Donation Advisor Clinical Decision Support Tool Study

NCT ID: NCT04661787

Last Updated: 2022-11-28

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

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-11

Study Completion Date

2023-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Organ Donation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gift of Life

OTHER

Sponsor Role collaborator

Canadian Blood Services

OTHER

Sponsor Role collaborator

Health Canada

OTHER_GOV

Sponsor Role collaborator

Canadian National Transplant Research Program

OTHER

Sponsor Role collaborator

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role collaborator

The Ottawa Hospital

OTHER

Sponsor Role collaborator

Unity Health Toronto

OTHER

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role collaborator

London Health Sciences Centre

OTHER

Sponsor Role collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sonny Dhanani, MD

Role: PRINCIPAL_INVESTIGATOR

CHEO-RI

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Andrew Seely, MD, PhD

Role: CONTACT

613-737-8899 ext. 74052

Jill Allan, RN, BN

Role: CONTACT

613-612-6117

Facility Contacts

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Andrew Seely, MD

Role: primary

613-737-8899 ext. 74892

Other Identifiers

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1920-HQ-000104

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PSI Grant Number 19-33

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CRRF 2169

Identifier Type: OTHER

Identifier Source: secondary_id

CTO Project ID 2117

Identifier Type: OTHER

Identifier Source: secondary_id

20200360-01T

Identifier Type: -

Identifier Source: org_study_id

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