- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01947270
Multidisciplinary Program "Optimization of Drug Prescription" : Impact on the Quality of Drug Prescription in Hospitalized Elderly Patients (OPMED)
OPMED STUDY: Multidisciplinary Program "Optimization of Drug Prescription" : Impact on the Quality of Drug Prescription in Hospitalized Elderly Patients
Drug prescription is a fundamental component of care for the elderly. Even if drugs are a chance for the older patient, because of changes in pharmacological, pharmacokinetic and pharmacodynamic parameters related with age and acute/or chronic pathologies, the risks associated with drug prescription, particularly those associated with potentially inappropriate medication (PIM), are increased in the elderly.
We suppose that many of hospitalized elderly have at least one prescribed medication without valid indication. Conversely, many diseases are currently undertreated in elderly patients: e.g. medicines used to treat heart failure and osteoporosis are underused in 20 to 70% of patients. Moreover, PMI prescription is associated with an increased of morbidity, mortality, risk of drug-related adverse events, utilization of health care system, care costs and impairment of quality of life. Thus, optimization of drug prescription is a major concern for improvement of the quality and safety of care in elderly.
The investigators' hypothesis is that a multidisciplinary program entitled "Optimisation de la Prescription MEDicamenteuse" ("Optimization of drug prescribing") focused on drug prescription optimization including a physician training to the specificity of the drug prescription in the elderly and a checklist allowing an adapted and standardized pharmaceutical analysis is effective in reducing PIM in elderly patients hospitalized in short-term medical and geriatric care departments.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Lyon, France, 69003
- Hospices civils de Lyon - Hôpital Edouard Herriot
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female subject aged over 75 years hospitalized in one of the participating department
- Patient agreed to participate
Exclusion Criteria:
- Patient with a predictive length of stay equal or less than 48 hours
- Patients admitted in terminal illness
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control group
Patients of this group are hospitalized in a time frame where the multidisciplinary intervention program is not implemented in the medical department.
Drug prescriptions are conducted under usual care in the department.
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Intervention group
Patients of this group are hospitalized in a time frame where the multidisciplinary intervention program is implemented in the medical department.
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The multidisciplinary intervention program include:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of potentially inappropriate medications (PIM) prescribed in discharge of hospitalized patients from 75 years old.
Time Frame: at discharge (average 3 weeks)
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Proportion of prescribed PIM will be expressed as the ratio of PIM to the total number of medication in discharge prescription sheet. PIM will be identified by 2 experts (1 doctor and 1 pharmacist) based on criteria from the lists STOPP/START and Laroche. |
at discharge (average 3 weeks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total number of drugs prescribed per discharge prescription sheet
Time Frame: at discharge (average 3 weeks)
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at discharge (average 3 weeks)
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Number of rehospitalization within 12 months following discharge
Time Frame: 12 months after inclusion
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12 months after inclusion
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Number of emergency admission within 12 months following hospitalization
Time Frame: 12 months after inclusion
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12 months after inclusion
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Mortality within 12 months after hospitalization
Time Frame: 12 months after inclusion
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12 months after inclusion
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D50789
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on " Optimisation de la Prescription MEDicamenteuse " ("Optimization of drug prescribing")
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Hospices Civils de LyonUnknownFunctional Autonomy LevelFrance