Clinical trial NCT05526963: Reduction of Polypharmacy in Elderly People With Multiple Diseases
Official title: Reduction of Polypharmacy in Elderly People With Multiple Diseases - a Stepped Wedge Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polypharmacy
Multimorbidity
Keywords: Primary Care
Polypharmacy
Multimorbidity
Drug-Related Side Effects and Adverse Reactions
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: University of Leipzig
name: Hannover Medical School
First posted: 2022-09-02
Enrollment: 1146
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-wedge cluster-randomized controlled trial
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of adverse drug reactions
timeFrame: 6 months
Secondary outcomes:
measure: Potentially inappropriate prescriptions
timeFrame: 6 months
measure: Hospitalizations
timeFrame: 6 months
measure: Adherence
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 6 months
measure: Family doctor consultations
timeFrame: 6 months
measure: Medication appropriateness
timeFrame: 6 months
measure: Deprescription
timeFrame: 6 months
measure: Types of adverse drug reactions
timeFrame: 6 months
Other outcomes:
Locations:
city: Halle
country: Germany
facility: HAP ANZ
state: Saxony-Anhalt
Study officials:
affiliation: MLU Halle-Wittenberg
name: Thomas Frese, Prof.
role: STUDY_CHAIR
References: