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
Phase: NA
Conditions: Kidney Failure, Chronic
Sponsor: Queen's University, Belfast

 
ACReDiT 
 
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 
 
Randomised Clinical Trial Protocol 
NCT02631200 
 
Advance Care Planning with Older Patients Who Have 
End-stage Kidney Disease

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1. Administrative Information……………………………………………………………………………………..Pg.7 
 
1.1 Title……………………………………………………………………………………………………………………………Pg.7 
1.2 Trial Registration……………………………………………………………………………………………………….Pg.7 
1.3 Protocol Version………………………………………………………………………………………………………..Pg.7 
1.4 Funding………………………………………………………………………………………………………………………Pg.7 
1.5 Authors’ Roles and Responsibilities…………………………………………......………………………….Pg.7 
1.6 World Health Organisation Trial Registration Data Set……………………………………………..Pg.9 
 
2. Introduction………………………………………………………………………………………………………………Pg.11 
 
2.1 Background and Rationale…………………………………………......………………………………………..Pg.11 
2.2 Need for a Trial…………………………………………......………………………………………………………….Pg.11 
2.3 Full Trial Aims and Objectives………………………………………………………………..…………………..Pg.13 
2.4 Feasibility Study Aims and Objectives………………………………………………………………………..Pg.13 
 
3. Methods: Design, setting, participants, interventions and outcomes……………………..Pg.15 
 
3.1 Trial Design…………………………………………………………………………………………………………………Pg.15 
3.2 Study Setting………………………………………………………………………………………………………………Pg.15 
3.3 Eligibility Criteria………………………………………………………………………………………………………..Pg.15 
3.4 Sample Size………………………………………………………………………………………………………………..Pg.16 
3.5 Sampling and Recruitment…………………………………………………………………………………………Pg.16 
3.6 Randomisation………………….………………………………………………………………….…………………..Pg.18 
3.7 Intervention………………………………………………………………………………………………................Pg.19 
3.8 Outcome Data Collection…………………………………………………………………………………………..Pg.20 
3.9 Timeline of Trial Outcome Measures………………………………………………………………………….Pg.20 
3.9.a Immediate Entry Group……………………………………………………………………………………..Pg.20 
3.9.b Deferred Entry Group…………………………………………………………………………………………Pg.21 
Contents 

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4. Methods: Data Analysis and Management…………………………………………………………..Pg.22 
4.1 Data analysis………………………………………………………………………………………………………..Pg.22 
4.1.a  Baseline Data………………………………………………………………………………………………..…Pg.22 
4.1.b Statistical Analysis of Trial Data………………………………………………………………………..Pg.22 
4.2 Economic Evaluation……………………………………………………………………………………………Pg.23 
4.2.a Outline of the economic analysis……………………………………………………………………….Pg.23 
4.2.b Outcomes for the analysis………………………………………………………………………………….Pg.23 
4.2.c Participant utilities…………………………………………………………………………………………….Pg.23 
4.2.d Detailed Statistical Analysis of Economic Data………………………………………………….Pg.23 
4.3  ACP process Evaluation……………………………………………………………………………………….Pg.24 
4.3a  Outcome Measures from the Process Evaluation……………………………………………..Pg.25 
4.4  Analysis of observational data…………………………………………………………………………….Pg.25 
4.5  Overall Outcomes and Outputs…………………………………………………………………………..Pg.25 
4.6  Data Management………………………………………………………………………………………………Pg.26 
 
5. Ethics and Dissemination………………………………………………………………………………………Pg.27 
 
6. Appendices…………………………………………………………………………………………………………….Pg. 
 
Appendix 1:  Patient consent forms……………………………………………………………………………Pg. 
Appendix 2:  Study Information sheets………………………………………………………………………Pg. 
Appendix 3:  Case report forms………………………………………………………………………………….Pg. 
Appendix 4:  Questionnaires………………………………………………………………………………………Pg. 
Appendix 5:  Consultant initial approach to patient script………………………………………….Pg. 
 

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Figures and Tables 
Table 1: Trial Sponsor……………………………………………………………………………………………………………..Pg.8 
Table 2: Roles and Responsibilities………………………………………………………………………………………..Pg.8-9 
Table 3: World Health Organisation Trial Registration Data Set……………………………………………Pg.10 
Table 4: CRF data collection, source and location…………………………………………………………………..Pg.18 
Table 5: Schedule of Trial Interventions and Assessments……………………………………………………..Pg.22 
 
 
 

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Abbreviations  
 
ACP  
Advanced care planning 
 
ADRT  
Advance decision to refuse treatment 
 
BHSCT 
Belfast Health and Social Care Trust 
 
CORE 34 
Clinical Outcomes in Routine Evaluation measure 
 
CRF 
Case Report Form 
 
ESKD 
End-stage kidney disease 
 
HSCT 
Health and Social Care Trust 
 
IST 15 
Isaacs Set Test 
 
KDQOL-36™ 
Kidney Disease Quality of Life instrument 
 
PI 
Principal Investigator 
 
RCT 
Randomised Clinical Trial 
 
RRT 
Renal replacement therapy 
 
SC 
Steering committee 
 
SES 
Socio-economic status 
 
SHARED 
Patient Experience of Shared Decision Making 
 
 
 
 
 
 
 
 
 
 

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1.1. 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. 
Trial acronym: ACReDiT  
 
1.2. Trial Registration 
ACReDiT (IRAS No 193402) 
ClinicalTrials.gov: NCT02631200 
 
1.3. Protocol Version 
Version 6.2: September 2016 
 
1.4. Funding 
This study is funded by Dunhill Medical Trust. Dunhill Medical Trust has no role in the design of this 
study and will not have any role during its execution, analyses, interpretation of the data, or decision 
to submit results. 
 
