Clinical trial NCT04661787: Donation Advisor Clinical Decision Support Tool Study
Official title: Implementation of Donation Advisor, a Personalized Clinical Decision Support Tool for Improved Efficiency and Effectiveness of Deceased Organ Donation and Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Organ Donation
Keywords: Organ Donation after Circulatory Determined Death (DCD)
Clinical Decision Support Tool
Organ Donation
Organ Transplantation
DCD
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Gift of Life
name: Canadian Blood Services
name: Health Canada
name: Canadian National Transplant Research Program
name: The Physicians' Services Incorporated Foundation
name: The Ottawa Hospital
name: Unity Health Toronto
name: Queen's University
name: London Health Sciences Centre
name: Sunnybrook Health Sciences Centre
name: Hamilton Health Sciences Corporation
name: University Health Network, Toronto
First posted: 2020-12-10
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60-80 organ donation patients 180-240 transplant recipients (anticipated average of 3 per donor patient) 30-40 health care professionals to participate in interviews (reviewing the Donation Advisor Tool Reports)

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Waveform collection from the bedside monitor
timeFrame: 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
measure: Systemic Ischemia
timeFrame: 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
measure: Efficacy of DCD outcome prediction by the Donation Advisor (DA) Tool
timeFrame: 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
measure: Donation Advisor (DA) Tool Report
timeFrame: From the date and time the Research Coordinator initiates the report to the date and time the report displays, assessed up to 1 week
measure: Enduser feedback on the Donation Advisor Tool Usability and Feasibility
timeFrame: Up to 1 week post declaration of death following withdrawal of life sustaining measures
measure: Success of Organ Transplantations
timeFrame: at 28 days from organ transplantation or hospital discharge if sooner than 28 days
Secondary outcomes:
measure: Resources and associated costs to further develop and expand implementation of the DA tool
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: CHEO-RI
name: Sonny Dhanani, MD
role: PRINCIPAL_INVESTIGATOR
References: