Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000200583
Ethics application status
Approved
Date submitted
16/02/2015
Date registered
2/03/2015
Date last updated
1/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Family meetings for hospitalized palliative care patients: Benefits and resource implications
Scientific title
For family carers of hospitalised palliative care patients, does a Structured Family Meeting shortly after admission to palliative care, compared to standard care only, improve psychological distress?
Secondary ID [1] 286133 0
None
Universal Trial Number (UTN)
U1111-1167-0972
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 294139 0
palliative care 294140 0
Condition category
Condition code
Public Health 294460 294460 0 0
Health service research
Mental Health 294461 294461 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A structured family meeting which is a meeting with key members of the family and key members of the health care team to discuss prognosis, plan care and address concerns of the family members. One structured family meeting will be conducted shortly following admission to palliative care (for the intervention group). The meeting will be held at the hospital and be approximately one hour in duration.
Intervention code [1] 291132 0
Treatment: Other
Comparator / control treatment
Standard treatment which includes all aspects of regular care from the palliative care team (including medical, nursing and psychosocial care) and may include some form of family meeting or discussion with the family.
Control group
Active

Outcomes
Primary outcome [1] 294246 0
Psychological Distress measured by the General Health Questionnaire
Timepoint [1] 294246 0
Psychological distress 8 weeks post-bereavement
Secondary outcome [1] 312868 0
Unmet needs as measured by the Family Inventory of Needs (FIN)
Timepoint [1] 312868 0
Unmet needs 10 days after time 1 data collection (approximately two weeks after admission to palliative care)
Secondary outcome [2] 312869 0
Quality of Life (SF-12)
Timepoint [2] 312869 0
Quality of life 8 weeks post-bereavement

Eligibility
Key inclusion criteria
Family members of hospitalised patients with advanced, non-curable disease referred to a specialist palliative care in-patient unit or palliative care consultancy service for inpatients who have been nominated by a patient as their primary support person and willing to attend a Structured Family Meeting if allocated to the intervention arm.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18; unable to understand English; unable to provide informed consent due to cognitive impairment; or not agreeable to being considered the primary family carer. A family carer of a patient who is imminently dying (unlikely to be alive in 7 days).

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



Intervention assignment
Other
Other design features
There are three sites participating in this trial. For th first six months all sites will recruit participants to the control condition. At six months, two of the three sites will be randomly selected (pulling two site names out of an envelope) to be the intervention sites. All participants recruited from the two intervention sites from that point will be recruited to the intervention condition. The remaining site will continue to recruit participants to the control condition only.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary outcome (H1) is measured via the General Health Questionnair (GHQ), a 12-item scale with a possible range of 0-36. Our previous study of 275 carers in which the mean GHQ difference was 2.8 (SD=5.6), represents a medium effect size (ES) of 0.5 which is a common estimate of a minimal important difference. The sample size calculations are based on a smaller mean difference between groups of 2.4, as some carers in the control group will have family meetings as part of standard care. Estimated sample size for two-sample comparison of means Test Ho: m1 = m2, where m1 is the mean in population 1and m2 is the mean in population 2 is 97 per group (total n=194). This calculation assumes that alpha=.05 (two sided), power=.90 (90%), m1=16.8, m2-14, sd1=6, sd2=6, n2/n1=1.00. In order to ensure a robust sample we aim to recruit 70 participants per site (total of n=210).

The main analyses will be performed on pooled data across sites for the intervention and control groups, following an analyses of the baseline data to identify any differences between sites. We will undertake analyses as follows. Summary statistics will be calculated to compare the characteristics of carers in each group. Linear mixed models will be used to (1) compare patterns of change over time by testing the intervention group by time interaction and (2) estimating and testing differences in scores between groups at T2 and at T3 via linear contrasts, and accounting for the non-independent nature of the data in clusters.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/02/2015
Actual
16/02/2015
Date of last participant enrolment
Anticipated
19/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3450 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 3451 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 3452 0
Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors
Funding source category [1] 290751 0
Government body
Name [1] 290751 0
Victorian Cancer Agency
Country [1] 290751 0
Australia
Primary sponsor type
Hospital
Name
Centre for Palliative Care, St Vincent's Hospital Melbourne
Address
PO Box 2900,
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 289436 0
Hospital
Name [1] 289436 0
Austin Health
Address [1] 289436 0
145 Studley Road
Heidelberg VIC 3084
Country [1] 289436 0
Australia
Secondary sponsor category [2] 289437 0
Hospital
Name [2] 289437 0
Royal Melbourne Hospital
Address [2] 289437 0
300 Grattan Street
Parkville VIC 3050
Country [2] 289437 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292381 0
St Vincent's Health Human Research Ethics Committee (Low Risk)
Ethics committee address [1] 292381 0
Ethics committee country [1] 292381 0
Australia
Date submitted for ethics approval [1] 292381 0
Approval date [1] 292381 0
15/01/2015
Ethics approval number [1] 292381 0
LRR 128/14
Ethics committee name [2] 292382 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [2] 292382 0
Ethics committee country [2] 292382 0
Australia
Date submitted for ethics approval [2] 292382 0
Approval date [2] 292382 0
19/01/2015
Ethics approval number [2] 292382 0
HREC 2014 208
Ethics committee name [3] 292383 0
Austin Health Human Research Ethics Committee
Ethics committee address [3] 292383 0
Ethics committee country [3] 292383 0
Australia
Date submitted for ethics approval [3] 292383 0
17/11/2014
Approval date [3] 292383 0
Ethics approval number [3] 292383 0

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

Contacts
Principal investigator
Name 54766 0
Prof Peter Hudson
Address 54766 0
Centre for Palliative Care
PO Box 2900
Fitzroy VIC 3065
Country 54766 0
Australia
Phone 54766 0
+61 3 9416 0000
Fax 54766 0
+61 3 9416 3919
Email 54766 0
[email protected]
Contact person for public queries
Name 54767 0
Peter Hudson
Address 54767 0
Centre for Palliative Care
PO Box 2900
Fitzroy VIC 3065
Country 54767 0
Australia
Phone 54767 0
+61 3 9416 0000
Fax 54767 0
+61 3 9416 3919
Email 54767 0
[email protected]
Contact person for scientific queries
Name 54768 0
Peter Hudson
Address 54768 0
Centre for Palliative Care
PO Box 2900
Fitzroy VIC 3065
Country 54768 0
Australia
Phone 54768 0
+61 3 9416 0000
Fax 54768 0
+61 3 9416 3919
Email 54768 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseBenefits and resource implications of family meetings for hospitalized palliative care patients: Research protocol.2015https://dx.doi.org/10.1186/s12904-015-0071-6
N.B. These documents automatically identified may not have been verified by the study sponsor.