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Completed

NCT Number: NCT06760728

Inappropriate Prescribing in the Elderly

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Regione del Veneto - AULSS n. 7 Pedemontana

Santorso, Vicenza, 36014, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of inappropriate prescribing in elderly patients at admission to an acute care hospital using STOPP/START criteria

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

    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).

Secondary outcomes

  1. Prevalence of inappropriate prescribing in elderly patients at discharge from an acute care hospital using STOPP/START criteria.

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

    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.
  2. Percentage of cases in which inappropriate prescribing will be detected at admission and discharge

    Time frame: 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 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.

  3. Association between the prevalence of inappropriate prescriptions and clinical variables, measured using univariate and multivariate regression.

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

    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.

Sponsors and collaborators

Lead sponsor

Regione del Veneto - AULSS n. 7 Pedemontana

Other

Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

Registry information

Official study title

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

Acronym: STOPP&START

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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