Promoting Organ Donor Registration in Family Physician Offices

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Organ Donation, Registration for Deceased Organ Donation

Intervention / Treatment
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* Behavioral: Reception staff providing handout.
* Behavioral: Mobile Tablet (e.g. iPad)


Participation Criteria
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Eligibility Criteria
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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/Exclusion Criteria for Family Physicians (Cluster level) Inclusion Criteria: - Working at a site that sees at least 100 patients per week Exclusion Criteria: - Working at multiple sites that cannot be separated in analyses

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped-wedge cluster randomized trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Usual care / Standard of care No intervention implemented | |
| Experimental: Intervention<br>Reception staff providing handout; Mobile tablet that provides the immediate opportunity for patients to register in the waiting room | Behavioral: Reception staff providing handout.<br>* Reception staff will provide an educational pamphlet to patients that have not yet registered for organ donation<br>Behavioral: Mobile Tablet (e.g. iPad)<br>* Patients will have the opportunity to immediately register for organ donation using an a mobile tablet (e.g. IPad)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor registration status at 7 days | Donor registration status (Yes/ Not registered) | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Donor registration status at 14 days | Donor registration status (Yes/ Not registered) | 14 days | 
| Donor registration status at 30 days | Donor registration status (Yes/ Not registered) | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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organ donation, family physician, primary care, clinical trial, registry trial, cluster trial, stepped-wedge