NCT05756400

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85,942

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 9, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

January 26, 2023

Last Update Submit

February 8, 2024

Conditions

Internal Medicine

Keywords

PolypharmacyPotentially Inappropriate Medication ListRisk FactorsCinical OutcomesPredication on Medication Related HarmDischargeInappropriate PrescribingDrug-related side effects and adverse reaction,ReadmissonPatient dischargePrediction toolStart and stopBeers

Outcome Measures

Primary Outcomes (1)

  • Prevalence of polypharmacy

    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).

    Two years, one year pre-admission and one year post-admisson, 2010-2020

Secondary Outcomes (7)

  • Incidence of polypharmacy

    Two years, one year pre-admission and one year post-admisson, 2010-2020

  • Potentially inappropriate prescribing by Beers criteria 2019

    2010-2020

  • Anticholinergic burden by applying the Anticholinergic burden scale

    2010-2020

  • Demographics

    2010-2020

  • Comorbidity burden

    2010-2020

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population is Internal medicine patients in hospital settings. The cohort will include 100% of tertiary care internal medicine admissions in Iceland and 70-80% of secondary care in Iceland. The study population includes 85942 number of participants.

You may qualify if:

  • 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

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Pharmaceutical Sciences

Reykjavik, Iceland

Location

Related Publications (1)

  • Jonsdottir F, Blondal AB, Gudmundsson A, Bates I, Stevenson JM, Sigurdsson MI. The association of degree of polypharmacy before and after among hospitalised internal medicine patients and clinical outcomes: a retrospective, population-based cohort study. BMJ Open. 2024 Mar 28;14(3):e078890. doi: 10.1136/bmjopen-2023-078890.

    PMID: 38548367DERIVED

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

March 6, 2023

Study Start

January 1, 2023

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

February 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations

IC(1)