Adverse Drug EventsDRP-ADNCT04692220
Drug-Related Problems : Focus on Age and Diabetes
An observational study of Adverse Drug Events, run by University Hospital, Montpellier at 1 site in France.
Trial 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... Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adverse Drug Events
- What is being tested?
- Detection of Adverse Drug Events or Drug-Related Problems
- How many people
- 27,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2011to 30 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population was composed of patient admitted in emergency department or medical units of Montpellier University hospital.
Who may be able to join
- Patients aged above 18 years old, admitted to the emergency department or hospital
Who cannot join
- Patients presenting acute psychological disturbance
- Patients that did not agree to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observatory of Drug-Related Problems: Impact of the Age and the Presence of Diabetes
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
Read more
- 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)
- Conditions
- Adverse Drug Events
- Being tested
- Detection of Adverse Drug Events or Drug-Related Problems
- Keywords
- Drug-Related Problems, Clinical Pharmacist, Elderly, Diabetes
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of Adverse Drug Events or Drug-Related ProblemsOther
Detection of Adverse Drug Events or Drug-Related Problems
| Study group | Role | What they receive |
|---|---|---|
| Patients with an Adverse Drug Events or Drug-Related Problems | Patients with an Adverse Drug Events or Drug-Related Problems Receives: 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 Receives: Other: Detection of Adverse Drug Events or Drug-Related Problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (1)
Number and type of Adverse Drug Events and Drug-Related Problems
Number and type of Adverse Drug Events and Drug-Related Problems
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Nov 2011
- Primary completion1 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug EventsStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyril BREUKER, PharmD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692220
- Sponsor's protocol ID
- RECHMPL20_0667
- Acronym
- DRP-AD
- Status last verified
- Oct 2021
- First submitted
- 28 Dec 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observatory of Drug-Related Problems: Impact of the Age and the Presence of Diabetes
- ClinicalTrials.gov ID
- NCT04692220
- Acronym / sponsor ID
- DRP-AD / RECHMPL20_0667
- Conditions
- Adverse Drug Events
- Keywords
- Drug-Related Problems, Clinical Pharmacist, Elderly, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2011 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with an Adverse Drug Events or Drug-Related Problems | – | Other: Detection of Adverse Drug Events or Drug-Related ProblemsPatients with 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 ProblemsPatients without an Adverse Drug Events or Drug-Related Problems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population was composed of patient admitted in emergency department or medical units of Montpellier University hospital.
Key inclusion criteria (1 listed)
- Patients aged above 18 years old, admitted to the emergency department or hospital
Key exclusion criteria (2 listed)
- Patients presenting acute psychological disturbance
- Patients that did not agree to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of Adverse Drug Events or Drug-Related ProblemsDetection of Adverse Drug Events or Drug-Related Problems | Other | Patients with an Adverse Drug Events or Drug-Related Problems, Patients without an Adverse Drug Events or Drug-Related Problems |
Primary outcome
Variables associated with the presence of an Adverse Drug Events or Drug-Related Problems
Time frame: 1 day
Variables associated with the presence of an Adverse Drug Events or Drug-Related Problems
1 secondary outcome
Number and type of Adverse Drug Events and Drug-Related Problems
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyril BREUKER, PharmD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Drug Events, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variables associated with the presence of an Adverse Drug Events or Drug-Related Problems (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.