HospitalizationOPTI-PPNCT02614638
Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy
A study testing One month of department-wide observation and Pharm Tech participates in department in people with Hospitalization, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to evaluate the impact of the presence of a pharmacy technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalization
- What is being tested?
- One month of department-wide observation and Pharm Tech participates in department
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to 16 Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- The patient must be insured or beneficiary of a health insurance plan
- The patient is hospitalized in the Hepato-Gastroenterology Department of the Nîmes University Hospital
Who cannot join
- The patient is under judicial protection
- The patient, or his/her legal guardian, expresses opposition to participation in the study
- It is impossible to correctly inform the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy in the Hepato-Gastroenterology Department of the Nîmes University Hospital
The main objective of this study is to evaluate the impact of the presence of a pharmacy technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.
This is a before-after study consisting of three sequential phases:
Month 1: one month of observation of what is happening in the department Month 2: one month wash out period Month 3: active participation of a pharmacy technician in the department
Read the detailed description
The secondary objectives of this study are:
A- To assess the impact of the presence of a pharmacy technician on the ratio of the number of patients with at least one medication error / number of included patients hospitalized in the service.
B- To characterize detected medication errors.
C- To identify and evaluate the potential causes of medication errors.
D- To evaluate whether the presence of a pharmacy technician reduces nursing time spent on medication management.
E- To evaluate the economic impact of the presence of a pharmacy technician.
F- To evaluate the acceptability of the intervention by the nursing staff and pharmacy technicians using questionnaires.
- Conditions
- Hospitalization
- Being tested
- One month of department-wide observation, Pharm Tech participates in department
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One month of department-wide observationOther
A pharmacy technician will be present full time in the care unit from Monday to Friday between 8:30 and 17h for 1 month for observational purposes only. During this phase, the pharmacy technician observes the current practices of preparation and administration of medication by nurses. He / she will collect medication errors and other observational data.
Pharm Tech participates in departmentOther
Following a 1 month wash-out period, a pharmacy technician will again be present full time (in practice, two technicians will relay each other) in the care unit from Monday to Friday between 8:30 and 17h for 1 month. He/she will actively take part in drug care activities in the department: management of product pathways, verification of injectable preparation, advice, etc. Medication errors and other observational data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| 1st observational period (before experimental intervention) | Active comparator | Patients in this arm are included during a first month of observation before the intervention is implemented.
Intervention: One month of department-wide observation Receives: Other: One month of department-wide observation |
| 2nd obs. period (during experimental intervention) | Experimental | Following a one-month wash-out period, patients in this arm are included during a second month of observation during which the intervention is implemented.
Intervention: Pharm Tech participates in department Receives: Other: Pharm Tech participates in department |
What is being measured
The primary outcome is the main question the study is designed to answer.
The following ratio (relative units): Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission
Primary Outcome Measure as given in protocol: Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission (during month 1 versus during month 3).
Measured: 5 days
Secondary outcomes (26)
Number of patients with at least one medication error / total number of hospitalized patients included in the service
Measured: 5 days
For each medication error: the name of the drug
Measured: 5 days
For each medication error: the type of error
Errors are classifies as one of the following types:
Omission; Drug; Dosage form; Expired or damaged drug; Dose; Concentration; Frequency of administration; Administration technique; Route of Administration; Rate of administration; Duration of administration; Administration Time; Patient; Drug interaction.
Measured: 5 days
For each medication error: the severity index
Measured: 5 days
For each medication error: when (which step) the error occurred during the drug pathway
The considered steps are:
Writing the prescription Medical decision for the prescription Transcription Pharmaceutical analysis Deliverance Preparation / reconstitution Pillbox Administration Procurement Storage Compliance Therapeutic and clinical follow-up
Measured: 5 days
For each medication error: the evolution of the adverse drug event, if occurred
Measured: 5 days
For each medication error: the criticality of the error
Criticality is graded according to the following classes:
- C: no potential harm to the patient;
- D: treatment or increased monitoring without harm to the patient
- (E to I): potential harm to the patient
3E: treatment or surgery with temporary harm 3F: longer duration of hospitalization with temporary harm 3G: permanent harm 3H: involving a life-threatening harm 3I: death
Criticality is determined by the concordance of two, independent expert opinions; or, in case of discordance, the concordance of 2 out 3 expert opinions.
Measured: 5 days
The potential causes of medication errors
Measured: 5 days
The average number of interruptions per hour during preparation or administration of drug doses by nurses
Measured: 5 days
The number of patients for whom personal treatments were managed by the nursing staff on admission / number of patients who brought their personal treatments to the care unit
Measured: 5 days
The number of patients for whom personal treatments were returned by the nursing staff at hospital discharge / number of patients who brought their personal treatments to the care unit
Measured: 5 days
Nursing staff time dedicated to: the preparation of individual doses
Measured: 5 days
Nursing staff time dedicated to: ordering health products
Measured: 5 days
Nursing staff time dedicated to: stock management and exceptional orders
Measured: 5 days
Nursing staff time dedicated to: the delivery, receipt and storage of health products
Measured: 5 days
Nursing staff time dedicated to: cabinet inventories
Measured: 5 days
Nursing staff time dedicated to: the management of expired drugs
Measured: 5 days
The number of calls made to the central pharmacy
Measured: 5 days
Staff time dedicated to managing exceptional requests
Measured: 5 days
The number of drugs consumed
Measured: 5 days
The number of medical devices consumed
Measured: 5 days
The number of immobilized drugs
Measured: 5 days
The number of immobilized medical devices
Measured: 5 days
The cost of adverse drug events care
Measured: 5 days
Care staff satisfaction questionnaire
Measured: 5 days
Pharmacy technician satisfaction questionnaire
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startSep 2016
- Primary completion16 Dec 2016
- Study completion16 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Géraldine Leguelinel-Blache, PharmD, PhD, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614638
- Sponsor's protocol ID
- LOCAL/2015/GL-01
- Other IDs
- 2015-A01309-40
- Acronym
- OPTI-PP
- Status last verified
- Jan 2017
- First submitted
- 19 Nov 2015
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy in the Hepato-Gastroenterology Department of the Nîmes University Hospital
- ClinicalTrials.gov ID
- NCT02614638
- Acronym / sponsor ID
- OPTI-PP / LOCAL/2015/GL-01
- Conditions
- Hospitalization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 16 Dec 2016 (actual)
- Study completion
- 16 Dec 2016 (actual)
- First posted
- 25 Nov 2015 (estimated)
- 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.
