Reduction of Polypharmacy in Elderly People With Multiple Diseases

Study Overview
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Brief Summary
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Elderly GP patients are often treated with five or more medications and therefore prone to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. The primary aim of this study to reduce the frequency of ADRs in multimorbid patients aged 70 years and older by reducing polypharmacy.

Detailed Description
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Introduction: Many elderly people are multimorbid and are treated with five or more medications (polypharmacy) at the same time. Due to age related physiological changes they are especially vulnerable to adverse drug reactions (ADR). Potentially inappropriate prescriptions (PIPs) lead to increased adverse events like falls, hospitalizations and mortality. Up to 16% of unplanned hospitalizations of elderly people with polypharmacy are caused by ADRs. The primary aim of this study is the evaluation of the effectivity of a multi-component-intervention to reduce the frequency of ADRs in multimorbid patients aged 70 years and older. Methods: We are planning a multi-center stepped wedge cluster randomized controlled trial at 40 primary care practices affiliated to the RaPHaeL-network (Research Practices Halle-Leipzig) in Saxony-Anhalt and Saxony, Germany. The planned intervention follows the recommendations of the New Medical Research Council and comprises a pharmacological medication plan review according to the STOPP/START-criteria and an adherence support measure employing motivational interviewing. Control group will receive usual care. Eligible patients are ≥ 70 years old, are diagnosed with three or more chronic medical conditions and are prescribed five or more medications. The primary outcome is the rate of ADRs six months post intervention. The secondary outcomes are number of ADRs, hospitalization rate due to ADRs, medication adherence (Morisky Adherence Score MMAS-8), the health-related quality of life (Euro-QOL EQ-5D-5L), the number of PIPs (according to STOPP/START), number of primary care physician per quarter, the medication appropriateness index and the mean number of de-prescriptions per patient. The planned sample size is 1,146 patients. Discussion: Multimorbid patients with polypharmacy show an increased risk for PIPs, since prescriptions can be based on evidence for pharmacological therapy of a single condition without taking into account the complex drug interactions. Based on the existing evidence we are aiming to reduce ADRs in this patient population.

Official Title
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Reduction of Polypharmacy in Elderly People With Multiple Diseases - a Stepped Wedge Cluster-randomized Controlled Trial

Conditions
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Polypharmacy, Multimorbidity

Intervention / Treatment
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* Other: Medication plan review
* Behavioral: Adherence support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 5 longterm medications (> 6 months) (polypharmacy) ≥ 3 chronic diseases (multimorbidity) ≥ 1 family doctor consultation within the last 6 months Exclusion Criteria: Patients with a critically reduced life expectancy Patients who cannot autonomously visit the family practice Patients who cannot participate in the informed consent process Patients who are residing in a nursing home Patients with dementia or a mental of behavioral disorder ICD-10 F00-F99 Patients who are participating in another medical study with a focus on polypharmacy or multimorbidity

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped-wedge cluster-randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Medication review (STOPP/START-criteria) + telephone-based adherence support measure (motivational interviewing) | Other: Medication plan review<br>* Intervention group patients will receive a revised medication plan by external pharmacologist based on the the STOPP/START criteria. The revised medication plan will be provided to the family physician who then will provide it to the patient. The revision comes along with evidence based information for the physician to prevent possible uncertainties by the physicians.<br>Behavioral: Adherence support<br>* Intervention group patients will receive a study nurse administered adherence support measure based on telephone-based motivational interviewing. The measure includes information on possible consequences of inadherence and signs of adverse drug reactions that is comprehensible for lay persons.<br>|
| No Intervention: Control Group<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse drug reactions | Rate of self-reported adverse drug reactions per patient based on a list of commonly reported drug-related symptoms in primary care. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potentially inappropriate prescriptions | The number of potentially inappropriate prescriptions based on the STOPP(Screening Tool of Older Persons' potentially inappropriate Prescriptions) and START (Screening Tool to Alert doctors to Right Treatment) criteria. | 6 months | 
| Hospitalizations | The frequency of hospitalizations due to adverse drug reactions. | 6 months | 
| Adherence | The patient's adherence to the medication plan based on the Morisky medication adherence score 8 (MMAS-8). Response categories are yes/no for each item with a dichotomous response and a 5-point Likert response for the last item. The summed total score ranges from 0 to 8 otal MMAS-8 scores can range from 0 to 8 and will be been categorized into three levels of adherence: high adherence (score = 8), medium adherence (score of 6 to < 8), and low adherence (score< 6). | 6 months | 
| Health-related quality of life | The health-related quality of life will be measured using the six-item European Quality of Life 5 Dimensions 3 Level Version (Euro-QOL EQ-5D-5L) tool, ranging from 0 to 100 on a visual analoge scale with higher values indicating a higher quality of life. | 6 months | 
| Family doctor consultations | The number of family doctor consultations within the time frame between recruitment and follow-up. | 6 months | 
| Medication appropriateness | The medication appropriateness will be measured using the medication appropriateness index (MAI) | 6 months | 
| Deprescription | The number of medication de-prescriptions per patient | 6 months | 
| Types of adverse drug reactions | Number and types of self-reported adverse drug reactions per patient based on a list of commonly reported drug-related symptoms in primary care. Each symptom's severity will be quantified by use of an analogue scale from 0 (no severity) to 10 (maximum imaginable severity) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Care, Polypharmacy, Multimorbidity, Drug-Related Side Effects and Adverse Reactions