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

February 8, 2024 updated by: University of Iceland

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

Active, not recruiting

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

56000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Reykjavik, Iceland
        • Faculty of Pharmaceutical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The study population is surgical patients in hospital settings. The cohort will include 100% of tertiary care surgical admissions in Iceland and 70-80% of secondary care in Iceland. The study population includes 56.000 number of participants.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Martin Sigurdsson, MD PhD, University of Iceland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2021

Primary Completion (Estimated)

June 2, 2024

Study Completion (Estimated)

January 2, 2025

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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