Transplant Trial Watch

A web-based education program to encourage organ donation registration among lower-educated adolescents in the Netherlands: study protocol for a cluster randomized controlled trial.

Steenaart E, Crutzen R, et al.

Trials, 2018; 19(1): 532.


Aims
To assess the effectiveness and quality of a web-based educational program aimed at encouraging lower-educated adolescents to register a well-informed choice about organ donation, regardless of it being as a donor or not.

Interventions
A cluster randomized controlled trial of a web-based educational program will be provided by the teachers during regular classes in Intermediate Vocational Education schools in the Netherlands. Classes will be matched to improve equivalence of groups and randomly assigned. The effectiveness will be assessed post-test using self-administered questionnaires for the primary outcome (i.e. intention to register). Students in the control groups will fill in the questionnaire before receiving the educational program, while the experimental groups will do this afterwards. A post-test design prevents the risk of testing bias.

Participants
The required sample size is 14 schools, with 10 classes per school and 13 unregistered students per class.

Outcomes
The self-administered questionnaire assesses demographics, behavioural determinants (attitude, self-efficacy, knowledge and social outcomes), intention to register as a donor and registration status. Registration status will be assessed again six months after delivery. A process evaluation will also be conducted to evaluate the quality of implementation using both qualitative and quantitative methods.

Follow-up
6 months

CET Conclusions
This study protocol aims to increase engagement with the organ donation register amongst lower-educated adolescents in the Netherlands, regardless of whether they register as a donor or not. The study will match classes and one will be randomised to the experimental group and one to the control group (cluster randomised controlled trial CRCT). This is a large and ambitious study, targeting 14 schools with 10 classes and 13 children per class; to give over 83% power. The intervention involves video fragments, group discussions, online work and quizzes.

Trial registration
Dutch Trial Register - NTR6771

Funding source
Non-industry funded