Jeong et al.

BMC Health Services Research (2019) 19:286

https://doi.org/10.1186/s12913-019-4118-x

STUDY PROTOCOL Open Access

Study protocol to investigate the efficacy of

normalisation of Advance Care Planning
(ACP) for people with chronic diseases in
acute and community settings: a quasi-
experimental design
Sarah Jeong1* , Tomiko Barrett2, Se Ok Ohr3, Peter Cleasby4, Michael David5, Sally Chan6, Helen Fairlamb7,
Ryan Davey8 and Peter Saul9

Abstract
Background: Advanced care planning (ACP) is a process that involves thinking about what medical care one
would like should individuals be seriously ill and cannot communicate decisions about treatment for themselves.
The literature indicates that ACP leads to increased satisfaction from both patients and healthcare professionals.
Despite the well-known benefits of ACP, it is still underutilised in Australia.
Methods: The aim of this study is to investigate the effects of normalising ACP in acute and community settings
with the use of specially trained normalisation agents. This is a quasi-experimental study, involving 16 sites
(8 intervention and 8 control) in two health districts in Australia. A minimum of total 288 participants will
be recruited (144 intervention, 144 control). We will train four registered nurses as normalisation agents in
the intervention sites, who will promote and facilitate ACP discussions with adult patients with chronic conditions in
hospital and community settings. An audit of the prevalence of ACP and Advanced Care Directives (ACDs) will be
conducted before and after the 6-month intervention period at the 16 sites to assess the effects of the ACP service
delivered by these agents. We will also collect interview and survey data from patients and families who participate,
and healthcare professionals who are involved in this service to capture their experiences with ACP.
Discussion: This study will potentially contribute to better patient outcomes with their health care services. Completion
of ACDs will allow patients to express their wishes for care and receive the care that they wish for, as well as ease their
family from the burden of making difficult decisions. The study will contribute to development of a new best practice
model to normalise ACP that is sustainable and transferable in the processes of: 1) initiation of conversation; 2) discussion
of important issues; 3) documentation of the wishes; 4) storage of the documented wishes; and 5) access and execution
of the documented wishes. The study will generate new evidence on the challenges, strategies and benefits
of normalising ACP into practice in acute and community settings.
(Continued on next page)

* Correspondence: [email protected]
1
School of Nursing and Midwifery, University of Newcastle, PO Box 127,
Ourimbah, NSW 2258, Australia
Full list of author information is available at the end of the article

© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Jeong et al. BMC Health Services Research (2019) 19:286 Page 2 of 10

(Continued from previous page)

Trial registration: This project has been approved by the Hunter New England Human Research Ethics
Committee (Approval No. 17/12/13/4.16). It has also been retrospectively registered on 3 October 2018 with
the Australian New Zealand Clinical Trials Registry (Trial ID: ACTRN12618001627246). This study will operate in
accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct
in Human Research (2007) and the CPMP/ICH Note for Guidance on Good Clinical Practice.
Keywords: Advanced care planning, Clinical trial, Nursing, Protocol, Normalisation, Chronic disease, Hospital,
Community

