Communication Regarding Organ and Tissue Donation in Intensive Care (COMFORT)

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.

Study Overview

• Status: Completed
• Conditions: Tissue and Organ Procurement
• Intervention / Treatment: Behavioral: Communication intervention

• Study Type: Interventional
• Enrollment (Actual): 417
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • New Lambton Heights, New South Wales, Australia, 2305
      • John Hunter Hospital
    • Sydney, New South Wales, Australia, 2145
      • The Children's Hospital at Westmead
    • Sydney, New South Wales, Australia, 2065
      • Royal North Shore Hospital
    • Sydney, New South Wales, Australia, 2010
      • St Vincent's Hospital
    • Sydney, New South Wales, Australia, 2031
      • Prince of Wales Hospital
    • Sydney, New South Wales, Australia, 2217
      • St George Hospital
    • Sydney, New South Wales, Australia, 1871
      • Liverpool Hospital
    • Sydney, New South Wales, Australia, 2052
      • Royal Prince Alfred Hospital
    • Sydney, New South Wales, Australia, 2217
      • NSW Organ and Tissue Donation Service
    • Tweed Heads, New South Wales, Australia, 2485
      • The Tweed Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: NSW Organ and Tissue Donation Service
• Investigators: Principal Investigator: Robert Herkes, NSW Organ and Tissue Donation Service

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): July 8, 2016
• Study Completion (Actual): December 21, 2016

Study Registration Dates

• First Submitted: August 10, 2013
• First Submitted That Met QC Criteria: August 12, 2013
• First Posted (Estimate): August 14, 2013

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: DR-01-2012; ACTRN12613000815763 (Registry Identifier: Australian New Zealand Clinical Trials Registry (ANZCTR))