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

NCT02631200 | Completed Results

• 1 other identifier: 20724-1
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Failure, Chronic

Keywords

Advance Care Planning; Palliative care; Frail Elderly; Renal Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Number of Participants With Agreement Between the Patient and Their Nominated Carer in Terms of the Patient's Preferences

  12 weeks post intervention

• Depression

  12 weeks post intervention

• The Degree to Which the Patient Felt That They Had Shared in Decision-making.

  12 weeks post intervention

Study Arms (2)

Advance care plan

EXPERIMENTAL

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

Behavioral: Advance care plan

Usual care

NO INTERVENTION

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

Interventions

Advance care plan 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.

Advance care plan

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Expected to die in the next three months

Sponsors & Collaborators

• Queen's University, Belfast: lead
• The Dunhill Medical Trust: collaborator

Study Sites (1)

Queen's University Belfast

Belfast, Northern Ireland, BT7 1NN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33187506 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Peter O'Halloran
• Organization: Queen's University Belfast

p.ohalloran@qub.ac.uk

02890972490

Study Officials

• Peter D O'Halloran, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: December 16, 2015
• Study Start: December 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication of the trial results\* with no end date. \*DOI https://doi.org/10.1186/s12882-020-02129-5
• Access Criteria: Available to qualified researchers for approved scientific uses.

Locations

GB (1)