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Communication with Families regarding Organ and Tissue Donation after Death in Intensive Care study

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000815763
Acronym
COMFORT
Enrollment
442
Registered
2013-07-24
Start date
2013-05-20
Completion date
2016-07-08
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 se

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.

Sponsors

The NSW Organ and Tissue Donation Service
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 27, 2026