Communication Regarding Organ and Tissue Donation in Intensive Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Tissue and Organ Procurement

Intervention / Treatment
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* Behavioral: Communication intervention


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Communication intervention<br>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. | Behavioral: Communication intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |