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

NCT07407387 | Not Yet Recruiting

• 1 other identifier: ISFSI_LIS_2025
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inappropriate Prescribing

Outcome Measures

Primary Outcomes (1)

• Medication Appropriateness Index (MAI)

  Reduction in the total MAI score per resident between pre-intervention (day 1) and post-intervention (day 180) periods. The MAI is calculated at the medication level for each long-term in-use medication (\>=3 months, excluding as needed medications), using a modified 10-item MAI scoring system. Each medication is scored from 0 to 17 (higher score=greater inappropriateness). A resident-level MAI is calculated by summing the MAI scores of all eligible medications.

  Pre-intervention (day 1) and post-intervention (day 180), for comparison

Secondary Outcomes (5)

• Indicator of inappropriate prescribing: potentially inappropriate prescriptions (PIPs)

  Pre-intervention (day 1) and post-intervention (day 180), for comparison

• Indicator of inappropriate prescribing: therapeutic duplicates (TDs)

  Pre-intervention (day 1) and post-intervention (day 180), for comparison

• Indicator of inappropriate prescribing: drug-drug interactions (DDIs)

  Pre-intervention (day 1) and post-intervention (day 180), for comparison

• Indicator of inappropriate prescribing: anticholinergic burden (ACB)

  Pre-intervention (day 1) and post-intervention (day 180), for comparison

• Resident-centred clinical outcomes

  Pre-intervention (day 1) and post-intervention (day 180), for comparison

Study Arms (1)

Appropriateness of medication prescribing

EXPERIMENTAL

Confirmatory, single-arm, non-randomized, pre-post study conducted in the geriatric clinical setting of seven nursing homes located in Southern Switzerland, coordinated by Lugano Istituti Sociali (LIS), in collaboration with the Institute of Pharmacological Sciences of Southern Switzerland and the Clinical Trial Unit of the Ente Ospedaliero Cantonale (ISFSI-EOC and CTU-EOC). Each resident will serve as their own control, with outcomes measured over a 3-month pre-intervention period and a 3-month post-intervention period. The intervention, lasting approximately 3 months, includes individualized medication review by clinical pharmacologists, face-to-face feedback and tailored educational sessions for nursing home healthcare professionals responsible for managing residents' medications.

Procedure: Multi-Component Intervention on Medication Prescribing

Interventions

Multi-Component Intervention on Medication Prescribing PROCEDURE

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-centred clinical outcomes; 2) face-to-face feedback with nursing home healthcare professionals responsible for managing residents' medications to discuss recommended adjustments for each resident, fostering inter-professional collaboration; 3) tailored educational sessions to nursing home healthcare professionals responsible for managing residents' medications, addressing common prescribing issues identified during medication review. No drugs or medical devices will be used during this procedure.

Appropriateness of medication prescribing

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lugano Istituti Sociali: lead
• Ente Ospedaliero Cantonale, Ticino, Switzerland: collaborator

Study Sites (1)

Institute of Pharmacological Science of Southern Switzerland, Ente Ospedaliero Cantonale

Lugano, 6900, Switzerland

Location

Central Study Contacts

Roberta Noseda, PhD

CONTACT

00410918116300; roberta.noseda@eoc.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-post study

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 12, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)