Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12613000815763 | Registry Identifier | Australian New Zealand Clinical Trials Registry (ANZCTR) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Communication intervention | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication intervention | Behavioral | 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. |
| 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. |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Herkes | NSW Organ and Tissue Donation Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hunter Hospital | New Lambton Heights | New South Wales | 2305 | Australia | ||
| Liverpool Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30482134 | Derived | Potter JE, Perry L, Elliott RM, Aneman A, Brieva JL, Cavazzoni E, Cheng AT, O'Leary MJ, Seppelt IM, Herkes RG; COMFORT study investigators. Communication with Families Regarding Organ and Tissue Donation after Death in Intensive Care (COMFORT): a multicentre before-and-after study. Crit Care Resusc. 2018 Dec;20(4):268-276. | |
| 28095838 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sydney |
| New South Wales |
| 1871 |
| Australia |
| St Vincent's Hospital | Sydney | New South Wales | 2010 | Australia |
| Prince of Wales Hospital | Sydney | New South Wales | 2031 | Australia |
| Royal Prince Alfred Hospital | Sydney | New South Wales | 2052 | Australia |
| Royal North Shore Hospital | Sydney | New South Wales | 2065 | Australia |
| The Children's Hospital at Westmead | Sydney | New South Wales | 2145 | Australia |
| NSW Organ and Tissue Donation Service | Sydney | New South Wales | 2217 | Australia |
| St George Hospital | Sydney | New South Wales | 2217 | Australia |
| The Tweed Hospital | Tweed Heads | New South Wales | 2485 | Australia |
| Potter JE, Herkes RG, Perry L, Elliott RM, Aneman A, Brieva JL, Cavazzoni E, Cheng AT, O'Leary MJ, Seppelt IM, Gebski V; COMFORT study investigators. COMmunication with Families regarding ORgan and Tissue donation after death in intensive care (COMFORT): protocol for an intervention study. BMC Health Serv Res. 2017 Jan 17;17(1):42. doi: 10.1186/s12913-016-1964-7. |