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 (DESIRE)

University of Aarhus

Status: Completed

Conditions: Kidney Failure; End of Life

Treatments: Other: Shared decision making intervention for patients with kidney failure when planning end-of-life care

Study type: Interventional

Funder types: Other

Identifiers

NCT05842772

PilotRCT_LEB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 2 patient groups

Intervention group

Experimental group

Description:

The DESIRE intervention which includes training of health professionals, a conversation with patients and their relatives, and a patient decision aid.

Treatment:

Other: Shared decision making intervention for patients with kidney failure when planning end-of-life care

Control group

Active Comparator group

Description:

Usual care

Treatment:

Other: Shared decision making intervention for patients with kidney failure when planning end-of-life care