NCT04692220

Brief Summary

Drug-Related Problems (DRP) are a variety of events or circumstances that can interfere with the expected results of a treatment. They may be due to the drug itself, its association with other treatments, its incompatibility with the patient, its misuse... When these situations result in harm, they are referred to as adverse drug events (ADEs). DRP and particularly ADE represent a major public health problem in healthcare institutions because of their impact on morbidity and health costs. DRPs are largely preventable and actions can be set up to detect and correct them. It is in this context that clinical pharmacy has expanded, with the development of new activities to help secure drug management. In our institution, the investigators have implemented several activities in different care services, including

  • medication reconciliation,
  • an ADE detection. These activities have interesting and encouraging results in terms of impact on the prevention of DRP. However, they can only be carried out on a limited number of patients, depending on the pharmaceutical resources available. The investigators therefore need tools to prioritize our activities on the most at-risk patients. In this study, the investigators seek to identify DRP risk factors and develop DRP risk scores, with the objective to improve the detection and even prevention of DRP. Translated with www.DeepL.com/Translator (free version)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2011

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

9.3 years

First QC Date

December 28, 2020

Last Update Submit

October 22, 2021

Conditions

Keywords

Drug-Related ProblemsClinical PharmacistElderlyDiabetes

Outcome Measures

Primary Outcomes (1)

  • Variables associated with the presence of an Adverse Drug Events or Drug-Related Problems

    Variables associated with the presence of an Adverse Drug Events or Drug-Related Problems

    1 day

Secondary Outcomes (1)

  • Number and type of Adverse Drug Events and Drug-Related Problems

    1 day

Study Arms (2)

Patients with an Adverse Drug Events or Drug-Related Problems

Patients with an Adverse Drug Events or Drug-Related Problems

Other: Detection of Adverse Drug Events or Drug-Related Problems

Patients without an Adverse Drug Events or Drug-Related Problems

Patients without an Adverse Drug Events or Drug-Related Problems

Other: Detection of Adverse Drug Events or Drug-Related Problems

Interventions

Detection of Adverse Drug Events or Drug-Related Problems

Patients with an Adverse Drug Events or Drug-Related ProblemsPatients without an Adverse Drug Events or Drug-Related Problems

Eligibility Criteria

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

Study population was composed of patient admitted in emergency department or medical units of Montpellier University hospital.

You may qualify if:

  • \- Patients aged above 18 years old, admitted to the emergency department or hospital

You may not qualify if:

  • Patients presenting acute psychological disturbance
  • Patients that did not agree to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsDiabetes Mellitus

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Cyril BREUKER, PharmD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 31, 2020

Study Start

November 1, 2011

Primary Completion

March 1, 2021

Study Completion

March 30, 2021

Last Updated

October 25, 2021

Record last verified: 2021-10

Locations