1.5. Roles and Responsibilities  
Authors’: Peter O’Halloran (PO) (a), Helen Noble (HN) (a),  Kelly Norwood (KN) (a), Jackie Boylan (JAB) (a), 
Kevin Brazil (KB) (a), Damian Fogarty (DF) (b), Joan Brown (JOB) (b), Peter Maxwell (PM) (b), Joanne 
Shields (JS) b),   Robert Mullan (RM) (c) Christopher Cardwell (CC) (d), Mike Clarke (MC) (d),  Rachael 
Morton (RM) (e), Fliss Murtagh (FM) (f). 
a: School of Nursing and Midwifery, Queen’s University, Belfast; b: Belfast Health and Social Care 
Trust; c: Northern Health and Social Care Trust; d: School of Medicine, Dentistry and Biomedical 
1. Administrative Information 

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Sciences, Queen’s University, Belfast; e: NHMRC Clinical Trials Centre, University of Sydney, Australia; 
f: King’s College London 
 
Authors’ contributions   
PO and HN conceived of the study 
PO, HN, FM, RM and DF initiated the study design and JOB, JS, PM, RM, KN, and JAB advised on 
engagement with clinical sites and implementation strategy 
RM, PO and JAB planned the economic evaluation 
PO, HN, KB, MC and CC are grant holders  
CC provided statistical expertise and CC, PO, KN, JOB, and RM will conduct study analyses 
All authors contributed to the refinement of the study protocol and approved the final manuscript. 
 
Table 1: Trial Sponsor 
Trial Sponsor 
Queen’s University, Belfast 
Sponsor’s Reference 
B16/06 
Contact Name 
Mrs Louise Dunlop, Head of Research Governance 
Address 
Queen’s University Belfast, 63 University Road, Belfast BT7 1NF 
Telephone 
028 9097 2529 
Email 
researchgovernance@qub.ac.uk 
 
 
Table 2: Roles and Responsibilities 
Principal investigator (PI) and Post-
Doctoral Research Fellows (PDRFs): 
 
Study design and implementation 
Preparation of protocol and revisions 
Preparation of data collection forms and CRFs (case 
report forms) 
Recruitment, data collection and completion 
of CRFs, along with follow up of study patients and 
adherence to study protocol. 
Publication of study reports 
Organising Trial Management Committee (TMC) 
meetings 

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Budget Administration 
Responsible for trial master file  
 
HSCT local principal investigators 
 
 
Recruitment of patients  
Liaising with PI and PDRFs 
 
Steering Committee (SC) 
Chairperson: Prof Vivien Coates 
Members: all investigators 
 
Agreement of final protocol 
Reviewing study progress 
Agreeing 
changes 
to 
the 
protocol 
and/or 
investigators’ brochures (if necessary) 
Overseeing management of trial master file  
Trial Management Committee (TMC) 
Chairperson: Dr Peter O'Halloran 
Members: PDRFs, and other CI’s as issues 
of particular relevance to their expertise 
are to be discussed, with increased input 
from the trial statistician during the 
analysis phase of the trial. 
Expert advice on methodology 
Study planning 
Organisation of steering committee meetings 
Data verification 
Randomisation 
Statistician (Chris Cardwell) 
 
 
Selection of statistical tests and advice on analyses 
and interpretation 
 
 
 
 
 

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1.6  Table 3: World Health Organisation Trial Registration Data Set 
Data Category 
Information 
Primary registry and trial identifying 
number 
ClinicalTrials.gov: NCT02631200 
Date of registration in primary 
registry 
October 28, 2015 
Source(s) of monetary or material 
support 
Dunhill Medical Trust 
Primary sponsor 
Queen’s University Belfast  
Contact for public and scientific 
queries 
Dr Peter O’Halloran; p.ohalloran@qub.ac.uk 
Public title 
Advance Care Planning With Older Patients Who Have End-stage Kidney Disease 
Scientific 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 
Countries of recruitment 
Northern Ireland, United Kingdom 
Health condition(s) or problem(s) 
studied 
Advance care planning, kidney failure, chronic 
Intervention(s) 
Behavioural: Advance care plan 
Key inclusion criteria 
• 
Attending the renal units taking part in the study 
• 
Receiving renal replacement therapy (RRT) 
• 
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 
Key exclusion criteria 
• 
Expected to die in the next three months 
Study type 
Interventional 
Date of first enrolment 
December 2016 
Target sample size 
80 (patients and relative/friends) 
Recruitment status 
Not yet recruiting 
Primary outcome(s) 
Quality of life: measured by the Kidney Disease Quality of Life instrument - Short 
Form (KDQOL-36™) 
Key secondary outcomes 
 
• 
Agreement between the patient and their nominated 
relative/friend in terms of the patient's preferences: measured by 
asking the relative/friend 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 
• 
Depression: measured by the Clinical Outcomes in Routine 
Evaluation measure (CORE 34) 
• 
The degree to which the patient felt that they had shared in 
decision-making: measured by the Patient Experience of Shared 
Decision Making (SHARED) instrument 
 
 
 
 

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2.1. Background and Rationale 
The prevalence of moderate to severe chronic kidney disease (defined as stages 3-5 CKD) has been 
estimated at 6-8.5% amongst adults in the UK1–3 and at over 30% in those aged 75 and over2. It is 
associated with rising risks of hospitalisation, cardiovascular events, cognitive impairment and 
death4. The rapidly growing minority of older patients with CKD who progress to end-stage kidney 
disease (ESKD) are at even greater risk5.  However, a substantial proportion of patients and their 
families do not discuss end-of-life care - including withdrawal of dialysis, ICU admission, involvement 
of specialist palliative care, cardiopulmonary resuscitation, and place of death – with health 
professionals6,7. Moreover, the high incidence of  impaired cognitive capacity amongst patients with 
ESKD limits their ability to make informed choices and places additional decision-making burdens on 
their families8,9. In this situation, advance care planning can be a useful approach to engaging with 
the patient and their family to help them think through their preferences for care at the end-of-life, 
leading to better communication between professionals and patients and their families, and 
improved decision-making should the patient become incapacitated. 
 
Advance care planning (ACP) has been defined as a process of discussion between an individual, 
their care providers, and often those close to them, about future care.10 It may lead to an advance 
statement of preferences; an advance decision to refuse treatment (ADRT); or to the appointment of 
someone with lasting power of attorney. ACP can be a complex and challenging process for patients, 
their families and professionals, raising cultural and personal sensitivities around death11; with 
uptake influenced by a range of social and cultural beliefs, and organisational issues12. Nevertheless, 
emerging evidence suggests ACP can reduce rates of hospital admission, increase use of hospice and 
palliative care, facilitate the delivery of care that is less aggressive, increase patient and family 
satisfaction, and reduce anxiety and depression in surviving relatives11,13–15. Consequently, in the UK 
ACP is seen as good practice for those with long-term conditions, or who are at the end of life16,17. It 
is also recognised as a mark of high quality care in CKD and ESKD18–20.  
 
 
2.2. Need for a trial 
 
Research into ACP in CKD is limited. A recent systematic review21 found some evidence that ACP led 
to increased well-being and reduced anxiety amongst patients and families. However, most studies 
2. Introduction 

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were descriptive, and intervention studies measured a limited set of outcomes. Issues for research 
included: 
 
1) Poor agreement between surrogate decision-makers and patients on end-of-life preferences 
such as stopping dialysis. 
2) Difficulties health professionals and patients have in knowing how and when to discuss end-
of-life care. 
3) Patients on dialysis may greatly overestimate their life expectancy.  
 
There is also little available data on cost-effectiveness to guide decision makers in allocating 
resources for ACP22. Given that ACP is recognised as good practice and yet is a challenging process, 
research is needed to address issues in relation to implementation, patients’ readiness to engage, 
conservative treatment, withdrawal of dialysis, quality of life, costs, and patient and family 
outcomes23.   
 
Benefits and harm:  
Participating patients will have the opportunity to complete an ACP with the support of trained 
facilitators and peer supporters. Evidence suggests that ACP can reduce rates of hospital admission, 
increase use of hospice and palliative care, facilitate the delivery of care that is less aggressive, and 
increase patient and family satisfaction. Use of ACP is also associated with reduced anxiety and 
depression in surviving relatives and there is also evidence that most patients and relatives find 
taking part in end-of-life research a positive experience, with satisfaction derived from contributing 
to research that may help others in the future. 
 
National guidance on implementing ACP recommends that peer education of patients should be 
included, using expert patients10; and this has been used successfully amongst dialysis patients24. 
Older patients with ESKD are suitable for inclusion in an evaluation of ACP amongst older adults 
because they exhibit the mixture of functional decline and co-morbidity typical of frail older people5. 
Implementation and evaluation of ACPs is challenging,25 so intervention processes and research 
methods should be thoroughly tested before larger scale evaluations are attempted. Therefore, 
following MRC guidance on the evaluation of complex interventions26, we propose a study to 
determine the feasibility of a randomised controlled trial (RCT), including a mixed methods process 
evaluation, to evaluate ACP delivered by professionals (working in partnership with peer 
supporters), for older patients with ESKD. 

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2.3. Full Trial Aims and Objectives 
The summary objectives for the proposed full trial are stated below so that the relevance of the 
objectives for the feasibility study can be appreciated.  
 
Full trial objectives: 
Primary objective: 
• 
Measure the degree to which implementation of ACP results in desired outcomes for 
patients with CKD and their families 
Secondary objectives: 
• 
Estimate the cost-effectiveness of ACP compared to standard care  
• 
Explain how the process of implementation and the organisational context affect the success 
or failure of the intervention 
 
2.4. Feasibility Study Aims and Objectives 
 
Aim of the feasibility study: To determine the feasibility of conducting a deferred entry RCT, 
incorporating a mixed methods process evaluation, to evaluate ACP with patients who have ESKD.  
 
Objectives of the feasibility study:  
 
• 
Acceptability of the intervention to patients, their relatives, and to health professionals 
(assessed through interview data) 
• 
Optimal systems for delivering ACP, including the recruitment, training and retention of peer 
educators (assessed through process mapping, interview data, and reflection by the TMC) 
• 
Recruitment, retention and participation rates (assessed through scrutiny of CRFs) 
• 
Effect sizes that might help inform sample-size estimates for a full trial (assessed by measuring 
numerical differences between immediate and deferred entry groups in terms of all outcome 
measures) 
• 
Randomisation procedures and participants’ willingness to enter a deferred entry trial (assessed 
by scrutiny of CRFs and interview data) 
• 
The suitability of a twelve-week deferral period and a nine month process evaluation (assessed 
by scrutiny of effect sizes and interview data) 

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• 
The suitability of survey instruments and outcome measures, including sensitivity of the 
instruments to detect a change in outcomes (assessed by scrutiny of effect sizes and interview 
data) 
• 
Time needed to collect and analyse data (assessed my scrutiny of CRFs and researcher records of 
process study data collection and analysis) 
• 
Estimated resource use and costs of delivering ACP and methods for assessing costs, benefits 
and cost effectiveness in a full trial (assessed through the range of measures detailed below in 
section 4.2) 
 
Criteria for progression to a full trial: A protocol for a full trial will be developed if the current study 
findings indicate that: 
 
• 
The ACP intervention is acceptable to patients, their relative/friends and to health 
professionals 
• 
Peer educators can be recruited, trained, and retained  
• 
ACP can be readily implemented by relevant staff 
• 
Recruitment, participation, and retention rates are likely to be adequate for a full trial 
• 
The instruments are not excessively burdensome to patients or data collectors, and show 
acceptable reliability and validity 
• 
An economic evaluation is feasible 
 
 
 
 
 
 
 
 
 
 
 
 

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3.1. Trial Design 
Patients and their nominated relative/friends will be recruited to a deferred entry RCT. A traditional 
RCT could be unethical as ACP issues would be raised but not followed through with patients in the 
control group. Consequently, this study incorporates a deferred entry trial, where participants are 
randomised either to an intervention group or a deferred entry control group, as recommended in 
guidance published by the Medical Research Council and the National Institute of Health Research 
(NIHR)27. Participants in the deferred entry group have outcomes measured contemporaneously 
with the immediate entry group but receive the intervention only after trial data collection for the 
immediate entry group is complete28. Patients, their nominated relative/friends and staff 
participants will be recruited into the process evaluation, which will last for 12 months from 
enrolment in the study. This will be underpinned by realist evaluation methodology29, and use 
qualitative and observational methods, to evaluate issues influencing the success of 
implementation30–32. 
 
3.2. Study Setting 
Two sites: the Regional Nephrology Unit at Belfast City Hospital, Belfast Health and Social Care Trust 
(BHSCT) and the Renal Unit at Antrim Area Hospital, Northern HSCT.  
 
3.3. Eligibility Criteria  
Eligible patients will be randomised in equal proportions between the immediate and deferred entry 
groups. 
 
Patient’s eligibility criteria: 
 
• 
English speaking 
• 
Attending the renal units above 
• 
Aged 65 years or more; with ESKD and receiving RRT 
3. Methods: Design, setting, participants, interventions and outcomes 

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• 
Capacity to understand, retain, and weigh the necessary information in English and 
communicate their decisions10 
• 
Identified by their consultant as having either worsening symptoms, functional decline, or 
two or more co-morbidities 
• 
Not expected to die in the next three months 
 
Relative/friend eligibility criteria: 
 
• 
Aged 18 years or older 
• 
Ability to read, write, and speak English 
• 
Identified by the patient as their nominated relative/friend  and willing to represent the 
patient’s wishes should they lose decision-making capacity 
 
3.4. Sample size  
Forty patient-relative/friend dyads will be recruited onto the trial. Assuming 25% attrition44, this 
sample size is thought to provide sufficient numbers to allow feasibility to be estimated, and to 
offset the bias in estimates of effect size produced by very small samples45,46. 
 
3.5 Sampling and recruitment  
Patients who are already attending the renal units (the Regional Nephrology Unit at Belfast City 
Hospital, Belfast Health and Social Care Trust (BHSCT) and the Renal Unit at Antrim Area Hospital, 
Northern HSCT) will be recruited into the study (see below).  
Sampling 
The sampling frame will be the sampling list of patients obtained from interrogation of the electronic 
record who appear to meet Stage 1 eligibility criteria as set out in the CRF i.e. 
• 
Attending one of the participating renal units 
• 
Aged 65 or more 
• 
Receiving RRT 
The PDRF will split the list by renal unit, and then number patients in an excel file. The two lists of 
numbers will be sent to Dr Cardwell, who will randomly select 60 numbers from the BCH list and 20 
from the AAH list, and then send these numbers back to the PDRF. These numbers will be matched 
with the sampling list to identify the first 80 patients to be approached to take part.  
These patients will be allocated a study ID number by the PDRF, who will also add the study ID to a 
CRF and print this out.  

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The PDRF will populate the first page of each CRF (sections 1 and 2) and then pass the CRFs to the 
ACP nurses in the renal units.      
Patient recruitment to the RCT 
• 
Patient screened for stage-one eligibility by the  QUB research team (PDRF) (CRF Section 2). 
o Patient may be screened out.  
 
• 
Patient screened for stage-two eligibility by the ACP Nurse (ACPN) and the patient’s 
consultant (CRF Section 3). 
o Patient may be screened out. CRF passed to the research team. 
 
• 
ACPN and consultant decide who will make the first approach to the eligible patient. 
 
• 
ACPN and/or consultant approach the patient to see if they will consider participation (CRF 
Section 4). 
o Patient may refuse to participate. CRF passed to the research team. 
 
• 
Patient expresses interest in the study. Given patient and relative information packs and 
opportunity to discuss the study. 
 
• 
2-7 days later, the ACPN follows up with the patient to see if the patient would like to take 
part (CRF Section 5). 
o Patient refuses to participate. CRF passed to the research team. 
 
• 
Patient agrees to participate. 
o ACPN checks to see if the patient would like to involve an expert patient in the ACP 
process (at the ACP discussion, through telephone support, or both). 
 
• 
Patient and ACPN sign the consent form. 
• 
 
Consent form passed to the research team 
 
• 
ACPN checks whether the patient will involve a relative or friend in the ACP process (CRF 
Section 6a). 
o Patient will not involve a relative/friend. CRF passed to the research team. 
 
• 
Patient may not yet have decided to involve a relative or friend in the ACP process. 
o ACPN encourages them to speak with a friend or relative and follows up with the 
patient in the next few days. 
 
• 
After 3 days/next dialysis session  ACPN checks whether the patient will involve a relative or 
friend in the ACP process (attending the ACP meeting, nominated on the ACP form, or both) 
(CRF Section 6b). 
o CRF passed to the research team. 
 

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• 
ACP not implemented until baseline data collection, randomisation, and recruitment of 
relative/friend to the research are completed. 
 
 
Relative recruitment to the RCT 
The initial approach to the relative/friend will be through the patient giving them a ‘Relative 
information pack.’ This will make clear that they can act as the patient’s nominated relative/friend 
and decide not take part in the research if they wish.  
The relative/friend information will contain the following request: 
‘If you decide to take part in the research, please do not discuss the details of their plan with the 
patient until the research starts. This is because we want to see if having an advance care plan makes 
a difference to the way you discuss these issues together.’ 
The relative/friend will be invited to express an interest in the research by contacting the research 
team directly using a dedicated phone number or email address, or a form and reply-paid envelope 
(CRF Section 8).  
If the relative/friend responds to the invitation, the research team will discuss the trial with them 
and, if they decide to proceed, post or email a consent form to them. 
If the patient has indicated that the relative/friend intends to be involved in the ACP process but the 
relative/friend has not contacted the research team to express an interest in the research, we will 
send one reminder to the relative/friend through the patient, asking them to consider also taking 
part in the research. 
If they do not respond to this, we will assume they do not wish to take part in the research. 
If the relative/friend consents to take part, we will inform them of which group the patient has been 
randomised to and proceed with data collection accordingly. 
We will also ascertain whether they intend to be present for the ACP discussion and inform the 
ACPN accordingly. 
 
Baseline data collection 

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Prior to randomisation, recruited patients will be asked to cooperate with baseline data collection, 
which will include socio-economic status, education, CKD stage, co-morbidities and time since 
beginning RRT38,39  (CRF Sections 8-14). We will collect the following data: 
 
Table 4: CRF data collection, source and location  
Data 
Data source 
Data collector 
When and where 
GP name, address, 
telephone 
Electronic record 
Research Fellow 
Trust premises 
Patient demographic 
data 
Electronic record 
Research Fellow 
Trust premises 
CKD and RRT status 
Electronic record 
Research Fellow 
Trust premises 
List and number of co-
morbidities 
Electronic record 
Research Fellow 
Trust premises 
Educational level 
Patient 
Research Fellow 
During dialysis 
Socio-economic status 
Patient 
Research Fellow 
During dialysis 
IST 15 
CORE 34 
KDQOL-36™ 
SHARED 
Patient 
Research Fellow 
During dialysis 
 
 
3.6. Randomisation  
Patients will be randomised once baseline data collection is complete. The randomisation sequence 
will use blocks of random sizes (from 2 to 8 which will be unknown to the research team members 
involved in recruitment) to prevent the research team from predicting the randomisation 
sequence.  The allocations will be concealed using sequentially numbered, opaque, sealed 
envelopes.  These envelopes will be opened sequentially after obtaining all patients’ consent and, 
their names and other details have been written on the appropriate envelope. The use of envelopes 
and participant allocation will be monitored to ensure that the envelopes are used in the correct 
sequence. 
 
3.7. Intervention  
This will take place in an outpatient context after the patient has been recruited and randomised: 
  
1. 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 the booklet, “Your life and your 

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choices: plan ahead,” produced by the Northern Ireland Public Health Agency and Macmillan 
Cancer Support33. At this stage, the ACP nurse will ask the participant to complete the 
‘Record of my wishes’ form found in the booklet. 
2. One-to-two weeks later, they will complete an ACP document (Advance Care Planning 
Summary) with the help of the ACP facilitator, working together with trained expert patients 
who (if the patient wishes) will provide peer support at the time of ACP completion and 
subsequently by telephone 10,24,34,35, assisted where necessary by the ACP facilitator.  
3. The patient’s nominated relative/friend will also be invited to take part in the discussion if 
the patient wishes and the relative/friend agrees. 
4. The ACP document will be based on that used within the BHSCT (“A record of my wishes”, 
recently developed by the Northern Ireland Palliative and End of Life Care Implementation 
Group and based on the booklet, “Your life and your choices: plan ahead”), resulting in the 
completion of the Advance Care Planning Summary, alongside the identification of a 
nominated person to help in decision-making as well as the following:  
 
a) What the patient would like to happen in the future 
b) What the patient would not want to happen 
c) Recording the presence and broad content of an ADRT if it already exists 
d) Preferred place of care at the end-of-life 
e) Special requests 
 
The patient will be encouraged to keep the ACP with them and to make it available to anyone caring 
for them. A summary of the patient’s wishes in the ACP will be kept with their medical notes and 
copied to their GP, relevant social and community services, and to out-of-hours and ambulance 
services. The ACP will be reviewed if circumstances change or the patient changes their mind, and in 
any case after twelve weeks. Participants in the deferred entry group will be offered the intervention 
twelve weeks after the immediate entry group. ACP implementation will be informed by a realist 
review of the literature36 and draw on the Consolidated Framework For Implementation Research,37 
which focuses on intervention characteristics, organisational setting, and the characteristics of the 
individuals involved. 
NB: Patient’s normal hospital care is not affected during the trial and they have the right to 
withdraw at any time. 
 
 
 

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3.8. Outcome Data collection 
RCT outcome measures 
1. Quality of life as measured by the Kidney Disease Quality of Life instrument – Short Form 
(KDQOL-36™)40 
2. Degree of cognitive impairment as measured by the Isaacs Set Test (IST 15)41 
3. Degree of anxiety, depression, well-being, functioning and risk as measured by the Clinical 
Outcomes in Routine Evaluation measure (CORE 34)42 
4. 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) 
instrument43 
5. Agreement between the patient and their nominated relative/friend 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 (a-e above), before taking part in the ACP. 
6. An economic evaluation of costs and benefits of the ACP intervention will be conducted 
utilising data collected from the following sources: 
a. Electronic hospital admissions and outpatient data for each patient 
b. Patient completed cost diaries documenting health and social care resource use 
c. Patient quality of life data using the SF-12 (contained within the (KDQOL-36™)40 
 
Resource use will be valued according to appropriate tariffs, allowing comparison of mean costs per 
patient by group allocation for the 12 week period of the trial. 
 
 
3.9. Timeline of Trial Outcome Measures  
3.9.a. Immediate Entry Group 
 
Baseline/Time 1: Following enrolment and prior to receiving the intervention, patients randomised 
to the immediate intervention group will complete the IST 15, CORE 34, and KDQOL-36™, and 
SHARED. Their nominated relative/friend will make an independent assessment of the patient’s ACP 
preferences before the patient receives the information booklet. Subsequently, the patient and (if 
the patient wishes) the relative/friend will participate in the ACP intervention. 
 

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ACReDiT Protocol; V6.2; 30/01/17 
 
Time 2: At two weeks following the intervention, the patient will complete the CORE 34 and 
SHARED, and review their ACP. The nominated relative/friend will make a second independent 
assessment of the patient’s preferences. 
 
Time 3: At 12 weeks the patient will again complete CORE 34, KDQOL-36™, and SHARED and both 
patient and relative/friend will review the ACP and make any desired changes. 
 
3.9.b. Deferred Entry Group 
Patients (and their nominated relative/friends) randomised to the deferred entry group will have 
outcomes measured contemporaneously with the immediate entry group but receive the 
intervention only after they have completed three sets of data i.e. at 12 weeks following entry to the 
trial. At 24 weeks the deferred entry group patients will again complete CORE 34, KDQOL-36™, and 
SHARED and both patient and relative/friend will review the ACP and make any desired changes. The 
deferred entry group may have more than one ACP review with the ACPN, however data will only be 
collected from this group at the final review. 
 
Table 5: Schedule of Trial Interventions and Assessments 
Time 
points 
Immediate entry 
Deferred entry 
 
Patient * 
Relative 
 
Patient*  
Relative/friend 
t1 baseline 
IST 15 
CORE 34 
KDQOL-36™ 
SHARED 
 
ACP agreement 
questionnaire 
IST 15 
CORE 34 
KDQOL-36™ 
SHARED 
 
ACP 
intervention 
ACP intervention 
2/52 
ACP 1st 
review 
 
CORE 34 
SHARED 
 
ACP agreement 
questionnaire (before 
review) 
 
ACP review** 
 
CORE 34 
SHARED 
 
12/52 
CORE 34 
KDQOL-36™ 
SHARED 
 
ACP 2nd 
review 
ACP agreement 
questionnaire (before 
review) 
 
 
ACP review** 
CORE 34 
KDQOL-36™ 
SHARED 
ACP agreement 
questionnaire 
 
ACP intervention 
 
ACP intervention 
 
24/52 
 
 
ACP review** 
  
ACP agreement 
questionnaire (before 

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ACReDiT Protocol; V6.2; 30/01/17 
 
CORE 34 
KDQOL-36™ 
SHARED 
review) 
 
ACP review** 
Key: 
IST 15 = Isaacs Set Test 
 
CORE 34 = Clinical Outcomes in Routine Evaluation measure 
 
KDQOL-36™ = Kidney Disease Quality of Life instrument – Short Form 
 
SHARED = Patient Experience of Shared Decision Making instrument 
* Patients in both groups will also complete a cost diary during intervention period as part of the 
economic evaluation 
** Relative/friend may or may not be at the review of the ACP with the patient (this is at the patient 
and/or relative friend’s discretion) 
 
 
 
 
4.1. Data analysis  
4.1.a. Baseline Data 
Baseline results will be presented in tables and analysed using a range of descriptive statistics in 
SPSS for both groups. Categorical variables will be presented as numbers and percentages of those 
patients who were in the immediate entry group. Continuous variables will include the mean, 
median, standard deviation and data range.  
 
4.1.b. Statistical Analysis of Trial Data 
The proportion of patients eligible for inclusion, agreeing to participate and completing the study 
will be calculated along with 95% confidence intervals (CIs).  Questionnaires (CORE 34, KDQOL-36™, 
SHARED) will be administered to both the immediate and deferred entry groups, at baseline, 2 and 
12 weeks post-intervention (includes immediate entry group only).   Analysis of covariance will be 
used to calculate the mean difference (and 95% CIs) in outcome variables (CORE 34, KDQOL-36™, 
SHARED) at 12 weeks between the intervention and control group adjusting for baseline values 
(reference BMJ. 2001 Nov 10; 323(7321): 1123–1124.). Alternatively, Mann-Whitney U tests will be 
performed on the change from baseline to 12 weeks in the two groups.  Further analyses employing 
paired t-test or Wilcoxon signed rank tests, will be conducted to compare changes in outcome 
measures within the immediate entry and deferred entry groups. Statistical analyses will employ the 
p<0.05 significance level. Investigation of the pattern of missing data (e.g. missing completely at 
random, missing at random, missing not at random) which will help determine the appropriate 
method for handling the missing data. For quality of life data, a weighted mean value for the group 
4. Methods: Data Analysis and Management 

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ACReDiT Protocol; V6.2; 30/01/17 
 
sample may be used to ‘fill in’ the missing items. Depending on the amount of missing data, multiple 
imputation will be considered.” 
 
