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Trial registered on ANZCTR


Registration number
ACTRN12613000815763
Ethics application status
Approved
Date submitted
8/07/2013
Date registered
24/07/2013
Date last updated
1/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Communication with Families regarding Organ and Tissue Donation after Death in Intensive Care study
Scientific title
A multicentre study of ICU staff who have undertaken specialist requester training and use a best practice procedure to conduct donation conversations with families of potential organ and/or tissue donors compared with current 'standard care' on the families' decision to agree or to decline donation and the families' perceptions of the requesting process and their decision at 90 days.
Secondary ID [1] 282792 0
NCT01922310
Universal Trial Number (UTN)
U1111-1145-3724
Trial acronym
COMFORT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deceased organ and tissue donation 289562 0
Condition category
Condition code
Public Health 289890 289890 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a modification of current standard practice procedures for requesting consent for donation. Essential ‘best practice’ elements of the intervention are:
*A designated requester has prime responsibility for discussions regarding organ and/or tissue donation with next of kin of a potential donor in the ICU.
*Designated requesters may be intensivists; experienced critical care nurses such as donation specialist nurses, or social workers, who have completed advanced training in sensitive communication.
*When next of kin raise the possibility of the patient donating organs or tissue after death, the managing ICU health professional will sensitively defer the requesting discussion to the designated requester.
*Separation of the donation discussion from the conversation where next of kin are notified of the patient’s death, or the inevitability of death.
*Donation conversations are conducted within a family meeting, structure based on evidence-based guidelines for high quality communication regarding end of life care.
*A balanced approach is used when providing information regarding organ donation to next of kin.

Evidence-based guidelines for communication with health care professionals and families regarding the patients’ values and preferences at the end of life include recommendations that meetings take place in a private room or special area for meetings, that multidisciplinary team planning has occurred, and everyday language is used with effective communication techniques.
References:
Australian and New Zealand Intensive Care Society (2013) "The ANZICS Statement on Death and Organ Donation." 2013.
Billings, J. A. (2011). "The end-of-life family meeting in intensive care part I: Indications, outcomes, and family needs." J Pall Med 14(9): 1042-1050.
Billings, J. A. (2011). "The end-of-life family meeting in intensive care part II: Family-centered decision making." J Pall Med 14(9): 1051-1057.
Billings, J. A. and S. D. Block (2011). "The end-of-life family meeting in intensive care part III: A guide for structured discussions." J Pall Med 14(9): 1058-1064.
Curtis, J. R. and D. B. White (2008). "Practical guidance for evidence-based ICU family conferences." Chest 134(4): 835-843.
Lautrette, A., M. Ciroldi, et al. (2006). "End-of-life family conferences: rooted in the evidence." Critical Care Medicine 34(11 Suppl): S364-372.
Lautrette, A., M. Darmon, et al. (2007). "A communication strategy and brochure for relatives of patients dying in the ICU." New England Journal of Medicine 356(5): 469-478.

The staff education and training modules are voluntary workshops designed to provide staged training and sequential learning through theory and practical training, as described in the Professional Education Package (The Organ and Tissue Authority. "Professional Education Package: Family Donation Conversation." Retrieved 8 July, 2013, from http://www.donatelife.gov.au/the-authority/education/professional-education-package). Also, in NSW designated requesters will attend a simulation workshop. This is a half day workshop developed in partnership with the University of Technology, Sydney.

The intervention period commences when the possibility of organ donation is first raised with the family, and includes the time for families to make a decision. This time may last up to 72 hours.

Longer term bereavement support involves the provision of written literature and counselling by the Donor Family Support Coordinator in the first month following bereavement. Referral to local grief counsellors is arranged if required. If they wish, families receive ongoing support, as do families who agreed to donation.
Intervention code [1] 287475 0
Behaviour
Comparator / control treatment
Active control: standard practice

Standard practice include family donation discussions led by health professionals other than designated requesters.
The control period continues contemporaneously as staff complete the training and become available as designated requesters.
Control group
Active

Outcomes
Primary outcome [1] 289951 0
Consent rate for deceased organ and/or tissue donation
Timepoint [1] 289951 0
Up to 72 hours subsequent to raising deceased donation with next of kin
Secondary outcome [1] 303644 0
Identification of predictors of senior available next of kin consent or decline to donation.

Characteristics of the donation process including degree of staff adherence to core elements of the intervention and demographic characteristics of the potential donor and senior next of kin will be modelled to identify predictors of senior available next of kin consent to donation.
Timepoint [1] 303644 0
90 days post enrolment.
Secondary outcome [2] 303645 0
Proportion of senior next of kin who report they regretted their final decision either to consent or to decline donation.

This outcome will be assessed using a telephone follow-up call.
Timepoint [2] 303645 0
90 days post enrolment.
Secondary outcome [3] 303646 0
Health professionals' adherence rates to core elements of the intervention.

