The effect of a structured medication review on quality of life in Parkinson's disease: The study protocol

BACKGROUND: Treatment of Parkinson's disease (PD) is symptomatic and frequently consists of complicated medication regimes. This negatively influences therapy adherence, resulting in lower benefit of treatment, drug related problems and decreased quality of life (QoL). A potential effective intervention strategy is a structured medication review, executed by community pharmacists. However, little is known about the effects on clinical endpoints like QoL, as well as on feasibility and cost-effectiveness in PD patients. OBJECTIVES: To assess the effect of a structured medication review on QoL in PD patients. Secondary objectives are measurements of physical disability, activities in daily life, non-motor symptoms, health state, personal carers' QoL and cost-effectiveness. Furthermore, a better insight in the process of performing medication reviews will be obtained from the perspective of community pharmacists. METHODS: In this multicenter randomized controlled trial we aim to enroll 200 PD patients from the outpatient clinic of three Dutch hospitals. Community pharmacists will perform a structured medication review in half of the assigned patients; the other half will receive usual care. Data obtained by use of six validated questionnaires will be collected at baseline and after 3 and 6 months of follow-up. Semi-structured interviews with community pharmacists will be conducted till data saturation has been reached. DISCUSSION: This trial targets a high-risk patient group for whom optimizing therapy by a structured medication review might be of added value. If effectiveness is proven, this could further promote the implementation of pharmaceutical care in a primary care setting.