210 CHAPTER 3.1 unrelated to STRIPA, these changes are entered manually. In cases where SDM is deferred to the GP, instructions for the GP are written by either the research physician or research pharmacist in the section of the GP report entitled “recommendations not yet applied during hospitalization”. The GP report should then be identical to the patient’s discharge prescription, and is mailed to the GP after the patient is discharged from hospital. Control arm and SHAM intervention Patients in the control group receive usual care, with the potential of a medication review by the prescribing physician in accordance with usual pharmaceutical care. Patients from both groups complete the 8-item Moriskey Medication Adherence Scale questionnaire (MMAS-8) [44] with a trained member of the intervention team. This is to prevent potential unblinding in the event of unblinded team members approaching patients when attending patients’ wards. Device deficiency Due to a software tool being used in this trial, there is the potential for a so-called device deficiency, defined by the European Medical Device Vigilance System (MEDDEV) 2.7/3 [45] as an “Inadequacy of a medical device related to its identity, quality, durability, reliability, safety or performance. This may include malfunctions, use error, or inadequacy in the information supplied by the manufacture.” All technical problems with the STRIPA system are reported, using the designated STRIPA feedback form, within 24h to the software developers, who then assess whether the problem in question is a possible device deficiency. They will then report back within 72h to the clinical site in question with details of the investigation of the issue and determine any actions to be taken. If corrective actions are required at all sites, all co-Principal Investigators (PIs) including the co-ordinating PI are informed within another 48h. Safety section The STRIPA software provides general recommendations and is not intended to impose firm decisions. It does not replace decision-making and clinical judgements made by physicians and pharmacists and this is explicitly stated in the disclaimer on the printed reports. It is expected that prescription recommendations made by the STRIPA system that turn out to be inappropriate for an individual patient are detected by a pharmacist or physician conducting the intervention and addressed appropriately to safeguard patients’ welfare. The prescribing physicians remain responsible for all final medical decisions concerning their patients.
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