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)

Peter O'Halloran, Helen Noble, Kelly Norwood, Peter Maxwell, Fliss Murtagh, Joanne Shields, Robert Mullan, Michael Matthews, Christopher Cardwell, Mike Clarke, Rachael Morton, Karan Shah, Trisha Forbes, Kevin Brazil, Peter O'Halloran, Helen Noble, Kelly Norwood, Peter Maxwell, Fliss Murtagh, Joanne Shields, Robert Mullan, Michael Matthews, Christopher Cardwell, Mike Clarke, Rachael Morton, Karan Shah, Trisha Forbes, Kevin Brazil

Abstract

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 .

Keywords: Advance care planning; Advance directives; End-of-life care; End-stage Kidney disease; Feasibility studies; Palliative care; Randomized controlled trial; Renal Dialysis.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow of participants through the trial
Fig. 2
Fig. 2
Process map: Advance care planning, Haemodialysis Unit

References

    1. UK Renal Registry. UK Renal Registry 21st Annual Report - data to 31/12/2017 [Internet]. Vol. 3349. Britstol, UK; 2019. Available from: .
    1. Liyanage T, Ninomiya T, Jha V, Neal B, Patrice HM, Okpechi I, et al. Worldwide access to treatment for end-stage kidney disease: a systematic review. Lancet. 2015;385(9981):1975–1982. doi: 10.1016/S0140-6736(14)61601-9.
    1. Tonelli M, Wiebe N, Guthrie B, James MT, Quan H, Fortin M, et al. Comorbidity as a driver of adverse outcomes in people with chronic kidney disease. Kidney Int. 2015;88(4):859–866. doi: 10.1038/ki.2015.228.
    1. National Collaborating Centre for Chronic Conditions . Chronic kidney disease. London: Royal College of Physicians; 2008. pp. 1–204.
    1. Anderson S, Halter JB, Hazzard WR, Himmelfarb J, Horne FM, Kaysen GA, et al. Prediction, progression, and outcomes of chronic kidney disease in older adults. J Am Soc Nephrol. 2009;20(6):1199–1209. doi: 10.1681/ASN.2008080860.
    1. Bikbov B, Purcell CA, Levey AS, Smith M, Abdoli A, Abebe M, et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: a systematic analysis for the global burden of disease study 2017. Lancet. 2020;395(10225):709–733. doi: 10.1016/S0140-6736(20)30045-3.
    1. Neovius M, Jacobson SH, Eriksson JK, Elinder CG, Hylander B. Mortality in chronic kidney disease and renal replacement therapy: a population-based cohort study. BMJ Open. 2014;4(2):1–9. doi: 10.1136/bmjopen-2013-004251.
    1. Arulkumaran N, Szawarski P, Philips BJ. End-of-life care in patients with end-stage renal disease. Nephrol Dial Transplant. 2012;27(3):879–881. doi: 10.1093/ndt/gfs028.
    1. Davison SN. Advance care planning in patients with chronic kidney disease. Semin Dial. 2012;25(6):657–663. doi: 10.1111/sdi.12039.
    1. Axelsson L, Alvariza A, Lindberg J, Öhlén J, Håkanson C, Reimertz H, et al. Unmet palliative care needs among patients with end-stage kidney disease: a National Registry Study about the last week of life. J Pain Symptom Manag. 2018;55(2):236–244. doi: 10.1016/j.jpainsymman.2017.09.015.
    1. Wachterman MW, Hailpern SM, Keating NL, Tamura MK, O’Hare AM. Association between hospice length of stay, health care utilization, and medicare costs at the end of life among patients who received maintenance hemodialysis. JAMA Intern Med. 2018;178(6):792–799. doi: 10.1001/jamainternmed.2018.0256.
    1. Luckett T, Sellars M, Tieman J, Pollock CA, Silvester W, Butow PN, et al. Advance care planning for adults with CKD: a systematic integrative review. Am J Kidney Dis. 2014;63(5):761–770. doi: 10.1053/j.ajkd.2013.12.007.
    1. Mullick A, Martin J, Sallnow L. An introduction to advance care planning in practice. BMJ. 2013;347(October):1–6. doi: 10.1136/bmj.f6064.
    1. Bernacki RE, Block SD, American College of Physicians High Value Care Task Force Communication about serious illness care goals. JAMA Intern Med. 2014;174(12):1994. doi: 10.1001/jamainternmed.2014.5271.
    1. Krouse RS, Rosenfeld KE, Grant M, Aziz N, Byock I, Sloan J, et al. Palliative care research: issues and opportunities. Cancer Epidemiol Biomark Prev. 2004;13(3):337–339.
    1. Houben CHM, Spruit MA, Groenen MTJ, Wouters EFM, Janssen DJA. Efficacy of advance care planning: a systematic review and meta-analysis. J Am Med Dir Assoc. 2014;15(7):477–489. doi: 10.1016/j.jamda.2014.01.008.
    1. Brinkman-Stoppelenburg A, Rietjens JA, van der Heide A. The effects of advance care planning on end-of-life care: a systematic review. Palliat Med. 2014;28(8):1000–1025. doi: 10.1177/0269216314526272.
    1. Department of Health . National service framework for renal services part two : chronic kidney disease, acute renal failure and end of life care. London: Department of Health; 2005.
    1. National Institute for Health and Clinical Excellence. Chronic kidney disease quality standard: NICE; 2012. [cited 2014 Jul 1]. Available from: .
    1. Crail S, Walker R, Brown M. Renal supportive and palliative care: position statement. Nephrology. 2013;18:393–400. doi: 10.1111/nep.12064/full.
    1. Lim CED, Ng RWC, Cheng NCL, Cigolini M, Kwok C, Brennan F. Advance care planning for haemodialysis patients. Cochrane Database Syst Rev. 2016;7:CD010737. doi: 10.1002/14651858.CD010737.pub2.
    1. CRD . Advance care planning [Internet] York: Centre for Reviews and Dissemination; 2013.
    1. O’Halloran P, Noble H, Norwood K, Maxwell P, Shields J, Fogarty D, et al. Advance care planning with patients who have end-stage kidney disease: a systematic realist review. J Pain Symptom Manag. 2018;56(5):795–807. doi: 10.1016/j.jpainsymman.2018.07.008.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: new guidance; 2008. Medical Research Council. Available from: .
    1. Higginson IJ, Booth S. The randomized fast-track trial in palliative care: role, utility and ethics in the evaluation of interventions in palliative care? Palliat Med. 2011;25(8):741–747. doi: 10.1177/0269216311421835.
    1. Evans CJ, Stone KA, Manthorpe J, Higginson IJ. MRC guidance on developing and evaluating complex interventions: application to research on palliative and end of life care. Methods Review 15 [Internet]. London: NIHR School for Social Care Research London School of Economics and Political Science Houghton Street London WC2A 2AE; 2013. 1–37 p. Available from: .
    1. SAGE & THYME® [Internet]. 2019 [cited 2019 Jan 22]. Available from: .
    1. Gibbons E, Fitzpatrick R. A structured review of patient-reported outcome measures for people with chronic kidney disease. 2010.
    1. Isaacs B, Kennie AT. The set test as an aid to the detection of dementia in old people. Br J Psychiatry. 1973;123(4):467–470. doi: 10.1192/bjp.123.4.467.
    1. Evans C, Mellor-Clark J, Margison F, Barkham M, Audin K, Connell J, et al. CORE: clinical outcomes in routine evaluation. J Ment Health. 2000;9(3):247–255. doi: 10.1080/713680250&magic=crossref||D404A21C5BB053405B1A640AFFD44AE3.
    1. Evans C, Connell J, Barkham M, Margison F, McGrath G, Mellor-Clark J, et al. Towards a standardised brief outcome measure: Psychometric properties and utility of the CORE–OM. Br J Psychiatry. 2002;180(01):51–60. doi: 10.1192/bjp.180.1.51.
    1. GEM . Patient experience of shared decision making (SHARED) [Internet]. Grid-enabled measures database. 2014.
    1. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287–291. doi: 10.1002/pst.185.
    1. Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008;31(January):180–191. doi: 10.1002/nur.20247.
    1. Vickers AJ, Altman DG. Statistics notes: analysing controlled trials with baseline and follow up measurements. BMJ. 2001;323(7321):1123–1124. doi: 10.1136/bmj.323.7321.1123.
    1. Statacorp . Stata 14 | Stata [Internet] 2015.
    1. Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMJ. 2013;346:f1049. doi: 10.1136/bmj.f1049.
    1. Ivankova NV, Creswell JW, Stick SL. Using mixed-methods sequential explanatory design: from theory to practice. Field Methods. 2006;18(1):3–20. doi: 10.1177/1525822X05282260.
    1. Antonacci G, Reed JE, Lennox L, Barlow J. The use of process mapping in healthcare quality improvement projects. Health Serv Manag Res. 2018;31(2):74–84. doi: 10.1177/0951484818770411.
    1. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239. doi: 10.1136/bmj.i5239.
    1. Hall RK, Luciano A, Pieper C, Colón-Emeric CS. Association of Kidney Disease Quality of Life (KDQOL-36) with mortality and hospitalization in older adults receiving hemodialysis. BMC Nephrol. 2018;19(1):11. doi: 10.1186/s12882-017-0801-5.
    1. Sudore RL, Fried TR. Redefining the “planning” in advance care planning: preparing for end-of-life decision making. Ann Intern Med. 2010;153(4):256–61.
    1. McMahan RD, Knight SJ, Fried TR, Sudore RL. Advance care planning beyond advance directives: perspectives from patients and surrogates. J Pain Symptom Manag. 2013;46(3):355–365. doi: 10.1016/j.jpainsymman.2012.09.006.
    1. Sudore RL, Stewart AL, Knight SJ, McMahan RD, Feuz M, Miao Y, et al. Development and validation of a questionnaire to detect behavior change in multiple advance care planning behaviors. PLoS One. 2013;8(9):e72465. doi: 10.1371/journal.pone.0072465.
    1. Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, et al. Measuring advance care planning: optimizing the advance care planning engagement survey. J Pain Symptom Manag. 2017;53(4):669–681.e8. doi: 10.1016/j.jpainsymman.2016.10.367.
    1. Steenkamp R, Pyart R, Fraser S. UK Renal Registry 20th Annual Report: Chapter 5 Survival and Cause of Death in UK Adult Patients on Renal. Replacement Therapy in 2016: National and Centre-specific Analyses. Nephron. 2018;139(suppl1):117–50. 10.1159/000490963.
    1. Detering K, Hancock A, Reade M, Silvester W. The impact of advance care planning on end of life care in elderly patients: randomised controlled trial. BMJ. 2010;340(7751) [cited 2014 Aug 27] Available from: .
    1. Royal College of Nursing. NHS pay scales 2017-18 [Internet]. [cited 2019 Nov 8]. Available from: .

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa