Ietje Perfors

113 Intervention: the Time Out Consultation In addition to usual care, patients in the intervention group were asked to schedule a TOC with their GP immediately after randomisation to prepare for the final treatment decision. The TOC was a 20-minute consultation with the GP. The aim of the TOC was to improve the SDM process and improve continuity of primary care. For the TOC, the GP was instructed to give psychosocial guidance, including discussing impact of diagnosis and consequences. Furthermore, the GP was instructed to check patient’s understanding of information, create awareness that a choice of treatment exists and stimulate the use of the ‘three questions’ model during the specialist consultation on the final treatment decision. The three questions model is used to support patient involvement and information exchange when discussing therapeutic options. 20 The three questions are: What are my options? What are the possible benefits and harms of those options? How likely are the benefits and harms of each option to occur for me? 20 The GPs of patients who were randomised to the intervention group were notified by phone by the researcher after the patient consented to participate. During this telephone contact, the researcher provided the necessary instructions to perform a TOC. In addition, information on the steps GPs were expected to take was provided by email and through a website. Outcomes To report the primary outcome (perceived level of SDM) and secondary outcomes (received information and perceived self-efficacy) patients filled in three validated questionnaires two weeks after inclusion (T1) online or, if preferred, on paper. Only perceived self-efficacy was measured at both baseline (T0) and T1. Non-responders were sent two automatic reminders by email after two and five days, and were contacted by phone by the researcher if non-response maintained. Primary outcome The perceived level of SDMwas measured using the Shared Decision-Making Questionnaire (SDM-Q-9), which contains nine items with a six-point Likert 5

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