Background: Advance Care Planning is recommended for people with end-stage kidney disease but evidence is limited. Robust clinical trials are needed to investigate the impact of advance care planning in this population. There is little available data on cost-effectiveness to guide decision makers in allocating resources for advance care planning. Therefore we sought to determine the feasibility of a randomised controlled trial and to test methods for assessing cost-effectiveness. Methods: A deferred entry, randomised controlled feasibility trial, incorporating economic and process evaluations, with people with end-stage kidney disease, aged 65 years or older, receiving haemodialysis, in two renal haemodialysis units in Northern Ireland, UK. A nurse facilitator helped the patient make an advance care plan identifying: a surrogate decision-maker; what the participant would like to happen in the future; any advance decision to refuse treatment; preferred place of care at end-of-life. Results: Recruitment lasted 189 days; intervention and data collection 443 days. Of the 67 patients invited to participate 30 (45%) declined and 36 were randomised to immediate or deferred advance care plan groups. Twenty-two (61%) made an advance care plan and completed data collection at 12 weeks; 17 (47.2%) were able to identify a surrogate willing to be named in the advance care plan document. The intervention was well-received and encouraged end-of-life conversations, but did not succeed in helping patients to fully clarify their values or consider specific treatment choices. There was no significant difference in health system costs between the immediate and deferred groups. Conclusions: A trial of advance care planning with participants receiving haemodialysis is feasible and acceptable to patients, but challenging. A full trial would require a pool of potential participants five times larger than the number required to complete data collection at 3 months. Widening eligibility criteria to include younger (under 65 years of age) and less frail patients, together with special efforts to engage and retain surrogates may improve recruitment and retention. Traditional advance care planning outcomes may need to be supplemented with those that are defined by patients, helping them to participate with clinicians in making medical decisions. Trial registration: Registered December 16, 2015. ClinicalTrials.gov Identifier: NCT02631200.
Bibliographical noteFunding Information:
This work was supported by The Dunhill Medical Trust [grant number R428/0715]. Neither the funders nor Queen’s University Belfast had any role in study design; collection, analysis, and interpretation of data; writing the report; and the decision to submit the report for publication. Acknowledgements
This work would not have been possible without the contributions of all the study participants and the nurses and nephrologists in the renal units. Members of the Northern Ireland Kidney Patient Association contributed to the implementation strategy for the advance care planning intervention. The Trial Steering Committee was chaired by Professor Vivien Coates of Ulster University. Special thanks to the ACP Nurses at the Regional Nephrology Unit, Belfast City Hospital, and the Renal Unit, Antrim Area Hospital, who provided invaluable insight, and support during the implementation phase.
© 2020, The Author(s).
Copyright 2020 Elsevier B.V., All rights reserved.
- Advance care planning
- Advance directives
- End-of-life care
- End-stage Kidney disease
- Feasibility studies
- Palliative care
- Randomized controlled trial
- Renal Dialysis