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Communication Regarding Organ and Tissue Donation in Intensive Care

Communication With Families Regarding Organ and Tissue Donation After Death in Intensive Care Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01922310
Acronym
COMFORT
Enrollment
417
Registered
2013-08-14
Start date
2013-05-01
Completion date
2016-12-21
Last updated
2017-10-05

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

Conditions

Tissue and Organ Procurement

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.

Interventions

BEHAVIORALCommunication intervention

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.

Sponsors

NSW Organ and Tissue Donation Service
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Proportion of families providing consent for deceased organ donation.Up to 72 hours subsequent to raising deceased donation with next of kin.Final decision of either written or verbal consent or decline to deceased organ donation provided at the hospital.

Secondary

MeasureTime frameDescription
Proportion of senior next of kin who report they regretted their final decision either to consent or to decline donation.90 days post enrollment.This outcome will be assesed using a telephone follow-up call.

Other

MeasureTime frameDescription
Health professionals' adherence rates to core elements of the intervention.Up to 72 hours subsequent to next of kin making their final donation decision.This will be measured by observation and self-report at the hospital.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026