Govert Veldhuijzen

69 E-PACO trial: CBE versus nurse counselling for patients to prepare for colonoscopy patient ability to understand medical information. The 14-item Dutch validated Health Literacy Scale is used to assess this item, divided in 3 subscales, at T0. 14 A new 21-item questionnaire is added as a measure for eHealth Literacy. 15 This contains questions regarding the skill and experience of patients in handling medical information online. Patients are confronted with options every day that may have major implications for their health. Effectively managing their choices requires knowledge, skill, and confidence. To this end these elements were mapped at T0 13-item Patient Activation Measure Scale (PAM-13). 16 The current health status of patients is evaluated with the Medical Outcomes Study 36-item health survey (RAND-36) at T0. 17 STATISTICAL ANALYSIS To statistically compare both groups on the primary outcome, the relative risk for an inadequately prepared colon, defined as a BBPS <6, is used. In literature, a 90% success rate (for an adequately prepared colon) is common, with a 10% non-inferiority margin as the maximum clinically acceptable difference. The non-inferiority power calculation resulted in 180 patients per group, 360 patients in total. This is required to exclude a difference in favour of the standard group of more than 10%. With a margin of ± 60% loss of patients before completing the protocol, based on earlier research, the target number of patients to approach is set at 1,000. In addition to the non-inferiority analyses, superiority analyses will be conducted to investigate effects on secondary outcome measures. PROTOCOL The study is authorized by the ethics review board of the Radboud University Medical Center (#2015-1742). Subsequent approval of the executive boards from each of the participating institutes is obtained (Trial registration: Dutch Trial Registry, NTR 5475). 1. Enrolling patients in the trial/randomization 1.1. Approach all referred patients by general practitioners, surgeons or internal medicine specialists for colonoscopy, to achieve a diverse sample. 1.2. Contact all eligible patients for inclusion by the outpatient’s clinic assistant by telephone call or face-to-face contact with the patient in a protocol led manner (described below). 1.2.1. Say the following: Good morning/afternoon, you are speaking to the gastroenterology department of the trial center. You have been referred for colonoscopy, correct? We have to inform you prior to the examination. Do 4