Clinical trial NCT06819345: Impact of PREMs in the Shared Decision Process for Renal Replacement Treatment Methods.
Official title: Patients and Health Providers Experience and Choice of Treatment in End Stage Renal Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Kidney Disease, Stage 4 (Severe)
Chronic Kidney Disease, Stage 5
Keywords: Chronic kidney disease
renal replacement therapy,
caregivers
PREM
PROM
shared decision making
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from the CKD patients cohort followed at the nephrology department Hôpital Edouard Herriot with at least 3 months of follow up at the department and referred to the consultation for renal replacement therapies information.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient related experience measure (PREM)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Nephrology, Hypertension, dialysis department of Edouard Herriot hospital
Study officials:
References: