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Trial registered on ANZCTR


Registration number
ACTRN12617000159358
Ethics application status
Approved
Date submitted
11/01/2017
Date registered
30/01/2017
Date last updated
2/07/2021
Date data sharing statement initially provided
2/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Proactive palliative care nurse specialist review compared to usual care, in residential care residents who are identified as being high risk of clinically significant health and functional decline.
Scientific title
Palliative care nurse specialist routine assessment of the older person in residential care facilities identified as being high risk of clinically significant health and functional decline: a pilot study in Invercargill.
Secondary ID [1] 290894 0
Nil known
Universal Trial Number (UTN)
U1111-1191-0863
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
palliative medicine 301609 0
terminal illness 301610 0
complex health needs
 301792 0
Condition category
Condition code
Public Health 301318 301318 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will undergo a structured assessment from a palliative care nurse specialist (PCNS). This assessment will take place in a face to face consultation and occur at the participants facility of residence. The participant, and their next of kin if appropriate, will attend the consultation, which will take approximately two hours to complete. Each participant will receive a single consultation. The PCNS will also review available medical and aged residential care (ARC) facility documentation as well as the current medication list to identify advance care planning issues, potential medication concerns or issues of polypharmacy. Based on the findings of that initial assessment and identified patient and family goals of care, an individualized care plan will be formulated for each participant. The plan of care will be formulated in conjunction with the patient/family, aged residential facility caregiver(s), general practitioner, and appropriate hospice interdisciplinary team member(s). Each plan of care will address management of suffering in the physical, emotional, relational, and spiritual domains, and attempt to align documented treatment preferences and medical/nursing care with identified goals of care. Outcomes will be measured at 1 month, 3 months and 6 months post consultation. This will allow investigators to monitor adherence to the plan of care.
Intervention code [1] 296840 0
Treatment: Other
Comparator / control treatment
The control group will receive routine facility care. This is defined as the live-in care that they are already receiving from aged care facility staff. This includes assistance with daily activities, food services, laundry, nursing care, dispensing of medications, and health care prescribed by a general practitioner.
Control group
Active

Outcomes
Primary outcome [1] 300725 0
Proportion of participants with a documented advance care plan in patient's facility record and the general practitioner's record.
Timepoint [1] 300725 0
1 month post consultation
Primary outcome [2] 300726 0
Pain score on ESAS or PAIN-AD
If participants are able to self-rate their pain, an ESAS will be completed. If participants are unable to self-rate their pain, a PAIN-AD will be completed.
Timepoint [2] 300726 0
1 month, 3 months and 6 months post consultation.
Secondary outcome [1] 330705 0
Polypharmacy (5 or more routine medications) as determined by review of medication list on file at the participants facility of residence.
Timepoint [1] 330705 0
1 month, 3 months and 6 months post consultation.
Secondary outcome [2] 330706 0
Number of acute care presentations as determined by review of medical records.
Timepoint [2] 330706 0
6 months post consultation.
Secondary outcome [3] 330707 0
Enrolment in a hospice programme as determined by review of facility records for documentation of a referral.
Timepoint [3] 330707 0
6 months post consultation.
Secondary outcome [4] 330708 0
Code status of "do not resuscitate" documented in aged residential care facility record
Timepoint [4] 330708 0
1 month post consultation.
Secondary outcome [5] 330709 0
Documented preferred location of death in the aged residential care facility record
Timepoint [5] 330709 0
1 month post consultation.
Secondary outcome [6] 330710 0
Prescribed laxative if an opioid is prescribed, determined by review of medication list on file at participants facility of residence.
Timepoint [6] 330710 0
1 month, 3 months and 6 months post consultation.
Secondary outcome [7] 330711 0
Latency to death, determined by review of medical records
Timepoint [7] 330711 0
6 months post consultation.
Secondary outcome [8] 330712 0
Patient satisfaction with care, assessed by responses to a list of questions quantified on a 5-point Likert Scale.
Timepoint [8] 330712 0
6 months post consultation.
Secondary outcome [9] 330713 0
General practitioner satisfaction with care, assessed by responses to a list of questions quantified on a 5-point Likert Scale.
Timepoint [9] 330713 0
6 months post consultation
Secondary outcome [10] 330714 0
Next of kin or enduring power of attorney (EPOA) satisfaction with care, assessed by responses to a list of questions quantified on a 5-point Likert Scale.
Timepoint [10] 330714 0
6 months post consultation.

