End Stage Renal DiseaseNCT07364292
Shared Decision Making in Dialysis Modality Selection: a Lived Experience From Nephrologists. A Nationwide Qualitative Study.
A study testing Q methodology in people with End Stage Renal Disease, run by Erasme University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Q methodology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Mar 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- nephrologists professionnaly active
Who cannot join
- non active or retired nephrologists
- nephrologist who do not have regular contact with ESKD patients or who do not engage in treatment discussion
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
However, some (a minority of) dialysis units succeed in solving part of these common issues, while most do not, suggesting that nephrologists and healthcare providers may not have all the clues or the vision of care to overcome these factors. This raises concerns about the primacy of a centre-oriented culture (unit management, cost-effectiveness, technical achievements) rather than prioritizing a patient-centred approach (meeting patients' therapeutic and life goals and actively engaging them in the modality decision-making process).
Within this explanatory research project, the primary objective is to explore in-depth insights into the perspective (beliefs and attitude) of healthcare professionals regarding dialysis decision making process.
The expected first benefit is a better understanding of individual behaviours, values, beliefs, and expectations regarding the implementation of shared decision-making in dialysis modality selection, as well as areas of consensus and disagreement surrounding this controversial topic.
Indeed, a lack of structured educational programs and national guidelines to support healthcare professionals in educating end-stage kidney disease patients is observed in many European countries and likely contributes to the low adoption rates and variable penetration of home-based treatments, as well as pre-emptive transplantation and conservative care.
Methods and analysis:
Investigators are using Q-sort methodology as the foundation for semi-structured interviews. Q-sort combines qualitative and quantitative approaches to measure subjectivity, such as opinions and beliefs. Unlike interviews, it assesses consensus and disagreement among individuals on a specific topic. The process involves creating a set of statements (Q-set) that capture the diversity of scientific or public opinions on that particular topic. Participants (P-set) then rank these statements based on their agreement using a forced-choice grid. Correlations are analyzed between participants' Q-sorts to identify shared perspectives within the group. This study is reported according to the Consolidated criteria for reporting qualitative research (COREQ) guidelines (12).
Study population:
Investigators are using maximum variation sampling. Twenty-five active nephrologists were purposively selected to represent diverse ages, dialysis and home dialysis experience, and gender perspectives nationwide. Dialysis units were chosen to represent different program sizes and organizational cultures. All participants gave written informed consent.
Data collection:
Investigators are using a Q-sort methodology involving the forced ranking of predefined actions in response to each clinical case vignette (Supplemental material). In total, four clinical vignettes, each with nine potential actions, were created based on the literature and consensus within the research team. In a pilot phase, all statements were assessed for clarity and absence of ambiguity. During the sorting process, a think-aloud approach was employed to elicit participants' reasoning behind their classifications, followed by a 30-minute semi-structured interview guided by the Q-sorts.
All sessions were conducted by two authors, audiotaped, and transcribed verbatim.
Q methodology is used to systematically study subjectivity-that is, subjective opinions, values, or beliefs-to answer questions about "how" and "what." It allows the identification of shared viewpoints on a topic, revealing areas of consensus and disagreement.
Correlations between participants, rather than correlations between measures, are explored; thus, the analysis correlates Q-sorts and provides indications of similar segments of subjectivity within the participant group. A post-sort interview, or "think-aloud" reasoning, is provided by respondents during or immediately after the Q-sort to explain their reasoning during the ranking process.
A structured approach, based on prior hypotheses or a literature review suggesting that the quality and content of pre-dialysis programs are influenced by several key factors, will be used. Thematic analysis includes:
- interest, expectations, and involvement of nephrologists and nurses in pre-dialysis care;
- emphasis on meaningful activities and life goals rather than modality-related technical aspects;
- level of perceived patient-related prejudice hindering true shared decision-making;
- transparency regarding all available options;
- service provision around alternative modalities.
Demographic data such as age, gender, academic work, peritoneal dialysis or home hemodialysis experience (in years), as well as overall professional experience of each participant, will be collected, analyzed, and reported.
- Conditions
- End Stage Renal Disease
- Being tested
- Q methodology
- Keywords
- shared-decision-making, dialysis modality selection, kidney failure, home-based therapies
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q methodologyBehavioural
Q- sorting operation is done during a face-to-face meeting of the participant and the interviewer. Participants rank-order a set of statements or opinions into a grid. They rank the importance of statements relative to all others. A specific characteristic of Q Sort is that participants are forced to prioritize amongst statements. During the ranking procedure, they must explain their reasoning process on their positioning of their cards ("thinking-aloud" their reasoning). This audiotaping of the thinking aloud during the actual completion of the Q-Sort allows to not only gain insights in the perceptions of the participants, but also in their underlying reasoning, emotions, and motivation.
| Study group | Role | What they receive |
|---|---|---|
| nephrologists | Other | no other arm Receives: Behavioral: Q methodology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: Time Frame: Once, at the baseline study visit (single Q-sort session), up to 90' per participant
Secondary outcomes (1)
Number and content of overarching themes and sub-themes identified from semi-structured interviews relevant to dialysis-decision making.
Semi-structured interviews (think-aloud and post-sort interview) will be audio-recorded, transcribed verbatim, and analyzed using thematic analysis with a phenomenological approach.
Outcomes will be reported as:
- Number of overarching themes identified (count),
- Number of sub-themes within each overarching theme (count),
- Thematic domains related to shared decision-making (SDM) in dialysis modality selection.
Measured: Once, during the baseline session (up to 30 minutes per participant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start15 Mar 2024
- Primary completion15 Sep 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- explanatory study using mixed method qualitative data analysed systematically by quantitative method (Q method)
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Lorraine Clause, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364292
- Sponsor's protocol ID
- SRB2023343
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Allen K, Shaw KL, Spry JL, Dikomitis L, Coyle D, Damery S, Fotheringham J, Lambie M, Williams IP, Davies S. How does organisational culture facilitate uptake of home dialysis? An ethnographic study of kidney centres in England. BMJ Open. 2024 Dec 27;14(12):e085754. doi: 10.1136/bmjopen-2024-085754.
PubMed 39732481Brown EA, Brivio GB, Van Biesen W. Towards a better uptake of home dialysis in Europe: understanding the present and looking to the future. Clin Kidney J. 2024 Jun 5;17(Suppl 1):i3-i12. doi: 10.1093/ckj/sfae082. eCollection 2024 May.
PubMed 38846418Cortvrindt C, Van Biesen W, Gambino G, Clause AL. Factors influencing renal replacement therapy modality choice from the nephrologist's perspective. J Nephrol. 2024 Apr;37(3):635-645. doi: 10.1007/s40620-024-01915-w. Epub 2024 Mar 21.
PubMed 38512379
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making in Dialysis Modality Selection: a Lived Experience From Nephrologists. A Nationwide Qualitative Study.
- ClinicalTrials.gov ID
- NCT07364292
- Acronym / sponsor ID
- SRB2023343
- Conditions
- End Stage Renal Disease
- Keywords
- shared-decision-making, dialysis modality selection, kidney failure, home-based therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
However, some (a minority of) dialysis units succeed in solving part of these common issues, while most do not, suggesting that nephrologists and healthcare providers may not have all the clues or the vision of care to overcome these factors. This raises concerns about the primacy of a centre-oriented culture (unit management, cost-effectiveness, technical achievements) rather than prioritizing a patient-centred approach (meeting patients' therapeutic and life goals and actively engaging them in the modality decision-making process).
Within this explanatory research project, the primary objective is to explore in-depth insights into the perspective (beliefs and attitude) of healthcare professionals regarding dialysis decision making process.
The expected first benefit is a better understanding of individual behaviours, values, beliefs, and expectations regarding the implementation of shared decision-making in dialysis modality selection, as well as areas of consensus and disagreement surrounding this controversial topic.
Indeed, a lack of structured educational programs and national guidelines to support healthcare professionals in educating end-stage kidney disease patients is observed in many European countries and likely contributes to the low adoption rates and variable penetration of home-based treatments, as well as pre-emptive transplantation and conservative care.
Methods and analysis:
Investigators are using Q-sort methodology as the foundation for semi-structured interviews. Q-sort combines qualitative and quantitative approaches to measure subjectivity, such as opinions and beliefs. Unlike interviews, it assesses consensus and disagreement among individuals on a specific topic. The process involves creating a set of statements (Q-set) that capture the diversity of scientific or public opinions on that particular topic. Participants (P-set) then rank these statements based on their agreement using a forced-choice grid. Correlations are analyzed between participants' Q-sorts to identify shared perspectives within the group. This study is reported according to the Consolidated criteria for reporting qualitative research (COREQ) guidelines (12).
