Polypharmacy (People Under Treatment With 5 or More Drugs)SPInaNCT07202962
Prevalence of Inappropriate Prescriptions and Omitted Therapies in Hospitalized Elderly: STOPP/START Criteria Analysis
An observational study of Polypharmacy (People Under Treatment With 5 or More Drugs) and Elderly (People Aged 65 or More), run by Regione del Veneto - AULSS n. 7 Pedemontana at 1 site in Italy.
Trial summary
Evaluate the prevalence of potentially inappropriate prescriptions (PIPs) and potential omitted prescriptions (PPOs) in elderly patient upon admission to the acute geriatric department, based on adherence or non-adherence to the recommendations specified in STOPP and START criteria. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Polypharmacy (People Under Treatment With 5 or More Drugs), Elderly (People Aged 65 or More), Deprescribing
- What is being tested?
- medication review and deprescribing
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jul 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients aged over 75 years on polypharmacotherapy, hospitalized for acute conditions in the Geriatrics Department of AULSS 7 Pedemontana Hospital.
Who may be able to join
- Elderly patients (aged >75 years) admitted to the Geriatrics Department at Santorso, Alto Vicentino Hospital.
- Currently undergoing pharmacological treatment at the time of admission.
Who cannot join
- Patients placed in palliative therapy upon admission to the department due to incurability of the underlying pathologies
Trial locations and contacts
1 site in 1 country.
Italy1 site
Regione del Veneto - AULSS n. 7 Pedemontana
Santorso, Vicenza, 36014
About this study
Official title: Study of Prevalence of Inappropriate Prescriptions in Hospitalized Elderly Patients According to STOPP&Amp;START Criteria (Screening Tools of Older Person Prescriptions and Screening Tool to Alert to Right Treatment) - SPIna Protocol
Evaluate the prevalence of potentially inappropriate prescriptions (PIPs) and potential omitted prescriptions (PPOs) in elderly patient upon admission to the acute geriatric department, based on adherence or non-adherence to the recommendations specified in STOPP and START criteria.
- Conditions
- Polypharmacy (People Under Treatment With 5 or More Drugs), Elderly (People Aged 65 or More), Deprescribing, Hospitalization
- Being tested
- medication review and deprescribing
- Keywords
- polypharmacotherapy, interactions, elderly people, STOPP&START CRITERIES, DEPRESCRIBING
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medication review and deprescribingDrug
The study protocol includes the following assessments:
- T0: first data collection upon admission to the ward;
- T1 assessment: pharmacological review at discharge. Subjects who meet all study eligibility criteria will come consecutively enrolled in the study during admission to the department (T0).
By consulting the electronic health record, interviewing patients and family members and personal documentation, the following data will be collected:
- Remote and immediate pathological history;
- Family and social history;
- Home therapy;
- BRIEF-MPI. Home therapy and therapy suggested at discharge will be compared with the STOPPandSTART criteria to evaluate the prevalence of potential therapies inappropriate and to study possible interactions and contraindications pharmacological and for reporting possible adverse reactions to drugs. The prevalence and possible prevalence of each individual STOPPandSTART criterion will be assessed association with other variables of interest.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Potentially Inappropriate Prescriptions (PIP) (%)
Percentage of elderly patients with at least one potentially inappropriate prescription identified at hospital admission (day 0) and at discharge (day 1) in the acute geriatric ward, based on the STOPP criteria. The measurement is performed by comparing the patient's medication regimen with the recommendations provided in the STOPP criteria.
Measured: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4
Prevalence of Potentially Omitted Prescriptions (PPO) (%)
Percentage of elderly patients with at least one potentially omitted prescription identified at hospital admission (day 0) and at discharge (day 1) in the acute geriatric ward, based on the START criteria. The measurement is based on the absence of indicated medications according to the START criteria recommendations.
Measured: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4
Secondary outcomes (3)
Prevalence of Pharmacological Interactions (%)
Percentage of patients with at least one clinically significant drug-drug interaction identified through analysis of the medication regimen using standard drug interaction checkers. Assessed at admission and discharge.
Measured: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4
Post-Discharge Destination (Binary Variable)
Discharge destination classified as a binary variable (e.g., Home vs. Institutional care). Each category is analyzed separately.
Measured: Data collected at time Day 0 is analyzed by day 4.
Presence of Geriatric Syndromes (Yes/No)
Presence of specific geriatric syndromes (e.g., delirium, falls, incontinence, pressure ulcers, etc.) assessed as separate binary variables (Yes/No) for each syndrome, based on clinical records and standardized assessment tools.
