Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000280303
Ethics application status
Approved
Date submitted
9/02/2017
Date registered
23/02/2017
Date last updated
25/02/2020
Date data sharing statement initially provided
25/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Advance Care Planning for Patients with advanced illnesses attending hospital outpatient clinics study
Scientific title
Effect of Advance Care Planning (ACP) on health resources utilisation and quality of care for patients with advanced illnesses attending hospital outpatient clinics
Secondary ID [1] 290720 0
None
Universal Trial Number (UTN)
U1111-1191-0560
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
advance care planning 301293 0
palliative care 301294 0
dementia 301295 0
chronic disease 301411 0
aged care 301412 0
Condition category
Condition code
Public Health 301064 301064 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Informational materials:
1. ACP brochure produced by NSW Health (v6) – contains basic information about ACP and where to get assistance if interested;
2. ACP workbook endorsed by NSW Health;
3. Enduring guardianship NSW booklet – produced by the Public Guardian Office of the NSW Government Department of Attorney General & Justice.
4. Consensus Plan - utilised for families to develop a plan (when the person is unable to develop an ACD).

Procedures, activities, processes used:
1. Provision of personalised information on ACP;
2. Facilitation of ACP discussions with patients, caregivers, family and relevant health professionals;
3. Assistance in completing appropriate ACP documents
4. Referral to relevant local legal services for witnessing as required
5. Organising and facilitating meetings and/or teleconferences with clinic staff, GPs, and other health care professionals involved in patient’s care to discuss the patient’s care and their wishes;
6. Assistance with dissemination of ACP documents on completion that may include upload to Local Health District record system and national eHealth record (contingent on LHD and national eHealth improvements during the study period), and forwarding the document to patient’s GP.

Who will deliver the intervention:
ACP trained clinical nurse consultants, ACP trained outpatient clinics staff

Mode of delivery:
Individually, face to face

Number of times the intervention will be delivered:
Depending on the needs of the patients and carers, one or more facilitated ACP discussions, each lasting min. 20 mins.
Duration of the intervention period for each participant = up to 6 months.
There is no maximum number of sessions, but we would not expect more than 6 to be required over a 6 month period.

Location:
Outpatient clinics
Intervention code [1] 296618 0
Behaviour
Comparator / control treatment
The control group patient participants will be given written information on Advance Care Planning. This represents the current standard care.
The written information will consist of:
1. ACP brochure produced by NSW Health (v6) – contains basic information about ACP and where to get assistance if interested;
2. ACP workbook endorsed by NSW Health;
3. Enduring guardianship NSW booklet – produced by the Public Guardian Office of the NSW Government Department of Attorney General & Justice.
4. Consensus Plan - utilised for families to develop a plan (when the person is unable to develop an ACD); a companion guide is being finalised.
Control group
Active

