NCT06904638

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Jun 2024Dec 2026

Study Start

First participant enrolled

June 20, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

March 25, 2025

Last Update Submit

March 25, 2025

Conditions

Older People

Keywords

underprescriptionSTART criteriapotential prescriptive omissions

Outcome Measures

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

    at baseline and 3 months later

Secondary Outcomes (1)

  • Characterisation of the potential prescription omissions (PPOs)

    at baseline and 3 months later

Study Arms (1)

older adults

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS INRCA Hospital

Ancona, 60127, Italy

RECRUITING

IRCCS INRCA Hospital

Cosenza, 87100, Italy

RECRUITING

Study Officials

  • Antonio Cherubini, MD

    IRCCS INRCA, Ancona, Italy

    STUDY CHAIR

Central Study Contacts

Anna Rita Bonfigli

CONTACT

0718003719a.bonfigli@inrca.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2025

First Posted

April 1, 2025

Study Start

June 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)