Advance Care Planning With Older Patients Who Have End-stage Kidney Disease

NCT ID: NCT02631200

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-08-31

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.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Advance care plan

Participants will be offered the opportunity to complete an advance care plan.

Group Type: EXPERIMENTAL

Advance care plan

Intervention Type: BEHAVIORAL

Participants will be offered the opportunity to complete an ACP by a nurse trained as an ACP facilitator, who will discuss the process with them using standard materials. At least 48 hours later, they will complete an ACP document with the help of the ACP facilitator, working together with trained expert patients who will provide peer support at the time of ACP completion and subsequently by telephone, assisted where necessary by the ACP facilitator.

Usual care

Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Advance care plan

Participants will be offered the opportunity to complete an ACP by a nurse trained as an ACP facilitator, who will discuss the process with them using standard materials. At least 48 hours later, they will complete an ACP document with the help of the ACP facilitator, working together with trained expert patients who will provide peer support at the time of ACP completion and subsequently by telephone, assisted where necessary by the ACP facilitator.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Dunhill Medical Trust

OTHER

Sponsor Role: collaborator

Queen's University, Belfast

OTHER

Sponsor Role: lead

Responsible Party

Peter O'Halloran

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter D O'Halloran, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University, Belfast

Locations

Queen's University Belfast

Belfast, Northern Ireland, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33187506 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20724-1

Identifier Type: -

Identifier Source: org_study_id