Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000627156
Ethics application status
Approved
Date submitted
15/04/2019
Date registered
26/04/2019
Date last updated
20/08/2021
Date data sharing statement initially provided
26/04/2019
Date results provided
20/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The COAST project: Introducing and implementing a transferable, readily accessible, and actionable end of life planning tool for patients with advanced serious illness or frailty in southern New Zealand.
Scientific title
Introducing and implementing a transferable, readily accessible, and actionable end of life planning tool for patients with advanced serious illness or frailty in southern New Zealand to reduce incongruent medical interventions, such as hospitalisation, for adults believed to be in their final year of life.
Secondary ID [1] 297978 0
None
Universal Trial Number (UTN)
U1111-1224-3706
Trial acronym
COAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Terminal illness
 312390 0
Advanced and progressive frailty 312391 0
Cancer 312437 0
Cardiovascular disease 312438 0
Dementia 312439 0
Respiratory disease 312440 0
Condition category
Condition code
Cancer 310943 310943 0 0
Any cancer
Cardiovascular 310944 310944 0 0
Coronary heart disease
Neurological 310945 310945 0 0
Dementias
Neurological 310946 310946 0 0
Neurodegenerative diseases
Neurological 310947 310947 0 0
Other neurological disorders
Cardiovascular 310948 310948 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
THE FORM
This project is designed to enhance and streamline processes already in place. There will be no attempt to influence the discussions between patients/proxies and clinicians, or to influence the clinical decision making. The intervention is simply the consolidation of multiple variable processes into one portable and universally acceptable medical order, with the hope of reducing incongruent medical interventions. It is up to the treating doctor/nurse practitioner to decide when it is appropriate to have the discussion and complete the form.

It should take no longer than 30 minutes to have the discussion and complete the COAST form. There are five sections of the form to complete:
1. Resuscitation Status
2. Medical Interventions
There are three options of care:
i. Full Treatment.
ii. Selective Treatment.
iii. Comfort-focused Treatment.
3. Fluid and Nutrition
4. Additional Orders
The section can be used for psychosocial, spiritual, or cultural considerations.
5. Clinical Decision Making
This section records the date of discussion with the patient/proxy and the signature of the relevant doctor or NP. The treating doctor or NP should complete and sign the COAST form. In most cases, this will be the GP. However, any doctor or NP who encounters an eligible patient should complete and sign the COAST form if it has not already been done.

The COAST form does not have an expiration date. COAST form should be reviewed periodically and updated as appropriate if there is a significant change in an individual’s health status, or the individual’s treatment preferences change

PILOT TIMELINE
Implemented in 3 phases: Phase 1 (3 months): Southland Hospital, Hospice Southland, Palliative Care Advisory Service. Phase 2 (3 months): Expand to GPs and ARC facilities in Invercargill. Phase 3 (3 months): Expand to Southland region.
This is not a randomised control trial. Any patient who meets the inclusion criteria and consents to the research will be included. Only patients presenting to health facilities/residing in ARC facilities in the Southland region will be included, as per each phase.

DATA COLLECTION
Copy of completed forms will be received by study co-ordinators at both Southland Hospital and Hospice Southland sites. An audit of the forms will be completed at the end of each implementation phase to determine whether they are valid (patient identified, all applicable fields completed, form signed and dated by the doctor/NP).

Participants will be asked to complete a survey after the COAST form has been completed. With consent, the study co-ordinators will then access the patient’s electronic health record. Patient demographics of all patients recruited will be recorded in a database to assess if the study population is representative of the population of southern New Zealand. Patient demographics will include age, gender, ethnicity, principal diagnosis, place and type of residence, and the encounter setting for discussion and completion of COAST. Part 1 of data collection will involve retrospective audit to assess number of emergency department presentations and hospitalisations in the 12 months preceding study enrolment. Part 2 of data collection will involve assessing number of emergency department presentations, hospitalisations, COAST form revocations and/or revisions, and care environment transitions for 12 months after study enrolment. Place and cause of death, if applicable, will be recorded.
Intervention code [1] 314203 0
Other interventions
Comparator / control treatment
The COAST form is meant to complement Advanced Care Planning, not replace it. Facilities, departments, and agencies have come up with a variety of ways to translate ACP into actionable clinical plans e.g. NFR forms, ceiling of care forms. A facility is welcome to have its own processes and documentation methods. If this is the case, the COAST form should still be completed for all eligible patients. The COAST form is intended to be a shared tool that streamlines and co-ordinates care across all settings.
Control group
Active

