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

Not Applicable

Completed

Conditions: Kidney Failure, Chronic

Interventions: Behavioral: Advance care plan

Registration Number: NCT02631200

Lead Sponsor: Queen's University, Belfast

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Advance care plan	Advance care plan	Participants will be offered the opportunity to complete an advance care plan.

Primary Outcome Measures

Name	Time	Method
Kidney Disease Quality	12 weeks post intervention	Quality of life as measured by the Kidney Disease Quality of Life instrument - Short Form (KDQOL-36™). The KDQOL-36 has five scales, including two generic health related quality of life (HRQOL) scales from the Short-Form (SF)-12 version 1 (12 items total) and three kidney-specific scales (24 items total). Each scale has a minimum score of zero and a maximum of 100. Higher scores reflect better quality of life and a better outcome. Subscales are not combined.

Secondary Outcome Measures

Name	Time	Method
Depression	12 weeks post intervention	Degree of anxiety, depression, well-being, functioning and risk as measured by the Clinical Outcomes in Routine Evaluation measure (CORE 34) a 34- item Likert-type scale scored on a 5-point scale ranging from 0 (not at all) to 4 (most or all the time). The minimum mean value is zero and the maximum is 4. Higher scores indicate greater distress and a worse outcome. Mean scores from reference groups are 1.86 (SD 0.75) for those referred to psychiatric services and 0.76 (SD 0.59) for the general population.
Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences	12 weeks post intervention	Number of Participants with Agreement between the patient and their nominated carer in terms of the patient's preferences. We will measure this by asking the carer to make an independent assessment of the patient's preferences in relation to the key information covered by the ACP intervention, before taking part in the ACP.
The Degree to Which the Patient Felt That They Had Shared in Decision-making.	12 weeks post intervention	The degree to which the patient felt that they had shared in decision-making about their care as measured by the Patient Experience of Shared Decision Making (SHARED) instrument. This is a a ten-item Likert-type scale ranging from 'Disagree strongly' to 'Agree strongly', with one point for 'Agree', two for 'Agree strongly', and no points for disagreement. The minimum score is zero and the maximum is 20. Higher scores indicate more sharing and a better outcome.