Global Medical Assessment of Elderly Frail PatientsOMAGENCT00450034
Optimization of Drug Treatment in Hospitalized Elderly (OMAGE)
A study testing drug - oriented multifaceted intervention in people with Global Medical Assessment of Elderly Frail Patients, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A randomized trial has been designed to determine if this complex intervention can significantly decrease the risk of unplanned readmissions in this very elderly population, compared with usual care. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Global Medical Assessment of Elderly Frail Patients
- What is being tested?
- drug - oriented multifaceted intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 665 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Jun 2009
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients hospitalized as a matter of urgency in unity(unit) of geriatrics acute
- Patients of more than 70 years old
- Hospitalization in the Unity(Unit) of Geriatrics foreseen(planned) superior acute in 5 days
- enlightened assent writing and signed
- preliminary medical examination
Who cannot join
- Patients in scheduled(programmed) hospitalization
- Patient in palliative care
- Patient whose vital forecast is engaged(opened) in 3 months
- Patient already include during a previous hospitalization Patient already included in a study concerning the therapeutic care
- Followed medical impossible (refusal of care, absence of alive regular, patient doctor abroad)
- not membership to a regime of Social Security or CMU
- Patient not speaking French
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Optimization of Drug Treatment of Elderly Admitted in 4 Acute Geriatric Wards : Randomized Trial
A randomized trial has been designed to determine if this complex intervention can significantly decrease the risk of unplanned readmissions in this very elderly population, compared with usual care.
Read the detailed description
Drug treatment in elderly is not yet optimal. 20 to 30% of admissions of elderly aged over 80 are related to drug problems, most of them being preventable. To decrease drug related hospitalizations need iatrogenic prevention, compliance improvement, and underuse decrease. A multifaceted intervention has been designed, included three dimensions : 1/ drug optimization 2/ patient and/or caregiver education and 3/ better coordination with home health professionals before discharge.
A randomized trial has been designed to determine if this complex intervention can significantly decrease the risk of unplanned readmissions in this very elderly population, compared with usual care.
- Being tested
- drug - oriented multifaceted intervention
- Keywords
- Frail Elderly, Patient Education, Drug optimization, Underuse, Vulnerable, Drug related hospitalization, Medical intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug - oriented multifaceted interventionProcedure or surgery
oriented multifaceted intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: drug - oriented multifaceted intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of unplanned readmissions, including emergency consultations,
Measured: during the study
Secondary outcomes (4)
Mortality at 6 months,
Measured: at 6 months
delay before readmission,
Measured: before readmission
number of drug events related readmissions.
Measured: readmissions
Data collected at 3 and 6 months
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2009
- Study completionJun 2009
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 Global Medical Assessment of Elderly Frail PatientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 665 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvie LEGRAIN, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450034
- Sponsor's protocol ID
- P060247
- Acronym
- OMAGE
- Status last verified
- Mar 2007
- First submitted
- 19 Mar 2007
- Last updated
- 1 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Legrain S, Tubach F, Bonnet-Zamponi D, Lemaire A, Aquino JP, Paillaud E, Taillandier-Heriche E, Thomas C, Verny M, Pasquet B, Moutet AL, Lieberherr D, Lacaille S. A new multimodal geriatric discharge-planning intervention to prevent emergency visits and rehospitalizations of older adults: the optimization of medication in AGEd multicenter randomized controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2017-28. doi: 10.1111/j.1532-5415.2011.03628.x. Epub 2011 Sep 27.
PubMed 22091692
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Optimization of Drug Treatment of Elderly Admitted in 4 Acute Geriatric Wards : Randomized Trial
- ClinicalTrials.gov ID
- NCT00450034
- Acronym / sponsor ID
- OMAGE / P060247
- Keywords
- Frail Elderly, Patient Education, Drug optimization, Underuse, Vulnerable, Drug related hospitalization, Medical intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 665 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 21 Mar 2007 (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.
A randomized trial has been designed to determine if this complex intervention can significantly decrease the risk of unplanned readmissions in this very elderly population, compared with usual care.
Detailed description
Drug treatment in elderly is not yet optimal. 20 to 30% of admissions of elderly aged over 80 are related to drug problems, most of them being preventable. To decrease drug related hospitalizations need iatrogenic prevention, compliance improvement, and underuse decrease. A multifaceted intervention has been designed, included three dimensions : 1/ drug optimization 2/ patient and/or caregiver education and 3/ better coordination with home health professionals before discharge.
A randomized trial has been designed to determine if this complex intervention can significantly decrease the risk of unplanned readmissions in this very elderly population, compared with usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: drug - oriented multifaceted intervention |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients hospitalized as a matter of urgency in unity(unit) of geriatrics acute
- Patients of more than 70 years old
- Hospitalization in the Unity(Unit) of Geriatrics foreseen(planned) superior acute in 5 days
- enlightened assent writing and signed
- preliminary medical examination
Key exclusion criteria (7 listed)
- Patients in scheduled(programmed) hospitalization
- Patient in palliative care
- Patient whose vital forecast is engaged(opened) in 3 months
- Patient already include during a previous hospitalization Patient already included in a study concerning the therapeutic care
- Followed medical impossible (refusal of care, absence of alive regular, patient doctor abroad)
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 |
|---|---|---|
| drug - oriented multifaceted interventionoriented multifaceted intervention | Procedure or surgery | 1 |
Primary outcome
Rate of unplanned readmissions, including emergency consultations,
Time frame: during the study
4 secondary outcomes
Mortality at 6 months,
Time frame: at 6 months
delay before readmission,
Time frame: before readmission
number of drug events related readmissions.
Time frame: readmissions
Data collected at 3 and 6 months
Time frame: at 3 and 6 months
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 Dec 2011.
- Results publication: PubMed 22091692Legrain S, Tubach F, Bonnet-Zamponi D, Lemaire A, Aquino JP, Paillaud E, Taillandier-Heriche E, Thomas C, Verny M, Pasquet B, Moutet AL, Lieberherr D, Lacaille S. A new multimodal geriatric discharge-planning intervention to prevent emergency visits and rehospitalizations of older adults: the optimization of medication in AGEd multicenter randomized controlled trial. J Am Geriatr Soc. 2011 Nov;59(11):2017-28. doi: 10.1111/j.1532-5415.2011.03628.x. Epub 2011 Sep 27.
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.
Sylvie LEGRAIN, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug - oriented multifaceted intervention in people with Global Medical Assessment of Elderly Frail Patients, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 7 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 Dec 2011. 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?
Rate of unplanned readmissions, including emergency consultations, (time frame: during the study). 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 NCT00450034, 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 1 Dec 2011.