How to Improve Healthcare for Patients with Multimorbidity and Polypharmacy in Primary Care: A Pragmatic Cluster-Randomized Clinical Trial of the Multipap Intervention

Abstract

Background: key problem in multimorbidity (MM) is polypharmacy (PP), which is associated with increased risks for partly preventable adverse outcomes. The Ariadne principles support primary care consultations that aim to prioritize and share appropriate treatment goals in MM. The aim of this study is to evaluate the effectiveness of the complex MULTIPAP intervention, which implements the Ariadne principles in a primary care population of young-elderly patients with MM&PP, at improving the appropriateness of prescription. Methods: We conducted a pragmatic cluster randomized clinical trial in 38 family practices in Spain. Family physicians (FPs) were randomly allocated to continue usual care or to provide the MULTIPAP intervention based on the Ariadne principles. The latter consisted of two key components: FP training (eMULTIPAP) and FP–patient interviews. Patients aged 65-74 years with MM&PP were recruited. The primary outcome was the baseline-adjusted Medication Appropriateness Index (MAI) score at 6 months. Participants were not blinded to group assignment, but the analysis of outcomes was blinded. Secondary outcomes were quality of life (EQ-5D-5 L), patient perceptions of shared decision making (collaboRATE), use of health services, treatment adherence, and incidence of drug adverse events (all at 1 year). We analysed the primary outcome in the intention-to-treat population, the missing data being multiply imputed. We analysed outcomes using multi-level regression models, with FP as a random effect. Findings: Between 8 Nov 2016 and 31 Dec 2017, we recruited 117 FPs and 593 of their patients. Mean patient age was 69.7 (2.7) years, 55.8% were women, 60.5% belonged to social classes V-VI, and 28.7% had low self-reported income. In the intention-to-treat analysis, the between-group difference in mean MAI score after 6 months’ follow-up was -2.42 (95% CI -4.27 to -0.59) and between baseline and 12 months’ follow-up was -3.40 (95% CI -5.45 to -1.34). There were no significant differences in another secondary outcomes. Interpretation: The MULTIPAP intervention improved medication appropriateness stably over time. Differences in secondary outcomes were not significant. Clinical Trial Registration: (Clinicaltrials.gov NCT02866799) Funding Statement: This work was supported by the Health Research Fund Coordinated project (grant references PI15/00276, PI15/00572, PI15/00996) from the Institute of Health Carlos III, Spain, and by the Chronic Disease Health Services Research Network (REDISSEC) (grant references RD16/0001/0006, RD16/0001/0005 and RD16/0001/0004) co-funded by the European Regional Development Fund (ERDF) A way to make Europe. Ethics Statement: The study was approved by the Ethics Committee for Clinical Research of Aragon 199 (CEICA, PI15/0217), was favourably evaluated by the Research Ethics Committee of the Province of Malaga 200 on 25 September 2015 and by the Central Committee of Primary Care Research of the Community of 201 Madrid Declaration of Interests: We declare no competing interest