Medication AdherenceProtocoleV4NCT05951881
Comparative Study of the Performance of Drug Anamneses in an Emergency Department
An observational study of Medication Adherence, run by Grand Hôpital de Charleroi at 1 site in Belgium.
Trial summary
After the first medical history by the nurse and the emergency physician, the pharmacist and the pharmacy assistant take a detailed history of the patient's medications separately. After checking with the patient's reference pharmacy, the pharmacist and pharmacy assistant compare their results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Emergency Care Unit - medicines
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Feb 2023to 15 Oct 2023
- 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: This research is aimed at patients admitted to the emergency department of the Saint-Joseph site. All patients over 18 years of age who are capable of giving informed consent and who are taking several medications prior to their admission to the emergency department.
Who may be able to join
- Admission to the emergency care unit
- Over 18 years old
- Giving consent to participate
Who cannot join
- Patients who do not take medication daily
- Unconscious patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between a Pharmacy Technician and a Pharmacist in the Performance of Medication Anamneses in Emergency Departments: a Skills Validation Study
After the first medical history by the nurse and the emergency physician, the pharmacist and the pharmacy assistant take a detailed history of the patient's medications separately.
After checking with the patient's reference pharmacy, the pharmacist and pharmacy assistant compare their results.
- Conditions
- Medication Adherence
- Being tested
- Emergency Care Unit - medicines
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Care Unit - medicinesOther
The same group of patients admitted to the emergency room will respond separately to a pharmacist and a pharmacy assistant about their daily medication.
The two medical records will be compared in order to evaluate the work of the pharmacy assistant on the basis of 3 sources :
- the Electronic Medical Record
- the patient's medication history
- the reference pharmacy
| Study group | Role | What they receive |
|---|---|---|
| Urgent care unit patients with medication | All patients admitted to the emergency department who agree to describe their medication Receives: Other: Emergency Care Unit - medicines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of identical medication anamneses between pharmacist and pharmacy assistant
A pharmacist and a pharmacy assistant will compare the medication history of all patients who meet the eligibility criteria
Measured: immediately after admission to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start15 Feb 2023
- Primary completion15 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grand Hôpital de Charleroi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Rosart, Pharmacist, Principal investigator, Grand Hôpital de Charleroi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951881
- Sponsor's protocol ID
- Pharmacie - Protocole V4
- Acronym
- ProtocoleV4
- Status last verified
- Feb 2024
- First submitted
- 20 Mar 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between a Pharmacy Technician and a Pharmacist in the Performance of Medication Anamneses in Emergency Departments: a Skills Validation Study
- ClinicalTrials.gov ID
- NCT05951881
- Acronym / sponsor ID
- ProtocoleV4 / Pharmacie - Protocole V4
- Conditions
- Medication Adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Grand Hôpital de CharleroiUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 19 Jul 2023 (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.
After the first medical history by the nurse and the emergency physician, the pharmacist and the pharmacy assistant take a detailed history of the patient's medications separately.
After checking with the patient's reference pharmacy, the pharmacist and pharmacy assistant compare their results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urgent care unit patients with medication | – | Other: Emergency Care Unit - medicinesAll patients admitted to the emergency department who agree to describe their medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This research is aimed at patients admitted to the emergency department of the Saint-Joseph site. All patients over 18 years of age who are capable of giving informed consent and who are taking several medications prior to their admission to the emergency department.
Key inclusion criteria (3 listed)
- Admission to the emergency care unit
- Over 18 years old
- Giving consent to participate
Key exclusion criteria (2 listed)
- Patients who do not take medication daily
- Unconscious patients
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 |
|---|---|---|
| Emergency Care Unit - medicinesThe same group of patients admitted to the emergency room will respond separately to a pharmacist and a pharmacy assistant about their daily medication. The two medical records will be compared in order to evaluate the work of the pharmacy assistant on the basis of 3 sources : * the Electronic Medical Record * the patient's medication history * the reference pharmacy | Other | Urgent care unit patients with medication |
Primary outcome
Percentage of identical medication anamneses between pharmacist and pharmacy assistant
Time frame: immediately after admission to the emergency department
A pharmacist and a pharmacy assistant will compare the medication history of all patients who meet the eligibility criteria
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 23 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Laurence Rosart, Pharmacist principal investigator
Grand Hôpital de Charleroi
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 Medication Adherence, run by Grand Hôpital de Charleroi at 1 site in Belgium.
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 3 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 23 Feb 2024. 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 Belgium. 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?
Percentage of identical medication anamneses between pharmacist and pharmacy assistant (time frame: immediately after admission to the emergency department). 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 23 Feb 2024.