Eligibility
Key inclusion criteria
Aged residential care resident
Not already enrolled in hospice programme
CHESS score of 4 or 5 on the most recent InterRAI assessment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Already enrolled in hospice programme
CHESS score < 4 on the most recent InterRAI assessment

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Intervention group participants reside at either of two local participating aged residential care facilities.
Control group participants reside at either of two local participating control aged residential care facilities.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot quality improvement initiative. As a new and untested initiative, it is difficult to determine the ideal number of participants needed to achieve statistical power. The goal is to enroll 15 participants in each group. Data will be analysed with chi squared analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2017
Actual
15/05/2017
Date of last participant enrolment
Anticipated
29/04/2017
Actual
16/01/2018
Date of last data collection
Anticipated
31/10/2017
Actual
5/09/2018
Sample size
Target
40
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 8566 0
New Zealand
State/province [1] 8566 0
Southland

Funding & Sponsors
Funding source category [1] 295323 0
Charities/Societies/Foundations
Name [1] 295323 0
Hospice Southland Charitable Trust
Country [1] 295323 0
New Zealand
Funding source category [2] 309054 0
Charities/Societies/Foundations
Name [2] 309054 0
Southland Medical Foundation
Country [2] 309054 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Hospice Southland Charitable Trust
Address
Gate 1
Southland Hospital Grounds
Elles Road
Strathern, Invercargill 9812
Country
New Zealand
Secondary sponsor category [1] 294145 0
Government body
Name [1] 294145 0
Ministry of Health
Address [1] 294145 0
PO Box 5013
Wellington 6140
Country [1] 294145 0
New Zealand
Other collaborator category [1] 279388 0
Individual
Name [1] 279388 0
Hannah Rose Hart
Address [1] 279388 0
Southland Hospital
Kew Road
Invercargill 9812
Country [1] 279388 0
New Zealand
Other collaborator category [2] 279389 0
Individual
Name [2] 279389 0
Yih Harng Chong
Address [2] 279389 0
Southland Hospital
Kew Road
Invercargill 9812
Country [2] 279389 0
New Zealand
Other collaborator category [3] 281901 0
Individual
Name [3] 281901 0
Dr Liam Watson
Address [3] 281901 0
Hospice Southland
Gate 1, Southland Hospital Grounds, Elles Road, Strathern, Invercargill 9812
Country [3] 281901 0
New Zealand
Other collaborator category [4] 281902 0
Individual
Name [4] 281902 0
Dr Mary Chalmers
Address [4] 281902 0
Southland Hospital
Gate 1, Southland Hospital Grounds, Elles Road, Strathern, Invercargill 9812
Country [4] 281902 0
New Zealand
Other collaborator category [5] 281903 0
Individual
Name [5] 281903 0
Dr Amanda McCorkindale
Address [5] 281903 0
Southland Hospital
Gate 1, Southland Hospital Grounds, Elles Road, Strathern, Invercargill 9812
Country [5] 281903 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296655 0
Health and Disability Ethics Committee
Ethics committee address [1] 296655 0
Ethics committee country [1] 296655 0
New Zealand
Date submitted for ethics approval [1] 296655 0
02/02/2017
Approval date [1] 296655 0
07/04/2017
Ethics approval number [1] 296655 0

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

Contacts
Principal investigator
Name 71650 0
Dr Amanda Sommerfeldt
Address 71650 0
Hospice Southland
Gate 1,
Southland Hospital Grounds,
Elles Road
Strathern, Invercargill 9812
Country 71650 0
New Zealand
Phone 71650 0
+64 0800 211 3081
Fax 71650 0
+64 03 211 3082
Email 71650 0
amandas@hospicesouthland.org.nz
Contact person for public queries
Name 71651 0
Amanda Sommerfeldt
Address 71651 0
Hospice Southland
Gate 1,
Southland Hospital Grounds,
Elles Road
Strathern, Invercargill 9812
Country 71651 0
New Zealand
Phone 71651 0
+64 0800 211 3081
Fax 71651 0
+64 03 211 3082
Email 71651 0
amandas@hospicesouthland.org.nz
Contact person for scientific queries
Name 71652 0
Amanda Sommerfeldt
Address 71652 0
Hospice Southland
Gate 1,
Southland Hospital Grounds,
Elles Road
Strathern, Invercargill 9812
Country 71652 0
New Zealand
Phone 71652 0
+64 0800 211 3081
Fax 71652 0
+64 03 211 3082
Email 71652 0
amandas@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
IPD not publicly available.


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.