ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

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]

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]

Consent rate for deceased organ and/or tissue donation

Timepoint [1]

Up to 72 hours subsequent to raising deceased donation with next of kin

Secondary outcome [1]

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]

90 days post enrolment.

Secondary outcome [2]

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]

90 days post enrolment.

Secondary outcome [3]

Health professionals' adherence rates to core elements of the intervention.

Health professionals will be supplied with a form to complete.

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

5/08/2013

Actual

20/05/2013

Date of last participant enrolment

Anticipated

Actual

8/07/2016

Date of last data collection

Anticipated

Actual

21/12/2016

Sample size

Target

140

Accrual to date

Final

442

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

John Hunter Hospital Royal Newcastle Centre - New Lambton

Recruitment hospital [2]

Liverpool Hospital - Liverpool

Recruitment hospital [3]

Prince of Wales Hospital - Randwick

Recruitment hospital [4]

Royal North Shore Hospital - St Leonards

Recruitment hospital [5]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [6]

St George Hospital - Kogarah

Recruitment hospital [7]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [8]

The Tweed Hospital - Tweed Heads

Recruitment hospital [9]

The Children's Hospital at Westmead - Westmead

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

The NSW Organ and Tissue Donation Service

Address [1]

P.O. Box 486, Kogarah, NSW 1485

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincent's Hospital

Ethics committee address [1]

St Vincent's Hospital Research Office
Level 6, De Lacey Building
390 Victoria Street
Darlinghurst
NSW 2010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

25/01/2013

Ethics approval number [1]

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

Dr Robert Herkes

Address

NSW Organ and Tissue Donation Service, P.O. Box 486, Kogarah NSW 1485

Country

Australia

Phone

+ 61 2 8566 1700

Fax

+ 61 2 8566 1755

roberth@usyd.edu.au

Contact person for public queries

Name

Julie Potter

Address

NSW Organ and Tissue Donation Service, P.O.Box 486, Kogarah NSW 1485

Country

Australia

Phone

+ 61 2 8566 1706

Fax

+ 61 2 8566 1755

julie.potter@health.nsw.gov.au

Contact person for scientific queries

Name

Robert Herkes

Address

NSW Organ and Tissue Donation Service, P.O. Box 486, Kogarah NSW 1485

Country

Australia

Phone

+ 61 2 8566 1700

Fax

+ 61 2 8566 1755

roberth@usyd.edu.au

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

Source	Title	Year of Publication	DOI
Embase	COMmunication with Families regarding ORgan and Tissue donation after death in intensive care (COMFORT): protocol for an intervention study.	2017	https://dx.doi.org/10.1186/s12913-016-1964-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

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