 
 
4.2. Economic Evaluation 
4.2.a. Outline of the economic analysis  
The feasibility of a cost-effectiveness and cost-utility analysis of the ACP intervention compared to 
usual care, conducted from a societal perspective, will be explored in the pilot study, to inform a full 
economic evaluation alongside the main trial. 
 
4.2.b. Outcomes for the analysis  
The analysis will report the cost per [primary endpoint achieved e.g. relative/friend agreement or 
SHARED]; and the cost per quality adjusted life year (QALY) gained of the ACP intervention compared 
to usual care.  
 
4.2.c. Participant utilities  
The SF-6D preference based instrument contained within the SF-12 and KDQoL-36 survey will be 
administered to all patient participants at baseline and 12 weeks. QALY weights (utilities with a value 
between 0 and 1) from self-reported data will be calculated using UK tariffs (the value set) of the SF-
6D. QALYs will be calculated by multiplying the utility with the time spent in that health state using 
an area under the curve approach. A minimally important difference in utility has been reported at 
0.03-0.05. Mean costs (including volume of resource use) and mean health outcomes per allocated 
group will be reported with 95% confidence intervals. Mean costs will be presented as unadjusted 
and adjusted for any baseline differences in age, sex, or SES. 
 
 
4.2.d. Detailed Statistical Analysis of Economic Data 
Skewed cost data: Cost data are likely to be right skewed as they are bounded by zero (i.e. can’t be 
negative); have no upper bound, and a small number of patients may incur very high costs, affecting 

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ACReDiT Protocol; V6.2; 30/01/17 
 
the mean. The cost distribution will be plotted in a histogram and non-parametric bootstrapping will 
be used for analysis. 
Results: The mean and total volume of major categories of resource use (e.g. hospitalisations; 
doctor’s visits; nurse visits;) will be reported for each group. The difference in the volume of 
resource use for each group and 95% confidence intervals for the difference will be reported.  
Total costs: The total cost will be calculated by multiplying the arithmetic mean cost by the number 
of participants in each group. Mean costs with standard deviations and total costs for each group 
will be reported in UK pounds for the most recent reference year. The difference in total costs will 
be assessed using the student t test and/or analysis of variance (ANOVA). Total costs will also be 
adjusted for relevant baseline characteristics (e.g. age, sex).  
Benefits will include: (i) quality of life, measured at baseline and 12 weeks with the KDQOL-36™ 
survey; (ii) the proportion of participants with a unit increase in CORE 34; (iii) the proportion of 
patients with a unit increase in either SHARED or relative/friend Agreement – [whichever will be the 
primary outcome] (iv) QALY gained at 12 weeks. 
Sensitivity analyses: One-way sensitivity analyses will be conducted around key variables including 
health and social care costs +/- individual patient costs; and health system resource use as measured 
in patient diaries compared to the base case measurement using hospital administrative records.     
 
4.3. ACP process Evaluation  
Participants will be followed for 12 months (or until bereavement, if earlier) from enrolment in the 
study. 
Five focus groups will be conducted with HSCT staff (see below), to elicit their experience of ACP and 
their views on barriers and facilitators of implementation. Staff will be recruited based on their close 
involvement in the ACP process and identified and contacted  
1. Four intervention facilitators 
2. Four peer supporters 
3. Four members of medical staff 
4. Four members of nursing/AHP staff 

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ACReDiT Protocol; V6.2; 30/01/17 
 
5. Those training staff in ACP 
Staff will be recruited based on their close involvement in the ACP process. Initially, they will be 
identified and contacted by co-investigators employed in the participating HSC Trusts. 
Interviews will also be conducted with 4 patients and their nominated relative/friends to examine 
their experiences of ACP 12-weesk post-intervention. Researcher’s will also observe staff training for 
ACP; carry out documentary analysis; and develop a process map47 of the personnel and systems 
involved in managing ACP. 
 
4.3.a. Outcome Measures from the Process Evaluation 
 
The proportion of patients who die during the study will be recorded. This will include whose end of 
life wishes were complied with, as measured by a comparison of their ACP and the record of the 
circumstances of their death in their medial notes, and in a survey of bereaved nominated 
relative/friends, carried out at least 3 months after their death. 
 
We will compare relative/friends, whose relative experienced care broadly in alignment with their 
wishes, with relative/friends of those who did not, in terms of their satisfaction with care, as 
measured by the After-Death Bereaved Family Interview48 and level of depression measured by the 
Patient Health Questionnaire (POQ9)49. 
 
 
4.4. Analysis of observational data 
 
Interviews will be digitally recorded and transcribed verbatim.  Each piece of interview and other 
data will be coded according to the initial theory derived from CFIR and the realist review to allow 
indexing and retrieval in a suitable database. The documentary evidence, process map, and 
interview transcripts will be reviewed searching for configurations that support, contradict and link 
theory, seeking to explain outcomes. 
 
