Ageing Clinical Trial
— OMAGE-POfficial title:
The OMAGE (Optimization of Medication in AGEd) Transitional Care-Pathway: Impact on Readmissions
Background : The transitional care OMAGE-P combines three best practices recommendations
from the French National Authority for Health (HAS) (i) a comprehensive review of diagnosis
and treatments (ii) a standardized medical report and (iii)a patient education program
specifically designed for older people with multiple chronic conditions and polypharmacy.
This transitional care is implemented in a pilot general hospital with the support of French
ministry of Health and Regional Agency for Health of Ile de France . The aim of the study is
to assess the impact of the OMAGE P transitional care on the readmissions of non demented
older people aged 75 years and over within the 3 months following their discharge to home
and its cost-effectiveness .
Study Population: non demented people aged 75 years and over admitted in emergency (ie via
an emergency department ) in the participating units
Study design:
Observational prospective monocentric non randomized comparative study Exposed patients:
eligible patients admitted in participating units and who does not oppose to the collection
of his personal data. The hospital physician in charge will conduct the comprehensive review
of diagnosis and treatments and will do the standardized medical report. Patient education
program will be conduct by the hospital physician and the OMAGE nurse during the
hospitalization (two sequences) and during 2 to 4 home visits in the month following patient
's discharge from hospital.
Non exposed patients: eligible patients from the usual care arm of the RCT OMAGE. To ensure
that risk for emergency readmissions is not different between exposed and non exposed , the
rate of emergency readmissions of non exposed group will be compared with the one of
eligible patient admitted in the participating units in 2013 and 2014.
Setting: General hospital of Eaubonne : geriatric department (acute geriatric unit,
rehabilitation unit , geriatric mobile unit ) and internal medicine department Number of
subjects to be included: 484 (242 in each arm). The data for the 242 non exposed patients
are still available, 242 patients has to be included in the exposed group
Status | Not yet recruiting |
Enrollment | 484 |
Est. completion date | January 2018 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 75 Years and older |
Eligibility |
Inclusion criteria: - Aged 75 years and over - Admitted in emergency (ie via an emergency unit) - Living in a pre-defined territory (surroundings of the Eaubonne hospital) - Not living in nursing home or no anticipated discharge in nursing home - Not suffering from dementia - Not receiving palliative care Non inclusion criteria - Patient's Opposition to collection of his personal data - Previous participation in the OMAGE-P study, - Inclusion in another therapeutic trial, - Not speaking french, - Impossible to follow up - Absence of any health insurance (as required by French law on clinical research). |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of days alive and without emergency readmissions | Emergency visits and mortality will be assessed in the same way as readmissions. Vital status of patients lost to follow-up will be assessed by By contacting the town hall of the born municipality. Drug related readmissions will be assessed by an expert committee who will adjudicate whether readmissions are drug related. The adjudication process will rely on medical hospital discharge reports for each readmission (and additional data on request, such as medical records, biological results, electrocardiographs) and will follow a standardized guide. Disagreements will be resolved by consensus between the experts. The items in the adjudication guide will include : cause(s) for readmission, ?nal diagnosis or diagnoses, imputability of drug related problems (ADRs, adherence problems, underuse) in the readmission. Death during readmission will be systematically adjudicated | up to 6 months after hospital discharge | Yes |
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