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Completed

NCT Number: NCT04661787

Donation Advisor Clinical Decision Support Tool Study

Every year, thousands of Canadians receive life-saving, cost-effective organ transplants, while thousands more still wait or die because not enough organs are available. Patients with non-recoverable illnesses, who are undergoing withdrawal of life sustaining measures, can donate their organs when they die by a process called donation after circulatory determined death (DCD). However, over 30% of all DCD attempts are unsuccessful because patients do not die within the time frame required for healthy organ retrieval and prolonged exposure to low oxygen during the dying process renders organs unsuitable for transplantation. Predicting successful DCD is difficult and leads to uncertainty in the clinical community. To address this issue, the investigators have developed a clinical decision support tool called Donation Advisor (DA) that will assist the healthcare team in identifying successful DCD donors and will provide an improved assessment of the health of their organs. The investigators are ready to implement DA and evaluate its impact in 7 hospitals in Ontario. The investigators believe use of DA will reduce unsuccessful DCD attempts, enhance family experience of donation, optimize system costs, and improve transplant outcomes

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Key information

Conditions

Organ Donation

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • for Organ Donation Patients: All patients eligible for DCD and whose substitute decision makers (SDMs) have been approached for consent by a Trillium Organ Tissue Donation Coordinator (OTDC).
  • for Organ Transplant Recipient Patients - All patients at any of the Transplant Centres participating in this study who are transplant recipients of the organs from enrolled donor patients.
  • for Health Care Professionals for Interviews to provide feedback on the Donation Advisor Tool - All physicians (donation and transplantation), bedside nurses and OTDCs who either have the potential to be involved in the care of study patients, or who been directly involved in the care of the study patients.

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Waveform collection from the bedside monitor

    Time frame: From date and time of enrollment until the date and time of declaration of death, assessed up to 6 hours post withdrawal of life sustaining measures

    Heart rate, systolic, mean and diastolic blood pressure and oxymetry will be downloaded from the bedside monitor. Automated algorithms will assess the quality of the waveform data, and detect the necessary fiducial markers (R peaks, systolic and diastolic peaks, and pulse pressure measurements), and perform cleaning of artifacts, missing data and noise, to form vital signs time series, which will be used to calculate variability metrics for the patient.

  2. Systemic Ischemia

    Time frame: From the date and time of withdrawal of life sustaining measures until the date and time of declaration of death, assessed up to 6 hours

    Duration of time when the systolic blood pressure and/or oxygen saturation fall below physiologic thresholds indicating organ ischemia

  3. Efficacy of DCD outcome prediction by the Donation Advisor (DA) Tool

    Time frame: From the date and time of withdrawal of life sustaining measures until the date and time of declaration of death, assessed up to 6 hours

    The predictive capacity of the models to accurately identify time between withdrawal of Life Sustaining Measures (WLSM) and death will be documented.

  4. Donation Advisor (DA) Tool Report

    Time frame: From the date and time the Research Coordinator initiates the report to the date and time the report displays, assessed up to 1 week

    Time to create the DA Report

  5. Enduser feedback on the Donation Advisor Tool Usability and Feasibility

    Time frame: Up to 1 week post declaration of death following withdrawal of life sustaining measures

    Data with be collected using 'Thinking aloud interviews' where Health Care Professional with review DA Reports. Data captured: misunderstandings, pauses, repetitions, and expressions of frustration or confusion. These "usability problems" will become target areas for improvements on subsequent versions of the tool. A series of direct questions will allow the interviewee to report on overall usability (clarity, ease of navigation) and usefulness of the tool. They will be asked about the feasibility and usefulness of using a tool like this in their clinical practice, as well as the amount of time one could reasonably expect a physician to spend with a tool like this in their clinical practice, to inform the final design goals for the tool. Finally, interviewees will be asked to report as many potential barriers to and drivers of use of the tool as they can.

  6. Success of Organ Transplantations

    Time frame: at 28 days from organ transplantation or hospital discharge if sooner than 28 days

    Including attempted DCD with no organs retrieved, The undergoing of DCD with at least one organ transplanted Number of organs donated per donor Failed organ transplants (i.e. proportion of organs discarded due to excessive warm ischemia time, or that fail after transplant) Proportion of recipients with early transplant graft dysfunction.

Secondary outcomes

  1. Resources and associated costs to further develop and expand implementation of the DA tool

    Time frame: through study completion, an average of 2 years

    Estimate of required resources and associated costs to further develop and expand implementation of the DA tool - The investigators will assess the economic feasibility of DA tool by calculating the cost of developing and implementing DA tool. A blended micro- and gross- costing approach will be used. The investigators will develop a data collection form to collect resource use for developing, operating, and maintaining the DA tool. Their unit costs will be obtained from program financial records, service level agreements, and the program budget with a close consultation with the project staff

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Canadian Blood Services
  • Canadian National Transplant Research Program
  • Gift of Life
  • Hamilton Health Sciences Corporation
  • Health Canada
  • Kingston Health Sciences Centre
  • London Health Sciences Centre
  • Sunnybrook Health Sciences Centre
  • The Ottawa Hospital
  • The Physicians' Services Incorporated Foundation
  • Unity Health Toronto
  • University Health Network, Toronto

Registry information

Official study title

Implementation of Donation Advisor, a Personalized Clinical Decision Support Tool for Improved Efficiency and Effectiveness of Deceased Organ Donation and Transplantation

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 10, 2020
Registry last updated
Sep 4, 2026

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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