Emergency Service, HospitalNCT03955965
Medication Reconciliation in an Emergency Department: How to Prioritize Patients ?
An observational study of Emergency Service, Hospital and Medication Reconciliation, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients. This study aimed to identify risk factors of unintended medication discrepancies (UMD) in an emergency department. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emergency Service, Hospital, Medication Reconciliation
- What is being tested?
- Medication reconciliation
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 15 Nov 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018
Who may be able to join
- All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018
Who cannot join
- Patients transfered to another hospital right after the emergency department visit
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: OPTICONCIL: Implementation of Medication Reconciliation Process in an Emergency Department : Which Patients Should be Prioritized and How to Optimize Patients' Therapeutics?
Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients.
This study aimed to identify risk factors of unintended medication discrepancies (UMD) in an emergency department. Secondary objectives were to identify the number and type of UMD, correction rate of UMD and the impact of emergency department organisation on UMD.
Read the detailed description
Emergency patients are at high risk of medication errors, for different reasons: emergency admission, patients who don't know their at-home treatment (polymedicated, cognitive disorders, etc) and who don't have their medical prescriptions available.
Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients. However, prioritization is essential to ensure a better efficiency of pharmaceutical resources.
In our center, a pharmacy resident has been assigned to medication reconciliation in the emergency department since November 2017, in collaboration with a clinical pharmacist. Every morning, 3 to 4 patients benefit from medication reconciliation (patients who will be transfered to another unit within our hospital).
The main objective was to identify risk factors of unintended medication discrepancies (UMD) in order to prioritize patients who will benefit from this newly implemented activity.
Secondary objectives were to identify the number and type of UMD, correction rate of UMD and the impact of emergency department organisation on UMD.
All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018 were included. Were not included patients with a medication reconciliation performed but transfered to another hospital right after the emergency department visit.
This was a retrospective, monocentric, observational study. Number of patients required was 200. Variables collected were:
- demographics (age, sex, lifestyle, comorbidities),
- emergency care variables (date and time of medical care beginning, ambulance arrival, adressing type, medical prescriptions availability, main diagnosis, date and hour of medical prescriptions in the emergency department, prescriber (pharmacy/doctor), destination unit of patients)
- organizational variables (number of daily emergency visits, number of patients hospitalized within the emergency department),
- medical notes information on at-home treatment (number of missing information, of incorrect information, number of prescriptions in at-home treatment)
- medication reconciliation variables (date of medication reconciliation, number of sources of information needed, number of actual prescriptions in at-home treatment, number of intended medication discrepancies, number and type of UMD, time needed for medication reconciliation).
- Being tested
- Medication reconciliation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication reconciliationOther
No intervention was performed other than collecting data on patients' medical files
| Study group | Role | What they receive |
|---|---|---|
| Emergency patients with medication reconciliation | All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018 Receives: Other: Medication reconciliation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variables influencing the number of UMD in the emergency department
Variation of the number of UMD for each variable was measured to identify the impact of each factor on medication errors (linear regression). Variables measured were the variables described in the protocol section.
Measured: Nov2017-Apr2018
Secondary outcomes (3)
Number and type of UMD
Measured: Nov2017-Apr2018
Correction rate of UMD
Measured: Nov2017-Apr2018
Impact of organizational variables on the number of UMD
Measured: Nov2017-Apr2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start1 Apr 2018
- Primary completion1 May 2018
- Study completion15 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Service, HospitalStudies 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Corny, PharmD, Principal investigator, Pharmacy Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955965
- Sponsor's protocol ID
- OPTICONCIL
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 20 May 2019
- 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 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTICONCIL: Implementation of Medication Reconciliation Process in an Emergency Department : Which Patients Should be Prioritized and How to Optimize Patients' Therapeutics?
- ClinicalTrials.gov ID
- NCT03955965
- Acronym / sponsor ID
- OPTICONCIL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 20 May 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.
Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients.
This study aimed to identify risk factors of unintended medication discrepancies (UMD) in an emergency department. Secondary objectives were to identify the number and type of UMD, correction rate of UMD and the impact of emergency department organisation on UMD.
Detailed description
Emergency patients are at high risk of medication errors, for different reasons: emergency admission, patients who don't know their at-home treatment (polymedicated, cognitive disorders, etc) and who don't have their medical prescriptions available.
Medication reconciliation has proven its efficiency in improving patients' care, especially for emergency patients. However, prioritization is essential to ensure a better efficiency of pharmaceutical resources.
In our center, a pharmacy resident has been assigned to medication reconciliation in the emergency department since November 2017, in collaboration with a clinical pharmacist. Every morning, 3 to 4 patients benefit from medication reconciliation (patients who will be transfered to another unit within our hospital).
The main objective was to identify risk factors of unintended medication discrepancies (UMD) in order to prioritize patients who will benefit from this newly implemented activity.
Secondary objectives were to identify the number and type of UMD, correction rate of UMD and the impact of emergency department organisation on UMD.
All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018 were included. Were not included patients with a medication reconciliation performed but transfered to another hospital right after the emergency department visit.
This was a retrospective, monocentric, observational study. Number of patients required was 200. Variables collected were:
- demographics (age, sex, lifestyle, comorbidities),
- emergency care variables (date and time of medical care beginning, ambulance arrival, adressing type, medical prescriptions availability, main diagnosis, date and hour of medical prescriptions in the emergency department, prescriber (pharmacy/doctor), destination unit of patients)
- organizational variables (number of daily emergency visits, number of patients hospitalized within the emergency department),
- medical notes information on at-home treatment (number of missing information, of incorrect information, number of prescriptions in at-home treatment)
- medication reconciliation variables (date of medication reconciliation, number of sources of information needed, number of actual prescriptions in at-home treatment, number of intended medication discrepancies, number and type of UMD, time needed for medication reconciliation).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency patients with medication reconciliation | – | Other: Medication reconciliationAll patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018
Key inclusion criteria (1 listed)
- All patients who beneficiated from medication reconciliation in the emergency department between November 2017 and April 2018
Key exclusion criteria (1 listed)
- Patients transfered to another hospital right after the emergency department visit
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 |
|---|---|---|
| Medication reconciliationNo intervention was performed other than collecting data on patients' medical files | Other | Emergency patients with medication reconciliation |
Primary outcome
Variables influencing the number of UMD in the emergency department
Time frame: Nov2017-Apr2018
Variation of the number of UMD for each variable was measured to identify the impact of each factor on medication errors (linear regression). Variables measured were the variables described in the protocol section.
3 secondary outcomes
Number and type of UMD
Time frame: Nov2017-Apr2018
Correction rate of UMD
Time frame: Nov2017-Apr2018
Impact of organizational variables on the number of UMD
Time frame: Nov2017-Apr2018
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 20 May 2019.
- 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.
Jennifer Corny, PharmD principal investigator
Pharmacy Department
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 Emergency Service, Hospital and Medication Reconciliation, run by Fondation Hôpital Saint-Joseph 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 20 May 2019. 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 influencing the number of UMD in the emergency department (time frame: Nov2017-Apr2018). 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 20 May 2019.