Measured: Data collected at time Day 0 is analyzed by day 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start17 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypharmacy (People Under Treatment With 5 or More Drugs)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regione del Veneto - AULSS n. 7 Pedemontana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Pellizzari, Regione del Veneto - AULSS n. 7 Pedemontana
- Investigators
- Luca Pellizzari Dr. Pellizzari, DR, Principal investigator, Regione del Veneto - AULSS n. 7 Pedemontana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202962
- Sponsor's protocol ID
- 1239
- Acronym
- SPIna
- Status last verified
- Dec 2024
- First submitted
- 27 Feb 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Prevalence of Inappropriate Prescriptions in Hospitalized Elderly Patients According to STOPP&Amp;START Criteria (Screening Tools of Older Person Prescriptions and Screening Tool to Alert to Right Treatment) - SPIna Protocol
- ClinicalTrials.gov ID
- NCT07202962
- Acronym / sponsor ID
- SPIna / 1239
- Conditions
- Polypharmacy (People Under Treatment With 5 or More Drugs), Elderly (People Aged 65 or More), Deprescribing, Hospitalization
- Keywords
- polypharmacotherapy, interactions, elderly people, STOPP&START CRITERIES, DEPRESCRIBING
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Regione del Veneto - AULSS n. 7 PedemontanaUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Oct 2025 (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.
Evaluate the prevalence of potentially inappropriate prescriptions (PIPs) and potential omitted prescriptions (PPOs) in elderly patient upon admission to the acute geriatric department, based on adherence or non-adherence to the recommendations specified in STOPP and START criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients aged over 75 years on polypharmacotherapy, hospitalized for acute conditions in the Geriatrics Department of AULSS 7 Pedemontana Hospital.
Key inclusion criteria (2 listed)
- Elderly patients (aged >75 years) admitted to the Geriatrics Department at Santorso, Alto Vicentino Hospital.
- Currently undergoing pharmacological treatment at the time of admission.
Key exclusion criteria (1 listed)
- Patients placed in palliative therapy upon admission to the department due to incurability of the underlying pathologies
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 |
|---|---|---|
| medication review and deprescribingThe study protocol includes the following assessments: * T0: first data collection upon admission to the ward; * T1 assessment: pharmacological review at discharge. Subjects who meet all study eligibility criteria will come consecutively enrolled in the study during admission to the department (T0). By consulting the electronic health record, interviewing patients and family members and personal documentation, the following data will be collected: * Remote and immediate pathological history; * Family and social history; * Home therapy; * BRIEF-MPI. Home therapy and therapy suggested at discharge will be compared with the STOPPandSTART criteria to evaluate the prevalence of potential therapies inappropriate and to study possible interactions and contraindications pharmacological and for reporting possible adverse reactions to drugs. The prevalence and possible prevalence of each individual STOPPandSTART criterion will be assessed association with other variables of interest. | Drug | – |
Primary outcome
Prevalence of Potentially Inappropriate Prescriptions (PIP) (%)
Time frame: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4
Percentage of elderly patients with at least one potentially inappropriate prescription identified at hospital admission (day 0) and at discharge (day 1) in the acute geriatric ward, based on the STOPP criteria. The measurement is performed by comparing the patient's medication regimen with the recommendations provided in the STOPP criteria.
Prevalence of Potentially Omitted Prescriptions (PPO) (%)
Time frame: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4
Percentage of elderly patients with at least one potentially omitted prescription identified at hospital admission (day 0) and at discharge (day 1) in the acute geriatric ward, based on the START criteria. The measurement is based on the absence of indicated medications according to the START criteria recommendations.
3 secondary outcomes
Prevalence of Pharmacological Interactions (%)
Time frame: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4
Post-Discharge Destination (Binary Variable)
Time frame: Data collected at time Day 0 is analyzed by day 4.
Presence of Geriatric Syndromes (Yes/No)
Time frame: Data collected at time Day 0 is analyzed by day 4.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
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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.
Luca Pellizzari Dr. Pellizzari, DR principal investigator
Regione del Veneto - AULSS n. 7 Pedemontana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polypharmacy (People Under Treatment With 5 or More Drugs) and Elderly (People Aged 65 or More), run by Regione del Veneto - AULSS n. 7 Pedemontana at 1 site in Italy.
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 1 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: finished, as of the sponsor's last update on 2 Oct 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of Potentially Inappropriate Prescriptions (PIP) (%) (time frame: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4). The study lists 2 primary outcomes in all. 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 2 Oct 2025.