Older PeopleUnder-PRESNCT06904638
Underprescribing in Geriatric Patients: a Prevalence Study and Analysis of Factors Contributing to Potential Prescription Omissions (Under-PRES)
An observational study of Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites in Italy.
Trial summary
This observational study will determine the prevalence of underprescription in a cohort of elderly patients, recruited at the time of an outpatient geriatric visit, or hospitalized, upon admission to a geriatric ward. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Older People
- How many people
- 374 participants
- Where
- 2 sitesItaly
- Study dates
- 20 Jun 2024to 31 Dec 2026
- Phase
- Observational
- 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
Study population: Older patients at admission to a geriatric ward or at the time of outpatient geriatric visits
Who may be able to join
- Geriatric ward admission or outpatient geriatric appointment
- Capacity to provide informed consent by the patient or legal guardian
Who cannot join
- Limited life expectancy as measured by the Clinical Frailty Scale (CFS) >8
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS INRCA Hospital
Ancona, 60127
Alessia Beccacece, PhD, a.beccacece@inrca.it
Antonio Cherubini, MD
- Recruiting
IRCCS INRCA Hospital
Cosenza, 87100
Luca Soraci, MD
Luca Soraci
About this study
This observational study will determine the prevalence of underprescription in a cohort of elderly patients, recruited at the time of an outpatient geriatric visit, or hospitalized, upon admission to a geriatric ward.
Read the detailed description
Polypharmacy in older patients is associated with both inappropriate drug prescribing and underprescription or omission of appropriate medications. Potential prescriptive omission (PPO), defined as the underprescription of potentially beneficial drugs, is increasing across all care settings and is associated with adverse clinical outcomes. However, in some cases, PPO may represent a legitimate medical decision.
The aim of this study is to investigate the phenomenon of underprescription by differentiating between justified and inappropriate potential prescriptive omissions (PPOs) in elderly patients in both hospital and outpatient settings, using the Screening Tool to Alert to Right Treatment (START) criteria, version 3.
- Conditions
- Older People
- Keywords
- underprescription, START criteria, potential prescriptive omissions
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 |
|---|---|---|
| older adults | Geriatric patients admitted to a geriatric hospital unit or attending an outpatient geriatric clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of potential prescription omissions (PPOs)
Prevalence of potential prescription omissions (PPOs) will be evaluated by Screening Tool to Alert doctors to Right Treatment (START) criteria version 3 in aged patients enrolled on admission to geriatric departments of participating centers or during geriatric outpatient clinic visits
Measured: at baseline and 3 months later
Secondary outcomes (1)
Characterisation of the potential prescription omissions (PPOs)
The reasons for underprescription will be investigated to differentiate between justified and inappropriate potential prescriptive omissions (PPOs). Patients and/or their family members and/or the general practitioner will be interviewed to assess the potential reasons related to underprescription.
Measured: at baseline and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start20 Jun 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older PeopleStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Cherubini, MD, Study chair, IRCCS INRCA, Ancona, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904638
- Sponsor's protocol ID
- INRCA_004_2025
- Acronym
- Under-PRES
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 1 Apr 2025
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Underprescribing in Geriatric Patients: a Prevalence Study and Analysis of Factors Contributing to Potential Prescription Omissions (Under-PRES)
- ClinicalTrials.gov ID
- NCT06904638
- Acronym / sponsor ID
- Under-PRES / INRCA_004_2025
- Conditions
- Older People
- Keywords
- underprescription, START criteria, potential prescriptive omissions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Apr 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.
This observational study will determine the prevalence of underprescription in a cohort of elderly patients, recruited at the time of an outpatient geriatric visit, or hospitalized, upon admission to a geriatric ward.
Detailed description
Polypharmacy in older patients is associated with both inappropriate drug prescribing and underprescription or omission of appropriate medications. Potential prescriptive omission (PPO), defined as the underprescription of potentially beneficial drugs, is increasing across all care settings and is associated with adverse clinical outcomes. However, in some cases, PPO may represent a legitimate medical decision.
The aim of this study is to investigate the phenomenon of underprescription by differentiating between justified and inappropriate potential prescriptive omissions (PPOs) in elderly patients in both hospital and outpatient settings, using the Screening Tool to Alert to Right Treatment (START) criteria, version 3.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| older adults | – | –Geriatric patients admitted to a geriatric hospital unit or attending an outpatient geriatric clinic |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older patients at admission to a geriatric ward or at the time of outpatient geriatric visits
Key inclusion criteria (2 listed)
- Geriatric ward admission or outpatient geriatric appointment
- Capacity to provide informed consent by the patient or legal guardian
Key exclusion criteria (1 listed)
- Limited life expectancy as measured by the Clinical Frailty Scale (CFS) >8
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
Rate of potential prescription omissions (PPOs)
Time frame: at baseline and 3 months later
Prevalence of potential prescription omissions (PPOs) will be evaluated by Screening Tool to Alert doctors to Right Treatment (START) criteria version 3 in aged patients enrolled on admission to geriatric departments of participating centers or during geriatric outpatient clinic visits
1 secondary outcome
Characterisation of the potential prescription omissions (PPOs)
Time frame: at baseline and 3 months later
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 1 Apr 2025.
- 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.
Antonio Cherubini, MD study chair
IRCCS INRCA, Ancona, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Older People, run by Istituto Nazionale di Ricovero e Cura per Anziani at 2 sites 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: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Contact Anna Rita Bonfigli (0718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of potential prescription omissions (PPOs) (time frame: at baseline and 3 months later). 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 1 Apr 2025.