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OpenTrials
Active, Not Recruiting

NCT Number: NCT06819345

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey form

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

Primary outcomes

  1. Patient related experience measure (PREM)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Patients and Health Providers Experience and Choice of Treatment in End Stage Renal Disease

Acronym: PEACE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 11, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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