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

Kidney Failure, Chronic Clinical Trial

— ACREDiT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631200
• Other study ID #: 20724-1
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	Queen's University Belfast	Belfast	Northern Ireland

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University, Belfast	The Dunhill Medical Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Quality of life as measured by the Kidney Disease Quality of Life instrument - Short Form (KDQOL-36™)	12 weeks post intervention
Secondary	Agreement between the patient and their nominated carer in terms of the patient's preferences.	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.	12 weeks post intervention
Secondary	Depression	Degree of depression as measured by the Clinical Outcomes in Routine Evaluation measure (CORE 34)	12 weeks post intervention
Secondary	The degree to which the patient felt that they had shared in decision-making.	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.	12 weeks post intervention