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

University of Aarhus27 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Kidney Failure End of Life

Interventions

Shared decision making intervention for patients with kidney failure when planning end-of-life careOTHER

Testing a shared decision making intervention and a patient decision aid for patients with kidney failure, their relatives, and the health professionals.

Eligibility

Sex: ALLMin age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Aarhus University Hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

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

Time frame: Through study completion, an average of 6 months

Secondary Outcomes

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.

Time frame: Through study completion, an average of 6 months

Data from ClinicalTrials.gov

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