Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001627246
Ethics application status
Approved
Date submitted
6/09/2018
Date registered
3/10/2018
Date last updated
27/03/2023
Date data sharing statement initially provided
14/03/2023
Date results information initially provided
14/03/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Normalisation of Advance Care Planning (ACP) for People With Chronic Diseases in acute and community settings
Scientific title
Efficacy of Normalisation of Advance Care Planning (ACP) for People With Chronic Diseases in acute and community settings: A non-randomised quasi-experimental study underpinned by Normalisation Process Theory
Secondary ID [1] 295861 0
Nil known
Universal Trial Number (UTN)
Trial acronym
NACP for PWCDs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Diseases
 309328 0
Diabetes
 309563 0
COPD 309564 0
Congestive Heart Disease 309565 0
Coronary Artery Disease 309566 0
Hypertension 309567 0
Cancer 309568 0
Chronic Kidney Disease 309569 0
Frailty 309570 0
Dementia 309571 0
Condition category
Condition code
Cancer 308192 308192 0 0
Any cancer
Cardiovascular 308390 308390 0 0
Coronary heart disease
Cardiovascular 308391 308391 0 0
Hypertension
Cardiovascular 308392 308392 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 308393 308393 0 0
Dementias
Renal and Urogenital 308394 308394 0 0
Kidney disease
Respiratory 308395 308395 0 0
Chronic obstructive pulmonary disease
Metabolic and Endocrine 308609 308609 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Registered Nurses (RNs) will be specially trained to introduce and engage in Advanced Care Planning (ACP) with patients with a Chronic Disease (CDs) at selected hospital and community health sites. The conversations will involve 2-3 face-to-face conversations with the patient and/or their substitute decision maker, each around 10 minutes in length. These conversations will discuss what ACP is and their future healthcare wishes. The nurses will be in place for a 6 month period at the intervention sites.

Nurses will receive approximately two days of online, self-paced learning and an additional ~ two days of face-to-face training, given by research investigators and partners who are recognized experts in ACP (Peter Saul, Lisa Shaw, Tomiko Barrett, Sarah Jeong, Seok Ohr & Peter Cleasby).

Prior to the two-day training course, the RNs will be directed to online, self-paced learning and will be expected to complete modules on:
• Benefits of advance care planning
• Medical decision-making
• The role of the substitute decision-maker
• Legal implications of advance care planning
• Advance care planning conversations
• Life prolonging treatments

As NSW Health staff, they will also be directed to complete relevant training / modules from ‘My Health Learning’ (including ‘Introduction to Advance care planning’ and ‘SHAPE End of Life Conversations’).

A two-day face-to-face training programme has been developed following recommendations from experienced ACP Coordinators both at HNELHD and CCLHD who have conducted numerous training sessions with medical and nursing staff in both health districts. This will cover:

• Research aims, design, methods,
• their role as RN ACP facilitators,
• how to screen potential participants for inclusion,
• how to discuss and clarify patient values, preferences for care and appointment of a PR or EG,
• what constitutes an ACD and how to aid completion of a legally valid ACD.
• How to broach, discuss and complete a Resuscitation plan,
• Completion, use and storage of the ‘ACP Conversation card’.
• Follow-up processes (after patient is discharges home or re-admitted to hospital).

Training will focus on how to have conversations about ACP by addressing their concerns and questions. It will incorporate role-plays between experienced ACP Coordinators and the trainees, scenario-based learning and trouble-shooting sessions. The focus will be on enhancing the skills required to facilitate challenging conversations.
Aboriginal Health Workers and Multicultural Liaison Officers will be involved in the training, to offer perspective and advice on cultural sensitivities.
Training will be specific to the individual and the requirements of the study, and may not be limited to the initial two-day training. A ‘Needs Assessment’ will be completed by RN ACP Facilitators before and after their training, as part of training evaluation. If they are deemed to require further training, the training period can be extended. Ongoing support and input will be provided by members of the study team, who themselves are recognised experts in this area.
Intervention code [1] 312197 0
Behaviour
Comparator / control treatment
Control groups are hospital and community health sites with no RN intervention.
Control group
Active

Outcomes
Primary outcome [1] 307157 0
Change in uptake of Advanced Care Planning (ACP) as assessed by audit of medical records.
Timepoint [1] 307157 0
6 Months from the beginning of the intervention period.
Secondary outcome [1] 352341 0
Satisfaction with patient healthcare experience, measured by follow up patient interview and/or survey (5- point Likert scale).
Timepoint [1] 352341 0
At the end of each month during the 6 month intervention period.
Secondary outcome [2] 352342 0
Identification of factors that influence the implementation of ACP in hospital and community health settings. Measured by feedback surveys from ACP facilitators and other medical personnel designed speficially for this study. Assessed by textual analysis.
Timepoint [2] 352342 0
The end of the intervention period.

