Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001123235
Ethics application status
Approved
Date submitted
29/06/2018
Date registered
9/07/2018
Date last updated
9/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study on feasibility of Intensive care unit bereavement follow-up service for family representatives of patients who die in the Intensive Care Unit (ICU).
Scientific title
Pilot study on feasibility of intensive care unit bereavement follow-up service for family representatives of patients who die in the Intensive Care Unit (ICU).
Secondary ID [1] 295367 0
none
Universal Trial Number (UTN)
Trial acronym
BFUP (Bereavement Follow-up Project)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-of-life care 308595 0
Bereavement 308694 0
Condition category
Condition code
Mental Health 307547 307547 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
4
Target follow-up type
Weeks
Description of intervention(s) / exposure
Prospective, single-centre observational study. Nominated family representative is identified at time of patient's death. The representative is contacted at 4 weeks. With his/her consent, a structured telephone interview is completed. Each telephone interview is anticipated to take around 30 minutes. The interview is based on the validated CAESAR tool, focused on care around the end-or-life. The areas covered include care, support and communication with patient and family, medical treatment of patient and discussion around organ donation.
Intervention code [1] 301690 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306524 0
To establish the feasibility of delivering a bereavement follow-up service by the ICU defined by the successful follow-up call rate.
Timepoint [1] 306524 0
4 weeks post death in ICU
Secondary outcome [1] 348781 0
To assess the value of feedback received about the end-of-life care: recorded as Likert scores and qualitative feedback.
Timepoint [1] 348781 0
4 weeks post death in ICU
Secondary outcome [2] 348782 0
How the bereavement follow-up service is viewed by family members: recorded as qualitative feedback.
Timepoint [2] 348782 0
4 weeks post death in ICU

Eligibility
Key inclusion criteria
All adult (age 18 or above) deaths in ICU
Medical consensus of end-of-life care
family representative contactable at time of patient's death
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Next-of-kin not contactable at time of death

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data recorded as Likert scores and qualitative data.
Study to be conducted for a year and review for feasibility to be continued beyond that

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/02/2018
Date of last participant enrolment
Anticipated
1/02/2020
Actual
Date of last data collection
Anticipated
29/02/2020
Actual
Sample size
Target
360
Accrual to date
35
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 11278 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 23165 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 299963 0
Government body
Name [1] 299963 0
Donate Life
Country [1] 299963 0
Australia
Primary sponsor type
Individual
Name
Nikki Yeo
Address
Intensive Care Unit,
Royal Adelaide Hospital,
Port Road,
Adelaide
SA 5000.
Country
Australia
Secondary sponsor category [1] 299341 0
Individual
Name [1] 299341 0
Benjamin Reddi
Address [1] 299341 0
Intensive Care Unit,
Royal Adelaide Hospital,
Port Road,
Adelaide
SA 5000.
Country [1] 299341 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300825 0
CALHN Human Research Ethics
Ethics committee address [1] 300825 0
Royal Adelaide Hospital Clinical Trial Centre
Wayfinder 3D460.02
Level 3 Royal Adelaide Hospital,
Port Road,
Adelaide SA 5000.
Ethics committee country [1] 300825 0
Australia
Date submitted for ethics approval [1] 300825 0
14/05/2018
Approval date [1] 300825 0
05/06/2018
Ethics approval number [1] 300825 0
R20180526

Summary
Brief summary
Around 30% of deaths at the Royal Adelaide Hospital (300 per annum) occur in the ICU or shortly after leaving ICU. The importance of reviewing end-of-life care in the ICU is well recognised. Benefits include assisting family members to process their grief and the opportunity to improve the care delivered to dying patients.

Primary aim of this study is to establish the feasibility of delivering a bereavement service by the intensive care unit. Secondary aims are to assess the value of feedback received about the end-of-life care and how the service is viewed by family members.

This is a prospective, observational study. All family representatives of patients who die in ICU are included in the study. They are excluded if a family representative is not contactable or declines participation..

Patients are referred to the bereavement follow-up service at medical consensus of end-of-life. After the patient's death, the appropriate family representative will be given a brochure providing bereavement information and a letter outlining the follow-up service. The 30 minute interview is based on the validated CAESAR tool, focused on care around the end-of-life. The responses will be recorded as Likert scores with the option to provide qualitative feedback. The bereavement calls will be made at 4 weeks, by clinicians who are experienced intensive care clinicians.

The telephone interview questionnaire consists of 16 questions in 4 sections. The first section of the questionnaire relates to the care of the patient and support for the family. The second section relates to the communication between ICU and the family. The care of the patient and the discussion around organ donation are covered in the next two sections. The last section consists of open-ended question relating to how the family member feel the end-of-life care can be improved.
Trial website
Trial related presentations / publications
Public notes
This project was initially conducted as a quality assurance project, hence the project commencement date preceded the ethics approval date.
Attachments [1] 2845 2845 0 0
/AnzctrAttachments/375469-Protocol - Bereavement Follow-up Project version 2.docx (Protocol)
Attachments [2] 2846 2846 0 0
/AnzctrAttachments/375469-R20180526 Approval Letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 84934 0
Dr Nikki Yeo
Address 84934 0
Intensive Care Unit,
Royal Adelaide Hospital,
Port Road,
Adelaide.
SA 5000.
Country 84934 0
Australia
Phone 84934 0
+61414203246
Fax 84934 0
Email 84934 0
[email protected]
Contact person for public queries
Name 84935 0
Dr Nikki Yeo
Address 84935 0
Intensive Care Unit,
Royal Adelaide Hospital,
Port Road,
Adelaide,
SA 5000.
Country 84935 0
Australia
Phone 84935 0
+61414203246
Fax 84935 0
Email 84935 0
[email protected]
Contact person for scientific queries
Name 84936 0
Dr Nikki Yeo
Address 84936 0
Intensive Care Unit,
Royal Adelaide Hospital,
Port Road,
Adelaide
SA 5000.
Country 84936 0
Australia
Phone 84936 0
+61414203246
Fax 84936 0
Email 84936 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
No additional documents have been identified.