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

BackgroundThere 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/designThis 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.DiscussionPromoting 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 registrationClinicalTrials.gov, ID: NCT03213171. Registered on 11 July 2017.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2333-5) contains supplementary material, which is available to authorized users.

Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration

“…Second, internet-enabled tablets will be provided in each waiting room to give patients the immediate opportunity to register for organ donation online via a secure provincial website. The location of the materials will be tailored according to the family physician office’s preferences.” 46 …”

“…Given some uncertainty around parameter estimates required for the stepped wedge sample size calculation, sensitivity of our detectable effect size to a range of alternative assumptions is presented in Table (not shown) . The results show that across a range of control arm proportions (from 0.4 to 0.5), average cluster sizes (from 100 to 400), and cluster autocorrelation coefficients (from 0.8 to 0.95), our sample size of 6 practices will achieve 80% power to detect absolute increases between 5% and 11%.” 46 …”

“…We will then arrange an in-person meeting with family physicians from interested sites to introduce our study and obtain written agreement from family physicians and offices agreeing to participate that meet our eligibility criteria. A statistician blinded to cluster identity and not involved in the intervention delivery will generate the allocation sequence using computer-generated random numbers.” 46 …”

Developing Behavior Change Interventions for Self-Management in Chronic Illness

“…For example, in a school-based intervention to prevent obesity, performance objectives (e.g., Communicate healthy behavior messages to parents and seek their support) are mapped against personal (e.g., self-efficacy) and external, environmental predictors (e.g., family support), and thus created actionable change objectives (e.g., confidence to seek parental support and social reinforcement from parents/family for interest in healthy lifestyles. These change objectives become the target of intervention techniques (Lloyd, Logan, Greaves, & Wyatt, 2011).…”

Introducing the new CONSORT extension for stepped-wedge cluster randomised trials

“…The study diagram in Fig. 1 corresponds to that used in the RegisterNow-1 trial: a SW-CRT of a theory-based intervention to promote registration for organ and tissue donation in family physician waiting rooms in Ontario, Canada [10]. The intervention consisted of trained reception staff checking patients’ health cards for donor status and providing unregistered patients with a pamphlet that addresses barriers and facilitators to registration, in addition to Internet-enabled tablets to facilitate registration on the spot.…”