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)

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Failure; End of Life
• Intervention / Treatment: Other: Shared decision making intervention for patients with kidney failure when planning end-of-life care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Usual care	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.
Experimental: Intervention group; 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; Testing a shared decision making intervention and a patient decision aid for patients with kidney failure, their relatives, and the health professionals.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Louise Engelbrecht Buur, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): October 6, 2023
• Study Completion (Actual): October 6, 2023

Study Registration Dates

• First Submitted: April 11, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Shared decision making; Patient decision aid
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Death; Renal Insufficiency
• Other Study ID Numbers: PilotRCT_LEB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No