Tissue and Organ ProcurementCOMFORTNCT01922310
Communication Regarding Organ and Tissue Donation in Intensive Care
A study testing Communication intervention in people with Tissue and Organ Procurement, run by NSW Organ and Tissue Donation Service at 10 sites in Australia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tissue and Organ Procurement
- What is being tested?
- Communication intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 417 participants
- Where
- 10 sitesAustralia
- Study dates
- 1 May 2013to 21 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Australia10 sites
John Hunter Hospital
New Lambton Heights, New South Wales, 2305
Liverpool Hospital
Sydney, New South Wales, 1871
St Vincent's Hospital
Sydney, New South Wales, 2010
Prince of Wales Hospital
Sydney, New South Wales, 2031
Royal Prince Alfred Hospital
Sydney, New South Wales, 2052
Royal North Shore Hospital
Sydney, New South Wales, 2065
The Children's Hospital at Westmead
Sydney, New South Wales, 2145
NSW Organ and Tissue Donation Service
Sydney, New South Wales, 2217
St George Hospital
Sydney, New South Wales, 2217
The Tweed Hospital
Tweed Heads, New South Wales, 2485
About this study
Official title: Communication With Families Regarding Organ and Tissue Donation After Death in Intensive Care Study
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.
- Conditions
- Tissue and Organ Procurement
- Being tested
- Communication intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Communication intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 hours subsequent to raising deceased donation with next of kin.
Secondary outcomes (1)
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.
Measured: 90 days post enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study start1 May 2013
- Primary completion8 Jul 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tissue and Organ ProcurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- NSW Organ and Tissue Donation Service
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Robert Herkes, Principal investigator, NSW Organ and Tissue Donation Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922310
- Sponsor's protocol ID
- DR-01-2012
- Other IDs
- ACTRN12613000815763
- Acronym
- COMFORT
- Status last verified
- Oct 2017
- First submitted
- 10 Aug 2013
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30482134Potter 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.
PubMed 28095838
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication With Families Regarding Organ and Tissue Donation After Death in Intensive Care Study
- ClinicalTrials.gov ID
- NCT01922310
- Acronym / sponsor ID
- COMFORT / DR-01-2012
- Conditions
- Tissue and Organ Procurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- NSW Organ and Tissue Donation ServiceOther government
- Study start
- 1 May 2013 (actual)
- Primary completion
- 8 Jul 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 14 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Communication intervention | Other | Behavioral: Communication interventionThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication interventionThe 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. | Behavioural | Communication intervention |
Primary outcome
Proportion of families providing consent for deceased organ donation.
Time frame: 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.
1 secondary outcome
Proportion of senior next of kin who report they regretted their final decision either to consent or to decline donation.
Time frame: 90 days post enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Derived from this study: PubMed 30482134Potter 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.
- Derived from this study: PubMed 28095838Potter 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.
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Kidney Failure, Chronic, Kidney Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Herkes principal investigator
NSW Organ and Tissue Donation Service
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication intervention in people with Tissue and Organ Procurement, run by NSW Organ and Tissue Donation Service at 10 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of families providing consent for deceased organ donation. (time frame: Up to 72 hours subsequent to raising deceased donation with next of kin.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01922310, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.