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

NCT05842772 | Completed DMC

• 1 other identifier: PilotRCT_LEB
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure; End of Life

Keywords

Shared decision making; Patient decision aid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participants and relatives' experiences of shared decision making and health professionals' conduction of shared decision making are secondary outcomes.

  Through study completion, an average of 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Usual care

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

Interventions

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may not qualify if:

• Adults who are cognitively unable to participate will be excluded from the research.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Buur LE, Bekker HL, Sondergaard H, Kannegaard M, Madsen JK, Khatir DS, Finderup J. Feasibility and acceptability of the ShareD dEciSIon making for patients with kidney failuRE to improve end-of-life care intervention: A pilot multicentre randomised controlled trial. Int J Nurs Stud Adv. 2024 Aug 5;7:100231. doi: 10.1016/j.ijnsa.2024.100231. eCollection 2024 Dec.

  PMID: 39221228 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Death

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Louise Engelbrecht Buur

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 6, 2023
• Study Start: March 20, 2023
• Primary Completion: October 6, 2023
• Study Completion: October 6, 2023
• Last Updated: May 10, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)