PrescriptionsSTOPP&STARTNCT06760728
Inappropriate Prescribing in the Elderly
An observational study of Prescriptions and Elderly (people Aged 65 or More), run by Regione del Veneto - AULSS n. 7 Pedemontana at 1 site in Italy.
Trial summary
The management of pharmacotherapy in elderly patients is an increasingly critical aspect, as polypharmacy, combined with the pharmacokinetic and pharmacodynamic changes typical of aging, makes older adults more sensitive to the development of adverse reactions. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Prescriptions, Elderly (people Aged 65 or More), Hospitalized
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2015to 1 Aug 2016
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged ≥ 70 years admitted to a geriatric ward, regardless of ethnicity, gender, or type of illness, will also be considered eligible for enrollment.
Who may be able to join
- Patients aged ≥ 70 years admitted to a geriatric ward
- Regardless of ethnicity, gender, or type of illness
- Patients transferred from another ward
- Patients admitted to another ward for support
Who cannot join
- Patients in the terminal phase (<6 months life expectancy)
- Criteria for exit from the study (Dropout):
- Patients transferred to another hospital ward
- Patients who have deceased
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: Multicenter Observational Study on the Prevalence of Inappropriate Prescribing in Elderly Patients At Admission and Discharge from a Hospital Ward Using the STOPP/START Criteria
The management of pharmacotherapy in elderly patients is an increasingly critical aspect, as polypharmacy, combined with the pharmacokinetic and pharmacodynamic changes typical of aging, makes older adults more sensitive to the development of adverse reactions. This highlights the importance of appropriate use of pharmacotherapy that considers the risks and benefits of individual treatments. The aim of this study is to measure the prevalence of pharmacological appropriateness using the STOPP/START criteria (version 2) at admission and discharge from an acute geriatric ward, thereby evaluating the impact of hospitalization on medication prescribing.
- Keywords
- polypharmacotherapy, medication review, Drug interactions, elderly patients, deprescribin, STOPP/START criteria, of potentially inappropriate prescriptions (PIPs), potential omitted prescriptions (PPOs), PIPs, POPs, Hospital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STOPP/START Team | Patients over 70 years old admitted to a geriatric ward, regardless of ethnicity, gender, or type of illness, will be considered eligible for enrollment. Patients transferred from another ward or admitted on a support basis to another ward will also be considered eligible. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of inappropriate prescribing in elderly patients at admission to an acute care hospital using STOPP/START criteria
The analysis of inappropriate prescriptions at admission "Day 0" will be evaluated as a single outcome measure by aggregating data using the STOPP/START criteria. Specific assessments will be reported separately, as they involve different types of information and units of measure:
- Prevalence of inappropriate prescriptions: The proportion of patients with prescriptions deviating from STOPP/START criteria (%).
- Characteristics of patient history: Data such as active and passive diseases (count), place of origin (categorical variable), reason for admission (categorical variable), and presence of ADL support (binary variable: Yes/No).
- Clinical indicators: Charlson Comorbidity Index (numerical score), number of medications (count), presence of geriatric syndromes (binary variable: Yes/No).
- Mobility status: Whether the patient is bedridden or ambulatory (categorical variable).
- Hospitalization history: Number of admissions in the past year (count).
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 inappropriate prescribing in elderly patients at discharge from an acute care hospital using STOPP/START criteria.
This analysis focuses on the prevalence of inappropriate prescriptions at discharge "Day 1", defined according to adherence to or deviation from the recommendations specified in the STOPP/START criteria.
-Prevalence of Inappropriate Prescriptions (%): The proportion of patients with prescriptions deviating from the STOPP/START criteria.
-Destination After Discharge: Categorical variable (e.g., home alone, home with assistance, nursing home, rehabilitation unit).
- Length of Stay (Days)
- Presence of Geriatric Syndromes (delirium, cognitive decline, urinary ) during Hospitalization Unit of Measurement: Binary variable (Yes/No).
- Barthel Index at Discharge Unit of Measurement: Numerical score (in points). Description: The Barthel Index score at the time of discharge. Information for each outcome measure will be obtained from discharge letters and from the physician who cared for the patient for the majority of the hospitalization.
Measured: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4
Percentage of cases in which inappropriate prescribing will be detected at admission and discharge
Percentage of cases in which inappropriate prescriptions are identified at the time of admission "Day 0" and discharge "Day 1" for each of the individual STOPP/START criteria, i.e., for each of its recommendations.
Measured: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4
Association between the prevalence of inappropriate prescriptions and clinical variables, measured using univariate and multivariate regression.
The association between the prevalence of inappropriate prescriptions at the time of admission "Day 0" and discharge "Day 1" and clinical variables of interest (such as place of origin, level of care, comorbidities, polypharmacy, and multidimensional geriatric assessment) was analyzed using univariate and multivariate regression. The univariate regression explored the association of each variable with the prevalence of inappropriate prescriptions, while the multivariate regression was used to estimate the simultaneous effect of multiple variables, controlling for potential confounding factors.
Measured: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 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 posted7 Jan 2025
- Study start1 Jul 2015
- Primary completion1 Aug 2016
- Study completion1 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrescriptionsStudies 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
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Responsible party
- Principal investigator, Luca Pellizzari, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Luca Pellizzari Dr. Pellizzari, DR, Principal investigator, Regione del Veneto - AULSS n. 7 Pedemontana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760728
- Sponsor's protocol ID
- 571CESC
- Acronym
- STOPP&START
- Status last verified
- Jan 2025
- First submitted
- 13 Nov 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD must be submitted to local Ethical Committee
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study on the Prevalence of Inappropriate Prescribing in Elderly Patients At Admission and Discharge from a Hospital Ward Using the STOPP/START Criteria
- ClinicalTrials.gov ID
- NCT06760728
- Acronym / sponsor ID
- STOPP&START / 571CESC
- Keywords
- polypharmacotherapy, medication review, Drug interactions, elderly patients, deprescribin, STOPP/START criteria, of potentially inappropriate prescriptions (PIPs), potential omitted prescriptions (PPOs)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Regione del Veneto - AULSS n. 7 PedemontanaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 7 Jan 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.
The management of pharmacotherapy in elderly patients is an increasingly critical aspect, as polypharmacy, combined with the pharmacokinetic and pharmacodynamic changes typical of aging, makes older adults more sensitive to the development of adverse reactions. This highlights the importance of appropriate use of pharmacotherapy that considers the risks and benefits of individual treatments. The aim of this study is to measure the prevalence of pharmacological appropriateness using the STOPP/START criteria (version 2) at admission and discharge from an acute geriatric ward, thereby evaluating the impact of hospitalization on medication prescribing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STOPP/START Team | – | –Patients over 70 years old admitted to a geriatric ward, regardless of ethnicity, gender, or type of illness, will be considered eligible for enrollment. Patients transferred from another ward or admitted on a support basis to another ward will also be considered eligible. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged ≥ 70 years admitted to a geriatric ward, regardless of ethnicity, gender, or type of illness, will also be considered eligible for enrollment.
Key inclusion criteria (4 listed)
- Patients aged ≥ 70 years admitted to a geriatric ward
- Regardless of ethnicity, gender, or type of illness
- Patients transferred from another ward
- Patients admitted to another ward for support
Key exclusion criteria (4 listed)
- Patients in the terminal phase (<6 months life expectancy)
- Patients transferred to another hospital ward
- Patients who have deceased
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of inappropriate prescribing in elderly patients at admission to an acute care hospital using STOPP/START criteria
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 analysis of inappropriate prescriptions at admission "Day 0" will be evaluated as a single outcome measure by aggregating data using the STOPP/START criteria. Specific assessments will be reported separately, as they involve different types of information and units of measure: * Prevalence of inappropriate prescriptions: The proportion of patients with prescriptions deviating from STOPP/START criteria (%). * Characteristics of patient history: Data such as active and passive diseases (count), place of origin (categorical variable), reason for admission (categorical variable), and presence of ADL support (binary variable: Yes/No). * Clinical indicators: Charlson Comorbidity Index (numerical score), number of medications (count), presence of geriatric syndromes (binary variable: Yes/No). * Mobility status: Whether the patient is bedridden or ambulatory (categorical variable). * Hospitalization history: Number of admissions in the past year (count).
3 secondary outcomes
Prevalence of inappropriate prescribing in elderly patients at discharge from an acute care hospital using STOPP/START criteria.
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 cases in which inappropriate prescribing will be detected at admission and discharge
Time frame: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4
Association between the prevalence of inappropriate prescriptions and clinical variables, measured using univariate and multivariate regression.
Time frame: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 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 7 Jan 2025.
- Individual participant dataSharing planned: No. IPD must be submitted to local Ethical Committee
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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 Prescriptions 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 4 inclusion and 4 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 7 Jan 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 inappropriate prescribing in elderly patients at admission to an acute care hospital using STOPP/START criteria (time frame: Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4). 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 7 Jan 2025.