Condition category
Mental and Behavioural Disorders
Date applied
27/07/2010
Date assigned
27/07/2010
Last edited
15/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Gladman

ORCID ID

Contact details

Division of Rehabilitation and Ageing
Medical School
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
-
john.gladman@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8368

Study information

Scientific title

Acute medical unit comprehensive geriatric assessment intervention study: a multicentre randomised interventional process of care trial

Acronym

AMIGOS

Study hypothesis

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.

Ethics approval

Nottingham Research Ethics Committee 1, 20/04/2010, ref: 10/H0403/1

Study design

Multicentre randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: All Diagnoses; Disease: Not Applicable

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Number of days spent at home over 90 days of follow up, defined as 90 days or the number of days from discharge until death, minus the number of days spent in residential intermediate care units, days in hospital due to unplanned readmission (community hospital, psychiatric hospital or other acute hospital), or the number of days spent in a new care home placement.

These outcomes will be ascertained from a variety of existing databases, including primary care, social care and secondary care systems. The validity of this approach will be tested in the pilot phase, comparing self reported days at home against those recorded in the various databases.

Secondary outcome measures

Outcomes will be collected at 90 days and will include an array of validated outcomes, which will be ascertained by examination of the above databases, by postal questionnaire or by individual interviews if required:
1. Death
2. Institutionalisation
3. Hospital use (Emergency Department, AMU admissions, clinics)
4. Personal Activities of Daily Living (Barthel ADL Index)
5. Self reported falls over previous 90 days
6. Medication audit against STOPP/START criteria at 90 days
7. Psychological wellbeing (General Health Questionnaire [GHQ12])
8. Quality of life (EuroQoL EQ5D) and ICECAP
9. Resource use
10. Carer strain: Caregiver Strain Index
11. Carer generic quality of life: EuroQol EQ5D
12. Carer specific quality of life: CQLIR

Overall trial start date

15/06/2010

Overall trial end date

31/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned sample size: 600

Participant exclusion criteria

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

Recruitment start date

15/06/2010

Recruitment end date

31/01/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR) (ref: RP-PG-0407-10147)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21864399
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24103444
2015 economic evaluation results in: http://www.ncbi.nlm.nih.gov/pubmed/25942421
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25973516

Publication citations

  1. Protocol

    Edmans J, Conroy S, Harwood R, Lewis S, Elliott RA, Logan P, Bradshaw L, Franklin M, Gladman J, Acute medical unit comprehensive geriatric assessment intervention study (AMIGOS)., Trials, 2011, 12, 200, doi: 10.1186/1745-6215-12-200.

  2. Results

    Edmans J, Bradshaw L, Franklin M, Gladman J, Conroy S, Specialist geriatric medical assessment for patients discharged from hospital acute assessment units: randomised controlled trial., BMJ, 2013, 347, f5874.

  3. Results

    Tanajewski L, Franklin M, Gkountouras G, Berdunov V, Edmans J, Conroy S, Bradshaw LE, Gladman JR, Elliott RA, Cost-Effectiveness of a Specialist Geriatric Medical Intervention for Frail Older People Discharged from Acute Medical Units: Economic Evaluation in a Two-Centre Randomised Controlled Trial (AMIGOS), PLoS One, 2015, 10, 5, e0121340, doi: 10.1371/journal.pone.0121340.

  4. Results

    Gladman J, Harwood R, Conroy S, Logan P, Elliott R, Jones R, Lewis S, Dyas J, Schneider J, Porock D, Pollock K, Goldberg S, Edmans J, Gordon A, Bradshaw L, Franklin M, Whittamore K, Robbins I, Dunphy A, Spencer K, Darby J, Tanajewski L, Berdunov V, Gkountouras G, Foster P, Frowd N, Medical Crises in Older People: cohort study of older people attending acute medical units, developmental work and randomised controlled trial of a specialist geriatric medical intervention for high-risk older people; cohort study of older people with mental health problems admitted to hospital, developmental work and randomised controlled trial of a specialist medical and mental health unit for general hospital patients with delirium and dementia; and cohort study of residents of care homes and interview study of health-care provision to residents of care homes.

Additional files

Editorial Notes