Outcomes
Primary outcome [1] 319766 0
The primary aim of the study will be to evaluate if the introduction of the document in southern New Zealand reduces hospitalisations for patients in their final year of life. Audit of number of emergency department presentations and hospitalisations in the 12 months preceding study enrolment, and 12 months after study enrolment, using Health Connect South.
Timepoint [1] 319766 0
12 months after COAST form initiated
Secondary outcome [1] 369453 0
The secondary aim of the study will be to assess the acceptability of the document from healthcare professionals involved in its use.

A survey will be distributed at the end of each implementation phase to address the secondary aim; investigating satisfaction of health practitioners with the COAST form and process, and any enablers or barriers to completion. Survey designed specifically for this study.
Timepoint [1] 369453 0
End of 9 month pilot
Secondary outcome [2] 369740 0
The secondary aim of the study will be to assess the acceptability of the document to patients and/or their proxy.

Patients will be given a survey to complete following completion of the COAST process , along with a postage-prepaid return envelope. Survey designed specifically for this study.
Timepoint [2] 369740 0
End of 9 month pilot

Eligibility
Key inclusion criteria
All adults aged 18 years and older in their final year of life assessed by one of the following criteria: Advanced progressive illness and/or frailty as identified by a doctor or nurse practitioner for whom the clinician answers “no” to the Surprise Question: “Would you be surprised if this patient died in the next 12 months?”, or referral for specialist palliative care services through Hospice Southland or the hospital-based Palliative Care Advisory Service.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient does not reside in Southland

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2019
Actual
1/05/2019
Date of last participant enrolment
Anticipated
31/01/2020
Actual
31/01/2020
Date of last data collection
Anticipated
1/02/2021
Actual
1/02/2021
Sample size
Target
500
Accrual to date
Final
183
Recruitment outside Australia
Country [1] 21406 0
New Zealand
State/province [1] 21406 0
Southland

Funding & Sponsors
Funding source category [1] 302502 0
Charities/Societies/Foundations
Name [1] 302502 0
Hospice Southland
Country [1] 302502 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Hospice Southland
Address
PO Box 7020, Invercargill, 9844
Country
New Zealand
Secondary sponsor category [1] 302416 0
Government body
Name [1] 302416 0
Southern DHB
Address [1] 302416 0
201 Great King St, Dunedin, 9016
Country [1] 302416 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303158 0
Health and Disability Ethics Committee New Zealand
Ethics committee address [1] 303158 0
Ethics committee country [1] 303158 0
New Zealand
Date submitted for ethics approval [1] 303158 0
15/02/2019
Approval date [1] 303158 0
11/04/2019
Ethics approval number [1] 303158 0
19/STH/44

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

Contacts
Principal investigator
Name 92682 0
Dr Amanda Sommerfeldt
Address 92682 0
Hospice Southland
75 Kew Road
Invercargill
9812
Country 92682 0
New Zealand
Phone 92682 0
+64 03 211 3081 / +64 0800 211 308
Fax 92682 0
Email 92682 0
amandas@hospicesouthland.org.nz
Contact person for public queries
Name 92683 0
Amanda Sommerfeldt
Address 92683 0
Hospice Southland
75 Kew Road
Invercargill
9812
Country 92683 0
New Zealand
Phone 92683 0
+64 03 211 3081 / +64 0800 211 308
Fax 92683 0
Email 92683 0
COAST@hospicesouthland.org.nz
Contact person for scientific queries
Name 92684 0
Amanda Sommerfeldt
Address 92684 0
Hospice Southland
75 Kew Road
Invercargill
9812
Country 92684 0
New Zealand
Phone 92684 0
+64 03 211 3081 / +64 0800 211 308
Fax 92684 0
Email 92684 0
COAST@hospicesouthland.org.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not consented for


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
SourceTitleYear of PublicationDOI
EmbaseIntroducing and Implementing a Universally Accepted, Readily Accessible, and Actionable End-of-Life Planning Tool for Patients with Advanced Serious Illness or Frailty in Southern New Zealand.2022https://dx.doi.org/10.1089/jpm.2021.0638
N.B. These documents automatically identified may not have been verified by the study sponsor.