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

BMC Medicine. 2022;20(1):75
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Abstract

BACKGROUND The shortage of available organs for life-saving transplants persists worldwide. While a majority support donating their organs or tissue when they die, many have not registered their wish to do so. When registered, next of kin are much more likely to follow-through with the decision to donate. In many countries, most people visit their family physician office each year and this setting is a promising, yet underused, site where more people could register for deceased organ donation. Our primary aim was to evaluate the effectiveness of an intervention to promote organ donation registration in family physician's offices. METHODS We developed an intervention to address barriers and enablers to organ donation registration that involved physician office reception staff inviting patients to register on a tablet in the waiting room while they waited for their appointment. We conducted a cross-sectional stepped-wedge cluster randomized controlled registry trial to evaluate the intervention. We recruited six family physician offices in Canada. All offices began with usual care and then every two weeks, one office (randomly assigned) started the intervention until all offices delivered the intervention. The primary outcome was registration for deceased organ donation in the provincial organ registration registry, assessed within the 7 days of the physician visit. At the end of the trial, we also conducted interviews with clinic staff to assess any barriers and enablers to delivering the intervention. RESULTS The trial involved 24,616 patient visits by 13,562 unique patients: 12,484 visits in the intervention period and 12,132 in the control period. There was no statistically significant difference in the percentage of patients registered for deceased organ donation in the intervention versus control period (48.0% vs 46.2%; absolute difference after accounting for the secular trend: 0.12%; 95% CI: - 2.30, 2.54; p=0.92). Interviews with clinic staff indicated location of the tablet within a waiting room, patient rapport, existing registration, confidence and motivation to deliver the intervention and competing priorities as barriers and enablers to delivery. CONCLUSIONS Our intervention did not increase donor registration. Nonetheless, family physician offices may still remain a promising setting to develop and evaluate better interventions to increase organ donation registration. Trial registration: Nct03213171.

CET Conclusion

Reviewer: Dr Liset Pengel, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford
This is a cross-sectional stepped-wedge cluster randomized controlled registry trial to evaluate an intervention that addresses barriers and enablers to organ donation registration versus no intervention in family physician waiting rooms. All family physician offices began with usual care and then every two weeks, one office (randomly assigned based on computer-generated random numbers) started the intervention until all offices were exposed to the intervention. The intervention was delivered at practice level and members of the public were involved in the design and conduct of the trial. A sample size calculation was based on detecting a 10% absolute increase in donor registrations. During the intervention period there were n=12,484 patient visits to a physician and n=12,132 patient visits during the control period. The percentage of patients that registered for organ or tissue donation was similar between the groups (46% in the control period versus 48% in the intervention period). Staff interviews revealed five themes regarding barriers and enablers to deliver the intervention, which can help to improve the intervention further.

Methodological quality

Jadad score : 3
Allocation concealment : YES
Data analysis : INTENTION TO TREAT

Study details

Aims : This study aimed to investigate whether the RegisterNow-1 intervention was effective in promoting organ donation registration in family physician offices.
Interventions : All participating family physician offices began with usual care, then after every two weeks, one office (which was randomly assigned) started the intervention until all offices delivered the intervention.
Participants : 6 family physician offices in Canada.
Outcomes : The primary endpoint was the percentage of patients registered for organ/tissue donation within 7 days of visit. The secondary endpoints were registration within 1 day, 14 days and 30 days of physician visit.
Follow up : 30 days

Metadata

Funding : Non-industry funding
Publication type : Randomised Controlled Trial
Trial registration : ClinicalTrials.gov - NCT03213171
Language : English
Author email : ali66@uwo.ca