Clinical trial NCT02631200: Advance Care Planning With Older Patients Who Have End-stage Kidney Disease
Official title: Advance Care Planning With Older Patients Who Have End-stage Kidney Disease: Feasibility of a Deferred Entry Randomised Controlled Trial Incorporating a Mixed Methods Process Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Keywords: Advance Care Planning
Palliative care
Frail Elderly
Renal Dialysis
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: The Dunhill Medical Trust
First posted: 2015-12-16
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will test the feasibility of carrying out a randomised controlled trial, incorporating a mixed methods process evaluation, to evaluate advance care planning with older patients who have end-stage kidney disease.

Detailed description: Kidney failure becomes more common as people age. It increases the risks of other major illnesses, sudden worsening of symptoms, and death. Even so, many people with kidney failure do not talk about their preferences for end-of-life care.

Advance care planning (ACP) can help patients and families think through their preferences for future care and discuss these with the professionals looking after them. This may lead to care more in keeping with patients' wishes and so reduce distress for patients and families. ACP is recommended as good practice for people with kidney failure.

However, questions remain about the impact of ACP on patients and families; and also about the best ways to put ACP into practice. Doing research about ACP is challenging for everyone involved, so we need to thoroughly test our research methods in a pilot study before we attempt a larger study that would fully answer those questions.

To test our methods we will carry out a small-scale randomised controlled trial comparing those patients who use ACP with those who do not, in terms of: quality of life, anxiety, depression, physical functioning, well-being, satisfaction with decision-making and agreement between the patient and their nominated carer in terms of the patient's preferences for care at the end of life.

Eligibility criteria: Inclusion Criteria:

* Attending the renal units taking part in the study
* Receiving renal replacement therapy
* Capacity to understand, retain, and weigh the necessary information and communicate their decisions
* Identified by their consultant as having worsening symptoms, functional decline, and two or more co-morbidities.

Exclusion Criteria:

* Expected to die in the next three months

Primary outcomes:
measure: Kidney Disease Quality
timeFrame: 12 weeks post intervention
Secondary outcomes:
measure: Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences
timeFrame: 12 weeks post intervention
measure: Depression
timeFrame: 12 weeks post intervention
measure: The Degree to Which the Patient Felt That They Had Shared in Decision-making.
timeFrame: 12 weeks post intervention
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Northern Ireland
Study officials:
affiliation: Queen's University, Belfast
name: Peter D O'Halloran, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Halloran P, Noble H, Norwood K, Maxwell P, Murtagh F, Shields J, Mullan R, Matthews M, Cardwell C, Clarke M, Morton R, Shah K, Forbes T, Brazil K. Nurse-led advance care planning with older people who have end-stage kidney disease: feasibility of a deferred entry randomised controlled trial incorporating an economic evaluation and mixed methods process evaluation (ACReDiT). BMC Nephrol. 2020 Nov 13;21(1):478. doi: 10.1186/s12882-020-02129-5.