Outcomes
Primary outcome [1] 300467 0
Number of unplanned hospital admissions as assessed by chart audit of patient medical records.
Timepoint [1] 300467 0
At 6 months and at 18 months
Secondary outcome [1] 330029 0
Ambulance services calls as assessed by data linkage to NSW Ambulance Data Collection
Timepoint [1] 330029 0
At 6 months and at 18 months
Secondary outcome [2] 330030 0
Emergency Department presentations as assessed by data linkage to NSW Emergency Department Data Collection
Timepoint [2] 330030 0
At 6 months and at 18 months
Secondary outcome [3] 330291 0
Total number of hospital admissions as assessed by data linkage to NSW Admitted Patient Data Collection
Timepoint [3] 330291 0
At 6 months and at 18 months
Secondary outcome [4] 330292 0
Date, place and causes of death as assessed by data linkage NSW Mortality Data
Timepoint [4] 330292 0
At 6 months and at 18 months
Secondary outcome [5] 330293 0
Resuscitation attempts as assessed by data linkage to NSW Emergency Department Data Collection, NSW Admitted Patient Data Collection, NSW Ambulance Data Collection
Timepoint [5] 330293 0
At 6 months and at 18 months
Secondary outcome [6] 331636 0
Intensive Care Unit admissions as assessed by data linkage to NSW Admitted Patient Data Collection
Timepoint [6] 331636 0
At 6 months
Secondary outcome [7] 331640 0
Data collected from patient participants: PACIC - Patient Assessment of Chronic Illness Care, SF-20 - 20-Item Short Form Health Survey.
Timepoint [7] 331640 0
At 6 months and at 18 months
Secondary outcome [8] 331641 0
Audit of ACP discussion sessions (intervention group only). For each session: time taken; number of attendees and their categories (e.g. patient, facilitator, family member, other health care professionals); number and types of documents completed; number and types of documents distributed; referrals made (if any).
Timepoint [8] 331641 0
At 6 months and at 18 months
Secondary outcome [9] 331643 0
Data collected from caregiver participants; SF-20 - 20-Item Short Form Health Survey, ZBI-12 - Zarit Burden Short Form Interview.
Timepoint [9] 331643 0
At 6 months
Secondary outcome [10] 331645 0
Data collected from clinical staff working in the outpatient clinics:
There are pre- and post- surveys on ACP knowledge. These were used by the investigators previously in non-research contexts. They have generic names: “Staff questionnaire: knowledge of ACP”.
Timepoint [10] 331645 0
At 6 months and at 18 months
Secondary outcome [11] 331894 0
Data collected from clinical staff working in the outpatient clinics:
There are pre- and post- surveys on ACP attitudes. These were used by the investigators previously in non-research contexts. They have generic names: “Staff questionnaire: attitudes to ACP”.
Timepoint [11] 331894 0
At 6 months
Secondary outcome [12] 331970 0
Audit of advance care directives. These audits aim to measure the output of Advance Care Planning as indicated by (a) the number and duration of discussion sessions; (b) documents created as a result of Advance Care Planning; (c) number of stakeholders participating in discussions; and (d) communication of the output to external stakeholders.
Timepoint [12] 331970 0
At 6 months and at 18 months

Eligibility
Key inclusion criteria
1. Attending an outpatient clinic of participating clinical services in the study.
2. Identified by Supportive & Palliative Care Indicators Tool (SPICT Trademark) as potentially having supportive and palliative care needs and at risk of dying in the next 12 months.
3. Identified by the ACP screening tool as not having a current Advance Care Directive / Plan or an enduring guardian AND is interested in engaging in further Advance Care Planning discussions.
4. Willing and able to give written informed consent and willing to participate to and comply with the study (or if the person lacks decision making capacity then the person responsible is willing to provide informed consent).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Less than 18 years of age.
2. Pregnant.
3. Identified by the ACP screening tool as having both an enduring guardian and an Advance Care Directive / Plan or is not interested in Advance Care Planning discussions.
4. Current inpatient.
5. Patient (or if patient lacks decision making capacity, guardian or person responsible) is unable or unwilling to provide informed consent.
6. Permanent resident of residential aged care facility.
7. Unable to provide informed consent and participate in ACP conducted in English due to difficulties in understanding and speaking English.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Stratification according to study site and according to number of hospital admissions in the past 6 months (<2 versus 2 or more).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation:
n=288 (control = 144, intervention = 144).
We assume an alpha of 0.05, power of 0.8 to detect at least 25% reduction (IRR 0.75) in unplanned hospital admissions over 6 months (from an average of 2.2 over 6 months to 1.65 admissions over 6 months assuming the number of admissions follows a Poisson distribution in each group). Based on these assumptions, we will need to recruit 100 people in each group who will have the full 6 month follow-up, so that the number of hospitalisations in the groups are 220 (control) and 165 (intervention). However, given that we expect a death rate in the 6 months of the trial of up to 35% of people, we will need to recruit 122 people in each arm of the trial. If we also expect a drop-out rate (withdrawal, loss to follow-up) of 15% we will need 144 people in each arm of the trial.

