Drug Related ProblemDRPINPATNCT03476733
Incidence and Risk Factor of Drug Related Problem Detected in Inpatient
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 to dispensing stage. Lack of follow-ups and reassessment of therapeutic outcomes may also contribute to DRPs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Related Problem
- What is being tested?
- Detection of drug related problem in inpatient
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 1 Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 department during the study period and hospitalized for at least 24 hours
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
cyril BREUKER, c-breuker@chu-montpellier.fr
About this study
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 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 and achieving achieve the desired therapeutic outcomes. Pharmaceutical care identifies and resolves actual or potential DRPs.
DRPs pose a challenge to the clinician, and that may affect patient's clinical outcomes and may result in morbidity or mortality and increased health care costs. Health care costs may become a burden to the patient or may be to the government or to the third parties. Clinical Pharmacy is a discipline that promotes the quality use of medicines through evidence-based medicine and helps in identification and resolving DRPs. A clinical pharmacist through his/her clinical accuracy checking may identify DRPs and come out with suitable solutions to resolve the same.
Consequently, the aims of our study were to assess prevalence and characteristics of DRPs identified in inpatient and to identify factors associated with DRPs.
Read the detailed description
At admission, pharmaceutics' team (senior pharmacist, one resident and two pharmacy students), conducted medication reconciliation process within 24 hours of admission or on the first working day following admission for admissions during week-ends. 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. Each DRP highlighted by pharmaceutical team were collected and were classified regarding drug class and problem' types. For each patient with an identified DRP, the potential clinical impact was determined through a consensus of an expert panel: 2 pharmacists (1 hospital senior pharmacist and the resident) and 2 senior clinicians from the clinical department. The index used to rate the significance of the errors was based on the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index for categorizing medication errors and adapted to get 4 severity categories with the type of error that leads to this severity: very serious, serious, moderate and minor.
For each medication, we collected its name, dosage, dosage forms and frequency of administration. For each DRP, we collected the type of DRP, the drug classes (according to anatomical therapeutic chemical classification system) and the potential clinical impact for the patient.
- Conditions
- Drug Related Problem
- Being tested
- Detection of drug related problem in inpatient
- Keywords
- Drug related problem, inpatient, Medication Error, Clinical Pharmacist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of drug related problem in inpatientOther
Detection of drug related problem in inpatient
| Study group | Role | What they receive |
|---|---|---|
| patient with drug related problem | patient with drug related problem Receives: Other: Detection of drug related problem in inpatient | |
| patient without drug related problem | patient without drug related problem Receives: Other: Detection of drug related problem in inpatient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of drug related problems
Number of drug related problems identified in inpatient
Measured: 1 day
Secondary outcomes (1)
number of variable associated with drug related problems
number of variable associated with 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 posted26 Mar 2018
- Study start1 Jan 2016
- Primary completion1 Nov 2035 (estimated)
- Study completion1 Jan 2036 (estimated)
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.
- 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
- Prospective
- Enrolment
- 20,000 participants (estimated)
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
- NCT03476733
- Sponsor's protocol ID
- RECHMPL18_0135
- Acronym
- DRPINPAT
- Status last verified
- Jun 2020
- First submitted
- 19 Mar 2018
- Last updated
- 5 Jun 2020
- 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 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factor of Drug Related Problem Detected in Inpatient
- ClinicalTrials.gov ID
- NCT03476733
- Acronym / sponsor ID
- DRPINPAT / RECHMPL18_0135
- Conditions
- Drug Related Problem
- Keywords
- Drug related problem, inpatient, Medication Error, Clinical Pharmacist
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Nov 2035 (estimated)
- Study completion
- 1 Jan 2036 (estimated)
- First posted
- 26 Mar 2018 (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 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 and achieving achieve the desired therapeutic outcomes. Pharmaceutical care identifies and resolves actual or potential DRPs.
DRPs pose a challenge to the clinician, and that may affect patient's clinical outcomes and may result in morbidity or mortality and increased health care costs. Health care costs may become a burden to the patient or may be to the government or to the third parties. Clinical Pharmacy is a discipline that promotes the quality use of medicines through evidence-based medicine and helps in identification and resolving DRPs. A clinical pharmacist through his/her clinical accuracy checking may identify DRPs and come out with suitable solutions to resolve the same.
Consequently, the aims of our study were to assess prevalence and characteristics of DRPs identified in inpatient and to identify factors associated with DRPs.
Detailed description
At admission, pharmaceutics' team (senior pharmacist, one resident and two pharmacy students), conducted medication reconciliation process within 24 hours of admission or on the first working day following admission for admissions during week-ends. 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. Each DRP highlighted by pharmaceutical team were collected and were classified regarding drug class and problem' types. For each patient with an identified DRP, the potential clinical impact was determined through a consensus of an expert panel: 2 pharmacists (1 hospital senior pharmacist and the resident) and 2 senior clinicians from the clinical department. The index used to rate the significance of the errors was based on the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index for categorizing medication errors and adapted to get 4 severity categories with the type of error that leads to this severity: very serious, serious, moderate and minor.
For each medication, we collected its name, dosage, dosage forms and frequency of administration. For each DRP, we collected the type of DRP, the drug classes (according to anatomical therapeutic chemical classification system) and the potential clinical impact for the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient with drug related problem | – | Other: Detection of drug related problem in inpatientpatient with drug related problem |
| patient without drug related problem | – | Other: Detection of drug related problem in inpatientpatient without drug related problem |
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 department 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of drug related problem in inpatientDetection of drug related problem in inpatient | Other | patient with drug related problem, patient without drug related problem |
Primary outcome
Number of drug related problems
Time frame: 1 day
Number of drug related problems identified in inpatient
1 secondary outcome
number of variable associated with drug related problems
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- 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.
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: looking for participants now, as of the sponsor's last update on 5 Jun 2020. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyril BREUKER, PharmD,Phd (467337121 ext. 33, c-breuker@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of 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 5 Jun 2020.