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Completed

NCT Number: NCT01922310

Communication Regarding Organ and Tissue Donation in Intensive Care

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.

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Key information

Conditions

Tissue and Organ Procurement

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

John Hunter Hospital, New Lambton Heights, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    This outcome will be assesed using a telephone follow-up call.

Other outcomes

  1. Health professionals' adherence rates to core elements of the intervention.

    Time frame: Up to 72 hours subsequent to next of kin making their final donation decision.

    This will be measured by observation and self-report at the hospital.

Sponsors and collaborators

Lead sponsor

NSW Organ and Tissue Donation Service

Other Gov

Registry information

Official study title

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

Acronym: COMFORT

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2013
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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