Patient Hospitalized in Internal Medicine UnitSCOREMENCT03422484
SCORE of Medication Error in Internal Medecin Unit
An observational study of Patient Hospitalized in Internal Medicine Unit, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Transfers between interfaces of care are recognized as a source of medication discrepancies, medication errors (MEs) and potentially adverse drug events. ME are very common at hospital and may have important clinical and economic consequences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Hospitalized in Internal Medicine Unit
- What is being tested?
- Detection and correction of medication error at hospital admission
- How many people
- 1,957 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2012to 1 Jan 2018
- 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 internal medecine unit of 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.
About this study
Official title: Developpemment of a Score to Assess Risk of Medication Errors in Internal Medecin Unit
Transfers between interfaces of care are recognized as a source of medication discrepancies, medication errors (MEs) and potentially adverse drug events. ME are very common at hospital and may have important clinical and economic consequences. The lack and loss of medication information and communication between health professionals at points of care transition may often lead to ME. According to the literature, up to two thirds of medication histories contain at least one error. Some studies have compared pharmaceutical team with physician or nurse on the detection of UMD or ME and have reported that pharmacists were one of the best health care providers to establish medication history. To improve medication safety and decrease MEs rate, several institutions have recommended to develop medication reconciliation at all transition points such as admission, transfer and discharge. Medication reconciliation is the process that compares a patient's medication order to all medications that the patient has been taking and should take at admission, transfer and discharge of hospitalization. Medication reconciliation programs led by pharmacists are effective to reduce medications discrepancies. However, studies evaluating the efficacy of medication reconciliation program are very heterogeneous in terms of populations, definitions and methodology. Thus, proportion of ME differs enormously between studies, ranging from under 10% to over 60% at admission of hospitalization. Elderly patients with their numerous comorbidities associated with polypharmacy, such as patients of internal medecin unit, are at high risk of ME and at risk of safety issues. However, medication reconciliation process is very time consuming with an average of 30 minutes by patient. Thereby, review of all inpatients within 24 hours of admissions is very difficult or impossible. Targeting "high-risk situation" and "high-risk patient" are crucial to detect ME before causing harm. Therefore, evaluating the risk of MEs and their potential consequences in specific population of internal medicine unit using a validated medication reconciliation process seems of utmost importance for internal medicine specialist clinical practice and the decrease of ME rate. Consequently, the aim of our study was to (i) evaluate the prevalence of ME in an internal medicine unit at admission of hospitalization, (ii) determine the type of medication involved and the potential clinical impact of ME and (iii) identify factors associated with a risk of ME and serious ME.
- Being tested
- Detection and correction of medication error at hospital admission
- Keywords
- Internal medecine unit, Medication Error, Clinical Pharmacist, Medication reconciliation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection and correction of medication error at hospital admissionOther
Detection and correction of medication error at hospital admission
| Study group | Role | What they receive |
|---|---|---|
| People with at least one medication error | People with at least one medication error at hospital admission Receives: Other: Detection and correction of medication error at hospital admission | |
| People without medication error at hospital admission | People without medication error at hospital admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of medication error
number of medication error at hospital admission detected by clinical pharmacist during medication reconciliation process
Measured: 1 day
Secondary outcomes (1)
number of variable associated to the risk of ME
number of variable associated to the risk of ME detected by logistic regression analysis
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 posted5 Feb 2018
- Study start1 May 2012
- Primary completion1 Nov 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Hospitalized in Internal Medicine UnitStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,957 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
- NCT03422484
- Sponsor's protocol ID
- RECHMPL18_0030
- Acronym
- SCOREME
- Status last verified
- Feb 2018
- First submitted
- 26 Jan 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Audurier Y, Roubille C, Manna F, Zerkowski L, Faucanie M, Macioce V, Castet-Nicolas A, Jalabert A, Villiet M, Fesler P, Lohan-Descamps L, Breuker C. Development and validation of a score to assess risk of medication errors detected during medication reconciliation process at admission in internal medicine unit: SCOREM study. Int J Clin Pract. 2021 Feb;75(2):e13663. doi: 10.1111/ijcp.13663. Epub 2020 Dec 14.
PubMed 32770845
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developpemment of a Score to Assess Risk of Medication Errors in Internal Medecin Unit
- ClinicalTrials.gov ID
- NCT03422484
- Acronym / sponsor ID
- SCOREME / RECHMPL18_0030
- Keywords
- Internal medecine unit, Medication Error, Clinical Pharmacist, Medication reconciliation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,957 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 5 Feb 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.
Transfers between interfaces of care are recognized as a source of medication discrepancies, medication errors (MEs) and potentially adverse drug events. ME are very common at hospital and may have important clinical and economic consequences. The lack and loss of medication information and communication between health professionals at points of care transition may often lead to ME. According to the literature, up to two thirds of medication histories contain at least one error. Some studies have compared pharmaceutical team with physician or nurse on the detection of UMD or ME and have reported that pharmacists were one of the best health care providers to establish medication history. To improve medication safety and decrease MEs rate, several institutions have recommended to develop medication reconciliation at all transition points such as admission, transfer and discharge. Medication reconciliation is the process that compares a patient's medication order to all medications that the patient has been taking and should take at admission, transfer and discharge of hospitalization. Medication reconciliation programs led by pharmacists are effective to reduce medications discrepancies. However, studies evaluating the efficacy of medication reconciliation program are very heterogeneous in terms of populations, definitions and methodology. Thus, proportion of ME differs enormously between studies, ranging from under 10% to over 60% at admission of hospitalization. Elderly patients with their numerous comorbidities associated with polypharmacy, such as patients of internal medecin unit, are at high risk of ME and at risk of safety issues. However, medication reconciliation process is very time consuming with an average of 30 minutes by patient. Thereby, review of all inpatients within 24 hours of admissions is very difficult or impossible. Targeting "high-risk situation" and "high-risk patient" are crucial to detect ME before causing harm. Therefore, evaluating the risk of MEs and their potential consequences in specific population of internal medicine unit using a validated medication reconciliation process seems of utmost importance for internal medicine specialist clinical practice and the decrease of ME rate. Consequently, the aim of our study was to (i) evaluate the prevalence of ME in an internal medicine unit at admission of hospitalization, (ii) determine the type of medication involved and the potential clinical impact of ME and (iii) identify factors associated with a risk of ME and serious ME.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with at least one medication error | – | Other: Detection and correction of medication error at hospital admissionPeople with at least one medication error at hospital admission |
| People without medication error at hospital admission | – | –People without medication error at hospital admission |
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 internal medecine unit of 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 and correction of medication error at hospital admissionDetection and correction of medication error at hospital admission | Other | People with at least one medication error |
Primary outcome
number of medication error
Time frame: 1 day
number of medication error at hospital admission detected by clinical pharmacist during medication reconciliation process
1 secondary outcome
number of variable associated to the risk of ME
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 Apr 2018.
- Derived from this study: PubMed 32770845Audurier Y, Roubille C, Manna F, Zerkowski L, Faucanie M, Macioce V, Castet-Nicolas A, Jalabert A, Villiet M, Fesler P, Lohan-Descamps L, Breuker C. Development and validation of a score to assess risk of medication errors detected during medication reconciliation process at admission in internal medicine unit: SCOREM study. Int J Clin Pract. 2021 Feb;75(2):e13663. doi: 10.1111/ijcp.13663. Epub 2020 Dec 14.
- Individual participant dataSharing planned: Undecided. NC
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 Patient Hospitalized in Internal Medicine Unit, 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 Apr 2018. 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 medication error (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03422484, which also lists 1 linked publication.
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 Apr 2018.