NCT04805151

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 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2025

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

3.4 years

First QC Date

March 15, 2021

Last Update Submit

February 8, 2024

Conditions

Keywords

PolypharmacyPotentially inappropriate medication listDrug-related side effects and adverse reactionReadmissionPatient dischargePrediction toolStart and stopInappropriate PrescribingGeneral surgeryBeers criteriaSTOPP START criteria

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Clinical variables associated with the prevalence and incidence of polypharmacy

    2010-2018

Interventions

No intervention

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Participants: surgery patients ≥18 years in admitted to Landspitali University Hospital over the period 2010-2018.

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, Guethmundsson A, Bates I, Stevenson JM, Sigurethsson MI. Epidemiology and association with outcomes of polypharmacy in patients undergoing surgery: retrospective, population-based cohort study. BJS Open. 2023 May 5;7(3):zrad041. doi: 10.1093/bjsopen/zrad041.

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Martin Sigurdsson, MD PhD

    University of Iceland

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 18, 2021

Study Start

January 2, 2021

Primary Completion

June 2, 2024

Study Completion

January 2, 2025

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations