Communication Regarding Organ and Tissue Donation in Intensive Care
- Conditions
- Tissue and Organ Procurement
- Interventions
- Behavioral: Communication intervention
- Registration Number
- NCT01922310
- Lead Sponsor
- NSW Organ and Tissue Donation Service
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 417
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Communication intervention Communication intervention 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (10)
St Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
Prince of Wales Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Royal North Shore Hospital
🇦🇺Sydney, New South Wales, Australia
The Children's Hospital at Westmead
🇦🇺Sydney, New South Wales, Australia
NSW Organ and Tissue Donation Service
🇦🇺Sydney, New South Wales, Australia
St George Hospital
🇦🇺Sydney, New South Wales, Australia
John Hunter Hospital
🇦🇺New Lambton Heights, New South Wales, Australia
Liverpool Hospital
🇦🇺Sydney, New South Wales, Australia
The Tweed Hospital
🇦🇺Tweed Heads, New South Wales, Australia