Study population:
Investigators are using maximum variation sampling. Twenty-five active nephrologists were purposively selected to represent diverse ages, dialysis and home dialysis experience, and gender perspectives nationwide. Dialysis units were chosen to represent different program sizes and organizational cultures. All participants gave written informed consent.
Data collection:
Investigators are using a Q-sort methodology involving the forced ranking of predefined actions in response to each clinical case vignette (Supplemental material). In total, four clinical vignettes, each with nine potential actions, were created based on the literature and consensus within the research team. In a pilot phase, all statements were assessed for clarity and absence of ambiguity. During the sorting process, a think-aloud approach was employed to elicit participants' reasoning behind their classifications, followed by a 30-minute semi-structured interview guided by the Q-sorts.
All sessions were conducted by two authors, audiotaped, and transcribed verbatim.
Q methodology is used to systematically study subjectivity-that is, subjective opinions, values, or beliefs-to answer questions about "how" and "what." It allows the identification of shared viewpoints on a topic, revealing areas of consensus and disagreement.
Correlations between participants, rather than correlations between measures, are explored; thus, the analysis correlates Q-sorts and provides indications of similar segments of subjectivity within the participant group. A post-sort interview, or "think-aloud" reasoning, is provided by respondents during or immediately after the Q-sort to explain their reasoning during the ranking process.
A structured approach, based on prior hypotheses or a literature review suggesting that the quality and content of pre-dialysis programs are influenced by several key factors, will be used. Thematic analysis includes:
- interest, expectations, and involvement of nephrologists and nurses in pre-dialysis care;
- emphasis on meaningful activities and life goals rather than modality-related technical aspects;
- level of perceived patient-related prejudice hindering true shared decision-making;
- transparency regarding all available options;
- service provision around alternative modalities.
Demographic data such as age, gender, academic work, peritoneal dialysis or home hemodialysis experience (in years), as well as overall professional experience of each participant, will be collected, analyzed, and reported.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- explanatory study using mixed method qualitative data analysed systematically by quantitative method (Q method)
| Arm | Type | Receives |
|---|---|---|
| nephrologists | Other | Behavioral: Q methodologyno other arm |
Who may qualify
- Ages
- 30 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- nephrologists professionnaly active
Key exclusion criteria (2 listed)
- non active or retired nephrologists
- nephrologist who do not have regular contact with ESKD patients or who do not engage in treatment discussion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q methodologyQ- sorting operation is done during a face-to-face meeting of the participant and the interviewer. Participants rank-order a set of statements or opinions into a grid. They rank the importance of statements relative to all others. A specific characteristic of Q Sort is that participants are forced to prioritize amongst statements. During the ranking procedure, they must explain their reasoning process on their positioning of their cards ("thinking-aloud" their reasoning). This audiotaping of the thinking aloud during the actual completion of the Q-Sort allows to not only gain insights in the perceptions of the participants, but also in their underlying reasoning, emotions, and motivation. | Behavioural | nephrologists |
Primary outcome
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.
1 secondary outcome
Number and content of overarching themes and sub-themes identified from semi-structured interviews relevant to dialysis-decision making.
Time frame: Once, during the baseline session (up to 30 minutes per participant)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 39732481Allen K, Shaw KL, Spry JL, Dikomitis L, Coyle D, Damery S, Fotheringham J, Lambie M, Williams IP, Davies S. How does organisational culture facilitate uptake of home dialysis? An ethnographic study of kidney centres in England. BMJ Open. 2024 Dec 27;14(12):e085754. doi: 10.1136/bmjopen-2024-085754.
- Background: PubMed 38846418Brown EA, Brivio GB, Van Biesen W. Towards a better uptake of home dialysis in Europe: understanding the present and looking to the future. Clin Kidney J. 2024 Jun 5;17(Suppl 1):i3-i12. doi: 10.1093/ckj/sfae082. eCollection 2024 May.
- Results publication: PubMed 38512379Cortvrindt C, Van Biesen W, Gambino G, Clause AL. Factors influencing renal replacement therapy modality choice from the nephrologist's perspective. J Nephrol. 2024 Apr;37(3):635-645. doi: 10.1007/s40620-024-01915-w. Epub 2024 Mar 21.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q methodology in people with End Stage Renal Disease, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07364292, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.