Potentially Inappropriate MedicationsOPMEDNCT01947270
Multidisciplinary Program "Optimization of Drug Prescription" : Impact on the Quality of Drug Prescription in Hospitalized Elderly Patients
An observational study of Potentially Inappropriate Medications, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Potentially Inappropriate Medications
- What is being tested?
- " Optimisation de la Prescription MEDicamenteuse " ("Optimization of drug prescribing")
- How many people
- 3,055 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Jun 2017
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Hospitalized elderly patients from 75 years old.
Who may be able to join
- Male or female subject aged over 75 years hospitalized in one of the participating department
- Patient agreed to participate
Who cannot join
- Patient with a predictive length of stay equal or less than 48 hours
- Patients admitted in terminal illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Potentially Inappropriate Medications
- Being tested
- " Optimisation de la Prescription MEDicamenteuse " ("Optimization of drug prescribing")
- Keywords
- Potentially inappropriate medications, Elderly, Prevention, Multidisciplinary program, Checklist, Stepped wedge design, AGED, 75 AND OVER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
" Optimisation de la Prescription MEDicamenteuse " ("Optimization of drug prescribing")Other
The multidisciplinary intervention program include:
- Awareness and training of doctors by two experts (a geriatrician and a pharmacist) within participating departments.
- Implementation of a checklist which aims to conduct an adapted and standardized pharmaceutical analysis
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| Intervention group | Patients of this group are hospitalized in a time frame where the multidisciplinary intervention program is implemented in the medical department. Receives: Other: " Optimisation de la Prescription MEDicamenteuse " ("Optimization of drug prescribing") |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of potentially inappropriate medications (PIM) prescribed in discharge of hospitalized patients from 75 years old.
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.
Measured: at discharge (average 3 weeks)
Secondary outcomes (4)
Total number of drugs prescribed per discharge prescription sheet
Measured: at discharge (average 3 weeks)
Number of rehospitalization within 12 months following discharge
Measured: 12 months after inclusion
Number of emergency admission within 12 months following hospitalization
Measured: 12 months after inclusion
Mortality within 12 months after hospitalization
Measured: 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Inappropriate MedicationsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 3,055 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947270
- Sponsor's protocol ID
- D50789
- Acronym
- OPMED
- Status last verified
- Sep 2017
- First submitted
- 26 Jul 2013
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPMED STUDY: Multidisciplinary Program "Optimization of Drug Prescription" : Impact on the Quality of Drug Prescription in Hospitalized Elderly Patients
- ClinicalTrials.gov ID
- NCT01947270
- Acronym / sponsor ID
- OPMED / D50789
- Conditions
- Potentially Inappropriate Medications
- Keywords
- Potentially inappropriate medications, Elderly, Prevention, Multidisciplinary program, Checklist, Stepped wedge design, AGED, 75 AND OVER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,055 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Sep 2013 (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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| Intervention group | – | Other: " Optimisation de la Prescription MEDicamenteuse " ("Optimization of drug prescribing")Patients of this group are hospitalized in a time frame where the multidisciplinary intervention program is implemented in the medical department. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Hospitalized elderly patients from 75 years old.
Key inclusion criteria (2 listed)
- Male or female subject aged over 75 years hospitalized in one of the participating department
- Patient agreed to participate
Key exclusion criteria (2 listed)
- Patient with a predictive length of stay equal or less than 48 hours
- Patients admitted in terminal illness
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 |
|---|---|---|
| " Optimisation de la Prescription MEDicamenteuse " ("Optimization of drug prescribing")The multidisciplinary intervention program include: * Awareness and training of doctors by two experts (a geriatrician and a pharmacist) within participating departments. * Implementation of a checklist which aims to conduct an adapted and standardized pharmaceutical analysis | Other | Intervention group |
Primary outcome
Proportion of potentially inappropriate medications (PIM) prescribed in discharge of hospitalized patients from 75 years old.
Time frame: at discharge (average 3 weeks)
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.
4 secondary outcomes
Total number of drugs prescribed per discharge prescription sheet
Time frame: at discharge (average 3 weeks)
Number of rehospitalization within 12 months following discharge
Time frame: 12 months after inclusion
Number of emergency admission within 12 months following hospitalization
Time frame: 12 months after inclusion
Mortality within 12 months after hospitalization
Time frame: 12 months after inclusion
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 28 Sep 2017.
Related trials for Potentially Inappropriate Medications
RecruitingObservational study
PIM Incidence in Older Cardiovascular Patients During COVID-19 Pandemics
Potentially Inappropriate Medications
Recruiting
e-ALIGN: A Patient Portal-based Intervention to Align Medications With What Matters Most
Dementia, Potentially Inappropriate Medication Use
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Potentially Inappropriate Medications, run by Hospices Civils de Lyon 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 2 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 28 Sep 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?
Proportion of potentially inappropriate medications (PIM) prescribed in discharge of hospitalized patients from 75 years old. (time frame: at discharge (average 3 weeks)). 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 28 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.