Feasibility Testing a shareD dEciSIon Making Intervention for People With Kidney failuRE, Their Relatives, and the Health Professionals in Kidney Services: a Pilot Randomized Controlled Trial Study Protocol

Kidney Failure Clinical Trial

— DESIRE  

Official title:

Feasibility Testing a shareD dEciSIon Making Intervention for People With Kidney failuRE (DESIRE), Their Relatives, and the Health Professionals in Kidney Services: a Pilot Randomized Controlled Trial Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05842772
• Other study ID #: PilotRCT_LEB
• Status: Completed
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: October 6, 2023

Study information

• Verified date: February 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this research is to test the acceptability and feasibility of a shared decision making intervention and a patient decision aid to support patients with kidney failure, relatives, and health professionals in planning and deciding about end-of-life care together.

Description:

The objectives of this study is to pilot test an intervention aiming to accomplish shared decision making when deciding about end-of-life care preferences in people with kidney failure. The intervention consists of shared decision making consultations for adults with kidney failure their relatives and contact health professionals regarding end-of-life care planning supported by a patient decision aid. We will evaluate how adults, relatives and, health professionals implements the intervention and if the intervention is acceptable to the different stakeholders. The research question will investigate if the adults, relatives, and health professionals are experiencing the intervention as shared decision making and if they feel involved in the decision making process. The DESIRE trial is designed as a pragmatic, pilot, randomized, controlled, non-blinded multicenter superiority trial with two parallel groups will test the acceptability and feasibility of the intervention on patients, relatives, and health professionals. Randomization will be performed as block randomization with a 1:1 allocation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 6, 2023
• Est. primary completion date: October 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Adults with kidney failure on haemodialysis, peritoneal dialysis, or on conservative kidney management and their relatives will be considered for participation. Inclusion criteria will be adults =75 years of age, with an estimated glomerular filtration rate <15, and not suited for a kidney transplant.

Exclusion Criteria:

• Adults who are cognitively unable to participate will be excluded from the research.

Related Conditions & MeSH terms

• Death
• End of Life
• Kidney Failure
• Renal Insufficiency

Intervention

Other:
• Shared decision making intervention for patients with kidney failure when planning end-of-life care
Testing a shared decision making intervention and a patient decision aid for patients with kidney failure, their relatives, and the health professionals.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in the patient's palliative care needs	The primary outcome will be the change in the adults' palliative needs, as measured using the Integrated Palliative Outcome Score (IPOS)-Renal patient version questionnaire	Through study completion, an average of 6 months
Secondary	Participants and relatives' experiences of shared decision making and health professionals' conduction of shared decision making are secondary outcomes.	Participants and relatives' experiences of shared decision making, as measured using the Patient Experience of Shared Decision Making (SHARED) tool and healthprofessionals' conduction of shared decision making, as measured using the Decision Support Analysis Tool (DSAT-10) are secondary outcomes.	Through study completion, an average of 6 months