Donation Advisor Clinical Decision Support Tool Study

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

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

Study Overview

• Status: Recruiting
• Conditions: Organ Donation

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Andrew Seely, MD, PhD; Phone Number: 74052 613-737-8899; Email: aseely@ohri.ca
• Study Contact Backup: Name: Jill Allan, RN, BN; Phone Number: 613-612-6117; Email: jallan@ohri.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • The Ottawa Hospital
      • Contact: Andrew Seely, MD; Phone Number: 74892 613-737-8899; Email: aseely@ohri.ca

Participation Criteria

Eligibility Criteria

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

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waveform collection from the bedside monitor	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.	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
Systemic Ischemia	Duration of time when the systolic blood pressure and/or oxygen saturation fall below physiologic thresholds indicating organ ischemia	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
Efficacy of DCD outcome prediction by the Donation Advisor (DA) Tool	The predictive capacity of the models to accurately identify time between withdrawal of Life Sustaining Measures (WLSM) and death will be documented.	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
Donation Advisor (DA) Tool Report	Time to create the DA Report	From the date and time the Research Coordinator initiates the report to the date and time the report displays, assessed up to 1 week
Enduser feedback on the Donation Advisor Tool Usability and Feasibility	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.	Up to 1 week post declaration of death following withdrawal of life sustaining measures
Success of Organ Transplantations	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.	at 28 days from organ transplantation or hospital discharge if sooner than 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resources and associated costs to further develop and expand implementation of the DA tool	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	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: University Health Network, Toronto; Sunnybrook Health Sciences Centre; Unity Health Toronto; The Ottawa Hospital; Hamilton Health Sciences Corporation; Queen's University; London Health Sciences Centre; The Physicians' Services Incorporated Foundation; Health Canada; Canadian Blood Services; Canadian National Transplant Research Program; Gift of Life
• Investigators: Principal Investigator: Sonny Dhanani, MD, CHEO-RI

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Organ Transplantation; Organ Donation; DCD; Organ Donation after Circulatory Determined Death (DCD); Clinical Decision Support Tool
• Other Study ID Numbers: 20200360-01T; 1920-HQ-000104 (Other Grant/Funding Number: Health Canada); PSI Grant Number 19-33 (Other Grant/Funding Number: Physicians' Services Incorporated Foundation); CRRF 2169 (Other Identifier: Ottawa Health Science Network Research Ethics Board); CTO Project ID 2117 (Other Identifier: Clinical Trials Ontario)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No