Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529887
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
What Does the Patient Experience Represent for Patients and Caregivers in Dialysis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluate the Vision Expectations of Patients and Caregivers for Patient-Reported Experience Measures PREMs Single-Center Prospective Study Calydial Mixed Research Quantitative and Qualitative
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EnquêteXP
Brief Summary:
The primary objective of this work is to describe the vision representations and beliefs of professionals and patients regarding the role and place of the user during their care journey at the Calydial renal health facility
Methodology a mixed qualitative and quantitative research
Qualitative research semi-structured interviews with patients and caregivers The objective is to define the meaning of the patient experience from the perspectives of patients and caregivers
Single-center prospective quantitative study design of two questionnaires one for patients and one for caregivers The objectives of the questionnaires are to
Evaluate the feelings experiences and representationsbeliefs of the patient experience by caregivers and patients
Assess the understanding of the patient experience by caregivers and patients
Compare the patient experience based on the following parameters age of patients gender treatment duration treatment location treatment modality patient autonomy
Measure the gap between patient and caregiver perspectives to identifyadjust actions
Methodology a mixed qualitative and quantitative research
Qualitative research semi-structured interviews with patients and caregivers The objective is to define the meaning of the patient experience from the perspectives of patients and caregivers
Single-center prospective quantitative study design of two questionnaires one for patients and one for caregivers The objectives of the questionnaires are to
Evaluate the feelings experiences and representationsbeliefs of the patient experience by caregivers and patients
Assess the understanding of the patient experience by caregivers and patients
Compare the patient experience based on the following parameters age of patients gender treatment duration treatment location treatment modality patient autonomy
Measure the gap between patient and caregiver perspectives to identifyadjust actions
Detailed Description:
Patient experience encompasses all interactions a healthcare organization has with a patient and their family potentially influencing their perceptions throughout their healthcare journey These interactions are shaped both by the policies implemented by the facility and by the personal history and culture of each patient Patient experience is a subjective concept that can be standardized and objectified Even if standardized known as a care pathway it will still be experienced differently by each patient depending on whether they are optimistic or pessimistic live alone or not and whether they reside in a rural or urban area
The objective of our work is to evaluate the experience of our care pathway the factors influencing patient experience and the caregiver experience Our facility comprises several units located in the south of Lyon and the north of Isère providing care for chronic kidney disease at all stages Our work focused on patients with stage 5 chronic kidney disease treated with hemodialysis center medically assisted dialysis unit and self-dialysis and home dialysis hemodialysis and peritoneal dialysis
The primary objective of this work is to describe the vision representations and beliefs of professionals and patients regarding the role and place of the user during their care journey at the Calydial renal health facility
Methodology mixed qualitative and quantitative research
Qualitative research semi-structured interviews with patients and caregivers The objective is to define the meaning of the patient experience from the perspectives of patients and caregivers
Single-center prospective quantitative study design of two questionnaires one for patients and one for caregivers
The objectives of the questionnaires are to
Evaluate the feelings experiences and representationsbeliefs of the patient experience by caregivers and patients
Assess the understanding of the patient experience by caregivers and patients
Compare the patient experience based on the following parameters age of patients gender treatment duration treatment location treatment modality patient autonomy
Measure the gap between patient and caregiver perspectives to identifyadjust actions
Study population The patient and caregiver questionnaires are offered to all patients and caregivers at Calydial
Inclusions The study population will consist of hemodialysis patients agreeing to respond to the questionnaire during their visit for a dialysis session
Inclusion criteria
Patient aged 18 years or older
On hemodialysis for more than 3 months in one of the participating centers
Regardless of the etiology of renal disease
Exclusion criteria
Person refusing to participate in the study
Person unable to read or understand French well enough to complete the questionnaires
Inability to express consent to participate in the study
Cognitive disorders deemed incompatible with study participation by the investigator
Psychiatric disorders deemed incompatible with study participation by the investigator
Person protected by law
Patient under legal protection safeguard of justice curatorship and guardianship
Study procedure This study is observational and exploratory non-interventional research single-center conducted using a self-administered questionnaire via electronic tablet The sponsor and investigators commit to conducting this research in accordance with the protocol Good Clinical Practice guidelines current legislative and regulatory provisions in France and internationally particularly the General Data Protection Regulation GDPR
The study is offered to hemodialysis patients during a dialysis session or consultation They are informed and their non-opposition to participation is collected Their participation consists of
Responding to an electronic self-assessment questionnaire on the patient experience A caregiver can assist the patient if necessary The questionnaire data is pseudonymized
Providing the following information age gender dialysis modality dialysis duration dialysis location participation in therapeutic education
Data collected
The quantitative questionnaire for patients will be administered on-site across all dialysis modalities It includes 4 categories to assess
Patient profile sociodemographic data
Patient care dialysis experience recognizing body reactions considering opinions feeling of being heard etc
Actions to be implemented patient participation in ETP workshops participation in working groups access to patient associations considering patient knowledge etc
Patient rights user commission user projects patient associations etc The questionnaire will be created using REDCAP software It will then be tested with 3 patients in a medically assisted dialysis unit and 2 professionals a clinical research associate and a dietitian The estimated duration of the questionnaire is 20 to 30 minutes for a patient and about 15 minutes for a professional
Data analysis An analysis of the sociodemographic and clinical characteristics of the population will be conducted The proportion of patients included within the total eligible population will be calculated and the characteristics sex age dialysis duration of included and eligible non-included patients will be compared to estimate the exhaustiveness and representativeness of the included population
A descriptive analysis will be carried out to describe the sociodemographic characteristics of the respondents Subsequently a comparative analysis will be performed to identify the expectations needs and opinions of professionals and patients for quality care Finally a multivariate analysis will be conducted to relate sociodemographic variables to the theme of the caregiver-patient relationship
Analyses will be performed using SAS 91 software A 5 bilateral threshold will be considered for defining statistical significance
The objective of our work is to evaluate the experience of our care pathway the factors influencing patient experience and the caregiver experience Our facility comprises several units located in the south of Lyon and the north of Isère providing care for chronic kidney disease at all stages Our work focused on patients with stage 5 chronic kidney disease treated with hemodialysis center medically assisted dialysis unit and self-dialysis and home dialysis hemodialysis and peritoneal dialysis
The primary objective of this work is to describe the vision representations and beliefs of professionals and patients regarding the role and place of the user during their care journey at the Calydial renal health facility
Methodology mixed qualitative and quantitative research
Qualitative research semi-structured interviews with patients and caregivers The objective is to define the meaning of the patient experience from the perspectives of patients and caregivers
Single-center prospective quantitative study design of two questionnaires one for patients and one for caregivers
The objectives of the questionnaires are to
Evaluate the feelings experiences and representationsbeliefs of the patient experience by caregivers and patients
Assess the understanding of the patient experience by caregivers and patients
Compare the patient experience based on the following parameters age of patients gender treatment duration treatment location treatment modality patient autonomy
Measure the gap between patient and caregiver perspectives to identifyadjust actions
Study population The patient and caregiver questionnaires are offered to all patients and caregivers at Calydial
Inclusions The study population will consist of hemodialysis patients agreeing to respond to the questionnaire during their visit for a dialysis session
Inclusion criteria
Patient aged 18 years or older
On hemodialysis for more than 3 months in one of the participating centers
Regardless of the etiology of renal disease
Exclusion criteria
Person refusing to participate in the study
Person unable to read or understand French well enough to complete the questionnaires
Inability to express consent to participate in the study
Cognitive disorders deemed incompatible with study participation by the investigator
Psychiatric disorders deemed incompatible with study participation by the investigator
Person protected by law
Patient under legal protection safeguard of justice curatorship and guardianship
Study procedure This study is observational and exploratory non-interventional research single-center conducted using a self-administered questionnaire via electronic tablet The sponsor and investigators commit to conducting this research in accordance with the protocol Good Clinical Practice guidelines current legislative and regulatory provisions in France and internationally particularly the General Data Protection Regulation GDPR
The study is offered to hemodialysis patients during a dialysis session or consultation They are informed and their non-opposition to participation is collected Their participation consists of
Responding to an electronic self-assessment questionnaire on the patient experience A caregiver can assist the patient if necessary The questionnaire data is pseudonymized
Providing the following information age gender dialysis modality dialysis duration dialysis location participation in therapeutic education
Data collected
The quantitative questionnaire for patients will be administered on-site across all dialysis modalities It includes 4 categories to assess
Patient profile sociodemographic data
Patient care dialysis experience recognizing body reactions considering opinions feeling of being heard etc
Actions to be implemented patient participation in ETP workshops participation in working groups access to patient associations considering patient knowledge etc
Patient rights user commission user projects patient associations etc The questionnaire will be created using REDCAP software It will then be tested with 3 patients in a medically assisted dialysis unit and 2 professionals a clinical research associate and a dietitian The estimated duration of the questionnaire is 20 to 30 minutes for a patient and about 15 minutes for a professional
Data analysis An analysis of the sociodemographic and clinical characteristics of the population will be conducted The proportion of patients included within the total eligible population will be calculated and the characteristics sex age dialysis duration of included and eligible non-included patients will be compared to estimate the exhaustiveness and representativeness of the included population
A descriptive analysis will be carried out to describe the sociodemographic characteristics of the respondents Subsequently a comparative analysis will be performed to identify the expectations needs and opinions of professionals and patients for quality care Finally a multivariate analysis will be conducted to relate sociodemographic variables to the theme of the caregiver-patient relationship
Analyses will be performed using SAS 91 software A 5 bilateral threshold will be considered for defining statistical significance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None