Introduction work conducted to increase the uptake of ACP, both

Chronic disease (e.g. cardiovascular, respiratory, dia- published research [16] and our study’s initial evidence
betes, dementia) contributes to more than 70% of the identified the following persisted problems in acute and
disease burden in Australia and the burden of chronic community healthcare settings.
disease is increased with the ageing population [1, 2].
Among the patients with chronic conditions, a total of 1. Despite many resources available on ACP and
17,372 people died after 38,905 hospitalisations repre- ACDs, awareness of ACP is low and completion of
senting 24% of total 165,000 hospitalisations in New ACD is very low in The Hunter New England
South Wales (NSW) in 2011/12 [3]. The majority (76%) (HNELHD) and Central Coast Local Health
were emergency admissions. Although about 42% of this Districts (CCLHD). This low rate is regardless of
sub-cohort died in hospital, only 4% of them received cultural and ethnic backgrounds, and stemmed
palliative care services [3]. Given the significant impacts from a lack of understanding of the concept, the
of rapid increase of ageing population with chronic dis- various terms and forms, being time consuming in
eases on the health of the people themselves and the the processes involved and the feeling ‘I don’t know
resources of the health care system, understanding the how to do it’ [17].
issues related to end of life (EOL) care and treatment 2. Adult children are the most preferred substitute-
options preferred by people with chronic diseases has decision-maker (SDM) to husband/wife, but the
become a priority for health care professionals [2, 4]. existing legal and ethical frameworks do not capture
Advance care planning (ACP) is a process that in- the current preference of people as SDMs [18].
volves thinking about what medical care one would like 3. The attitudes towards the end-of-life issues differ
should individuals be seriously ill or injured and cannot within the context and depending on individuals’
make or communicate decisions about care or treatment cultural and religious beliefs and values, and
for themselves [5]. An Advance Care Directive (ACD) preferences for care [19].
can only be made by an adult with decision-making cap- 4. Despite education and resources available for health
acity. It is a written statement by those who can make care professionals (e.g. doctors and nurses), they
medical decisions for themselves for the time when one feel unconfident and unprepared, and their
is unable to make decisions. It should include what is commitment remains minimal [16, 20]
important to the person such as values, life goals and 5. The challenges in ACP lie in the processes of: 1)
preferred outcomes [5]. It is widely considered optimal if initiation of conversation; 2) discussion of important
ACP happens earlier in life, when the person is still well issues; 3) documentation of the wishes; 4) storage of
and capable of making decisions [6]. The benefits of the documented wishes; and 5) access and execution
ACP are well documented in Australian context and of the documented wishes, and that an effective and
worldwide. ACP improves the quality of EOL care, pa- consistent solution for increasing practice of ACP
tient and family satisfaction, and reduces stress, anxiety remains elusive.
and depression in surviving relatives [7–15].
Significant work has been done to promote ACP inter- The proposed intervention in this project is informed
nationally. In NSW, Australia, many resources are available by existing evidence that complex ACP interventions
about ACP and ACDs including legally binding ACD forms have resulted in increased frequency of out-of-hospital
[5], and policies (e.g. End-of-life care and Decision-making and out-of-ICU care, increased adherence to patients’
Guidelines, A National framework for Advance Care Direc- preferences, and increased satisfaction with their health
tives, Using Advance Care Directives, Advance Planning for care experience [7]. We established and tested evidence
quality care at end of life: Action Plan 2013–2018). Despite from the literature and clinical experiences over the last
the well-known benefits of ACP for people, and substantial 10 years, and concluded that normalisation of ACP by a
Jeong et al. BMC Health Services Research (2019) 19:286 Page 3 of 10

designated person and using the patient’s own language Design

is the optimal implementation strategy. However, this The project is a quasi-experimental design with two
approach has only been implemented and tested by a groups: 1) intervention groups with RN ACP facilitators,
few individual clinicians on an ad hoc basis. The pro- and 2) control groups without RN ACP facilitators. See
posed intervention is built on these previous findings Fig. 1. Research Flow Chart below.
and will provide us with an opportunity to test and ACP will be normalised into practice for 6 months by
evaluate this approach in a wider scale. RN ACP facilitators (normalisation agents) in nominated
In this study we examine the effect of trained general wards/units in acute and community settings in two
(not specialised) registered nurses (RNs) to promote and Local Health Districts (LHDs). Pre and post measures
normalise ACP for people with chronic conditions in (the number of people who have ACDs in medical
hospital and community health settings. The targeted records, Resuscitation plan, any records or notes about
population in this project (people with chronic diseases) ACP discussion and documentation, and the concordance
is aligned with targeted populations for special Advance between the expressed wishes and the care delivered) will
Care Planning needs [6], which includes; Diabetes, Con- be obtained for the two groups. Post qualitative data (text-
gestive Heart Failure, Coronary Artery Disease, Chronic ual data, individual/focus group interviews with patients,
Obstructive Pulmonary Disease, Hypertension, Chronic SDMs and staff participants) will be collected and inform
Kidney Disease, Cancer, frailty and Dementia. the challenges, strategies and implications for future policy
and practice.

Methods/design Study setting and sample selection

Aims Participants will be recruited from acute and community
The primary aim: To test the feasibility and effectiveness settings across LHD 1 and LHD 2, NSW, Australia.
of normalisation of ACP for people with chronic diseases Research sites are listed below in Table 2.
in acute and community settings. The 16 research sites were pair-matched (eight inter-
The secondary aims are: vention, eight control) and selection was based on ad-
mission rates, patient profile, number of deaths per
1. To identify the characteristics of the most effective month/year, average length of stay and number of refer-
setting and demographics for ACP implementation. rals from/to hospital and community. To minimise po-
2. To investigate the nature and extent to which tential contamination of intervention the sites chosen
planning for future health care wishes are initiated, are geographically separated. Both public funded and
discussed and documented among people with non-public sites are involved in this research, to maxi-
chronic diseases, their family members, and RN mise the generalisability.
ACP facilitators. All newly admitted patients to a site listed as an ‘inter-
3. To identify the effect of ACP on patient/SDM vention site’ will be offered facilitated ACP conversa-
satisfaction with their healthcare experience. tions, and all other sites will continue to deliver usual
4. To identify factors that influence the implementation care (control sites).
of ACP in hospital and community health settings. Once potential participants are identified by inclusion
5. To assess and estimate the financial impact of and exclusion criteria (Table 3), a robust screening
normalisation of ACP on our health care system. process will be applied which includes; patients with
mental capacity and the ability to give valid informed
consent as established by admitting medical officer or
Theoretical framework for the study admitting RN by using Montreal Cognitive Assessment
This project proposes an innovative approach to address (MOCA) and Mini-Mental State Examination (MMSE).
the above problems by promoting ‘ACP conversations’ as MOCA (26/30) and MMSE are done as part of new
part of routine (normal) clinical practice, underpinned admission process (if a contemporaneous assessment
by Normalisation Process Theory (NPT). This theory is has not already been completed by another unit/ward/
centred on the work of embedding and of sustaining department i.e. ED). Those who have a score of 10 or
practices within interaction chains [21]. NPT focuses on above will be nominated to participate. Those who have
what people do in the process of implementation. The score of 10–24 (MOCA) and whose capacity is in question
theory constructs four mechanisms that explain the so- will be formally assessed by RN ACP Facilitators using
cial process in the implementation of material practices NSW Capacity Tool Kit [22]. A conservative approach to
by specialised ‘agents’. These mechanisms are coherence, recruitment will be applied. If capacity to consent is
cognitive participation, collective action, and reflexive unclear for any potential participants these individuals will
monitoring (Table 1) [21]. not be approached. Screening for potential participants
Jeong et al. BMC Health Services Research (2019) 19:286 Page 4 of 10

Table 1 Agents and for mechanisms for Normalisation Process Theory

Agents Agents are individuals and/or groups who contribute to the processes that lead to implementation, embedding,
and integration of new practice. For this study, agents are healthcare professionals (admitting Medical Officer,
Registered Nurse, Social Workers and RN ACP facilitators). They use the NSW Health ‘ACP – Making your wishes
known’ information to patients, to initiate, engage in discussion, and answer any questions.
Coherence This involves what and how things should be done which starts with how it has been done and what
we should do differently. The meaning of new practice needs to be learned, experienced and internalised
by the agents. The agents in this study are provided with the opportunities to learn, experience and internalise.
Cognitive participation When the process of coherence is internalised, the agents engage in a new practice across the context.
The agents in this study are given 6 months to internalise and normalise ACP as a routine practice.
Collective action The new practice is operated and enacted in practice. In this study, material and human resources, working
relationships between agents, a degree of autonomy are closely monitored and enacted upon.
Reflexive monitoring This is an evaluation of implementation process. The agents will engage in an evaluation of the implementation
process that reflects cognitive participation and collective action. It involves both individual and group appraisal
and reconfiguration of ACP practice to embed and sustain a new ACP practice.

will occur before consent has been obtained. This will pre- by RN ACP facilitators for English Proficiency, cognitive
vent patients that are not defined as relevant to the aims impairment and acute episode of mental illness by ask-
of this research through the inclusion/exclusion criteria ing the following questions as recommended by NSW
from being informed of a service they will not receive Planning Ahead Tools [5].
and/or overburdening people.
1) Do you remember and/or understand the ACP
Sample size calculation brochure given by MO or RN or SW?,
Power calculations were conducted to determine the sam- 2) Who should your doctor talk to about your medical
ple size required to detect a change of at least 10% in the treatment?
primary outcome; that being the proportion of completed 3) You have a choice to have or not to have a
NSW ACDs. Change was defined as the difference be- conversation(s) with me. Do you want to have a
tween the proportion at baseline, assumed to be 5% and at conversation(s) with me?
follow-up. Setting alpha at 5%, power at 80% and assum-
ing a non-response rate of 25%, a sample size of 288 is RN ACP facilitators will begin with open ended ques-
needed (144 in intervention sites and 144 in control sites). tions exploring the person’s knowledge, attitude and
Given an average admittance rate of at least 10 per week desire to participate in ACP. RN ACP facilitators will
per site and over a six-month period, there is almost also clarify the person’s goals and values; identification
complete surety that the study will not be under-powered. of whom should be involved in these conversations; and
the person’s understanding of diagnosis, prognosis and
Intervention preferences for treatment options and place of care.
The intervention, ACP, is offered as part of routine ser- According to responses, RN ACP facilitator will initi-
vice to the patients who are admitted to participating ate and facilitate a series of conversations between per-
intervention wards/community centres. The intervention son, the nominated SDM, treating medical team, and/or
is a series of facilitated conversations about the compo- a Health Care Interpreter or appropriate Cultural
nents of ACP between people with chronic diseases, Support Person if required. The components of ACP in-
their SDMs and RN ACP facilitators. clude personal details, Person Responsible, personal
values about dying, directions about medical care, spe-
Conversation 1 cific requests for organ and tissue donation, and author-
On admission, as a routine service, people with chronic isation with signatures in Section 1 to 5 in NSW
diseases (and/or family if present) in intervention wards/ Ministry of Health ‘Making an ACD’ [5]. A summary of
community centres will be given a one-page ACP Bro- outcomes of these conversations will be entered: 1) in
chure (produced by NSW Ministry of Health - Making the person’s medical record; 2) A Conversation Log; and
your wishes known) by admitting Medical Officer (MO) 3) A ‘Conversation card’ which is a size of business card
&/or admitting Registered Nurse (and Social Worker if when folded and which will be carried in participating
applicable). patient’s wallet/purse.
Ongoing commitment from participants is not re-
Conversation 2 and more quired. The series of conversations are optional and con-
All people with chronic diseases and their nominated sent to proceed will be checked repeatedly through the
SDMs who meet the inclusion criteria will be assessed course of discussion. The post-evaluative surveys and
Jeong et al. BMC Health Services Research (2019) 19:286 Page 5 of 10

Fig. 1 Research flow chart

interviews are also voluntary and are ‘one-off ’ so do Data collection

not involve ongoing follow up or appointment. All Audit of ACP related practice
potential participants will have as much time as they Data on the prevalence of ACP and ACDs will be
require to consider participation, but at least 24 h be- collected through an audit of the medical records of
tween provision of information (written information patients admitted to the 16 research sites within the
statement and verbal explanation) and gaining written following time frames:
informed consent for participation is recommended in
line with the National Statement on Ethical Conduct – The two month period before the introduction of
in Human Research [23] and Good Clinical Practice the intervention period,
guidelines [24]. – The six month period of the intervention
Jeong et al. BMC Health Services Research (2019) 19:286 Page 6 of 10

Table 2 Research sites

Acute Community
Intervention Control Intervention Control
LHD 1 Geriatric Rehab Unit (LHD1HIS1) Geriatric Rehab Unit Public Community Health Centre Public Community Health Centre
(LHD1HCS3) (LHD1CIS5) (LHD1CCS7)
Medical ward at Hospital (LHD1HIS2) Medical ward at Hospital Non-public Home and Community Non-public Home and Community
(LHD1HCS4) Care (LHD1CIS6) Care (LHD1CCS8)
LHD 2 Medical ward at Hospital (LHD2HIS9) Medical ward at Hospital Public Community Health Centre Public Community Health Centre
(LHD2HCS11) (LHD2CIS13) (LHD2CCS15)
Medical ward at Hospital (LHD2HIS10) Medical ward at Hospital Non-public Home and Community Non-public Home and Community
(LHD2HCS12) Care Service (LHD2CIS14) Care Service (LHD2CCS16)
Note: Hospital Intervention Site (HIS), Hospital Control Site (HCS), Community Intervention Site (CIS), Community Control Site (CCS). One full-time RN for 2 wards in
one hospital and one full-time RN for 2 community service providers at one setting are allocated in each LHD

The audit will initially check for the presence or ab- 2. Medical Record Numbers (MRN) of those containing
sence of evidence of ACP only. Then the individuals evidence of ACP will be recorded. They will then be
whose medical records contain evidence of ACP will be posted a letter of invitation and consent form with a
invited to consent to access the content of ACDs (or pre-paid, self-addressed envelope.
documentation detailing personal values or specific 3. The individuals will return the consent form
wishes relating to medical care &/or organ donation). directly to the Research team. Where a completed
The audit involves the following steps. consent form is returned, the individuals’ medical
records will be re-accessed to collect information to
1. Medical records from all individuals admitted to a assess the quality and completeness of any ACP or
research site at the given times will be requested from ACD, and whether there is concordance of care
relevant medical records departments. Records will be with the individuals expressed wishes, values and
audited for the presence or absence of ACP only. beliefs.

Table 3 Inclusion and exclusion criteria for participants in this study

Group Inclusion criteria Exclusion criteria
Group 1: People with Chronic Diseases ▪ Patients aged ≥18 years old ▪ Women who are pregnant and the human foetus.
▪ Admitted to the wards/community centres ▪ Children and/or young people (< 18 years old).
in participating hospitals and community ▪ People highly dependent on medical care.
settings, ▪ People who are experiencing acute severe
▪ Identified in Medical Records as having a physical illness and/or an acute episode of mental
chronic health condition(s) (defined within illness (a diagnosis of anxiety alone may not
this research project as; Diabetes, Congestive exclude participation)
Heart Failure, Coronary Artery Disease,
Chronic Obstructive Pulmonary Disease,
Hypertension, Chronic Kidney Disease, Cancer,
Frailty and Dementia.
▪ Patients who do not currently have an
Advance Care Directive
Group 2: Substitute Decision Makers (SDMs) • ≥18 years old ▪ Children and/or young people (< 18 years old).
• Nominated as an SDM by people with ▪ People who are experiencing acute severe
chronic diseases at intervention site physical illness and/or an acute episode of mental
• The ability to give valid informed consent illness (a diagnosis of anxiety alone may not
exclude participation)
Group 3: Admitting Healthcare Professionals ▪ ≥18 years old ▪ Not working in one of the research units listed
(MOs, RNs, &/or SW) at intervention sites ▪ The ability to give valid informed consent
(normalisation agents level one, or NA1) ▪ Working in a professional capacity admitting
patients to one of the research units listed, or
▪ Employed and trained as a NA2 for this
research study.
Group 4: RNs delivering the intervention ▪ ≥18 years old ▪ Not employed and trained as a NA2 for this
(referred to as ‘RN ACP Facilitators’) at ▪ The ability to give valid informed consent research study
intervention sites (normalisation agents ▪ Employed and trained as a NA2 for this
level two, or NA2). research study.
Jeong et al. BMC Health Services Research (2019) 19:286 Page 7 of 10

Post-evaluative survey for and interviews with people with in interviews, and consent will be implied when the survey
chronic diseases/SDMs at control and intervention sites is returned.
Individuals will be invited to participate in a post inter-
view and/or survey. These will be distributed to potential Risks
participants either in person (Intervention site) by RN Depending on individuals’ background and circum-
ACP Facilitators (Intervention site) or via post (Control stances, some participants may experience a degree of
site) by Administrative Officer, who are not the members discomfort with some aspects of the project. If participa-
of the research team. tion in conversations and interview causes personal dis-
The Information Statement posted to these partici- tress or discomfort, it will be stopped immediately, and
pants will emphasise that participation is voluntary, that they will be offered support services by appropriate
refusal to participate will not impact upon their current personnel. Participants have the right to withdraw from
health care services, and that any data collected would the project at any time without any disadvantage.
be anonymous and be will be stored confidentially.
Benefits
Evaluative survey for and individual/focus group interviews In the previous work done by the research team, people
with healthcare professionals who shared their experiences in interviews found the in-
Healthcare professionals (MOs, RNs, SWs & RN ACP terviews therapeutic. Those patients and families who
Facilitators) at intervention sites will be invited to engage in ACP service may experience an increased
complete a short survey and post-evaluation interview sense of feeling cared for and understood. Patients’
shortly after the six-month intervention period. wishes and preferences for care documented in ACDs
There will be packages containing information state- will be respected, and families and health professionals
ments, interview consent forms, surveys and self-addressed are eased from the burden of decision making on pa-
return envelopes available in the tea room, MOs’ office, and tients’ behalf.
nurses’ station of the selected wards/community centres. The experiences including challenges and enablers that
The decision to participate in survey and/or interview is the participants share will be beneficial for researchers
that of the healthcare professionals and their decision not and clinicians to understand what it means to dis/engage
to participate will not impact upon their employment or fu- in ACP service and what needs to be done to improve
ture training opportunities. Participant experience for all normalisation of ACP and support services in future.
groups is summarised in Table 4.
Data analysis
Ethical considerations Qualitative data collection & analysis: audio-recorded
The study has been approved by the Hunter New individual/focus interviews
England Human Research Ethics Committee, approval Qualitative data will be collected through audits, sur-
no. 17/12/13/4.16 and registered at the Australian veys, individual interviews and/or focus groups for both
New Zealand Clinical Trials Registry, trial ID: baseline and post-intervention. Content of Individual/
ACTRN12618001627246. Focus Interviews will be audio recorded (if consent
There is no actual direct physical, psychological, and given) and will be transcribed to text. Textual data will
economic harm to participants in this study. A number be broken down, line-by-line, and open coded i.e. spe-
of strategies have been implemented in the study design cific categories relevant to the research aim and ques-
and processes to ensure autonomy, beneficence, non- tions will be pre-identified and labelled but new
maleficence, justice, equity, privacy and confidentiality. categories and sub-categories will be added during ana-
The risks and benefits will be clearly stated in informa- lysis. Open codes will be systematically inspected and
tion statement that will be distributed to each group of scrutinised in relation to a ‘paradigm model’ in NTP.
potential participants. Informed consent will be sought With the research aims and questions in mind, the ana-
and obtained for uptake of ACP service and participation lysis will focus on the agents (who), coherence in

Table 4 Participant experience for all groups

Groups Intervention sites Control sites
Intervention Interview Survey Intervention Interview Survey
Group 1: People with Chronic Diseases & Group 2: SDMs ✓ ✓ ✓ ✘ ✓ ✓
Group 3: MOs, RNs & SWs ✓ ✓ ✓ N/A N/A N/A
Group 4: RN ACP facilitators ✓ ✓ ✓ N/A N/A N/A
SDMs Substitute Decision Makers, MO Medical Officers, RNs Registered Nurses, SW Social Workers, Advance Care Planning: ACP
Jeong et al. BMC Health Services Research (2019) 19:286 Page 8 of 10

conditions or context (where, when, why), coherent/col- adjustment during analysis. To account this and for clus-
lective actions/interactions (process) and reflexive moni- tering at the site level, multi-level regression models
toring (e.g. outcomes). NVivo Software will be used to with mixed effects will be built to estimate interven-
handle the large amount of data. tional effect. For each model building process, variables
Textual analysis (directed content analysis) will be found to be significantly associated with respective out-
undertaken on the following: come measures in the univariable analysis at the 10%
level will be retained in the final modelling.
– Transcripts of interviews with people with chronic As the primary predictor of interest, intervention effect
diseases & SDMs will be forced into the multivariable modelling. Continu-
– Transcripts of Individual/Focus Interviews with ous outcome measures will be analysed using linear re-
healthcare professionals (MO, RN, SW, RN ACP gression models. For binary outcome measures, analysis
Facilitator) will be by binary logistic regression, while multinominal
– Completed open-ended questions from Surveys of logistic regression will be used to analyse non-binary cat-
people with chronic diseases & SDMs, healthcare egorical measures. Model diagnostics will be conducted
professionals (MO, RN, SW, RN ACP Facilitator). on all models.
All tests of significance will be set at 5%. Statistical
Directed content analysis will also be undertaken on analysis will be performed using Stata version 15.0
information collected/recorded during delivery of the (StataCorp, College Station, TX, USA).
research intervention (facilitated conversations docu-
mented in medical notes and on a ‘conversation log’ and
Health economic evaluation
potential completion of a ‘conversation card’ and other
This project will assess the cost-effectiveness of ACP
ACP related documents, as follows:
normalisation for people with chronic diseases in acute
and community settings within the LHD 1 and LHD 2.
– Questions, concerns, comments, reasons for uptake
To facilitate this, estimates of intervention effect (i.e.
and refusal of the service (i.e. reasons for consenting
the number of ACDs completed) will be measured at
to, or declining participation in the study).
pre and post intervention. Decision tree modelling, pop-
– What participants already know [about ACP], and
ulated by effect and cost estimates will then be used to
want to know.
estimate intervention impact in the form of incremental
– The extent and the recorded reasons for
cost-effectiveness ratios (ICERs) and their respective
discordance [between patients’ and SDMs’ expressed
levels of precision. Discounting of costs will not be in-
wishes and the actual care they received].
corporated into the modelling due to follow-up being
– The experiences of patients and SDMs with ACP.
less than 1 year. One-way sensitivity analyses will be
– The experiences of ‘normalisation agents’ [MOs,
conducted by varying model inputs within a range repre-
RNS &/or SWs and RN ACP Facilitators].
senting high and low plausible values. Monte Carlo
simulation will be used to assess the robustness of our
The reporting of qualitative measures will follow the
results by varying all model inputs simultaneously over
Standards for Reporting Qualitative Research (SRQR) [25].
10,000 iterations in Ersatz v1.3 (Epigear, 2009).
Quantitative data analysis
Participant demographics and characteristics will be col- Data management
lected at each site and will be tabulated to show the dis- Other than the data collected in the completed ACDs,
tribution of participant characteristics between control which should and will be made available to treating
and intervention sites (i.e. age, sex, primary reason for healthcare professionals, all data will be non-identifiable.
admission &/or chronic health condition). Continuous Any personal information from survey and interview will
variables will be described by mean (standard deviation) be kept anonymous, and it will be recorded as code and
if normally distributed and by median (interquartile will not be possible to identify participants. Identifying
range) otherwise. Categorical variables will be described data (i.e. names and contact details) will be stored separ-
by count (percentage). Group comparisons for continu- ately in a password protected file.
ous outcomes will be undertaken by either the Student All data obtained for this project will be stored in a
t-test or Mann-Whitney U test. The Fisher’s Exact test secure manner. Data from interviews and surveys will be
will be used for categorical outcomes. stored electronically in password protected files on the
Baseline characteristics of study groups will be com- University server. Any data collected in paper copy will
pared to assess similarity at study entry, thereby allowing be stored separately in locked filing cabinets. Only the
for the identification of significant imbalances requiring key research personnel will have access to this data.
Jeong et al. BMC Health Services Research (2019) 19:286 Page 9 of 10

Discussion Funding
Given the nature of study design, it is not possible to en- The study is funded by the NSW Health Translational Research Grant
Scheme (Round II #116). The funding body was not directly involved
sure that participants in this study will be representative with the conception and development of the project. The funding body
of the entire population of people with chronic condi- reviewed and approved the design of the study and the method of
tions and their SDMs. It is also possible that the exclu- data collection and analysis. The funding body has no role in the design
of the study, collection, analysis or interpretation of data, and in writing
sion of participants with chronic diseases other than the manuscript.
listed may limit the generalisability. It is also important
to acknowledge the limitations derived from the nature
Availability of data and materials
of self-reported interview and/or survey including re- The findings of this study will be reported to the funding body ‘NSW
sponse bias and social desirability bias which may lower Ministry of Health’, and will also be disseminated via peer reviewed
reliability and validity. The findings from self-reported publications and conference presentations. The findings will also be
presented to participating wards/units as requested. The proposed study will
data will provide valuable insights to answer secondary include ACDs completed by a number of participants which is unknown at
outcomes measures. The study will be well powered to this stage. The content and extent of ACDs completed will provide clinicians
test the primary outcome measure and the cost-effect- with valuable information to deliver care and treatments as requested.
However, it is not possible to protect the identities of participants given the
iveness calculations. nature information filled in ACDs by participants. Therefore, we are not
The benefits of ACP are well known. Patients’ planning to share raw data but the de-identified data from ACDs completed
wishes and preferences for care will be respected, and will be reported in peer reviewed publications.
families and health professionals will be eased from
the burden of decision-making on patients’ behalf. Authors’ contributions
But more importantly, normalised ACP will promote SJ and TB conceived the study. PC, SJ, SO, TB, PS, SC & MD obtained the
funding. PC and SJ are the chief investigators. SJ and HF prepared the study
the actual process of discussing end-of-life issues, protocol. SJ and RD wrote the first draft of the paper. PC, TB, SO, SC and PS
leaving patients and families with an increased sense revised the manuscript for relevant scientific content. MD specifically revised
of feeling of cared for and understood. Furthermore, the statistical analyses and power calculation sections of the paper. SJ
overseas the day-to-day running of the study. All authors approved the final
it will assist the uptake of ‘Planning ahead’ practices version of the manuscript.
among people with chronic disease in acute and com-
munity settings.
Ethics approval and consent to participate
To the Authors knowledge, NPT has not previously The study has been approved by the Hunter New England Human Research
been used to develop, implement, and evaluate ACP for Ethics Committee, approval no. 17/12/13/4.16 and retrospectively registered
people with chronic diseases in acute and community on 3 October 2018 at the Australian New Zealand Clinical Trials Registry, trial
ID: ACTRN12618001627246. Informed consent will be sought and obtained
settings. The evidence generated from this project will for uptake of ACP service and participation in interviews, and consent will be
open a new level of understanding of end-of-life care implied when survey is returned.
needs of people and the meanings attached to ACP. It
will also contribute to development of new best practice Consent for publication
model to normalise ACP across acute and community Not applicable.
settings, which is sustainable, transferable and scalable.
The normalisation of ACP provides people with chronic Competing interests
diseases and their family, clinicians and policy makers The authors declare that they have no competing interests.
with a feasible and essential opportunity to focus on
what matters to people in life, at the end of life, and at
the very end of life. Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in
published maps and institutional affiliations.

Abbreviations Author details

ACD: Advanced Care Directive; ACP: Advanced care planning; 1
School of Nursing and Midwifery, University of Newcastle, PO Box 127,
CC: Central Coast; CCS: Community Control Site; CIS: Community Ourimbah, NSW 2258, Australia. 2Department of Aged Care Services, Wyong
Intervention Site; ED: Emergency department; EOL: End of life; Hospital, PO Box 4200, Lakehaven, NSW 2263, Australia. 3Hunter New
HCS: Hospital Control Site; HIS: Hospital Intervention Site; HNE: Hunter England Nursing and Midwifery Research Centre, James Fletcher Campus,
New England; ICU: Intensive care unit; LHD: Local Health District; Gate Cottage, 72 Watt St, Newcastle, NSW 2300, Australia. 4Division of Aged,
MMSE: Mini-Mental State Examination; MO: Medical Officer; Subacute and Complex Care, PO Box 6088, Long Jetty, NSW 2261, Australia.
MOCA: Montreal Cognitive Assessment; MRN: Medical Record Numbers; 5
School of Medicine and Public Health, University of Newcastle, Callaghan,
NPT: Normalisation Process Theory; NSW: New South Wales; NSW 2308, Australia. 6School of Nursing and Midwifery, University of
RN: Registered Nurse; SDM: Substitute decision-maker; SRQR: Standards Newcastle, Callaghan, NSW 2308, Australia. 7Cumbria Partnership National
for Reporting Qualitative Research; SW: Social Workers Health Service Foundation Trust. E27 Ruskin Corridor, The Carleton Clinic,
Cumwhinton Drive, Carlisle CA1 3SX, UK. 8School of Nursing and Midwifery,
University of Newcastle, PO Box 127, Ourimbah, NSW 2258, Australia. 9Calvary
Acknowledgements Mater Hospital & Newcastle Private Hospital ICU, Organ and Tissue donation
We would like to thank the funding body, the advisory committee members for the Hunter New England Local Health District , New Lambton Heights,
and the partners for their support and contribution to the project. Australia.
Jeong et al. BMC Health Services Research (2019) 19:286 Page 10 of 10

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