Inappropriate Prescribing in the Elderly (STOPP&START)

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.

Study Overview

• Status: Completed
• Conditions: Prevalence; Hospitalized; Prescriptions; Elderly (people Aged 65 or More)

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Italy
  • Vicenza
    • Santorso, Vicenza, Italy, 36014
      • Regione del Veneto - AULSS n. 7 Pedemontana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Data collected at time Day 0 is analyzed by day 4. Data collected at time Day 1 is analyzed by day 4

Collaborators and Investigators

• Sponsor: Regione del Veneto - AULSS n. 7 Pedemontana
• Collaborators: Azienda Ospedaliera Universitaria Integrata Verona
• Investigators: Principal Investigator: Luca Pellizzari Dr. Pellizzari, DR, Regione del Veneto - AULSS n. 7 Pedemontana

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: January 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Hospital; Drug interactions; medication review; elderly patients; STOPP/START criteria; polypharmacotherapy; deprescribin; of potentially inappropriate prescriptions (PIPs); potential omitted prescriptions (PPOs); PIPs; POPs
• Other Study ID Numbers: 571CESC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD must be submitted to local Ethical Committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No