The OMAGE (Optimization of Medication in AGEd) Transitional Care-Pathway: Impact on Readmissions
NCT ID: NCT02657642
Last Updated: 2016-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
484 participants
OBSERVATIONAL
2016-01-31
2018-01-31
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1 (exposed)
cohort 1: patients who will receive the OMAGE-P transitional care in geriatric or internal medicine departement of the Eaubonne Hospital
No interventions assigned to this group
Cohort 2 (non exposed)
Cohort 2: : patients included in the usual care arm of the OMAGE RCT study in 2007-2008
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
75 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Sylvie Legrain, Professor
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Central Contacts
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Other Identifiers
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15-086
Identifier Type: -
Identifier Source: org_study_id
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