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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorLugano Istituti Sociali

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Multi-Component Intervention on Medication Prescribing

Treatment groups

219 Participants
are divided into 1 treatment group

Sponsors and collaborators

Lugano Istituti Sociali

Lead sponsor

Ente Ospedaliero Cantonale, Ticino, Switzerland

Collaborator