The aim of this multicenter, randomised controlled trial is to establish whether the active participation of a clinical pharmacy team on the surgical ward reduces preventable adverse drug events (ADEs) cost-effectively for the Dutch setting. Also, this study will clarify whether the cost-effectiveness of a ward-based pharmacy team including skilled but less costly pharmacy technicians in reducing the number of preventable ADEs in Dutch hospitals.In the experimental group, all critical steps in the medication process during the surgical pathway are covered by the ward-based pharmacy team, including changes in medication at admission, in the perioperative hospital phase (changes of medication to and from the operating room, recovery room or ICU), and at discharge. The impact of the ward-based pharmacy team will be established by comparing the incidence and severity of preventable ADEs in the patients of the control units to those in the patients of the experimental units. Also, the cost-effectiveness of the intervention is calculated (costs of care relative to preventable ADEs).
Summary Objective: The Dutch Inspectorate for Health Care states that hundreds of people die each year as a result of preventable adverse drug events (ADEs that are caused by medication errors). International studies have shown that hospital pharmacists effectively reduce preventable ADEs when they actively participate on the ward. The applicability of these findings to the Dutch setting is unknown as our health care system is differently organized and hospital pharmacists are scarce and more costly. The aim of the proposed study is to establish whether the active participation of a clinical pharmacy team on thesurgical ward reduces preventable ADEs cost-effectively.Design: Three hospitals will participate. First, baseline assessments will be made in each hospital at two comparable surgical wards. Then, in each centre, one unit will randomly be assigned (one-time randomisation) as experimental unit (ward-based pharmacy), whereas the other unit will serve as control unit (usual pharmacy care). Population: Consecutive patients admitted to a surgical ward for elective surgery (sentinel procedure) with an expected length of stay of more than 2 days.Intervention: The ward-based pharmacy team assesses a complete medication history at admission and daily optimizes the patient medication during hospital stay. Patients admitted to control units receive standard care.Outcome measures: The number of preventable ADEs per 100 admissions in experimental unit patients will be compared to that of control unit patients, corrected for differences at baseline. A blinded expert team assesses the presence and severity of a preventable ADE.Power/data analysis: An inclusion of 1444 eligible patients (baseline assessment n=480, experimental units 482 and control units 482 (n=964) allows us to detect a 60% reduction in preventable ADEs (from 5 to 2 or lower preventable ADEs per 100 admissions, power 0.80, 0.05, one-sided), corrected for possible baseline differences.Economic evaluation: A cost-effectiveness analysis will be performed from a societal perspective with the number of preventable ADEs per 100 admissions as the primary outcome measure. In a sensitivity analysis the impact of weighing by severity of ADEs will be assessed.Time schedule: Run-in baseline study: 4 months, baseline assessment 8 months, analysis baseline period and run-in pre-intervention: 2 months, study period of 18 months. Final data analysis: 4 months. |
