Title: The UNPACK study: Understanding treatment preferences of older Patients and their families deciding between dialysis and comprehensive conservative Care for Kidney failure
Funder: Department of Health and Social Care

Abstract: Background In the UK 22,000 over-65 year olds receive dialysis. Few are well enough for transplantation, so dialysis usually continues life-long. For multimorbid older people dialysis is associated with reduced quality of life and minor survival benefit. Some choose comprehensive conservative care' (CCC) instead, receiving medication and support alone. They live less long than those receiving dialysis, but are older and more comorbid when treatment begins. However, they are less likely to be admitted to or die in hospital. Dialysis and CCC must be adapted for the ageing population. Better ways of matching treatments and individuals are needed.Most older patients receive haemodialysis, travelling for treatment three times every week. Just 15% receive treatment at home, typically with peritoneal dialysis. The number choosing CCC is unmeasured. How people decide between dialysis and CCC is unclear. Interview studies suggest they experience great uncertainty. Many patients report inadequate guidance when choosing a treatment, pressure to accept dialysis and regret undertaking it. Patients emphasise quality of life over survival. Haemodialysis may be the best treatment for many people, but for other recipients it may be: Unsuitable less appropriate for their needs than an alternative, such as CCC and/or Unfitting misaligned with their values and preferences A single choice experiment showed patients may trade survival on dialysis against disruption to routine. Family members assist in decision-making, but were less willing to trade life-expectancy. The study involved younger, transplantable patients in Australia where home dialysis rates are high. The findings cannot be generalised given the cultural, prognostic and clinical differences for older UK patients. The UNPACK study will identify aspects of dialysis and CCC which influence these people's treatment decisions, in order to make targeted service improvements and enhance decision support.Aim To characterise and compare the dialysis and CCC preferences of UK older people approaching kidney failure and their family membersObjectives Identify attributes of CCC and dialysis that influence treatment decisions Quantify the trade-offs patients and family members will make between these attributes Identify clinical/demographic factors associated with differences in treatment preferences Hypotheses Patients will be more willing than family members to trade-off life-expectancy to reduce treatment burden Patient and family preferences will be associated with:Age Prognosis Patient-reported/proxy-reported quality of life Plan Work package A Literature review A systematic search of qualitative studies and meta-ethnography will inform objective 1. An interview topic guide will be developed for package B.Work package B Interview study Semi-structured interviews with up to 30 patients and family members will build an in-depth understanding for objective 1, including concepts unreported in the literature. Attributes (e.g. treatment frequency) and levels (weekly, fortnightly, etc.) will be determined for the choice experiment.Work package C Choice experiment A choice experiment will be developed to quantify trade-offs made when deciding between dialysis and CCC. Treatment preferences from 125 patients and 125 family members will be characterised and compared, informing objective 2. Socio-demographic and clinical factors that influence treatment preferences will be identified, addressing objective 3.Benefits to patients Within five years Identification of dialysis and CCC service aspects that could be modified to make them more suitable for older people. Improving patient, clinician and family education packages. This may be especially valuable when best-interest' decisions are needed for those who have lost capacity to decide. Future The group's NIHR/HTA-funded PrepareME trial will quantify benefits and harms of dialysis/CCC. UNPACK will tell us how important these differences are to patients. Contemporary dialysis practices, like daily therapy, bring increased burdens. UNPACK will inform how acceptable new approaches might be to older patients.

Lay abstract: Every day in the UK ten people older than 65 develop kidney failure. They must choose what treatment to have. A kidney transplant is desirable, but older people are usually too unwell to receive one. People who cannot get a transplant must choose between dialysis and non-dialysis comprehensive conservative care' (CCC). Dialysis can prolong life, but this is not guaranteed for people with major health problems. Treatment is exhausting and requires big lifestyle changes. Aspects such as travelling for dialysis are particularly hard for older people. People who choose CCC are more able to continue with their usual routine. They spend less of their remaining lives in hospital and tend to die better' deaths. There is a need to make dialysis and CCC more suitable for older people and improve how we help patients decide between them.Little research is available regarding what older patients with kidney disease want and what is important to them. We know they experience uncertainty when making up their minds. They can feel pressurised to start dialysis and those receiving it can regret starting. The right' treatment depends upon what is most important to an individual. Family members are often involved in decisions, but their preferences do not necessarily match those of their loved ones. Some patients who receive dialysis may find CCC more fitting.The UNPACK study will improve our understanding of older peoples' preferences when deciding between dialysis and CCC. This will help to identify the aspects of dialysis and CCC that influence which treatment they choose. With this information, services could be improved, including: Adapting dialysis/CCC programmes to be more suitable for older people Making information resources more appropriate for older people who cannot get a transplant Helping doctors and family members make better decisions for people too unwell to decide for themselves The study involves a choice experiment'. Some people choose CCC because they don't want intrusive treatment and are willing to live shorter lives to avoid it. Choice experiments can be used to measure such trade-offs'. Participants choose between treatments in a series of questions. Their responses are used to determine the importance of treatment aspects and how willing people are to trade them. For example, how many days in hospital patients will accept in order to extend their life by one year. Only one choice experiment has assessed trade-offs in this setting. Patients were willing to trade fifteen months of life to make holidaying easier. Relatives were less willing to trade-away life expectancy. The study took place in Australia and included young, fit people. Life expectancy, treatment options and the cultural setting are different for older UK patients, so these findings cannot be generalised to them. The UNPACK study will investigate the trade-offs these older UK patients are willing to make.Design and methods The UNPACK study includes three work packages. Work package A Literature review I will search the literature for treatment aspects known to affect decision-making. Findings will be used to inform questions for the interviews in work package B. Work package B Interview study I will interview up to 30 older patients with kidney disease and people close to them. Patients will be over 65 and have less than 20% kidney function. Family members will be related or unrelated close people. I will analyse the interviews for treatment aspects that affect choices. I will use these to develop the questions for the choice experiment. Work package C Choice experiment I will recruit patients and family members from five UK sites to participate in the choice experiment. As with work package B, patients will be over 65 and have less than 20% kidney function. Family members will be related or unrelated close people. 125 patients and 125 family members will be enlisted. Trade-offs made by patients and family members will be compared. I will look for factors such as age that affect treatment preferences. Patient and public involvement Twelve older patients and relatives were recruited to help with study-development. Four patient/family representatives volunteered to meet regularly to oversee the study and to review/edit patient-facing materials. A focus group of patients will be held to assist with analysis of work package B interviews. Patient co-authors will be sought to write a patient-facing publication of study findings.Dissemination I will share study findings with: Participants Patient representatives The British Kidney Patient Association Journals/conferences Patient-facing publications Twitter @UNPACKstudy @BarnyHole with 1.3k followers including: Patients GPs Kidney doctors/nurses Journalists Policy-makers

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: RENAL AND UROGENITAL