Eligibility
Key inclusion criteria
Patients aged >18 years old.
Admitted to the wards/community centres in participating hospitals and community settings,
Identified in Medical Records as having a chronic health condition(s) (defined within this research project as; Diabetes, Congestive 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are pregnant and the human foetus.
Children and/or young people ( < 18 years old).
People highly dependent on medical care.
People who are experiencing acute severe physical illness and/or an acute episode of mental illness (a diagnosis of anxiety alone may not exclude participation).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise study variables. Categorical variables will be reported as counts and proportions. If normally distributed, continuous variables will be presented as means and standard deviations. Otherwise, they will be presented as medians and interquartile ranges. Baseline characteristics of study groups will be compared to assess similarity at study entry, thereby allowing for the identification of significant imbalances requiring adjustment during analysis. To account for clustering at the site level, multi-level regression models with mixed effects will be built to estimate interventional effect. For each model building process, variables found to be significantly associated with respective outcome measures in the univariable analysis at the 10% level will be retained in the final model. As the primary predictor of interest, intervention effect will be forced into the multivariable model in the form of 2-level categorical variable. Continuous outcome measures will be analysed using linear regression models. For binary outcome measures, analysis will be by binary logistic regression, while multinominal logistic regression will be used to analyse non-binary categorical measures. Model diagnostics will be conducted on all models. All tests of significance will be set at 5%. Statistical analysis will be performed using Stata 14.2 statistical software.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/08/2018
Date of last participant enrolment
Anticipated
Actual
5/04/2019
Date of last data collection
Anticipated
Actual
30/05/2019
Sample size
Target
384
Accrual to date
Final
482
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11804 0
Gosford Hospital - Gosford
Recruitment hospital [2] 11805 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment hospital [3] 11806 0
Maitland Hospital - Maitland
Recruitment hospital [4] 11807 0
Belmont Hospital - Belmont
Recruitment postcode(s) [1] 23931 0
2250 - Gosford
Recruitment postcode(s) [2] 23932 0
2259 - Hamlyn Terrace
Recruitment postcode(s) [3] 23933 0
5573 - Maitland
Recruitment postcode(s) [4] 23934 0
2280 - Belmont

Funding & Sponsors
Funding source category [1] 300459 0
Government body
Name [1] 300459 0
NSW Health Translational Research Grant Scheme (TRGS) Round 2
Country [1] 300459 0
Australia
Primary sponsor type
Individual
Name
Mr Peter Cleasby
Address
Service Manager, Palliative Care Services| Division of Aged, Subacute and Complex Care PO Box 6088 Long Jetty NSW 2261 (The organisation is called Aged, Subacute and Complex Care)
Country
Australia
Secondary sponsor category [1] 299927 0
Individual
Name [1] 299927 0
Associate Professor Sarah Yeun-Sim Jeong
Address [1] 299927 0
School of Nursing & Midwifery
University of Newcastle
PO Box 127
Ourimbah NSW 2258
Country [1] 299927 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301262 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 301262 0
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [1] 301262 0
Australia
Date submitted for ethics approval [1] 301262 0
13/12/2017
Approval date [1] 301262 0
09/03/2018
Ethics approval number [1] 301262 0
17/12/13/4.16

Summary
Brief summary
This study aims to evaluate the uptake of Advance Care Planning (ACP) for people with chronic diseases in acute and community settings.

Who is it for?

You may be eligible to join this study if you are aged 18 years or above, are admitted to a ward/community centre in a participating hospital or community setting, and have a chronic health condition (diabetes, congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease, hypertension, chronic kidney disease, cancer, frailty and/or dementia).

Study details

Participants admitted to an intervention site will receive Advance Care Planning assistance from a specially trained registered nurse. This involves a series of facilitated conversations regarding you or your family member’s healthcare wishes for the future. Participants admitted to a control site will receive standard care only.
This study will measure uptake of Advance Care Planning. Participants will also be followed up after 6 months in order to evaluate the level of satisfaction with their healthcare experience. It is hoped that this study will promote Advance Care Planning conversations as part of routine (normal) clinical practice.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86406 0
Mr Peter Cleasby
Address 86406 0
Service Manager, Palliative Care Services| Division of Aged, Subacute and Complex Care.
PO Box 6088 Long Jetty NSW 2261 (The organisation is called Aged, Subacute and Complex Care)
Country 86406 0
Australia
Phone 86406 0
+610243367777
Fax 86406 0
Email 86406 0
[email protected]
Contact person for public queries
Name 86407 0
Mr Peter Cleasby
Address 86407 0
Service Manager, Palliative Care Services| Division of Aged, Subacute and Complex Care.
PO Box 6088 Long Jetty NSW 2261 (The organisation is called Aged, Subacute and Complex Care)
Country 86407 0
Australia
Phone 86407 0
+610243367777
Fax 86407 0
Email 86407 0
[email protected]
Contact person for scientific queries
Name 86408 0
A/Prof Sarah Yeun-Sim Jeong
Address 86408 0
School of Nursing & Midwifery
University of Newcastle
PO Box 127
Ourimbah NSW 2258
Country 86408 0
Australia
Phone 86408 0
+610243494535
Fax 86408 0
Email 86408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sharing requires permission from the Ethics Committee and LHDs.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18589Study protocolJeong S, Barrett T, Ohr S, Cleasby P, David M, Chan S, Fairlamb H, Davey R, Saul P. (2019). 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. BMC Health Service Research, 19, 286-295. https://doi.org/10.1186/s12913-019-4118-xhttps://doi.org/10.1186/s12913-019-4118-x[email protected]
18590Other https://doi.org/10.1186/s12913-021-06928-w  Study protocol is published. Other publications wi... [More Details]



Results publications and other study-related documents

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