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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inappropriate Prescribing
• Intervention / Treatment: Procedure: Multi-Component Intervention on Medication Prescribing

• Study Type: Interventional
• Enrollment (Estimated): 219
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberta Noseda, PhD; Phone Number: 00410918116300; Email: roberta.noseda@eoc.ch

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Institute of Pharmacological Science of Southern Switzerland, Ente Ospedaliero Cantonale
    • Contact: Roberta Noseda, PhD; Phone Number: 00410918116300; Email: roberta.noseda@eoc.ch
    • Principal Investigator: Francesca Bedussi, Medical degree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Appropriateness of medication prescribing; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resident-centred clinical outcomes	Frequency of falls, fractures, delirium, hyper-sedation, drug-related emergency department visits and hospitalizations. The occurrence of the specified outcomes will be ascertained through extraction of data from the electronic health records of nursing home residents, where such information is routinely recorded as part of standard clinical documentation.	Pre-intervention (day 1) and post-intervention (day 180), for comparison
Indicator of inappropriate prescribing: potentially inappropriate prescriptions (PIPs)	Frequency of potentially inappropriate prescriptions (PIPs), identified according to the American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults (2023). This indicator will be determined for each participant based on the individual medication list.	Pre-intervention (day 1) and post-intervention (day 180), for comparison
Indicator of inappropriate prescribing: therapeutic duplicates (TDs)	Frequency of therapeutic duplicates (TDs), defined as the concurrent prescription of two or more drugs within the same Anatomical Therapeutic Chemical (ATC) subgroup at the fourth level. This indicator will be determined for each participant based on the individual medication list.	Pre-intervention (day 1) and post-intervention (day 180), for comparison
Indicator of inappropriate prescribing: drug-drug interactions (DDIs)	Frequency of drug-drug interactions (DDIs), assessed by clinical pharmacologists through consultation of Lexicomp (external drug interaction database). This indicator will be determined for each participant based on the individual medication list.	Pre-intervention (day 1) and post-intervention (day 180), for comparison
Indicator of inappropriate prescribing: anticholinergic burden (ACB)	Frequency of anticholinergic burden (ACB), evaluated by clinical clinical pharmacologists according to the ACB scale 2012. This indicator will be determined for each participant based on the individual medication list.	Pre-intervention (day 1) and post-intervention (day 180), for comparison

Collaborators and Investigators

• Sponsor: Lugano Istituti Sociali
• Collaborators: Ente Ospedaliero Cantonale, Ticino, Switzerland

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ISFSI_LIS_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No