Pathways to Equitable Access to Kidney Transplantation in Spain: A Transformative Mixed-methods Study Protocol
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital del Mar
About this trial
Introduction. Chronic kidney disease (CKD) affects 10%-15% of the global population and is projected to become the fifth leading cause of years of life lost by 2040. Despite the benefits of kidney transplantation (KT), access remains inequitable. In Spain, which leads the world in KT rates per million population, disparities may persist due to structural, territorial, and professional barriers. This study aims to explore the mechanisms underlying treatment deprivation and inequity in KT access using a mixed-methods approach.
Methods and analysis. A transformative mixed-methods design will be implemented in four phases: (1) systematic reviews on instruments assessing treatment deprivation and inequalities in CKD and KT; (2) a multicenter quantitative study and qualitative interviews with professionals and patients; (3) a pre-experimental evaluation of a training program on KT; and (4) triangulation and translation of findings to inform national policy. The protocol adheres to GRAMMS and PRISMA guidelines.
Ethics and dissemination. Approved by the Hospital del Mar Research Institute Ethics Committee (ID: XX), the study complies with EU data protection laws. Informed consent will be obtained. Findings will be disseminated via peer-reviewed publications, conferences, social media, and patient forums to support equity-focused strategies in KT.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
People with CKD
Disqualifiers
Pediatrics
Trial population
A transformative mixed-methods design will be implemented in four phases: (1) systematic reviews on instruments assessing treatment deprivation and inequalities in CKD and KT; (2) a multicenter quantitative study and qualitative interviews with professionals and patients; (3) a pre-experimental evaluation of a training program on KT; and (4) triangulation and translation of findings to inform national policy.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Description
Other interventionNo intervention
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Inequities in access to kidney transplantation among individuals with chronic kidney disease
Quantitative assessment of inequities in access to kidney transplantation using validated questionnaires developed in Phase 1, complemented by sociodemographic and clinical variables. The outcome will measure disparities according to age, sex, socioeconomic status, region, and clinical condition.
Time frame
Baseline (at study inclusion)Secondary outcomes
1
Patient experiences related to access to kidney transplantation
Analysis of experiences collected through structured questionnaires to evaluate patients' perceptions of their health status, quality of life, and barriers or facilitators in the transplant process.
Time frame
Baseline (at study inclusion)2
Professional perspectives on inequities in access to kidney transplantation
Qualitative assessment through semi-structured interviews with nephrologists, nurses, healthcare managers, and patient advocates to explore their perceptions of systemic inequities and barriers in the transplant pathway.
Time frame
Within the first 12 months of the studyOther outcomes
1
Thematic categories of inequities in kidney transplantation access
Inductive thematic analysis of qualitative data to identify key categories and central themes related to inequities in transplantation access, triangulated with quantitative findings.
Time frame
At study completion (24 months)Sponsors and contacts
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Hospital del Mar
Lead sponsor
Organización Nacional de Trasplantes (ONT)
Collaborator
Source ClinicalTrials.gov
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