Trial Review

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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] 262130 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dying patient 265802 0
Condition category
Condition code
Mental Health 265959 265959 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 266014 266014 0 0
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] 264546 0
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] 266738 0
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] 266738 0
Relative interviewed at two weeks post bereavement

Nurse and doctor interviewed within 48 hours of patient's death
Secondary outcome [1] 276316 0
Nil
Timepoint [1] 276316 0
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
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 3581 0
New Zealand
State/province [1] 3581 0

Funding & Sponsors
Funding source category [1] 265079 0
Self funded/Unfunded
Name [1] 265079 0
Country [1] 265079 0
Primary sponsor type
Hospital
Name
Wellington Regional Hospital
Address
Private Bag 7902
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 264157 0
None
Name [1] 264157 0
Address [1] 264157 0
Country [1] 264157 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 267046 0
Central Regional Ethics Committee
Ethics committee address [1] 267046 0
Ethics committee country [1] 267046 0
New Zealand
Date submitted for ethics approval [1] 267046 0
24/05/2011
Approval date [1] 267046 0
Ethics approval number [1] 267046 0

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

Contacts
Principal investigator
Name 32581 0
Address 32581 0
Country 32581 0
Phone 32581 0
Fax 32581 0
Email 32581 0
Contact person for public queries
Name 15828 0
Dr Sinead Donnelly
Address 15828 0
Palliative Medicine Department
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country 15828 0
New Zealand
Phone 15828 0
+64 21 1255908
Fax 15828 0
Email 15828 0
[email protected]
Contact person for scientific queries
Name 6756 0
Dr Sinead Donnelly
Address 6756 0
Palliative Medicine Department
Wellington Regional Hospital
Private Bag 7902
Wellington 6242
Country 6756 0
New Zealand
Phone 6756 0
+64 21 1255908
Fax 6756 0
Email 6756 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.