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Promoting Organ Donor Registration in Family Physician Offices

Promoting Organ and Tissue Donation Registration in Family Physician Offices: a Pragmatic Stepped-wedge Cluster Randomized Controlled Registry Trial (RegisterNow Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03213171
Enrollment
6
Registered
2017-07-11
Start date
2017-09-27
Completion date
2019-04-01
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organ Donation, Registration for Deceased Organ Donation

Keywords

organ donation, family physician, primary care, clinical trial, registry trial, cluster trial, stepped-wedge

Brief summary

This study evaluates the effects of using reception staff to prompt patients by providing a pamphlet and an opportunity to register in the waiting room via a mobile tablet on deceased organ donor registration rates.

Detailed description

Background: There is a worldwide shortage of organs available for transplant, leading to preventable morbidity and mortality. While the majority of the general public in many countries support organ donation, actual donor registration rates are substantially out of step with these views. For instance, in Canada most Canadians support organ donation but less than 25% in most provinces have registered. The family physician office is a promising yet underused setting in which to address known barriers and facilitators to registration for deceased organ and tissue donation and to provide an immediate opportunity to register while in the waiting room for those wanting to do so. Methods/Design: The investigators aim to evaluate the effects of having reception staff in family physician offices to prompt patients upon check-in with an educational pamphlet using a cluster, stepped-wedge randomized design. A mobile tablet will also be added to the waiting area to provide patients with the immediate opportunity to register. Family physicians are also provided with an educational booklet and encouraged to discuss organ donation with their patients. The investigators will use behaviour change techniques designed to address previously anticipated barriers and enablers to organ and tissue donation registration. The investigators will evaluate the effectiveness of the intervention conducted in six family physician offices in Ontario, Canada. Following a two-week baseline control period, offices will cross sequentially into the intervention arm in a random sequence at two-week intervals until all offices deliver the intervention (baseline + two weeks for each of six offices). The primary outcome will be the proportion of patients that have registered for deceased organ donation following in the 7 days following their office visit, using routinely collected registry data (i.e. administrative databases). The investigators will also conduct a qualitative post-trial process evaluation will assess reception staff and family physicians experiences with the intervention. Discussion: Promoting organ and donor registration remains an important strategy for organ procurement organizations and patients worldwide. The results of this trial will inform a provincial roll-out strategy to promote organ donation in family physician offices.

Interventions

BEHAVIORALReception staff providing handout.

Reception staff will provide an educational pamphlet to patients that have not yet registered for organ donation

BEHAVIORALMobile Tablet (e.g. iPad)

Patients will have the opportunity to immediately register for organ donation using an a mobile tablet (e.g. IPad)

Sponsors

Ottawa Hospital Research Institute
CollaboratorOTHER
Institute for Clinical Evaluative Sciences
CollaboratorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Stepped-wedge cluster randomized trial

Eligibility

Sex/Gender
ALL
Age
16 Years to 105 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion/

Exclusion criteria

for Patients Inclusion Criteria: * Patients that visited a family physician * Patients that are at least 16 years of age with a valid health card (eligibility criteria to register for organ donation in Ontario) Inclusion/

Design outcomes

Primary

MeasureTime frameDescription
Donor registration status at 7 days7 daysDonor registration status (Yes/ Not registered)

Secondary

MeasureTime frameDescription
Donor registration status at 14 days14 daysDonor registration status (Yes/ Not registered)
Donor registration status at 30 days30 daysDonor registration status (Yes/ Not registered)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026