Health professionals will be supplied with a form to complete.
Timepoint [3] 303646 0
Up to 72 hours subsequent to next of kin making their final donation decision.

Eligibility
Key inclusion criteria
Participants in this study are the next of kin of patients eligible for organ and/or tissue donation and the staff involved in each decision-making scenario.
a) A patient who is a potential organ and/or tissue donor in a participating ICU, and the staff involved in each decision-making scenario.
Additionally, for the primary outcome only, patients must not have registered their preference for deceased donation in life.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) A patient who is not medically suitable for organ or tissue donation;
b) A patient who does not have next of kin available to participate in donation conversations;
c) Refusal for organ or tissue donation by the coroner;
d) An adult patient in the ICU who is able to provide first person consent for deceased donation, for example a patient with spinal injuries.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1221 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 1222 0
Liverpool Hospital - Liverpool
Recruitment hospital [3] 1223 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 1224 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 1225 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [6] 1226 0
St George Hospital - Kogarah
Recruitment hospital [7] 1227 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [8] 1228 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [9] 4024 0
The Children's Hospital at Westmead - Westmead

Funding & Sponsors
Funding source category [1] 287565 0
Government body
Name [1] 287565 0
The NSW Organ and Tissue Donation Service
Address [1] 287565 0
P.O. Box 486, Kogarah, NSW 1485
Country [1] 287565 0
Australia
Primary sponsor type
Government body
Name
The NSW Organ and Tissue Donation Service
Address
P.O. Box 486, Kogarah, NSW 1485
Country
Australia
Secondary sponsor category [1] 286320 0
None
Name [1] 286320 0
Address [1] 286320 0
Country [1] 286320 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289544 0
St Vincent's Hospital
Ethics committee address [1] 289544 0
St Vincent's Hospital Research Office
Level 6, De Lacey Building
390 Victoria Street
Darlinghurst
NSW 2010
Ethics committee country [1] 289544 0
Australia
Date submitted for ethics approval [1] 289544 0
Approval date [1] 289544 0
25/01/2013
Ethics approval number [1] 289544 0
HREC/12/SVH/271

Summary
Brief summary
The overarching aim of this study is to examine the process of organ donation decision-making and to determine whether changes in requesting practices may effect changes in consent for donation, and family-based outcomes.

This study uses a single arm design with current ‘controls’ to explore an intervention, the procedure for providing information and requesting consent for donation, that uses new agreed best practice procedures led by specially trained intensive care health professionals. Discussing the possibility of organ donation with families of patients who are potential organ and/or tissue donors is usual care by staff in the intensive care unit. The study intervention is a staff education and training module intended to provide a framework and preparation for select critical care staff to conduct organ donation discussions in line with best practice. Donation decision-making processes will be compared before (‘control’) and after (‘intervention’) staff have received this training.

In addition to standard bereavement follow-up provided by the hospital, senior next of kin who declined donation will be offered bereavement aftercare provided by the NSW Organ and Tissue Donation Service. This longer term bereavement support is usual care for those who agreed to donation and will be offered to those who declined donation.

Evaluation of the intervention will include audit data on adherence to core elements of the requesting process. Critical care staff will be asked to complete a form to record details of request conversations and procedures. Clinical and administrative data will be collected from databases and paper records. Senior next of kin who agreed to bereavement aftercare will be invited to participate in a structured telephone interview 90 days post bereavement to evaluate their perceptions of their donation decision, and to provide some personal information.

A sample of 400 potential donation scenarios are possible over the intervention study period from approximately 10 NSW hospitals.
Trial website
Trial related presentations / publications
Potter JE, Herkes RG, Perry L, et al. COMmunication with Families regarding ORgan and Tissue donation after death in intensive care (COMFORT): protocol for an intervention study. BMC Health Serv Res 2017;17(1):42. doi: 10.1186/s12913-016-1964-7
Public notes

Contacts
Principal investigator
Name 41254 0
Dr Robert Herkes
Address 41254 0
NSW Organ and Tissue Donation Service, P.O. Box 486, Kogarah NSW 1485
Country 41254 0
Australia
Phone 41254 0
+ 61 2 8566 1700
Fax 41254 0
+ 61 2 8566 1755
Email 41254 0
roberth@usyd.edu.au
Contact person for public queries
Name 41255 0
Ms Julie Potter
Address 41255 0
NSW Organ and Tissue Donation Service, P.O.Box 486, Kogarah NSW 1485
Country 41255 0
Australia
Phone 41255 0
+ 61 2 8566 1706
Fax 41255 0
+ 61 2 8566 1755
Email 41255 0
julie.potter@health.nsw.gov.au
Contact person for scientific queries
Name 41256 0
Dr Robert Herkes
Address 41256 0
NSW Organ and Tissue Donation Service, P.O. Box 486, Kogarah NSW 1485
Country 41256 0
Australia
Phone 41256 0
+ 61 2 8566 1700
Fax 41256 0
+ 61 2 8566 1755
Email 41256 0
roberth@usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary