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

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ClinicalTrials.gov Identifier: NCT02631200
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
The Dunhill Medical Trust
Information provided by (Responsible Party):
Peter O'Halloran, 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.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Behavioral: Advance care plan Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
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
Actual Study Start Date : December 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


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).



Primary Outcome Measures :
  1. Quality of life [ Time Frame: 12 weeks post intervention ]
    Quality of life as measured by the Kidney Disease Quality of Life instrument - Short Form (KDQOL-36™)


Secondary Outcome Measures :
  1. Agreement between the patient and their nominated carer in terms of the patient's preferences. [ Time Frame: 12 weeks post intervention ]
    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.

  2. Depression [ Time Frame: 12 weeks post intervention ]
    Degree of depression as measured by the Clinical Outcomes in Routine Evaluation measure (CORE 34)

  3. The degree to which the patient felt that they had shared in decision-making. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631200


Locations
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United Kingdom
Queen's University Belfast
Belfast, Northern Ireland, United Kingdom, BT7 1NN
Sponsors and Collaborators
Queen's University, Belfast
The Dunhill Medical Trust
Investigators
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Principal Investigator: Peter D O'Halloran, PhD Queen's University, Belfast

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Responsible Party: Peter O'Halloran, Dr, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT02631200     History of Changes
Other Study ID Numbers: 20724-1
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Peter O'Halloran, Queen's University, Belfast:
Advance Care Planning
Palliative care
Frail Elderly
Renal Dialysis

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic