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

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

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.

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic
• Intervention / Treatment: Behavioral: Advance care plan

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT7 1NN
      • Queen's University Belfast

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advance care plan; Participants will be offered the opportunity to complete an advance care plan.	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.
No Intervention: Usual care; Participants will be offered usual care for 12 weeks (and only then be offered the opportunity to complete an advance care plan).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney Disease Quality	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.	12 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences	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.	12 weeks post intervention
Depression	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.	12 weeks post intervention
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. 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.	12 weeks post intervention

Collaborators and Investigators

• Sponsor: Queen's University, Belfast
• Collaborators: The Dunhill Medical Trust
• Investigators: Principal Investigator: Peter D O'Halloran, PhD, Queen's University, Belfast

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: October 28, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimated): December 16, 2015

Study Record Updates

• Last Update Posted (Actual): July 29, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Palliative care; Renal Dialysis; Advance Care Planning; Frail Elderly
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
• Other Study ID Numbers: 20724-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Deidentified data that underlie the results reported in this article are available to qualified researchers for approved scientific uses immediately following publication of the trial results* with no end date. Data access proposals should be directed to the corresponding author. The Trial Protocol is available on request.

*DOI https://doi.org/10.1186/s12882-020-02129-5

IPD Sharing Time Frame

Immediately following publication of the trial results* with no end date.

*DOI https://doi.org/10.1186/s12882-020-02129-5

• IPD Sharing Access Criteria: Available to qualified researchers for approved scientific uses.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL