Reduction of Polypharmacy in Elderly People With Multiple Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medication plan review, Adherence support.
- Who it may be relevant to
- Registry conditions: Polypharmacy, Multimorbidity. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reduction of Polypharmacy in Elderly People With Multiple Diseases - a Stepped Wedge Cluster-randomized Controlled Trial
Overview
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.
Interventions
- Other Medication plan review
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. - Behavioral Adherence support
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.
Primary outcome measures
- Rate of adverse drug reactions [Time frame: 6 months]
Secondary outcome measures (8)
- Potentially inappropriate prescriptions [Time frame: 6 months]
- Hospitalizations [Time frame: 6 months]
- Adherence [Time frame: 6 months]
- Health-related quality of life [Time frame: 6 months]
- Family doctor consultations [Time frame: 6 months]
- Medication appropriateness [Time frame: 6 months]
- Deprescription [Time frame: 6 months]
- Types of adverse drug reactions [Time frame: 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- HAP ANZ — Halle
Identifiers
NCT: NCT05526963 · RaPHaeL_001_RED