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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)

Primary Purpose

Kidney Failure, End of Life

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Shared decision making intervention for patients with kidney failure when planning end-of-life care
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Kidney Failure focused on measuring Shared decision making, Patient decision aid

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aarhus University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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

Usual care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 11, 2023
Last Updated
April 24, 2023
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT05842772
Brief Title
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
Acronym
DESIRE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, End of Life
Keywords
Shared decision making, Patient decision aid

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The researcher who will conduct the data analyses will type the answers into REDCap and will be blinded to the identity of the participants only knowing them by their unique number.
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The DESIRE intervention which includes training of health professionals, a conversation with patients and their relatives, and a patient decision aid.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Other
Intervention Name(s)
Shared decision making intervention for patients with kidney failure when planning end-of-life care
Intervention Description
Testing a shared decision making intervention and a patient decision aid for patients with kidney failure, their relatives, and the health professionals.
Primary Outcome Measure Information:
Title
change in the patient's palliative care needs
Description
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 Outcome Measure Information:
Title
Participants and relatives' experiences of shared decision making and health professionals' conduction of shared decision making are secondary outcomes.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Louise Engelbrecht Buur
Phone
+4526802251
Email
louikr@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jeanette Finderup
Email
jeajee@rm.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise Engelbrecht Buur
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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