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RecruitingNCT06904638Under-PRESUpdated Apr 1, 2025

Underprescribing in Geriatric Patients: a Prevalence Study and Analysis of Factors Contributing to Potential Prescription Omissions (Under-PRES)

An observational study in Older People, sponsored by Istituto Nazionale di Ricovero e Cura per Anziani. Recruiting at 2 sites in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Istituto Nazionale di Ricovero e Cura per Anziani · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
374
Ages
65 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Older People

Keywords

  • underprescription
  • START criteria
  • potential prescriptive omissions
03

In context

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani is the lead sponsor of 41 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Older patients at admission to a geriatric ward or at the time of outpatient geriatric visits

Inclusion criteria

  • Geriatric ward admission or outpatient geriatric appointment
  • Capacity to provide informed consent by the patient or legal guardian

Exclusion criteria

Exclusion Criteria:

  • Limited life expectancy as measured by the Clinical Frailty Scale (CFS) >8
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
374 participants (estimated)
Patient registry
No

Groups and cohorts

  • older adults

    Geriatric patients admitted to a geriatric hospital unit or attending an outpatient geriatric clinic

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: at baseline and 3 months later

07

Study locations

2 of 2 sites recruiting
  • IRCCS INRCA Hospital
    Ancona, 60127, Italy
    • Alessia Beccacece, PhD · Contact · a.beccacece@inrca.it
    • Antonio Cherubini, MD · Principal investigator
    Recruiting
  • IRCCS INRCA Hospital
    Cosenza, 87100, Italy
    • Luca Soraci, MD · Contact
    • Luca Soraci · Principal investigator
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06904638
Lead sponsor
Istituto Nazionale di Ricovero e Cura per Anziani
Responsible party
Sponsor
First posted
Apr 1, 2025
Start date
Jun 20, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 1, 2025

Study contacts

Anna Rita Bonfigli
Contact
a.bonfigli@inrca.it
0718003719
Antonio Cherubini, MD
study chair · IRCCS INRCA, Ancona, Italy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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