- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05756400
Polypharmacy Among Internal Medicine Patients
Polypharmacy and Associated Risk Factors and Clinical Outcomes for Internal Medicine Patients Discharged From Hospital
The World Health Organisation Patient Safety Challenge: Medication Without Harm has brought our attention to the importance of medication-related harm as a global public health issue. One of the major contributing factors is polypharmacy, the usage of multiple medicines at the same time. People are getting older and living longer with chronic diseases; they need more medications, which frequently leads to polypharmacy. Subsequently, they are at more risk of medication-related harm. The planned project is an epidemiological study on polypharmacy, medication appropriateness, risk factors, and clinical outcomes post-discharge from a hospital for internal medicine patients.
The study group hypothesise that pre- and post-admission polypharmacy and potentially inappropriate prescribing is common, especially among older patients, patients with a high comorbidity and frailty burden. Our hypothesis is additionally that preadmission polypharmacy and potentially inappropriate prescribing is associated with higher short- and long-term mortality, a longer primary hospitalization length of stay, and a higher risk of readmission.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Reykjavik, Iceland
- Faculty of Pharmaceutical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Population-based cohort study that included all patients ≥18 years hospitalized in internal medicine ward at Landspitali - The National University Hospital of Iceland during the study period 1st January 2010 and 31st December 2020
Exclusion Criteria:
- Under 18 years of age
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of polypharmacy
Time Frame: Two years, one year pre-admission and one year post-admisson, 2010-2020
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Polypharmacy measured by by the number of different ATC classes of medications filled in the year preceding and year following surgery.
Polypharmacy further quantified into categories of non-polypharmacy (<5), polypharmacy (5-9) and hyper-polypharmacy (≥10).
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Two years, one year pre-admission and one year post-admisson, 2010-2020
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of polypharmacy
Time Frame: Two years, one year pre-admission and one year post-admisson, 2010-2020
|
Polypharmacy measured by by the number of different ATC classes of medications filled in the year preceding and year following surgery.
Polypharmacy further quantified into categories of non-polypharmacy (<5), polypharmacy (5-9) and hyper-polypharmacy (≥10).
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Two years, one year pre-admission and one year post-admisson, 2010-2020
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Potentially inappropriate prescribing by Beers criteria 2019
Time Frame: 2010-2020
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The association of potentially inappropriate prescribing by applying Beers criteria 2019 with polypharmacy (summary score, yes/no)
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2010-2020
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Anticholinergic burden by applying the Anticholinergic burden scale
Time Frame: 2010-2020
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The association of anticholinergic burden by applying the Anticholinergic burden scale with polypharmacy ((summary score, yes/no)
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2010-2020
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Demographics
Time Frame: 2010-2020
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Gender (male, female),age (years), comorbidity based on the International Statistical Classification of Diseases, and Related Health Problems, ninth or tenth revision, ICD9/10 classification system
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2010-2020
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Comorbidity burden
Time Frame: 2010-2020
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The association of comorbidity burden will be described by calculating the Charlson Comorbidity Index and Elixhauser comorbidity index (summary score) with polypharmacy ((summary score, yes/no)
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2010-2020
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Drug classes
Time Frame: 2010-2020
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Drug classes based on ATC-codes on filled medications from the Prescription Medicines Registry and association with polypharmacy
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2010-2020
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Clinical outcomes
Time Frame: 2010-2020
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Mortality (short-and long-term mortality) Length of hospital stay (number of days, ≥ ten days) Readmission (number of days until readmission, readmission <30 days)
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2010-2020
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- UI-2022-Polypharmacy-medicine
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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