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Clinical Trials/NCT07364292
NCT07364292CompletedNot Applicable

Shared Decision Making in Dialysis Modality Selection: a Lived Experience From Nephrologists. A Nationwide Qualitative Study.

Erasme University Hospital1 site in 1 country25 target enrollmentStarted: March 15, 2024Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
25
Locations
1
Primary Endpoint
Number of distinct Q-methodology viewpoints (factors) identified from nephrologists' Q-sorts related to shared decision-making in dialysis modality choice, as derived from Q-factor analysis.

Study Overview

Brief Summary

International guidelines for kidney failure emphasize the importance of aligning renal replacement therapy (RRT) modality selection with individuals' preferences through high-quality, structured education. However, observational qualitative studies suggest that pre-dialysis education remains inconsistently delivered, with substantial centre-to-centre variation in the content and organization of Belgian pre-dialysis programs despite a shared healthcare policy.

Multiple barriers to home-based therapies have been repeatedly reported at both the unit and patient levels, including nursing shortages, limited availability of trained staff, financial constraints, high rates of unplanned dialysis initiation, distress at treatment start, low health literacy, and an increasingly frail and comorbid patient population.

Yet, a minority of dialysis units appear able to mitigate these barriers more effectively than others. This discrepancy raises concern that centre-oriented priorities (unit throughput, cost-effectiveness, technical performance) may still outweigh patient-centred goals (supporting life priorities and meaningful shared decision-making).

This study aims to explore nephrologists' beliefs, knowledge, and attitudes regarding shared decision-making in dialysis modality selection and their potential influence on the adoption of alternative RRT modalities beyond in-centre hemodialysis. Q methodology will be used to capture and compare shared viewpoints and patterns of disagreement across participants.

Detailed Description

Objective: To explore the nephrologist's lived experience regarding shared-decision making during dialysis decision making process.

Design: Prospective, monocentric, interventional, mixed-methods design (qualitative and quantitative) using Q methodology.

Rationale:

International guidelines related to kidney failure strongly support individuals' preferences when choosing their renal replacement modality through appropriate education provision. However, previous observational qualitative studies have shown that pre-dialysis education is poorly delivered, with wide centre-to-centre variation in the content and organization of Belgian pre-dialysis programs, despite a shared healthcare policy.

Many logistical issues raised as "barriers" at the centre level, but also at the patient level, have already been identified in previous studies: shortage of nurses, lack of trained staff in home-based treatment or education provision, limited financial resources, a high rate of unplanned patients, patient distress at dialysis initiation, a high rate of poor health literacy, and a shift in patient mix toward higher rates of comorbidities and frailty are the most frequently cited barriers.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
30 Years to 67 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • nephrologists professionnaly active

Exclusion Criteria

  • non active or retired nephrologists
  • nephrologist who do not have regular contact with ESKD patients or who do not engage in treatment discussion

Arms & Interventions

nephrologists

Other

no other arm

Intervention: Q methodology (Behavioral)

Outcomes

Primary Outcomes

Number of distinct Q-methodology viewpoints (factors) identified from nephrologists' Q-sorts related to shared decision-making in dialysis modality choice, as derived from Q-factor analysis.

Time Frame: Time Frame: Once, at the baseline study visit (single Q-sort session), up to 90' per participant

Q-sort data will be collected using a forced-ranking of predefined actions in response to clinical vignettes. The primary quantitative endpoint is the number of interpretable factors extracted from participants' Q-sorts using principal component factor analysis with varimax rotation. Results will be reported as: * Number of factors identified (count), * Number (%) of participants significantly loading on each factor (p \< 0.01) * Factor loadings (correlation coefficients) per factor reported as mean (SD) and range.

Secondary Outcomes

  • Number and content of overarching themes and sub-themes identified from semi-structured interviews relevant to dialysis-decision making.(Once, during the baseline session (up to 30 minutes per participant))

Investigators

Sponsor
Erasme University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anne-Lorraine Clause

Medical doctor in nephrology

Erasme University Hospital

Study Sites (1)

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