Statistical Analysis Plan:
The primary outcome will be the number of unplanned hospital admissions during follow-up. A Poisson regression model, including follow-up time as an offset will be fitted to compare the mean number of admissions between the trial arms. The analysis will also adjust for the variables used in stratification in the randomisation (number of admissions in 6 months prior to the trial, and the study site). The secondary outcomes will be analysed similarly to the primary outcome; as well as using descriptive statistics and linear regression adjusting for stratification variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/03/2017
Actual
20/04/2017
Date of last participant enrolment
Anticipated
2/10/2017
Actual
1/12/2017
Date of last data collection
Anticipated
30/11/2018
Actual
8/08/2019
Sample size
Target
288
Accrual to date
Final
197
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7104 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 7105 0
The Sutherland Hospital - Caringbah
Recruitment hospital [3] 7114 0
St George Hospital - Kogarah
Recruitment hospital [4] 7116 0
War Memorial Hospital - Waverley
Recruitment hospital [5] 7118 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 14862 0
2031 - Randwick
Recruitment postcode(s) [2] 14863 0
2229 - Caringbah
Recruitment postcode(s) [3] 14877 0
2024 - Waverley
Recruitment postcode(s) [4] 14878 0
2139 - Concord
Recruitment postcode(s) [5] 24089 0
2217 - Kogarah Bay

Funding & Sponsors
Funding source category [1] 295148 0
Government body
Name [1] 295148 0
NSW Ministry of Health: Translational Research Grant
Country [1] 295148 0
Australia
Primary sponsor type
Government body
Name
South Eastern Sydney Local Health District
Address
Department of Geriatric Medicine
Prince of Wales Hospital
High St
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 293967 0
Government body
Name [1] 293967 0
Sydney Local Health District
Address [1] 293967 0
Department of Geriatric Medicine
Concord Hospital
Building 12
Hospital Road
Concord NSW 2139
Country [1] 293967 0
Australia
Secondary sponsor category [2] 293992 0
University
Name [2] 293992 0
University of New South Wales
Address [2] 293992 0
Centre for Primary Health Care and Equity
University of New South Wales Sydney
UNSW SYDNEY NSW 2052
Country [2] 293992 0
Australia
Secondary sponsor category [3] 293994 0
University
Name [3] 293994 0
Sydney University of Technology
Address [3] 293994 0
Faculty of Health
235 Jones Street
Ultimo NSW 2007
Country [3] 293994 0
Australia
Secondary sponsor category [4] 293995 0
University
Name [4] 293995 0
University of Wollongong
Address [4] 293995 0
Graduate Medicine
University of Wollongong
Wollongong NSW 2522
Country [4] 293995 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296518 0
South Eastern Sydney LHD Human Research Ethics Committee
Ethics committee address [1] 296518 0
Ethics committee country [1] 296518 0
Australia
Date submitted for ethics approval [1] 296518 0
03/11/2016
Approval date [1] 296518 0
13/02/2017
Ethics approval number [1] 296518 0
NEAF Ethics Approval 16-321
Ethics committee name [2] 301496 0
NSW Population & Health Services Research Ethics Committee
Ethics committee address [2] 301496 0
Ethics committee country [2] 301496 0
Australia
Date submitted for ethics approval [2] 301496 0
26/10/2017
Approval date [2] 301496 0
17/01/2018
Ethics approval number [2] 301496 0
Ethics committee name [3] 305453 0
University of Wollongong Human Reaserch Ethics Committee
Ethics committee address [3] 305453 0
Ethics committee country [3] 305453 0
Australia
Date submitted for ethics approval [3] 305453 0
12/03/2019
Approval date [3] 305453 0
13/03/2019
Ethics approval number [3] 305453 0
HREC 2019/103

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71066 0
A/Prof Joel Rhee
Address 71066 0
Graduate Medicine
Faculty of Science, Medicine and Health
University of Wollongong
Wollongong NSW 2522
Country 71066 0
Australia
Phone 71066 0
+61 2 42215586
Fax 71066 0
Email 71066 0
[email protected]
Contact person for public queries
Name 71067 0
Diane Harland
Address 71067 0
Graduate Medicine
Faculty of Science, Medicine and Health
University of Wollongong
Wollongong NSW 2522
Country 71067 0
Australia
Phone 71067 0
+61 2 42214262
Fax 71067 0
Email 71067 0
[email protected]
Contact person for scientific queries
Name 71068 0
Diane Harland
Address 71068 0
Graduate Medicine
Faculty of Science, Medicine and Health
University of Wollongong
Wollongong NSW 2522
Country 71068 0
Australia
Phone 71068 0
+61 2 42214262
Fax 71068 0
Email 71068 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
We will not be able to share the data from the trial due to privacy and confidentiality reasons


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.