Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000917134
Ethics application status
Approved
Date submitted
12/06/2019
Date registered
1/07/2019
Date last updated
10/11/2021
Date data sharing statement initially provided
1/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Communication with bereaved family members after death in the Intensive Care Unit
Scientific title
Communication with bereaved family members after death in the Intensive Care Unit
Secondary ID [1] 298459 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CathartiC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 313201 0
Anxiety 313202 0
Post-traumatic stress disorder 313203 0
Complicated grief 313204 0
Condition category
Condition code
Mental Health 311662 311662 0 0
Depression
Mental Health 311663 311663 0 0
Anxiety
Mental Health 311664 311664 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The legal representative of a patient who has recently died while receiving treatment in the Intensive Care Unit will receive one of three interventions as part of a bereavement follow up:

Group A is the control group (please see below).
Group B will receive a short, semi-structured telephone call from a Clinical Nurse Consultant (senior Intensive Care Nurse) four weeks following the death.
The telephone call is expected to last less than 5 minutes in duration and will have 2 objectives:
i/ Expression of condolences.
ii/ Offer of further telephone call or in-person meeting with a representative from the Intensive Care Unit.
Group C will not receive any communication from the Intensive Care Unit following the death.
Intervention code [1] 314701 0
Behaviour
Comparator / control treatment
The legal representative of a patient who has recently died while receiving treatment in the Intensive Care Unit will receive one of three interventions as part of a bereavement follow up:

Group A will receive a standardised condolence letter four weeks following the death. This is current standard practice and consequently has been selected as the control group. The condolence letter serves 2 objectives:
i/ Expression of condolences.
ii/ Provision of contact details should further contact with a representative of the ICU or hospital be desired.
Group B and C are intervention groups, as detailed above.
Control group
Active

Outcomes
Primary outcome [1] 320368 0
Incidence of anxiety and depression, as determined by a total Hospital Anxiety and Depression Score (HADS-T) of greater than or equal to 11/42.
Timepoint [1] 320368 0
The Hospital Anxiety and Depression Scale assessment tool will be measured at 6 months following the death.
Secondary outcome [1] 371373 0
Incidence of anxiety, as determined by a Hospital Anxiety and Depression Scale, Anxiety sub-scale score (HADS-A) of greater than or equal to 8/21.
Timepoint [1] 371373 0
The Hospital Anxiety and Depression Scale assessment tool will be measured at 6 months following the death.
Secondary outcome [2] 371374 0
Incidence of depression, as determined by a Hospital Anxiety and Depression Scale, Depression sub-scale score (HADS-D) of greater than or equal to 8/21.
Timepoint [2] 371374 0
The Hospital Anxiety and Depression Scale assessment tool will be measured at 6 months following the death.
Secondary outcome [3] 371375 0
Incidence of Post-Traumatic Stress Disorder, as determined by an' Impact of Event Scale - Revised' score of greater than or equal to 33/88.
Timepoint [3] 371375 0
The 'Impact of Event Scale - Revised' assessment tool will be measured at 6 months following the death.
Secondary outcome [4] 371376 0
Incidence of Complicated Grief, as determined by an 'Inventory of Complicated Grief' score of greater than or equal to 25/76.
Timepoint [4] 371376 0
The 'Inventory of Complicated Grief' assessment tool will be measured at 6 months following the death.
Secondary outcome [5] 371377 0
Incidence of Complicated Grief, as determined by an 'CAESAR' score of less than or equal to 59/75.
Timepoint [5] 371377 0
The 'CAESAR' assessment tool will be measured at 6 months following the death.

Eligibility
Key inclusion criteria
Intensive Care Unit Patient Criteria:
i/ Aged greater than 18 years of age
ii/ Non-pregnant
iii/ Admitted to the Intensive Care Unit as a patient for greater than 24 hours

Legal Representative of Patient Criteria:
i/ Legal representative of patient
ii/ Aged greater than 18 years of age
iii/ Visited patient on one or more occasions during their Intensive Care Unit stay
iv/ Attended one or more Intensive Care Unit family meetings
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Legal Representative of Patient:
- Has limited understanding of English.
- Has multiple relatives admitted to the Intensive Care Unit.
- Is expected not to be contactable by phone or mail at 6 months follow up.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be maintained until after randomisation, with investigators informed of treatment group via RedCap. The subset of investigators undertaking the six-month follow-up will not have the treatment allocation available to them, however if the participant chooses to reveal which intervention they were subject to this cannot be avoided.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Selection bias will be minimised by with randomisation schedule using a fixed seed number, and thus a reproducible schedule, using Stata (Stata version 15.1, College Station, Texas) routine ralloc. The seed number will be kept securely so the sequence can be re-generated and if necessary extended as desired.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This small pilot study will focus on comparing descriptive statistics (means, proportions, medians) and their associated confidence intervals or quantile ranges between the three groups, to provide an estimate of possible treatment effects.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Ceased recruitment on 24th March 2020 due to impact of COVID pandemic on ICU resources, case mix and model of care in Melbourne, Victoria
Date of first participant enrolment
Anticipated
1/07/2019
Actual
12/08/2019
Date of last participant enrolment
Anticipated
30/06/2020
Actual
24/03/2020
Date of last data collection
Anticipated
30/12/2020
Actual
16/09/2020
Sample size
Target
200
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13971 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 26746 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 303002 0
Hospital
Name [1] 303002 0
Melbourne Health
Country [1] 303002 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
Melbourne Health
Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Country
Australia
Secondary sponsor category [1] 302994 0
None
Name [1] 302994 0
Address [1] 302994 0
Country [1] 302994 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303551 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 303551 0
Ethics committee country [1] 303551 0
Australia
Date submitted for ethics approval [1] 303551 0
27/03/2019
Approval date [1] 303551 0
23/05/2019
Ethics approval number [1] 303551 0
HREC/52855/MH-2019

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

Contacts
Principal investigator
Name 94058 0
Dr Laurie Showler
Address 94058 0
Intensive Care Unit
Royal Melbourne Hospital
Level 5, B building
300 Grattan Street
Parkville VIC 3050
Country 94058 0
Australia
Phone 94058 0
+61 416958489
Fax 94058 0
Email 94058 0
[email protected]
Contact person for public queries
Name 94059 0
Laurie Showler
Address 94059 0
Intensive Care Unit
Royal Melbourne Hospital
Level 5, B building
300 Grattan Street
Parkville VIC 3050
Country 94059 0
Australia
Phone 94059 0
+61 416958489
Fax 94059 0
Email 94059 0
[email protected]
Contact person for scientific queries
Name 94060 0
Laurie Showler
Address 94060 0
Intensive Care Unit
Royal Melbourne Hospital
Level 5, B building
300 Grattan Street
Parkville VIC 3050
Country 94060 0
Australia
Phone 94060 0
+61 416958489
Fax 94060 0
Email 94060 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
At the present time there is no intention to share IPD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2319Ethical approval    377750-(Uploaded-12-06-2019-12-28-21)-Study-related document.pdf



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.