Donation Advisor Clinical Decision Support Tool Study

Ottawa Hospital Research Institute70 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Organ Donation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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

Systemic Ischemia

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

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.

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

Donation Advisor (DA) Tool Report

Time to create the DA 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

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.

Time frame: 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.

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

Secondary Outcomes

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

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