ANZCTR - Registration

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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]

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

Bereavement

Condition category

Condition code

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To establish the feasibility of delivering a bereavement follow-up service by the ICU defined by the successful follow-up call rate.

Timepoint [1]

4 weeks post death in ICU

Secondary outcome [1]

To assess the value of feedback received about the end-of-life care: recorded as Likert scores and qualitative feedback.

Timepoint [1]

4 weeks post death in ICU

Secondary outcome [2]

How the bereavement follow-up service is viewed by family members: recorded as qualitative feedback.

Timepoint [2]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Donate Life

Address [1]

Level 6, 45 Grenfell Street, Adelaide SA 5000.

Country [1]

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]

Individual

Name [1]

Benjamin Reddi

Address [1]

Intensive Care Unit,
Royal Adelaide Hospital,
Port Road,
Adelaide
SA 5000.

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CALHN Human Research Ethics

Ethics committee address [1]

Royal Adelaide Hospital Clinical Trial Centre
Wayfinder 3D460.02
Level 3 Royal Adelaide Hospital,
Port Road,
Adelaide SA 5000.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/05/2018

Approval date [1]

05/06/2018

Ethics approval number [1]

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]

/AnzctrAttachments/375469-Protocol - Bereavement Follow-up Project version 2.docx (Protocol)

Attachments [2]

/AnzctrAttachments/375469-R20180526 Approval Letter.pdf (Ethics approval)

Contacts

Principal investigator

Name

Dr Nikki Yeo

Address

Intensive Care Unit,
Royal Adelaide Hospital,
Port Road,
Adelaide.
SA 5000.

Country

Australia

Phone

+61414203246

Fax

nikkiyky@hotmail.com

Contact person for public queries

Name

Nikki Yeo

Address

Intensive Care Unit,
Royal Adelaide Hospital,
Port Road,
Adelaide,
SA 5000.

Country

Australia

Phone

+61414203246

Fax

nikkiyky@hotmail.com

Contact person for scientific queries

Name

Nikki Yeo

Address

Intensive Care Unit,
Royal Adelaide Hospital,
Port Road,
Adelaide
SA 5000.

Country

Australia

Phone

+61414203246

Fax

nikkiyky@hotmail.com

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.

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