Condition category
Not Applicable
Date applied
03/10/2014
Date assigned
03/10/2014
Last edited
17/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sasha Shepperd

ORCID ID

Contact details

Nuffield Department of Population Health
Richard Doll Building
Old Road Campus
Headington
Oxford
OX3 7LF
United Kingdom
+44 1865 289 237
sasha.shepperd@ndph.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17311

Study information

Scientific title

A Multi-Centre Randomised Controlled Trial to Compare the Effectiveness of Admission Avoidance Hospital at Home with Comprehensive Geriatric Assessment vs. Inpatient Comprehensive Geriatric Assessment on the Number of Frail Older People ‘Living at Home’

Acronym

RCT of Comprehensive Geriatric Assessment in a HAH setting v 1.0

Study hypothesis

The aim of this study is to test the cost-effectiveness of admission avoidance HaH with CGA compared with hospital admission with CGA and investigate the generalizability and cost-effectiveness of CGA in settings where health and social care provision vary.

Ethics approval

Wales REC 4, 06/08/2014, ref: 14/WA/1081

Study design

Randomised; Interventional; Design type: Process of Care, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Primary Care, Ageing; Subtopic: Other Primary Care, Ageing, Ageing; Disease: All Ageing

Intervention

CGA in hospital at home: Admission avoidance HaH with CGA is a specialist led service providing assessment and a tailored management plan, multidisciplinary management and coordinated care in the patient’s own home. If this service was not available then the patient would be admitted to an acute ward. Usual care will be hospital-based inpatient CGA. CGA is specialist led co-ordinated care involving simultaneous multi-level assessment by a multidisciplinary team to ensure that problems are identified, quantified and mana; Follow Up Length: 12 month(s); Study Entry : Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Living at home; Timepoint(s): 6 and 12 months

Secondary outcome measures

1. Activities of daily living; Timepoint(s): 6 and 12 months
2. Cognitive impairment; Timepoint(s): 6 and 12 months
3. Delirium; Timepoint(s): 3 and 5 days, 1 mont
4. Mortality; Timepoint(s): 6 and 12 months
5. New long term residential care; Timepoint(s): 6 and 12 months
6. Quality of life; Timepoint(s): 6 and 12 months
7. Resource use; Timepoint(s): 6 and 12 months
8. Transfer to hospital; Timepoint(s): 6 and 12 months

Overall trial start date

30/11/2014

Overall trial end date

31/10/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Older patients with frailty who are aged >65 years and who have been referred to the admission avoidance HaH service with CGA and who would otherwise require admission to hospital for an acute medical event. This will include patients presenting with delirium, functional decline, dependence, falls, immobility or a background of dementia presenting with physical disease

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 1554; UK Sample Size: 1554

Participant exclusion criteria

The following people will be excluded from this trial:
1. Patient with acute coronary syndrome
2. Patients needing acute surgical assessment
3. Patients presenting with a suspected stroke
4. Patients who are receiving end of life care as part of a palliative care pathway
5. Patients who refuse the HaH service
6. Patients considered by the clinical staff to be too high risk for home based care, for example those who are physiologically unstable, who are at risk to themselves or if the carer reports HaH care would not be acceptable (in keeping with existing clinical practices for HaH).
7. The presence of a carer will not be a requirement for enrolment and will depend on the individual circumstances of the patient; this will be at the discretion of the clinician responsible for the patient (as is current clinical practice in each centre).

Recruitment start date

30/11/2014

Recruitment end date

07/07/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of Public Health and Primary Health CareUniversity of Oxford, Old Road Headington
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Old Road Campus
Roosevelt Drive Headington
Oxford
OX3 7DQ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR - Health Services & Delivery Research Programme (HS&DR); Grant Codes: 12/209/66

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

Publication citations

Additional files

Editorial Notes

17/05/2016: The recruitment end date has been updated from 31/10/2016 to 07/07/2017.