Inappropriate PrescribingNCT07407387
Ensuring Clinical Appropriateness and Safety of Pharmacological Therapies in Nursing Home Residents
A study testing Multi-Component Intervention on Medication Prescribing in people with Inappropriate Prescribing, run by Lugano Istituti Sociali at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Inappropriate Prescribing
- What is being tested?
- Multi-Component Intervention on Medication Prescribing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Institute of Pharmacological Science of Southern Switzerland, Ente Ospedaliero Cantonale
Lugano, 6900
About this study
Official title: 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.
Read more
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
- Being tested
- Multi-Component Intervention on Medication Prescribing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Component Intervention on Medication PrescribingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Multi-Component Intervention on Medication Prescribing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention (day 1) and post-intervention (day 180), for comparison
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention (day 1) and post-intervention (day 180), for comparison
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.
Measured: Pre-intervention (day 1) and post-intervention (day 180), for comparison
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start1 May 2026
- Primary completion30 Nov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate PrescribingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-post study
- Masking
- None (open label)
- Enrolment
- 219 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lugano Istituti Sociali
- Sponsor type
- University, hospital or other
- Collaborators
- Ente Ospedaliero Cantonale, Ticino, Switzerland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407387
- Sponsor's protocol ID
- ISFSI_LIS_2025
- Status last verified
- Aug 2026
- First submitted
- 29 Jan 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07407387
- Acronym / sponsor ID
- ISFSI_LIS_2025
- Conditions
- Inappropriate Prescribing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 219 participants (estimated)
- Lead sponsor
- Lugano Istituti SocialiUniversity, hospital or other
- Collaborators
- Ente Ospedaliero Cantonale, Ticino, Switzerland
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-post study
| Arm | Type | Receives |
|---|---|---|
| Appropriateness of medication prescribing | Experimental | Procedure: Multi-Component Intervention on Medication PrescribingConfirmatory, 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Component Intervention on Medication PrescribingThe 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. | Procedure or surgery | Appropriateness of medication prescribing |
Primary outcome
Medication Appropriateness Index (MAI)
Time frame: Pre-intervention (day 1) and post-intervention (day 180), for comparison
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.
5 secondary outcomes
Indicator of inappropriate prescribing: potentially inappropriate prescriptions (PIPs)
Time frame: Pre-intervention (day 1) and post-intervention (day 180), for comparison
Indicator of inappropriate prescribing: therapeutic duplicates (TDs)
Time frame: Pre-intervention (day 1) and post-intervention (day 180), for comparison
Indicator of inappropriate prescribing: drug-drug interactions (DDIs)
Time frame: Pre-intervention (day 1) and post-intervention (day 180), for comparison
Indicator of inappropriate prescribing: anticholinergic burden (ACB)
Time frame: Pre-intervention (day 1) and post-intervention (day 180), for comparison
Resident-centred clinical outcomes
Time frame: Pre-intervention (day 1) and post-intervention (day 180), for comparison
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Component Intervention on Medication Prescribing in people with Inappropriate Prescribing, run by Lugano Istituti Sociali at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Appropriateness Index (MAI) (time frame: Pre-intervention (day 1) and post-intervention (day 180), for comparison). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.