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ISRCTN
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ISRCTN21800480
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ClinicalTrials.gov identifier
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Public title
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Acute medical unit comprehensive geriatric assessment intervention study
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Scientific title
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Acronym
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AMIGOS
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Serial number at source
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8368
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Study hypothesis
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Most hospitals have an acute medical unit (AMU), a central admissions ward designed to look after unwell patients 24 hours per day, 365 days per year. Many older people attend AMUs, but are not admitted to the main hospital wards and so return home within a day or two. Many people sent home have ongoing issues, and some return to hospital or even die in the year following their original attendance. This may be partly due to a lack of comprehensive coordinated care. This research is part of a programme of research to develop and evaluate comprehensive, coordinated care for such people.
We will do this by recruiting approximately 600 patients aged 70 years or over attending and discharged from AMUs in Nottingham and Leicester; they will all be at high risk of adverse outcomes. We will collect baseline information about their health, disability and mental health. Participants will then be allocated to either the intervention (specialist geriatric care) or the usual care group. The decision as to which group participants go into is worked out by chance, just like tossing a coin (randomisation). This is a common technique used in studies of this type.
Those in the usual care group will go home, and will have access to GPs, community therapy teams etc. Those receiving specialist geriatric care will also be assessed and followed up in the community by a geriatrician. The geriatric assessment will focus on common problems, such as falls, incontinence, medication and for some, end of life issues. We will then measure participants' health and use of resources three months later. We will also measure the levels of strain and quality of life of the carers of these patients, at baseline and at follow up. The results of this study will help us better design services for older people.
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Ethics approval
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MREC approved on the 20th April 2010 (ref: 10/H0403/1)
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Study design
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Multicentre randomised interventional process of care trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Mental Health Research Network; Subtopic: All Diagnoses; Disease: Not Applicable
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Participants - inclusion criteria
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Patient participant:
1. Attending and being discharged from the Acute Medical Unit at Queen's Medical Centre, Nottingham or Leicester Royal Infirmary, Leicester
2. Aged 70 years or over, either sex
3. Identified as being at high risk of adverse outcomes using the Identification of Seniors At Risk (ISAR) score
When the decision to discharge the patient has been made, usually by duty consultant, the Multidisciplinary Team responsible for making the discharge arrangements will identify all those who are 70 years old or over who score positive on the ISAR score and are living within the usual catchment area of the hospital and indicate them to the study researcher. Patients with potential exceptional reasons for non-recruitment will be discussed with the researcher. These methods have worked successfully in a related cohort study run on the unit in Nottingham already.
Carer participant:
4. Identified as carer of a patient participant; any carer present with the patient participant will be invited to be a carer participant for the study. If a carer participant is not present on the AMU but known to exist, an invitation and information sheet, consent form and questionnaire will be given to the patient participant.
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Participants - exclusion criteria
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1. Patient without capacity where there is no consultee available
2. Any exceptional reason cited by the AMU should not be recruited (e.g. dangerous)
3. Patient not resident in normal hospital catchment area
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Anticipated start date
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15/06/2010
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Anticipated end date
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31/01/2013
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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Planned sample size: 600
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Interventions
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Comprehensive Geriatric Assessment:
Once consent and the baseline data and beside measurements have been collected, the participants will be allocated to the intervention or the control arm (usual care), using an internet based randomisation procedure. Those allocated to usual care will go home as planned. Those allocated to the interface geriatrician will be reviewed by a geriatrician prior to being discharged. The geriatrician will reassess their clinical care, focusing on geriatric syndromes, such as polypharmacy (multiple medications).
Follow-up length: 3 months
Study entry: single randomisation only
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Primary outcome measure(s)
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Readmission, functional decline or death, measured at 90 days
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0407-10147)
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Trial website
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Publications
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Contact name
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Prof
John
Gladman
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Address
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Queens Medical Centre
Derby Road
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Email
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john.gladman@nottingham.ac.uk
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Sponsor
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University of Nottingham (UK)
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Address
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Queens Medical Centre
Derby Road
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Sponsor website:
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http://www.nottingham.ac.uk/
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Date applied
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27/07/2010
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Last edited
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27/07/2010
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Date ISRCTN assigned
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27/07/2010
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