Drug Related ProblemEvalMedReportNCT04165889
Hospital Medication Report
An observational study of Drug Related Problem, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Drug Related Problem (DRP) is defined as an event that may potentially affect the health outcomes in the patients. DRPs can occur at all stages of the medication usage process starting from prescribing (included medication error and inappropriate prescription) to dispensing stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Related Problem
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2019to 1 Feb 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 hospitalized in Montpellier University hospital.
Who may be able to join
- Patients aged above 18 years old, admitted to the medicine unit during the study period and hospitalized for at least 24 hours
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Establishment of a Hospital Medication Report for Pharmacists and General Practitioners
Drug Related Problem (DRP) is defined as an event that may potentially affect the health outcomes in the patients. DRPs can occur at all stages of the medication usage process starting from prescribing (included medication error and inappropriate prescription) to dispensing stage. Lack of follow-ups and reassessment of therapeutic outcomes may also contribute to DRPs. Pharmaceutical care is a co-operative activity in concert with other health care professionals and offered directly to the patient for improved quality use of medicines. Pharmaceutical care identifies and resolves actual or potential DRPs.
In our clinical practice, during the patient admission in internal medicine unit, a medication reconciliation process was conducted according to a validated protocol. The first step consists of getting the Best Possible Medication History (BPMH), defined as the most comprehensive list of all medications taken by the patient. The second step consists of comparing the BPMH with admission prescription made by the physician in charge. During pharmacist interview, pharmacist discussed about medication adherence and knowledge. The third step consists of characterizing, solving and documenting DRPs.
Read more
During the patient's hospitalization, the pharmacist participates at the medication prescription revision. At the discharge of hospitalization, a pharmaceutical standardised interview is carried out during which the pharmacist explains the modifications of treatments to the patient. During this interview, the hospital pharmacist updates the latest treatment changes. For patient with more than 65 years old and long-term affection (or patient with more than 75 years old with or without long-term affection) and 5 medications, the hospital pharmacist write a medication discharge report (MDR) to patient, community pharmacist and general practitioner.
For each medication, the investigators collected its name, dosage, dosage forms and frequency of administration. For each DRP, the investigators collected the type of DRP and the drug classes (according to anatomical therapeutic chemical classification system).
For each MDR, the investigators collected number of medication, number and type of DRP including inappropriate prescription.
- Conditions
- Drug Related Problem
- Keywords
- hospitalized in internal medicine unit, adult patient, Medication Error, Clinical Pharmacist
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with MDR
number of patients with MDR
Measured: 1 day
Secondary outcomes (1)
number of patients with MDR and DRP
number of patients with MDR and DRP
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 posted18 Nov 2019
- Study start1 May 2019
- Primary completion30 Dec 2019
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Related ProblemStudies 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
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyril BREUKER, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165889
- Sponsor's protocol ID
- RECHMPL19_0434
- Acronym
- EvalMedReport
- Status last verified
- Feb 2021
- First submitted
- 13 Nov 2019
- Last updated
- 24 Feb 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 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Establishment of a Hospital Medication Report for Pharmacists and General Practitioners
- ClinicalTrials.gov ID
- NCT04165889
- Acronym / sponsor ID
- EvalMedReport / RECHMPL19_0434
- Conditions
- Drug Related Problem
- Keywords
- hospitalized in internal medicine unit, adult patient, Medication Error, Clinical Pharmacist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 18 Nov 2019 (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 Problem (DRP) is defined as an event that may potentially affect the health outcomes in the patients. DRPs can occur at all stages of the medication usage process starting from prescribing (included medication error and inappropriate prescription) to dispensing stage. Lack of follow-ups and reassessment of therapeutic outcomes may also contribute to DRPs. Pharmaceutical care is a co-operative activity in concert with other health care professionals and offered directly to the patient for improved quality use of medicines. Pharmaceutical care identifies and resolves actual or potential DRPs.
In our clinical practice, during the patient admission in internal medicine unit, a medication reconciliation process was conducted according to a validated protocol. The first step consists of getting the Best Possible Medication History (BPMH), defined as the most comprehensive list of all medications taken by the patient. The second step consists of comparing the BPMH with admission prescription made by the physician in charge. During pharmacist interview, pharmacist discussed about medication adherence and knowledge. The third step consists of characterizing, solving and documenting DRPs.
During the patient's hospitalization, the pharmacist participates at the medication prescription revision. At the discharge of hospitalization, a pharmaceutical standardised interview is carried out during which the pharmacist explains the modifications of treatments to the patient. During this interview, the hospital pharmacist updates the latest treatment changes. For patient with more than 65 years old and long-term affection (or patient with more than 75 years old with or without long-term affection) and 5 medications, the hospital pharmacist write a medication discharge report (MDR) to patient, community pharmacist and general practitioner.
For each medication, the investigators collected its name, dosage, dosage forms and frequency of administration. For each DRP, the investigators collected the type of DRP and the drug classes (according to anatomical therapeutic chemical classification system).
For each MDR, the investigators collected number of medication, number and type of DRP including inappropriate prescription.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 hospitalized in Montpellier University hospital.
Key inclusion criteria (1 listed)
- Patients aged above 18 years old, admitted to the medicine unit during the study period and hospitalized for at least 24 hours
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of patients with MDR
Time frame: 1 day
number of patients with MDR
1 secondary outcome
number of patients with MDR and DRP
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 24 Feb 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 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 Drug Related Problem, 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 1 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 24 Feb 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?
number of patients with MDR (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 24 Feb 2021.