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

NCT02657642 | Unknown

• 1 other identifier: 15-086
• Study Type: observational
• Target: 484
• Locations: 0 countries
• Sites: N/A

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

Conditions

Ageing

Keywords

drug related problems, elderly

Outcome Measures

Primary Outcomes (1)

• 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, final 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

Study Arms (2)

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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
• Patient's Opposition to collection of his personal data
• Previous participation in the OMAGE-P study,
• Not speaking french,
• Impossible to follow up
• Absence of any health insurance (as required by French law on clinical research).

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Officials

• Sylvie Legrain, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie Legrain, Professor

CONTACT

33 1 53111804; sylvie.legrain@aphp.fr

Dominique Bonnet-Zamponi, MD

CONTACT

33 1 40275025; dominique.bonnet@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 18, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 18, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share