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 Overview
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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.

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.

Official Title
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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

Conditions
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Kidney Failure, End of Life

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The DESIRE intervention which includes training of health professionals, a conversation with patients and their relatives, and a patient decision aid. | Other: Shared decision making intervention for patients with kidney failure when planning end-of-life care<br>* Testing a shared decision making intervention and a patient decision aid for patients with kidney failure, their relatives, and the health professionals.<br>|
| Active Comparator: Control group<br>Usual care | Other: Shared decision making intervention for patients with kidney failure when planning end-of-life care<br>* Testing a shared decision making intervention and a patient decision aid for patients with kidney failure, their relatives, and the health professionals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shared decision making, Patient decision aid