Chapter 2 28 patients’ and physicians’ satisfaction during the subsequent consultation at the outpatient clinic. 2. Methods 2.1 Design overview In this study, a randomized, parallel-group study was combined with a prepost intervention design. Participating patients were randomized in a 1:1 ratio. Randomization sequence was created using Castor EDC (electronic data capture) software and was stratified by gender in a 1:1 ratio using random block sizes of 4, 6, and 8. Participating physicians were trained halfway through the study period. This resulted in 4 groups (physicians before training and patients without conversation aid (=reference group), physicians before training and patients with conversation aid, physicians after training and patients without conversation aid, physicians after training and patients with conversation aid (=intervention group) (Figure 1). The required sample size was expected to be reached after 6-9 months, based on average number of outpatient clinic consultations per physician. 42% of eligible patient population could not be reached by phone on multiple occasions and therefore could not be approached. Furthermore, a third of the approached patients refused to participate. Due to the lower-than-expected recruitment rate and the inability to further postpone physicians’ training for logistical reasons, physicians’ training took place 7 months after the first inclusion, before half of the intended sample size was reached. The study was terminated early after 16 months because inclusion was slowing down since an increasing part of the eligible population was already approached. At this moment 80% of the attempted sample size was reached. Besides, due to the low number of actual decisions on care decisions, one of our secondary outcomes (decisional conflict) could not be properly statistically assessed. Instead, we show number of care decision discussions and decisions made. No other changes have been made to the study protocol. This study was performed in line with the principles of the Declaration of Helsinki and approved by the Medical Research Ethics Committee Utrecht (MREC 18-465) and prospectively registered 04/05/2018 at the Dutch trial register (http://www.trialregister.nl, NTR 7188).
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