The main objective of this study is to evaluate the impact of the presence of a pharmacy technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.
This is a before-after study consisting of three sequential phases:
Month 1: one month of observation of what is happening in the department Month 2: one month wash out period Month 3: active participation of a pharmacy technician in the department
Detailed description
The secondary objectives of this study are:
A- To assess the impact of the presence of a pharmacy technician on the ratio of the number of patients with at least one medication error / number of included patients hospitalized in the service.
B- To characterize detected medication errors.
C- To identify and evaluate the potential causes of medication errors.
D- To evaluate whether the presence of a pharmacy technician reduces nursing time spent on medication management.
E- To evaluate the economic impact of the presence of a pharmacy technician.
F- To evaluate the acceptability of the intervention by the nursing staff and pharmacy technicians using questionnaires.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st observational period (before experimental intervention) | Active comparator | Other: One month of department-wide observationPatients in this arm are included during a first month of observation before the intervention is implemented. Intervention: One month of department-wide observation |
| 2nd obs. period (during experimental intervention) | Experimental | Other: Pharm Tech participates in departmentFollowing a one-month wash-out period, patients in this arm are included during a second month of observation during which the intervention is implemented. Intervention: Pharm Tech participates in department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient must be insured or beneficiary of a health insurance plan
- The patient is hospitalized in the Hepato-Gastroenterology Department of the Nîmes University Hospital
Key exclusion criteria (3 listed)
- The patient is under judicial protection
- The patient, or his/her legal guardian, expresses opposition to participation in the study
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| One month of department-wide observationA pharmacy technician will be present full time in the care unit from Monday to Friday between 8:30 and 17h for 1 month for observational purposes only. During this phase, the pharmacy technician observes the current practices of preparation and administration of medication by nurses. He / she will collect medication errors and other observational data. | Other | 1st observational period (before experimental intervention) |
| Pharm Tech participates in departmentFollowing a 1 month wash-out period, a pharmacy technician will again be present full time (in practice, two technicians will relay each other) in the care unit from Monday to Friday between 8:30 and 17h for 1 month. He/she will actively take part in drug care activities in the department: management of product pathways, verification of injectable preparation, advice, etc. Medication errors and other observational data will be collected. | Other | 2nd obs. period (during experimental intervention) |
Primary outcome
The following ratio (relative units): Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission
Time frame: 5 days
Primary Outcome Measure as given in protocol: Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission (during month 1 versus during month 3).
26 secondary outcomes
Number of patients with at least one medication error / total number of hospitalized patients included in the service
Time frame: 5 days
For each medication error: the name of the drug
Time frame: 5 days
For each medication error: the type of error
Time frame: 5 days
For each medication error: the severity index
Time frame: 5 days
For each medication error: when (which step) the error occurred during the drug pathway
Time frame: 5 days
For each medication error: the evolution of the adverse drug event, if occurred
Time frame: 5 days
For each medication error: the criticality of the error
Time frame: 5 days
The potential causes of medication errors
Time frame: 5 days
The average number of interruptions per hour during preparation or administration of drug doses by nurses
Time frame: 5 days
The number of patients for whom personal treatments were managed by the nursing staff on admission / number of patients who brought their personal treatments to the care unit
Time frame: 5 days
The number of patients for whom personal treatments were returned by the nursing staff at hospital discharge / number of patients who brought their personal treatments to the care unit
Time frame: 5 days
Nursing staff time dedicated to: the preparation of individual doses
Time frame: 5 days
Nursing staff time dedicated to: ordering health products
Time frame: 5 days
Nursing staff time dedicated to: stock management and exceptional orders
Time frame: 5 days
Nursing staff time dedicated to: the delivery, receipt and storage of health products
Time frame: 5 days
Nursing staff time dedicated to: cabinet inventories
Time frame: 5 days
Nursing staff time dedicated to: the management of expired drugs
Time frame: 5 days
The number of calls made to the central pharmacy
Time frame: 5 days
Staff time dedicated to managing exceptional requests
Time frame: 5 days
The number of drugs consumed
Time frame: 5 days
The number of medical devices consumed
Time frame: 5 days
The number of immobilized drugs
Time frame: 5 days
The number of immobilized medical devices
Time frame: 5 days
The cost of adverse drug events care
Time frame: 5 days
Care staff satisfaction questionnaire
Time frame: 5 days
Pharmacy technician satisfaction questionnaire
Time frame: 5 days
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 1 Feb 2017.
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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.
Géraldine Leguelinel-Blache, PharmD, PhD study director
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One month of department-wide observation and Pharm Tech participates in department in people with Hospitalization, run by Centre Hospitalier Universitaire de Nīmes 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 2 inclusion and 3 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 1 Feb 2017. 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?
The following ratio (relative units): Number of medication errors / number of medications administered and omitted from among all those listed on the prescription for admission (time frame: 5 days). 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 1 Feb 2017.