Govert Veldhuijzen

66 Chapter 4 points and step-by-step instructs the patient how to perform bowel preparation. In our pilot study we showed that CAI for colonoscopy enhanced bowel preparation to the level that is comparable to nurse counselling. The research group sought to enhance the efficacy of the developed CAI. Its limitation was that it was a unidirectional tool that delivered information but did not allow acquiring patient specific information concerning medical history and medication use. This is an important part of the nurse counselling visit, as it allows a pre-sedation risk assessment when judged by the nurse. Therefore, a dedicated questionnaire was developed, designed to collect data points for structured risk assessment. This questionnaire is completed by the patient at the end of the CAI. This eliminates the need for a face-to-face meeting with a nurse or physician at this point in time. The use of two-way communication (combining CAI with a questionnaire) is practical and provides high quality information to the patient whilst at the same time attending to the need of the endoscopist for information on sedation risks. This combined instruction and acquiring of information is known as computer based education (CBE). 7 The goal of this trial is to test the utility, practicality, and patient-perceived usefulness of CBE off-center, in comparison to conventional nurse counselling. The hypothesis is that CBE is non-inferior to nurse counselling in achieving high quality of bowel preparation during colonoscopy. This process is independent of time and space and therefore can be viewed in the comfort of the patients’ home. Accordingly, the chosen secondary outcomes are patient related outcome measures such as a short leave absence, anxiety, satisfaction and comprehension of information, as these might benefit from delivery through this digital channel. Included process measures are patient activation, health and eHealth literacy to determine which patients benefit most from this tool. STUDY DESIGN The trial is set up as an endoscopist blinded multicenter randomized controlled trial design. Inclusion criteria are adult age and a referral for elective complete colonoscopy. Exclusion criteria are illiteracy in Dutch and significant audio-visual handicaps and mental disabilities that preclude delivery of CBE. Also, patients were excluded if there is no internet access or a relative with internet access. (Table 1.) Patients will be recruited by back office staff at the outpatient’s clinic in 4 large volume endoscopy centers in the Netherlands. All patients receive a split dose laxative regime based on either polyethylene glycol or sodium picosulfate. After evaluation of in- and exclusion criteria by trained staff, patients are randomized in 1:1 distribution per trial site using a randomization tool (described in the protocol below). Reasons for declining to participate are recorded. The trial flowchart is presented in figure 1.