Communication Regarding Organ and Tissue Donation in Intensive Care (COMFORT)

NSW Organ and Tissue Donation Service

Status: Completed

Conditions: Tissue and Organ Procurement

Treatments: Behavioral: Communication intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01922310

DR-01-2012

ACTRN12613000815763 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 417 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

417 participants in 1 patient group

Communication intervention

Other group

Description:

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. 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.

Treatment:

Behavioral: Communication intervention