Communication Regarding Organ and Tissue Donation in Intensive Care

Tissue and Organ Procurement Clinical Trial

— COMFORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01922310
• Other study ID #: DR-01-2012
• Secondary ID: ACTRN12613000815
• Status: Completed
• Phase: N/A
• First received: August 10, 2013
• Last updated: October 3, 2017
• Start date: May 1, 2013
• Est. completion date: December 21, 2016

Study information

• Verified date: October 2017
• Source: NSW Organ and Tissue Donation Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: December 21, 2016
• Est. primary completion date: July 8, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Tissue and Organ Procurement

Intervention

Behavioral:
• Communication 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.

Locations

Country	Name	City	State
Australia	John Hunter Hospital	New Lambton Heights	New South Wales
Australia	Liverpool Hospital	Sydney	New South Wales
Australia	NSW Organ and Tissue Donation Service	Sydney	New South Wales
Australia	Prince of Wales Hospital	Sydney	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales
Australia	St George Hospital	Sydney	New South Wales
Australia	St Vincent's Hospital	Sydney	New South Wales
Australia	The Children's Hospital at Westmead	Sydney	New South Wales
Australia	The Tweed Hospital	Tweed Heads	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
NSW Organ and Tissue Donation Service

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health professionals' adherence rates to core elements of the intervention.	This will be measured by observation and self-report at the hospital.	Up to 72 hours subsequent to next of kin making their final donation decision.
Primary	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	Proportion of senior next of kin who report they regretted their final decision either to consent or to decline donation.	This outcome will be assesed using a telephone follow-up call.	90 days post enrollment.