Less Medicines in Older Patients in the Netherlands, The Lemon Study: Study Protocol of a Cluster Randomised Controlled Trial

Research Article

Phys Med Rehabil Int. 2022; 9(2): 1201.

Less Medicines in Older Patients in the Netherlands, The Lemon Study: Study Protocol of a Cluster Randomised Controlled Trial

Abou J¹*, Elders PJM², Huijts D¹, Domic J¹, Marum RV3,4 and Hugtenburg J¹

1Department of Clinical Pharmacology & Pharmacy, Amsterdam University Medical Centers, The Netherlands

2Department of General Practice, Amsterdam UMC, location VU, Amsterdam Public Health research institute, The Netherlands

3Department of Elderly Care Medicine, Amsterdam Public Health Research Institute, The Netherlands

4Department of Clinical Pharmacology, Jeroen Bosch Hospital, s-Hertogenbosch, The Netherlands

*Corresponding author: Jamila Abou, Department of Clinical Pharmacology & Pharmacy, Amsterdam University Medical Centres, location VUMC, Amsterdam, The Netherlands

Received: June 14, 2022; Accepted: July 18, 2022; Published: July 25, 2022


Background and Objective: Overtreatment with cardiometabolic medication is a common phenomenon in older patients. Up to 20% of these patients may be eligible for deprescribing. Deprescribing may decrease the risk of adverse drug events and is indicated when a drug may lead to more harm than benefits. The LeMON study aims to develop, implement and evaluate a standardized template for the performance of clinical medication reviews (CMR) using evidence based tools and training to support deprescribing of cardiometabolic medication.

Method: A clustered randomized controlled study involving twenty community pharmacists (CP). CP will be asked to conduct a CMR in ten patients. The intervention group will receive training on the background of deprescribing cardiometabolic medication and the use of tools and the control group will perform a CMR according to standard practice. Follow-up will take place within four weeks (T1) and after three months (T2) following the CMR. Patients 70 years or older; polypharmacy and chronic use of at least one blood pressure medicine and having a systolic blood pressure below 140 mmHg, or chronic use of glucose lowering medication and HbA1c level below 54 mmol/ mol were included.

Discussion: The LeMON study will assess whether a primary care-based intervention educating CPs about deprescribing cardiometabolic medication reduces the number of cardiometabolic medication used by older patients with a blood pressure or HbA1c lower than the treatment targets tment. The use of algorithms including information on blood pressure and/or HbA1c and cardiometabolic medication use has not been studied previously.

Keywords: Deprescribing; Polypharmacy; Cardiometabolic medication


Patients with cardiometabolic diseases are treated with a variety of medication to decrease the risk of complications, such as cerebrovascular disease and myocardial infarction [1]. Treatment plans including the prescription of medication are generally based on national and international guidelines for the treatment of diseases. These guidelines include recommendations aimed at specific treatment targets, infrequently taking into account patient characteristics such as co-morbidities, co-medication and the patients’ age. In case treatment goals are not reached with first line medicine choices, second and third line medicines can be added to the treatment regimen. As a result, and particular in case of comorbidities, patients may use more than 5 medicines, which is recognized as polypharmacy [2].

Polypharmacy is associated with an elevated risk of drug related problems, such as adverse drug reactions, drug-drug interactions, contra-indications and non-adherence, which may result in increased morbidity and hospitalization, and unnecessary health care costs [3-7]. This risk is more profound in older adults due to age related changes in pharmacodynamics and -kinetics but also due to increasing frailty which increases susceptibility to negative effects of medication [8].

In order to provide guidance on the prescribing of adequate medication in older patients in 2012 the Dutch Multidisplinary Guideline ‘Polypharmacy in Older Patients’ (MDR Polypharmacy [MDRP]) was published. An important tool to optimize the medication of older patients with polypharmacy is the periodicallyconducted clinical medication review (CMR). Applying the MDRP in primary care was stimulated by obliging CPs and GPs to annually perform a minimum number of CMRs for patients at risk and reimbursing these HCPs.

Several studies show that (frail) older adults may benefit from less strict target values of blood pressure and blood glucose than recommended in younger individuals [9]. The Dutch guidelines for cardiovascular risk management and diabetes recommend =150 mmHg and 53-69 mmol/mol as target values for systolic blood pressure and HbA1c in (frail) older adults [10,11]. With these less strict treatment targets, medication often can be tapered or discontinued. Deprescribing has recently been introduced as ‘the process of withdrawal of an inappropriate medication, supervised by a healthcare provider (HCP) with the goal of managing polypharmacy and improving outcomes’ [3]. Deprescribing may improve quality of life and decrease the risk of adverse drug events [4] and is indicated when a medication may lead to more harm than benefits [12]. Several tools with regard to deprescribing have been developed [13-15]. Deprescribing of glucose-lowering and antihypertensive medication in patients with multiple comorbidities, frailty, hypoglycemic risk, or a limited life expectancy seems feasible and safe [16,19]. Although deprescribing of cardiometabolic medication seems feasible, its implementation needs further support [9].

However, in daily practice the MDRP turned out to be difficult to apply and results were somewhat disappointing, particularly because CP recommendations to deprescribe medication often did not result in dose reductions and discontinuation [20,23]. The Dutch MDRP has therefore recently been supplemented by a guideline on deprescribing, partially filling the evidence and information gap by adding fact sheets on the most common disorders in older patients [24]. In these documents considerations and criteria have been summarized that support the decision-making to discontinue or continue the use of certain medications.

To implement the MDRP in daily practice, CP needs training and support. We therefore developed a practical model for the performance of CMR for CPs with an integrated module for deprescribing cardiometabolic medication with a training including information from existing guidelines, which will be implemented and evaluated in a cluster randomized trial. The protocol for this study is described in the present article.


Study Design and Setting

A clustered randomized controlled trial will be performed. In total, 20 community pharmacies will be recruited. Each CP will be randomly assigned to either the intervention or control group. CPs in the intervention group will receive training on deprescribing cardiometabolic medication. Subsequently, intervention CPs will perform a CMR in 10 patients. Each control CP will perform CMRs in 10 patients according to usual care. Follow-ups will take place within four weeks (T1) and after three months (T2) following the CMR. A process evaluation will be performed at the end of the study. A flowchart of the study is presented in (Figure 1).

Citation: Abou J, Elders PJM, Huijts D, Domic J, Marum RV and Hugtenburg J. Less Medicines in Older Patients in the Netherlands, The Lemon Study: Study Protocol of a Cluster Randomised Controlled Trial. Phys Med Rehabil Int. 2022; 9(2): 1201.