Ensuring Clinical Appropriateness and Safety of Pharmacological Therapies in Nursing Home Residents

Официальное название

Appropriateness of Medication Prescribing in Nursing Homes: A Pre-Post Study to Evaluate the Effectiveness of a Clinical Pharmacology Team-Led, Digitally Supported, Inter-Professional Collaboration

Обзор

The goal of this clinical study is to evaluate whether a structured, clinical pharmacology team-led medication review improves the appropriateness and safety of medication prescribing in elderly nursing home (NH) residents. The study will also assess the impact of the intervention on indicators of inappropriate prescribing and resident-centred clinical outcomes. The main questions the study aims to answer are: 1) Does a structured, digitally supported, medication review led by clinical pharmacologists reduce inappropriate medication prescribing, as measured by the Medication Appropriateness Index (MAI), in elderly NH residents? 2) Does the intervention reduce indicators of inappropriate prescribing, including potentially inappropriate prescriptions, therapeutic duplicates, drug-drug interactions and anticholinergic burden? 3) Does the intervention improve resident-centred clinical outcomes, such as falls, fractures, delirium, hyper-sedation, emergency department visits and hospitalizations? This is a single-arm, non-randomized, pre-post study conducted in seven NHs in Southern Switzerland. Each resident will serve as their own control, with outcomes compared between a 3-month pre-intervention period and a 3-month post-intervention period. The intervention consists of: 1) An individualized, digitally supported, medication review conducted by the team of clinical pharmacologists; 2) Face-to-face feedback to NH healthcare professionals responsible for managing residents' medications; 3) Tailored educational sessions addressing common prescribing issues identified during the medication review. Participants will: be aged 65 years or older and reside in participating NHs; have their routinely collected clinical and medication data assessed during a 3-month pre-intervention period; receive the intervention integrated into routine care, with any medication changes implemented by treating clinicians. The study is low-risk, non-invasive, and embedded in routine NH care. The results will provide evidence on the clinical effectiveness of integrating clinical pharmacology expertise into inter-professional medication management in Swiss NHs.

Вмешательства

• Процедура Multi-Component Intervention on Medication Prescribing
  The study intervention is a multi-component procedure led by a team of clinical pharmacologists to improve medication prescribing among nursing home residents. It includes: 1) individualized medication review with a comprehensive review of each resident's medications, digitally supported; the assessment of medication prescribing appropriateness using the Medication Appropriateness Index (MAI), the identification of key indicators of inappropriate prescribing and the assessment of resident-centre

Первичные конечные точки

• Medication Appropriateness Index (MAI) [Срок оценки: Pre-intervention (day 1) and post-intervention (day 180), for comparison]

Вторичные конечные точки (5)

• Indicator of inappropriate prescribing: potentially inappropriate prescriptions (PIPs) [Срок оценки: Pre-intervention (day 1) and post-intervention (day 180), for comparison]
• Indicator of inappropriate prescribing: therapeutic duplicates (TDs) [Срок оценки: Pre-intervention (day 1) and post-intervention (day 180), for comparison]
• Indicator of inappropriate prescribing: drug-drug interactions (DDIs) [Срок оценки: Pre-intervention (day 1) and post-intervention (day 180), for comparison]
• Indicator of inappropriate prescribing: anticholinergic burden (ACB) [Срок оценки: Pre-intervention (day 1) and post-intervention (day 180), for comparison]
• Resident-centred clinical outcomes [Срок оценки: Pre-intervention (day 1) and post-intervention (day 180), for comparison]

Критерии участия

Критерии включения

• Expected to remain in the nursing home for the duration of the study
• Able to provide informed consent or having a legally authorized representative able to provide consent if the resident lacks capacity

Критерии исключения

• Residents in their probable last hours or days of life
• Residents with moderate to severe cognitive impairment (Cognitive Performance Scale, CPS, score >4
• Residents housed in assisted nursing home wards, including those requiring palliative care (either in dedicated palliative units or receiving palliative care in general wards), those in the hemodialysis unit, and those with severe obesity (body mass index >=40kg/m2)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Швейцария · 1 центр

• Institute of Pharmacological Science of Southern Switzerland, Ente Ospedaliero Cantonale — Lugano

Идентификаторы

NCT: NCT07407387 · ISFSI_LIS_2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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