- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805151
Polypharmacy and Associated Risk Factors and Clinical Outcomes for Surgical Patients Discharged From Hospital
Polypharmacy, Medication Appropriateness, Risk Factors, Clinical Outcomes and Predication on Medication Related Harm Post- Discharge From a Hospital for Surgical Patients
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 surgical patients.
The study group hypothesise that pre-and post-operative polypharmacy and potentially inappropriate prescribing is common, especially among older patients, patients with a high comorbidity and frailty burden, and patients undergoing more complicated surgery. Our hypothesis is additionally that preoperative polypharmacy and potentially inappropriate prescribing is associated with a higher short- and long-term mortality, a longer primary hospitalization length of stay, and a higher risk of readmission.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
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:
- Participants: surgery patients ≥18 years in admitted to Landspitali University Hospital over the period 2010-2018.
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 |
---|---|---|
Polypharmacy
Time Frame: 2010-2018
|
Prevalence of polypharmacy (≥5 or more regular medicines) and hyper-polypharmacy (≥10 regular medicines) pre-admission and prevalence and incidence post-discharge for surgery patients ≥18 years in Iceland
|
2010-2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical variables associated with the prevalence and incidence of polypharmacy
Time Frame: 2010-2018
|
Clinical variables associated with the prevalence and incidence of polypharmacy and hyper-polypharmacy for the surgery patients ≥18 years in Iceland. Prevalence of potentially inappropriate prescribing amongst patients ≥65 years in Iceland by applying Beers 2019 and Start and Stopp explicit prescribing criteria. To investigate the association of potentially inappropriate prescribing with polypharmacy, patient-specific factors, drug classes, and outcomes. Prevalence of anticholinergic burden by applying the Anticholinergic burden scale in individuals aged ≥18 years in Iceland and investigate the association of anticholinergic burden with polypharmacy, patient-specific factors, drug classes (ACD-codes), and selected outcomes (temporary admission, long-term mortality, time to readmission) |
2010-2018
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Martin Sigurdsson, MD PhD, University of Iceland
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- 2021 polypharmacy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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