Ageing Clinical Trial
Official 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
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 (Legrain et
al, JAGS, 2011). 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 The OMAGE-P
transitional care: this transitional care is derived from the OMAGE intervention, which has
proved to be associated with a significant reduction of readmitted patient 3 month after
their discharge from acute geriatric unit (, 20.2% of Intervention group participants had
been readmitted on an emergency basis, compared with 28.4% of control group participants, P
= .01, RRR = 28.9%, 95% CI = 6.0-51.5%, Legrain et al JAGS 2011). The OMAGE -P transitional
care consisted in (i) a comprehensive review of diagnosis and treatments, performed by
hospital physician. The physician of participating units have been training to this medical
review using a simple tool derived from a HAS program for the optimization of prescription
in elderly. This tool consists in a table confronting patient's health problems and its
treatments . This review necessitate an in depth treatments history (performed by physician
in collaboration with usual patient's pharmacist ), a collaboration with general
practitioner and an assesment of patient's problems regarding drug management (including
adherence, self-medication ..etc) performed by the OMAGE nurse.
(ii) a standardized medical report. This report relies on the HAS recommendations regarding
medical report which include notably a table indicating drugs at admission, drugs at
discharge and reasons for modifications.
(iii) a patient education program specifically designed for older people with multiple
chronic conditions and polypharmacy . This program aimed to promote the participant as
active partners in care by assessing the participants' health priorities (preferences,
values, and treatment burden) and strengthening participants' ability to better manage their
own follow-up. It consists in two sequences at hospital (educational assessment by OMAGE
nurse and sequence about links between patient's health problems by hospital physician) and
2 to 4 sequences during home visits by OMAGE nurse about red flags and situations at risk
for patient's health, drug management and nutrition and physical activities adapted to
patient's health. The OMAGE nurse performs this visits in close collaboration with GP and
usual health professionals implicate din patient's care.
Statistical analysis: intention to treat analysis . Our hypothesis, based on the results of
the OMAGE RCT, is that the OMAGE P transitional care is associated with a reduction in
3-month emergency readmissions from 30% to 20%. To detect such reduction with 80% power and
an alpha risk of 5%, 242 participants are required per arm.
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