Tissue and Organ Procurement Clinical Trial
— COMFORTOfficial title:
Communication With Families Regarding Organ and Tissue Donation After Death in Intensive Care Study
Verified date | October 2017 |
Source | NSW Organ and Tissue Donation Service |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
NSW Organ and Tissue Donation Service |
Australia,
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. |
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