Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry

Abstract

Background: There is a worldwide shortage of organs available for transplant, leading to preventable mortality associated with end-stage organ disease. While most citizens in many countries with an intent-to-donate "opt-in" system support organ donation, registration rates remain low. In Canada, most Canadians support organ donation but less than 25% in most provinces have registered their desire to donate their organs when they die. The family physician office is a promising yet underused setting in which to promote organ donor registration and address known barriers and enablers to registering for deceased organ and tissue donation. We developed a protocol to evaluate an intervention to promote registration for organ and tissue donation in family physician waiting rooms.

Methods/design: This protocol describes a planned, stepped-wedge, cluster randomized registry trial in six family physician offices in Ontario, Canada to evaluate the effectiveness of reception staff providing patients with a pamphlet that addresses barriers and enablers to registration including a description of how to register for organ donation. An Internet-enabled tablet will also be provided in waiting rooms so that interested patients can register while waiting for their appointments. Family physicians and reception staff will be provided with training and/or materials to support any conversations about organ donation with their patients. Following a 2-week control period, the six offices will cross sequentially into the intervention arm in randomized sequence at 2-week intervals until all offices deliver the intervention. The primary outcome will be the proportion of patients visiting the office who are registered organ donors 7 days following their office visit. We will evaluate this outcome using routinely collected registry data from provincial administrative databases. A post-trial qualitative evaluation process will assess the experiences of reception staff and family physicians with the intervention and the stepped-wedge trial design.

Discussion: Promoting registration for organ donation in family physician offices is a potentially useful strategy for increasing registration for organ donation. Increased registration may ultimately help to increase the number of organs available for transplant. The results of this trial will provide important preliminary data on the effectiveness of using family physician offices to promote registration for organ donation.

Trial registration: ClinicalTrials.gov, ID: NCT03213171 . Registered on 11 July 2017.

Keywords: Behavior change; Cluster randomized trial; Organ and tissue donation; Organ and tissue donor registration; Protocol; Stepped-wedge trial.

Conflict of interest statement

Ethics approval and consent to participate

We received ethics approval from Western University Health Sciences Research Ethics Board to conduct the intervention. We obtained a waiver of consent for data collection of patients because we are not obtaining any identifiable private information from them. We obtained a waiver of consent for study intervention because it was deemed that our intervention posed minimal to no risk to patients. Family physicians will serve as gatekeepers who provide permission for their clinic to be enrolled in our study. We will also obtain written consent to obtain and link their information to routinely collected data held at the Institute for Clinical Evaluative Sciences to identify patients who visit their clinic during the course of the study for evaluating our intervention. More information about our ethics process can be found in the “Ethics” section.

Consent for publication

Not applicable for the study protocol.

Competing interests

Jeremy Grimshaw is the Editor-in-Chief of the Trials journal. The authors declare that they have no other competing interests.

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Figures

Fig. 1

Stepped-wedge design

Fig. 2

Trial schedule of enrollment, intervention and assessment (as recommended by SPIRIT; Figure displaying schedule of enrollment and interventions)