Medication Review in patients with Polypharmacy in primary care: Effects of the Clinical Rules Engine and the Outcome Prioritisation Tool on Patient and Clinical Outcomes: CRE-OPT study

INTRODUCTION Polypharmacy – the use of five or more chronic medications - is widely recognized as a serious medical problem. The resulting complex medication regimes can seriously burden patients, decrease their treatment satisfaction and indirectly lower medication adherence and worsen treatment outcomes. For health professionals, patients with complex multimorbidity and polypharmacy are often difficult to manage, also due to conflicting disease specific guidelines. An integral medication review can support medical management and is imposed by the Dutch Health Care Inspectorate. Asking for patient preferences is the acknowledged imperative when dealing with patients with complex multimorbidity and polypharmacy, and this is also advised in the Dutch Multidisciplinary Guideline Polypharmacy. However, in practice performing medication reviews on a structural basis, incorporating patient preferences in no sinecure. OBJECTIVES In the proposed project we evaluate the potential benefits and feasibility of including (a) a decision support system, ‘Clinical Rules Engine’ (CRE) and (b) patient preferences, using the ‘Outcome Prioritization Tool’ (OPT) in a comprehensive integrated multidisciplinary medication review as compared to usual care. The joined intervention will be further indicated as CRE-OPT. This results in two research questions: 1. Does the application of CRE-OPT in patients with complex multimorbidity and polypharmacy result in: a. better treatment satisfaction with prescribed medication as compared to usual care? b. fewer or less serious medication alerts from CRE, different changes in medication prescriptions ,better medication adherence, lower drug burden index, and increased quality of life as compared to usual care? 2. What is the perceived added value and feasibility of including CRE-OPT in the medication review? a. Patient perspective: Do patients experience that their preferences are heard and taken into account in the medication review? How do patients evaluate OPT? Do patients experience difficulties using OPT? b. GP / nurse practitioner / pharmacist perspective: Does CRE-OPT support the GPs / pharmacists in their medication review? Do GPs and pharmacists consider the inclusion of CRE-OPT an added value to the medication review? Do GPs, nurse practitioners and pharmacists consider CRE-OPT a feasible tool to implement in daily practice? METHODS 1) Cluster randomized clinical trial. Randomization is at practice level stratified to region (Maastricht/Groningen). Per treatment arm 9 practices together with their preferred pharmacist will recruit 180 patients (total 360 patients). Eligible patients: aged = 60 years with at least 5 chronic medication prescriptions in at least two different organ systems. Excluded are patients who cannot act for themselves, patients with insufficient knowledge of the Dutch language, patients with a life-expectancy of less than one year, according to the GP. Intervention: integral medication review, including a home visit by the nurse practitioner, and consultation of GP and pharmacist, but augmented with sophisticated medication review software (‘Clinical Rules Engine’ (CRE)) and including an explicit assessment of patient preferences using a feasible tool (‘Outcome Prioritization Tool’ (OPT)). Patients in the control group receive care as usual; GPs are roughly informed about the intervention and are stimulated to evaluate the prescribed medication of the patients participating in the study, in their usual way. Main outcome is treatment satisfaction with prescribed medication; secondary outcomes are: type and number of medication alerts, changes in medication prescription, medication adherence, drug burden index, and quality of life. Relevant outcomes will be measured at baseline (before the intervention), after completion of the intervention, and after 12 months follow-up. 2) Process evaluation. Both the perspectives of patients and health professionals will be involved in the evaluation of the added value and feasibility of the intervention (CRE-OPT). Quantitative methods (questionnaires) and qualitative methods (patient interviews) will be applied. PLANNING The study is a collaborative project of the Department of Family Medicine of Maastricht University, the Department of General Practice of University Medical Center Groningen, the Department of Pharmacy of Zuyderland Medisch Centrum – Sittard-Geleen and Huis voor de Zorg. The researcher will be stationed in Maastricht, but study participants will be recruited in both regions. Throughout the study, patient representatives will be involved in the preparation of the data collection and interpretation of the study results. Additional patients will be recruited with support from the regional patient organisation ‘Huis voor de Zorg’ and are different patients that the ones who participate within the study. These meetings will take place in the Maastricht region.