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AgeingOMAGE-PNCT02657642

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

An observational study of Ageing, run by Assistance Publique - Hôpitaux de Paris.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Ageing
How many people
484 participants
Where
No sites listed yet
Study dates
Jan 2016to Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: non demented older people aged 75 years and over admitted in emergency in medical units living in community

Who may be able to join

  • 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
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  • Non inclusion criteria
  • 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).

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet.

Sylvie Legrain, Professor contact

33 1 53111804

sylvie.legrain@aphp.fr

Dominique Bonnet-Zamponi, MD contact

33 1 40275025

dominique.bonnet@aphp.fr

About this study

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

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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. 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

Read the detailed description

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.

Conditions
Ageing
Keywords
drug related problems, elderly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02657642
Study groupRoleWhat they receive
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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 6 months after hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionNov 2017 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
484 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02657642
Sponsor's protocol ID
15-086
Acronym
OMAGE-P
Status last verified
Jan 2016
First submitted
14 Jan 2016
Last updated
18 Jan 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Ageing, run by Assistance Publique - Hôpitaux de Paris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sylvie Legrain, Professor (33 1 53111804, sylvie.legrain@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of days alive and without emergency readmissions (time frame: up to 6 months after hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.

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