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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01922310




Registration number
NCT01922310
Ethics application status
Date submitted
10/08/2013
Date registered
14/08/2013
Date last updated
5/10/2017

Titles & IDs
Public title
Communication Regarding Organ and Tissue Donation in Intensive Care
Scientific title
Communication With Families Regarding Organ and Tissue Donation After Death in Intensive Care Study
Secondary ID [1] 0 0
ACTRN12613000815763
Secondary ID [2] 0 0
DR-01-2012
Universal Trial Number (UTN)
Trial acronym
COMFORT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tissue and Organ Procurement 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Communication intervention

Other: 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.


BEHAVIORAL: Communication intervention
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of families providing consent for deceased organ donation.
Timepoint [1] 0 0
Up to 72 hours subsequent to raising deceased donation with next of kin.
Secondary outcome [1] 0 0
Proportion of senior next of kin who report they regretted their final decision either to consent or to decline donation.
Timepoint [1] 0 0
90 days post enrollment.

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/12/2016
Sample size
Target
Accrual to date
Final
417
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [3] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [4] 0 0
Prince of Wales Hospital - Sydney
Recruitment hospital [5] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [6] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [7] 0 0
The Children's Hospital at Westmead - Sydney
Recruitment hospital [8] 0 0
NSW Organ and Tissue Donation Service - Sydney
Recruitment hospital [9] 0 0
St George Hospital - Sydney
Recruitment hospital [10] 0 0
The Tweed Hospital - Tweed Heads
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
1871 - Sydney
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2031 - Sydney
Recruitment postcode(s) [5] 0 0
2052 - Sydney
Recruitment postcode(s) [6] 0 0
2065 - Sydney
Recruitment postcode(s) [7] 0 0
2145 - Sydney
Recruitment postcode(s) [8] 0 0
2217 - Sydney
Recruitment postcode(s) [9] 0 0
2485 - Tweed Heads

Funding & Sponsors
Primary sponsor type
Government body
Name
NSW Organ and Tissue Donation Service
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01922310
Trial related presentations / 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Robert Herkes
Address 0 0
NSW Organ and Tissue Donation Service
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01922310