Reduction of Polypharmacy in Elderly People With Multiple Diseases
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Medication plan review, Adherence support.
- Кому может быть актуально
- Состояния в реестре: Polypharmacy, Multimorbidity. Базовые параметры: от 70 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Reduction of Polypharmacy in Elderly People With Multiple Diseases - a Stepped Wedge Cluster-randomized Controlled Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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. - Поведенческое 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.
Первичные конечные точки
- Rate of adverse drug reactions [Срок оценки: 6 months]
Вторичные конечные точки (8)
- Potentially inappropriate prescriptions [Срок оценки: 6 months]
- Hospitalizations [Срок оценки: 6 months]
- Adherence [Срок оценки: 6 months]
- Health-related quality of life [Срок оценки: 6 months]
- Family doctor consultations [Срок оценки: 6 months]
- Medication appropriateness [Срок оценки: 6 months]
- Deprescription [Срок оценки: 6 months]
- Types of adverse drug reactions [Срок оценки: 6 months]
Критерии участия
Критерии включения
- ≥ 5 longterm medications (> 6 months) (polypharmacy)
- ≥ 3 chronic diseases (multimorbidity)
- ≥ 1 family doctor consultation within the last 6 months
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Германия · 1 центр
- HAP ANZ — Halle
Идентификаторы
NCT: NCT05526963 · RaPHaeL_001_RED