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

NCT ID: NCT06819345

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2028-01-01

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.

Conditions

Chronic Kidney Disease, Stage 4 (Severe); Chronic Kidney Disease, Stage 5

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

-Patients with chronic renal disease stage 4-5 not on dialysis followed by a nephrologist for at least three months.

Survey form

Intervention Type: OTHER

PPE15 (Picker Patient Experience Questionnaire) at all visit of the study KDQOL-SF (Kidney Disease Quality Of Life -short form) at inclusion and 3 months after initiation of RRT ou 24 months after inclusion SDMQ9 (Shared Decision Making Questionnaire): at inclusion and 3 months after receiving information related to RRT SDRS (Score Decision Regret Scale) : 3 months after initiation of RRT ou 24 months after inclusion HLS EU 16 (Health Literacy Survey) : at inclusion or 3 months after information on RRT

Caregivers

First non-professional natural caregiver identified by the patient for all voluntary caregivers.

• Caregiver with a sufficient level of oral comprehension of French, able to understand the research

Survey form

Intervention Type: OTHER

PPE15 (Picker Patient Experience Questionnaire) at all visit of the study KDQOL-SF (Kidney Disease Quality Of Life -short form) at inclusion and 3 months after initiation of RRT ou 24 months after inclusion SDMQ9 (Shared Decision Making Questionnaire): at inclusion and 3 months after receiving information related to RRT SDRS (Score Decision Regret Scale) : 3 months after initiation of RRT ou 24 months after inclusion HLS EU 16 (Health Literacy Survey) : at inclusion or 3 months after information on RRT

Health professionals

Nephrologists and nurses or other health professionals caring for patients included in the study.

Survey form

Intervention Type: OTHER

PPE15 (Picker Patient Experience Questionnaire) at all visit of the study KDQOL-SF (Kidney Disease Quality Of Life -short form) at inclusion and 3 months after initiation of RRT ou 24 months after inclusion SDMQ9 (Shared Decision Making Questionnaire): at inclusion and 3 months after receiving information related to RRT SDRS (Score Decision Regret Scale) : 3 months after initiation of RRT ou 24 months after inclusion HLS EU 16 (Health Literacy Survey) : at inclusion or 3 months after information on RRT

Interventions

Survey form

PPE15 (Picker Patient Experience Questionnaire) at all visit of the study KDQOL-SF (Kidney Disease Quality Of Life -short form) at inclusion and 3 months after initiation of RRT ou 24 months after inclusion SDMQ9 (Shared Decision Making Questionnaire): at inclusion and 3 months after receiving information related to RRT SDRS (Score Decision Regret Scale) : 3 months after initiation of RRT ou 24 months after inclusion HLS EU 16 (Health Literacy Survey) : at inclusion or 3 months after information on RRT

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nephrology, Hypertension, dialysis department of Edouard Herriot hospital

Lyon, , France

Countries

France

Other Identifiers

908

Identifier Type: -

Identifier Source: org_study_id