15250-m-cuypers

174 Chapter 9 distributed or monitoring of actual usage. For example, leaflet DAs could be distributed in waiting room areas, and in such circumstances it is unknown who takes them. For an online DA that is publicly available, it is often unknown which visitors are actually patients facing a treatment decision at that particular moment. Moreover, if a DA is used in multiple hospitals, and detailed information on actual uptake and usage is lacking, less can be learned from local best practices. A novel web-based Dutch Pca treatment DA, which was investigated in a cluster randomized controlled trial, allowed for structural monitoring of DA uptake and usage in a quantifiable patient population 16 . Therefore, this study aimed to improve understanding of the implementation results by comparing the DA uptake across hospitals and the actual usage of the DA and its elements (e.g. VCEs) by patients. METHODS Study sites Eighteen Dutch hospitals agreed to participate in the trial, and after randomization, the DA was implemented in nine Dutch hospitals. The other nine hospitals formed the control arm and delivered care as usual 17 . One academic medical center participated in the trial, which was randomized into the control arm. All other hospitals were teaching hospitals. Two hospitals that were involved in DA development (before randomization) were randomized by pure chance into the intervention arm. Randomization was performed by an independent statistician, blind to hospital names 17 . The hospitals involved offered either one (AS) or two treatments (AS and surgery or radiotherapy) at their own location. Referral to another hospital for specific treatments is common in The Netherlands. Implementation started in August 2014 and data collection ended in January 2016. The need for ethical approval was waived by the regional medical ethics committee (reference: NW2014-03). Implementation/delivery method All urology departments of the hospitals enrolled in the trial’s DA group were visited by the researchers and received an explanation of the purpose of the RCT. The DA was presented to the medical staff and the proposed method of delivery was explained. The explanation included that the DA would be introduced to patients in addition to the presentation of standard information. Depending on local work routines, the DA would usually be introduced by the urologist at diagnosis or by an oncology nurse during consultation following diagnosis. Next to the DA, patients received all information and materials (e.g. hospital brochures) that would also have been provided otherwise.