
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Patients

• Stage 4-5 chronic kidney disease not on dialysis with a nephrologist follow up >3 months
• Glomerular filtration rate estimated by the CKD EPI formula < 20 ml/min/1.73 m2,
• Referred for consultation and information on renal replacement therapies.
• Age >18 years old.
• Patient with a sufficient level of oral comprehension of French, able to understand the research

Exclusion Criteria

• significant cognitive disorders preventing decision making
• patients under guardianship, or legal protection
• referred for ultrafiltration in the context of cardio renal syndrome

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient related experience measure (PREM)	3 months after the announcement of stage V renal failure during the usual follow-up nephrology consultation And 3 months after the start of renal replacement therapy	The main objective is to describe and monitor the evolution of the chronic renal failure patient experience during the decision-making process regarding renal replacement therapies (PD, HD or transplantation).; Using the questionnaire : Picker Patient Experience PPE15

Trial Locations

Locations (1)

Nephrology, Hypertension, dialysis department of Edouard Herriot hospital; 🇫🇷 Lyon, France