Less Is More: Optimized Pharmacotherapy With Improved coNtinuity of CarE in hospitaLized oLder peOple — LIMONCELLO  

Polypharmacy Clinical Trial

Official title: Less Is More: Optimized Pharmacotherapy With Improved coNtinuity of CarE in hospitaLized oLder peOple

Status Recruiting

Clinical Trial Summary

The goal of this cluster randomized controlled trial is to compare transitional multidisciplinary pharmacotherapeutic care (TMPC) with usual care in patients aged 70 years or older with polypharmacy, admitted to the hospital via the emergency department for longer than 24 hours and that have an elevated risk of drug related readmissions.

The primary aims of the study are:

• To assess whether TMPC leads to a decrease in number of DRreAs compared to usual care during the first 30 days after index hospitalisation.

• To assess whether TMPC is cost-effective

Participants will receive TMPC in hospitals allocated to the intervention. TMPC will be executed by a pharmacotherapeutic team, it consists of the following four elements:

• pharmacotherapeutic analysis

• transitional multidisciplinary discussion

• pharmacotherapeutic care interview and discussion with the patient

• discharge note with the pharmacotherapeutic care plan

Researchers will compare TMPC with usual care to assess the effect and cost-effectiveness of TMPC.

Clinical Trial Description

Rationale: Polypharmacy poses an ongoing healthcare challenge, as it is associated with negative outcomes such as adverse drug events, lower quality of life and mortality. These risks are especially elevated for the frail and old, leading to high numbers of drug related admissions (DRAs) and unplanned emergency department visits. Approximately half of the DRAs are potentially preventable, and therefore a possible target point for interventions. Unfortunately, until now, despite multiple efforts to decrease drug related harm, the number of drug related admissions has not decreased. Several studies have previously investigated the effect of a structured medication review with varying success. Identified strengths were multicomponent approaches, multidisciplinary approaches and selection of specifically high-risk patients. The LIMONCELLO study will take this into account and will study a multidisciplinary multicomponent intervention with focus on transitional care in a patient population that is most likely to benefit from this intervention. It is hypothesised that transitional multidisciplinary pharmacotherapeutic care (TMPC) is superior in preventing drug related readmissions (DRreAs) compared to usual care.

Objective: The LIMONCELLO study aims to assess the effect and cost-effectiveness of TMPC compared to usual care.

Study design: This is a cluster randomised controlled trial, a cluster will be defined at the hospital level, with each cluster randomly allocated to the intervention or control group. Patients aged 70 years or older with polypharmacy, admitted to the hospital via the emergency department for longer than 24 hours, with completed medication verification and with an elevated risk of drug related readmissions (calculated by use of the DRA prediction model, an algorithm developed by the OPERAM study group) will be included. Participants in intervention hospitals will receive TMPC during index hospitalisation. TMPC consists of four elements: pharmacotherapeutic analysis, transitional multidisciplinary discussion, pharmacotherapeutic care interview and discussion with the patient, and a discharge note with the pharmacotherapeutic care plan. The comparator is usual care as is provided in the participating hospitals. Follow-up will be 1 year, participants will be called 30 days, 3 months and 12 months after index hospitalisation.

Statistical considerations: 16 clusters will participate in the study, requiring a total of 161 patients per cluster to be included, 2,576 participants in total. Results will be analysed by intention-to-treat analysis and per-protocol analysis. For the primary outcome, drug related readmissions, a generalized linear mixed model with a binomial distribution and logit link function will be used for the analysis on an individual level, adjusting for clustering. ;

Related Conditions & MeSH terms

• Medication Review
• Polypharmacy

• NCT number: NCT05899114
• Study type: Interventional
• Source: Radboud University Medical Center
• Contact: Sjacky Cooijmans, MSc
• Phone: +31 (0)24 361 36 91
• Email: limoncello@zorgevaluatienederland.nl
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2023
• Completion date: June 5, 2025