Polypharmacy and Associated Risk Factors and Clinical Outcomes for Surgical Patients Discharged From Hospital

Polypharmacy Clinical Trial

Official title:

Polypharmacy, Medication Appropriateness, Risk Factors, Clinical Outcomes and Predication on Medication Related Harm Post- Discharge From a Hospital for Surgical Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04805151
• Other study ID #: UI- 2021 polypharmacy
• Status: Active, not recruiting
• Start date: January 2, 2021
• Est. completion date: January 2, 2025

Study information

• Verified date: February 2024
• Source: University of Iceland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

This is an observational, retrospective, single centered study, using clinical data from the patient's medical record from the hospital, the national prescription database of the Directorate of Health, and the and ICD-10 codes from primary care records. For this analysis, medicines will be classified into drug classes based on the first five characters of their WHO Anatomical Therapeutic Chemical (ATC) code. The prevalence (pre) and incidence (post) of polypharmacy (≥5 or more regular medicines) and hyper-polypharmacy (≥10 regular medicines) will be calculated. Potentially inappropriate prescribing will be assessed in individuals ≥65 years applying Beers 2019, Start and Stopp 2014, explicit prescribing criteria. The analysis will be restricted to older individuals, as Beers criteria have not been validated in younger age groups. The anticholinergic burden will be assessed for all individuals ≥18 years will be assessed by applying the anticholinergic burden scale This stratification is important in order to deliver targeted interventions in resource-limited healthcare settings

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56000
• Est. completion date: January 2, 2025
• Est. primary completion date: June 2, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• General Surgery
• Polypharmacy

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Iceland	Faculty of Pharmaceutical Sciences	Reykjavik

Sponsors (2)

Lead Sponsor	Collaborator
University of Iceland	Landspitali University Hospital

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polypharmacy	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	Clinical variables associated with the prevalence and incidence of polypharmacy	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