4.5. Overall Outcomes and Outputs 
 
Immediate outcome of this study will be an appraisal of the feasibility of a full study, with an analysis 
of the factors crucial to successful implementation of ACP, paving the way for a future definitive 
evaluation of the impact of ACP on the well-being of patients with complex co-morbidities and their 

26 
 
ACReDiT Protocol; V6.2; 30/01/17 
 
families, and identification of the key factors leading to successful implementation. The full study 
will evaluate the impact of ACP on patients who have ESKD and on associated costs, with anticipated 
benefits of greater adherence to their wishes at the end of life; reduced rates of hospital admission; 
greater use of hospice and palliative care services; less anxiety and depression; increased perception 
of shared decision-making; and greater well-being, and physical and social functioning. 
Relative/friends should experience greater agreement with patients’ wishes, greater satisfaction 
with care, and less depression on bereavement. 
 
4.6. Data Management 
Patients will only be identifiable by their participant code – all identifying personal information will 
be stored in a locked filing cabinet, in a locked room. Access to study data will be restricted to the 
minimum number of individuals necessary for quality control and analysis – the PI and the 
researchers. Outside of the direct care team, only the PI and the researchers will have access to 
participants' personal data. A password system will be utilised to control access and passwords will 
be changed on a regular basis. Participant files are to be stored in numerical order and will be 
retained in storage for a period of 5years following study completion. Digital data will be stored on a 
password protected central server accessed through a password protected computer at the School 
of Nursing and Midwifery, Queen's University. Belfast. Checks will be applied at the time of data 
entry into a specific field and before the data is written (committed) to the database. Data will be 
analysed by members of the research team in Queen's University Belfast, Kings College London, and 
(in the case of data for the economic evaluation) the University of Sydney. All data will be 
anonymised before it is transferred or analysed. We will use the secure 'DropBox' facility provided 
by Queen's University to transfer password protected data files. Hard copies of documents 
containing research data will be stored in a locked filing cabinet in a locked room at the School of 
Nursing and Midwifery. Only PO will have access to this data. Tapes from interviews and focus 
groups will be destroyed after the data has been transcribed and recorded verbatim. Researchers 
will send weekly email reports to the PI with any information on missing data, missing forms, and 
missing visits. 
 
 

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Research Ethics has been granted from QUB research governance and from Belfast and Northern 
Trusts.  Any amendments to the protocol which may affect the conduct of the study, benefits to 
patients, including changes to the study design, study objectives, patient population and sample 
sizes, procedural details will require a formal amendment to REC body. Informed consent for both 
participants and patients will be obtained by ACP nurses on both sites. All trial-related information 
will be stored securely at the Medical Biology Centre, Queen’s University, Belfast (please see 4.6 for 
further information). Governance of the study will be guided by a Trial Management Committee and 
a Steering Committee. The Trial Management Committee will meet at least monthly and will oversee 
day-to-day aspects of the trial. It will be chaired by the PI, Dr O’Halloran, and include the two PDRF, 
and other CI’s as issues of particular relevance to their expertise are to be discussed, with increased 
input from the trial statistician during the analysis phase of the trial. The Trial Steering Committee 
will be chaired by Professor Vivien Coates (Professor of Nursing Research, University of Ulster) and 
will comprise the PI and all the CI. It will meet in full face to face twice during the trial and there will 
also be two other meetings, which might take place by teleconference. The two face-to-face 
meetings will be near the beginning and the end of the funding period, to approve the final set-up 
plans for the trial and to consider the findings, prepare a publication and other dissemination 
activities, and plan the main trial and its funding application. The Trial Steering Committee will 
determine whether or not the trial has met the criteria to show that a main trial is feasible. The PI’s 
and CI’s have no competing interests to share for the overall trial and each study site. 
 
 
 
 
 
 
 
 
 
5. Ethics and dissemination 

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ACReDiT Protocol; V6.2; 30/01/17 
 
 
 
 
 
Appendix 1:  Patient consent forms 
Appendix 2:  Study Information sheets 
Appendix 3:  Case report forms 
Appendix 4:  Questionnaires 
Appendix 5: Cost diaries; resource use case report forms 
Appendix 5:  Consultant initial approach to patient script 
 
 
6. Appendices 

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ACReDiT Protocol; V6.2; 30/01/17 
 
First approach by a consultant or ACPN to a patient who may take part in the ACP (ACREDIT) study  
 
INTRODUCTION 
• 
Hello, Mr/Mrs……………….. 
my name is ……… 
• 
I’m here to ask if you would consider helping us with some research we are doing? 
• 
You don’t have to make up your mind right away. 
• 
But if it’s OK with you, I’ll tell you the basics now – is that all right? 
• 
Then, if you are interested, I’ll ask one of the nurses to give you the details so you can make up 
your mind about whether you want to take part.  
~ 
EXPLANATION 
• 
We want to do some research into something called ‘advance care planning.’  
• 
Have you heard of that?  
• 
Advance care planning is where you discuss your options and choices for future care with your 
doctors and nurses. 
• 
This means we know about what you would like to happen if your condition gets worse and we 
can try and make sure things work out as you would wish. 
• 
You can also include your relatives in the advance care planning if you want to. 
~ 
 
INVITATION 
• 
We want to do some research about this so that we can see how well advance care planning 
works for patients and their relatives. 
• 
As I say, you don’t have to make your mind up now. 
• 
But if you think you might be interested in taking part I’ll ask the nurse to come and speak with 
you and give you some more details. 
• 
Would you be interested in finding out a bit more? 
~ 
 
PATIENT SAYS YES 
• 
Thank you. 
• 
I’ll ask the nurse to come and talk to you and give you some more details. 
• 
If you have any questions then please do ask me or one of the nurses.  
~ 
 
PATIENT SAYS NO 
• 
That’s perfectly all right. We won’t bother you again about it. 
• 
But if you have any questions, or if you change your mind and think you might want to take part, 
just speak to me or to the nurse in charge. 
• 
Thanks for discussing it with me. 
 
 

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