Inappropriate Prescribing in the Elderly

NCT06760728 | Completed

• 1 other identifier: 571CESC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prescriptions; Elderly (people Aged 65 or More); Hospitalized; Prevalence

Keywords

polypharmacotherapy; medication review; Drug interactions; elderly patients; deprescribin; STOPP/START criteria; of potentially inappropriate prescriptions (PIPs); potential omitted prescriptions (PPOs); PIPs; POPs; Hospital

Outcome Measures

Primary Outcomes (1)

• 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).

  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.

  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

  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.

  Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4

Study Arms (1)

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.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regione del Veneto - AULSS n. 7 Pedemontana: lead
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator

Study Sites (1)

Regione del Veneto - AULSS n. 7 Pedemontana

Santorso, Vicenza, 36014, Italy

Location

Study Officials

• Luca Pellizzari Dr. Pellizzari, DR

  Regione del Veneto - AULSS n. 7 Pedemontana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Geriatrics

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: January 7, 2025
• Study Start: July 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)