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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2023-10-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Kidney Failure End of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

An independant research assistant will type the answers into Excel. The study principal investigator will conduct the data analyses and will be blinded to the identity of the participants only knowing them by their unique number.

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Control group

Usual care

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER