ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12611000519954

Ethics application status

Not yet submitted

Date submitted

12/05/2011

Date registered

19/05/2011

Date last updated

19/05/2011

Type of registration

Prospectively registered

Titles & IDs

Public title

Relative's and staff's experience of the moment of death in the Intensive Care unit of a tertiary referral hospital

Scientific title

Relative's and staff's experience of the moment of death in the Intensive Care unit of a tertiary referral hospital

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dying patient

Condition category

Condition code

Mental Health

Studies of normal psychology, cognitive function and behaviour

Public Health

Health service research

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Grounded theory approach to a qualitative enquiry into the experience of relatives, nurses and doctors present at the moment of death of a patient in Intensive Care Unit. Relatives to be interviewed as individuials or in group 2 weeks following the patient's death. Nurse and doctor to be interviewed separately and individually within 48 hours of the patient's death. . With the primary consultant’s permission, the researcher, a medical doctor not involved in the patient’s care and not working in ICU, will meet the family to explain the study during the patient’s admission and following the patient’s death will telephone to obtain consent to visit at home where the interview will take place or in the hospital if the interviewee prefers. Meeting the family prior to the patient’s death will facilitate the early post-bereavement research interview. The nurse and doctor most involved in the patient’s care at the time of their death will be approached to request an interview as soon as possible after the death. The nurse and doctor caring for the patient at the time of his/her death cannot be identified in advance as we do not know exactly when the patient will die and staff change daily and during the day. As a result chance of behaviour change due to the study is much less than if they could be identified and approached before the patient dies. An information sheet will be given/posted to the potential interviewee. Written informed consent will be obtained from the interviewee(s) prior to the interview. Participants will be informed that the interview can be terminated at any point and that confidentiality will be maintained. All interviewees will be offered bereavement support from ICU bereavement team or Hospital pastoral Care team. Mindful of the sensitivity of the topic, emphasis will be placed on minimizing potential distress to interviewees, at all times being tactful and considerate. The interview will take approximately 30-60 minutes opening with the invitation to the interviewee to describe their experience of the patient's dying and death.

Intervention code [1]

Not applicable

Comparator / control treatment

Relatives, nurse and doctor will be interviewed separately about their experience of the same event ie death of the patient. However this is not comparative study but instead a grounded theory approach where the depth and detail of the experience is sought.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Theory as to the significant components that contribute to the relative's, nurse's and doctor's experience of a patient dying in ICU

Timepoint [1]

Relative interviewed at two weeks post bereavement

Nurse and doctor interviewed within 48 hours of patient's death

Secondary outcome [1]

Nil

Timepoint [1]

Nil

Eligibility

Key inclusion criteria

Families of patients who are dying in ICU.

Families live within Wellington, Hutt, Kapiti areas

Families present at the moment of death

Nurse present at the time of patient's death

Doctor present at the time of patient's death

Minimum age

16 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Families of child dying in ICU

Families whose first language is other than English

Study design

Purpose

Natural history

Duration

Cross-sectional

Selection

Convenience sample

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/07/2011

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Hospital

Name

Wellington Regional Hospital

Address

Private Bag 7902
Wellington 6242

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Central Regional Ethics Committee

Ethics committee address [1]

Po Box 5013
Wellington

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

24/05/2011

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The moment of death, a compelling image and dominant concept throughout history has become increasingly marginalised. Although the majority of deaths occur in hospital it has been suggested that dying in hospital is largely a negative experience. 
As doctors working in Palliative Medicine we care for people who ultimately will die yet rarely are we present at the moment of their death. Much published work on the moment of death has been written by anthropologists and sociologists but not by those involved directly in the care of the dying (Glaser & Strauss, 1968; Kastenbaum & Normand, 1990; Kellehear, 1984; Seale, 1995). Palliative Care programmes continue to demonstrate that enlightened and dedicated care can markedly reduce the suffering of patients with advanced cancer and their families yet Kastenbaum (1999) questions why the vast experience acquired has not yet been translated into a vision of the moment of death. The moment of death has become increasingly marginalised. 
There is a suggestion that institutionalized death cannot be a good death (Gomes & Higginson, 2008) and hospitalization of death is criticised (Seymour, 2001). Death at home is identified as the ideal location (Gomes & Higginson, 2006; Hunt, Bonett & Roder, 1993; Middlewood, Gardner & Gardner, 2001; Tang, 2003). Yet in many countries the majority of patients die in hospital and will continue to do so (Gott, Seymour, Bellamy, Clark & Ahmedzai, 2004).    
This is the fifth qualitative research study on the experience of the moment of death (Donnelly et al, 2006; Donnelly & Donnelly, 2009, Donnelly & Battley, 2010). This study focuses on what actually happens at the time of death in the ICU of a tertiary referral hospital of 427 beds, as described by the witnessing family, matched by the observations of nurses and doctors.

Trial website

Trial related presentations / publications

Donnelly, S. (1999a). Folklore associated with dying in the west of Ireland. Palliative Medicine; 13, 57-62. 
Donnelly, S. (1999b). Folklore associated with dying in the west of Scotland. Journal of Palliative Care;15, 64-69.

Donnelly, S., & Michael, N. (2006). The experience of the moment of death at home. Mortality, 11(4),352-367.

Donnelly, S., & Donnelly, C. (2009).The experience of the moment of death in a specialist palliative care unit. Irish Medical Journal 102; 143-145.

Donnelly, S., & Battley, J. (2010). Relatives’ experience of the moment of death in hospital. Mortality 15; 81-100

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Sinead Donnelly

Address

Palliative Medicine Department
Wellington Regional Hospital
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 21 1255908

Fax

sinead.donnelly@ccdhb.org.nz

Contact person for scientific queries

Name

Dr Sinead Donnelly

Address

Palliative Medicine Department
Wellington Regional Hospital
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 21 1255908

Fax

sinead.donnelly@ccdhb.org.nz

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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