A randomized controlled trial is currently in progress to evaluate the effectiveness of collaborative medication reviews in improving the health-related quality of life (HRQoL) for older individuals who are managing multiple medications. This initiative seeks to bridge the gap between hospital and primary care settings, ensuring a more coordinated and patient-centered approach to medication management.
Intervention Design
The intervention consists of three key components: a comprehensive clinical assessment and medication review by a hospital-based physician specialized in general practice, supervision by a geriatrician, and a collaborative telephone meeting between the hospital physician and the patient's general practitioner (GP). The medication reviews are structured using guidelines from the Norwegian Directorate of Health and the Scottish NHS, emphasizing a personalized approach that considers each patient's unique health conditions, symptoms, and preferences.
The hospital physician gathers information on the patient's medical history and medication use, conducts necessary diagnostic tests, and performs a physical examination. All medications are systematically reviewed to ensure appropriateness, optimize disease control, ensure correct dosing and minimize the risk of adverse effects and drug interactions. Tools such as drug interaction databases and lists of anticholinergic drugs are used to support this process.
Geriatric Supervision and GP Collaboration
To ensure comprehensive oversight, the hospital physician consults with a geriatrician to review patient findings and proposed medication adjustments. This consultation occurs before the meeting with the patient’s GP. Following the clinical medication review, the hospital physician arranges a telephone meeting with the patient’s GP to discuss the findings and collaboratively develop a step-by-step plan for adjusting medications. If direct contact is not possible, the GP receives a written summary of the clinical medication review.
Study Outcomes and Measures
The primary outcome measure is HRQoL, assessed using the 15D instrument at 16 weeks, adjusted for baseline score. The 15D instrument is a validated patient-reported outcome measure encompassing 15 dimensions, including mobility, vision, mental function, and vitality. A change of ± 0.015 or more is considered the minimum important change (MIC).
Secondary outcomes, also assessed at 16 weeks, include physical and cognitive function, oral health, falls, admissions to healthcare facilities, and mortality. The study will also evaluate long-term outcomes in terms of mortality rates and admissions to healthcare facilities up to 1 year.
Sample Size and Recruitment
The trial aims to recruit a total of 350 patients, with 175 in the intervention group. This sample size is calculated to provide at least 80% power to detect a clinically significant difference in HRQoL, assuming a mean difference between groups of 0.04 on the 15D instrument and a standard deviation of 0.13. The recruitment team combines clinical expertise with research experience to ensure efficient and effective participant enrolment.
Significance
This trial addresses the critical need for improved medication management in older adults with polypharmacy. By fostering collaboration between healthcare providers and implementing structured medication reviews, the study aims to enhance patients' quality of life and reduce the burden of adverse drug events and healthcare utilization.
