Clinical trial NCT01922310: Communication Regarding Organ and Tissue Donation in Intensive Care
Official title: Communication With Families Regarding Organ and Tissue Donation After Death in Intensive Care Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tissue and Organ Procurement
Lead sponsor: NSW Organ and Tissue Donation Service
Sponsor class: OTHER_GOV
First posted: 2013-08-14
Enrollment: 417
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of families providing consent for deceased organ donation.
timeFrame: Up to 72 hours subsequent to raising deceased donation with next of kin.
Secondary outcomes:
measure: Proportion of senior next of kin who report they regretted their final decision either to consent or to decline donation.
timeFrame: 90 days post enrollment.
Other outcomes:
measure: Health professionals' adherence rates to core elements of the intervention.
timeFrame: Up to 72 hours subsequent to next of kin making their final donation decision.
Locations:
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Sydney
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Sydney
country: Australia
facility: NSW Organ and Tissue Donation Service
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
state: New South Wales
Study officials:
affiliation: NSW Organ and Tissue Donation Service
name: Robert Herkes
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Potter 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.