Decision support software-guided medication reviews in elderly patients with polypharmacy: a prospective analysis of routine data from community pharmacies (OPtiMed study protocol)

BACKGROUND: Pharmacist-led medication reviews are considered a valuable measure to address risks of polypharmacy. The software Medinspector(®) is used in community pharmacies to assist the performance of this complex service by structuring the medication review process and supporting pharmacists in their decision-making with targeted clinical knowledge. Key feature is a computerized risk assessment of both the initial and adjusted medication regimen of a patient in multiple domains, thus aiming to support the identification and solving of drug-related problems. This study will examine the effects of medication reviews performed with the clinical decision support system in daily routine practice on medication-related and patient-reported outcomes in elderly patients with polypharmacy. METHODS: A prospective, before–after observational study is conducted in German community pharmacies aiming to include 148 patients aged 65 or older, who chronically use five or more active pharmaceutical substances with systemic effects and utilize the software-supported medication review service. The study is based on routine documentation within the software over the course of the medication review, including a patient’s baseline medication, the medication proposed by pharmacists, and the final medication regimen. A software-implemented questionnaire comprising self-developed and literature-derived instruments is used to collect patient-reported outcome data at baseline and follow-up. Primary outcome is the appropriateness of medication measured with an adapted version of the Medication Appropriateness Index (MAI). Secondary medication-related outcomes are medication underuse, exposition towards anticholinergic/sedative drugs, number of drugs in long-term use and the implementation of pharmacist-proposed medication adjustments by the physicians. Secondary patient-reported outcomes are symptom burden, medication-related quality of life, adherence, fulfillment of medication review-related goals, and perception of the service. DISCUSSION: With the recently introduced remuneration of community pharmacist-led MR in Germany, the demand for digital tools supporting the MR process is assumed to rise. The OPtiMed-study is expected to create evidence on the effects of a novel tool on patient care in a vulnerable patient population. Trial registration German Clinical Trials Register, DRKS00027410. Registered 22 December 2021, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00027410. Also available on the WHO meta-registry: https://trialsearch.who.int/?TrialID=DRKS00027410