Communication Regarding Organ and Tissue Donation in Intensive Care
COMFORT
Communication With Families Regarding Organ and Tissue Donation After Death in Intensive Care Study
2 other identifiers
interventional
417
1 country
10
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 change rates of consent for donation, and other family-based outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 10, 2013
CompletedFirst Posted
Study publicly available on registry
August 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2016
CompletedOctober 5, 2017
October 1, 2017
3.2 years
August 10, 2013
October 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of families providing consent for deceased organ donation.
Final decision of either written or verbal consent or decline to deceased organ donation provided at the hospital.
Up to 72 hours subsequent to raising deceased donation with next of kin.
Secondary Outcomes (1)
Proportion of senior next of kin who report they regretted their final decision either to consent or to decline donation.
90 days post enrollment.
Other Outcomes (1)
Health professionals' adherence rates to core elements of the intervention.
Up to 72 hours subsequent to next of kin making their final donation decision.
Study Arms (1)
Communication intervention
OTHERThis 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. 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.
Interventions
The intervention is a modification of current standard practice procedures for requesting consent for donation. 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.
Eligibility Criteria
You may qualify if:
- Donation events identified by a patient who is a potential organ and tissue donor in a participating ICU or under the care of ICU health professionals.
- For the primary endpoint only, patients must not have registered their donation wishes.
You may not qualify if:
- A patient who is not medically suitable for organ or tissue donation.
- A patient who does not have next of kin available to participate in donation conversations.
- A patient in the ICU who is able to provide first person consent for deceased donation, for example a patient with spinal injuries.
- A patient who is suitable to donate only tissue after death.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
John Hunter Hospital
New Lambton Heights, New South Wales, 2305, Australia
Liverpool Hospital
Sydney, New South Wales, 1871, Australia
St Vincent's Hospital
Sydney, New South Wales, 2010, Australia
Prince of Wales Hospital
Sydney, New South Wales, 2031, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, 2052, Australia
Royal North Shore Hospital
Sydney, New South Wales, 2065, Australia
The Children's Hospital at Westmead
Sydney, New South Wales, 2145, Australia
NSW Organ and Tissue Donation Service
Sydney, New South Wales, 2217, Australia
St George Hospital
Sydney, New South Wales, 2217, Australia
The Tweed Hospital
Tweed Heads, New South Wales, 2485, Australia
Related Publications (2)
Potter JE, Perry L, Elliott RM, Aneman A, Brieva JL, Cavazzoni E, Cheng AT, O'Leary MJ, Seppelt IM, Herkes RG; COMFORT study investigators. Communication with Families Regarding Organ and Tissue Donation after Death in Intensive Care (COMFORT): a multicentre before-and-after study. Crit Care Resusc. 2018 Dec;20(4):268-276.
PMID: 30482134DERIVEDPotter JE, Herkes RG, Perry L, Elliott RM, Aneman A, Brieva JL, Cavazzoni E, Cheng AT, O'Leary MJ, Seppelt IM, Gebski V; COMFORT study investigators. COMmunication with Families regarding ORgan and Tissue donation after death in intensive care (COMFORT): protocol for an intervention study. BMC Health Serv Res. 2017 Jan 17;17(1):42. doi: 10.1186/s12913-016-1964-7.
PMID: 28095838DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Herkes
NSW Organ and Tissue Donation Service
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2013
First Posted
August 14, 2013
Study Start
May 1, 2013
Primary Completion
July 8, 2016
Study Completion
December 21, 2016
Last Updated
October 5, 2017
Record last verified: 2017-10