Communication Regarding Organ and Tissue Donation in Intensive Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2016-12-21

Brief Summary

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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.

Detailed Description

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Conditions

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Tissue and Organ Procurement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Study Groups

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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.

Group Type OTHER

Communication intervention

Intervention Type 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.

Interventions

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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 Type BEHAVIORAL

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Herkes

Role: PRINCIPAL_INVESTIGATOR

NSW Organ and Tissue Donation Service

Locations

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