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The OMAGE (Optimization of Medication in AGEd) Transitional Care-Pathway: Impact on Readmissions (OMAGE-P)

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ClinicalTrials.gov Identifier: NCT02657642
Recruitment Status : Unknown
Verified January 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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


Condition or disease
Ageing

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 484 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The OMAGE (Optimization of Medication in AGEd) Transitional Care-Pathway: Impact on Readmissions
Study Start Date : January 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : January 2018

Group/Cohort
Cohort 1 (exposed)
cohort 1: patients who will receive the OMAGE-P transitional care in geriatric or internal medicine departement of the Eaubonne Hospital
Cohort 2 (non exposed)
Cohort 2: : patients included in the usual care arm of the OMAGE RCT study in 2007-2008



Primary Outcome Measures :
  1. Number of days alive and without emergency readmissions [ Time Frame: up to 6 months after hospital discharge ]
    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, final diagnosis or diagnoses, imputability of drug related problems (ADRs, adherence problems, underuse) in the readmission. Death during readmission will be systematically adjudicated



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
non demented older people aged 75 years and over admitted in emergency in medical units living in community
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657642


Contacts
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Contact: Sylvie Legrain, Professor 33 1 53111804 sylvie.legrain@aphp.fr
Contact: Dominique Bonnet-Zamponi, MD 33 1 40275025 dominique.bonnet@aphp.fr

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Sylvie Legrain, Professor Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02657642     History of Changes
Other Study ID Numbers: 15-086
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
drug related problems, elderly