Condition category
Not Applicable
Date applied
03/10/2014
Date assigned
03/10/2014
Last edited
10/07/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Protocol

Plain English Summary

Background and study aims
Hospital at home is a service that is provided in some parts of the U.K, but we do not know how this service compares to being admitted to hospital. The aim of this study is to find out if providing healthcare in hospital at home (sometimes called healthcare in the home), instead of
hospital, helps older people to recover from a deterioration in their health. We also aim to find out how much this type of healthcare costs, compared to hospital care, and how people experience healthcare in the home and in hospital.

Who can participate?
Older people who experienced a change in their health, and for whom healthcare in hospital was considered, were invited to participate in this research from nine locations across the UK

What does the study involve?
We collected data on various aspects of their health that included possible confusion, ability to move around and look after themselves and where they were living at six and twelve months after the study had started. We also collected data on resources used, so we could calculate the cost of this type of healthcare.

What are the possible benefits and risks of participating?
None

Where is the study run from?
Nuffield Department of Population Health, University of Oxford (UK)

When is the study starting and how long is it expected to run for?
November 2014 to January 2020 (updated 10/07/2020, previously: July 2019)

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Prof. Sasha Shepperd, sasha.shepperd@ndph.ox.ac.uk

Trial website

https://www.hahstudy.org

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 (0)1865 289 237
sasha.shepperd@ndph.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17311; HS&DR 12/209/66

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

Not available in web format, please use the contact details to request a 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 measure

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 month
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

31/01/2020

Reason abandoned (if study stopped)

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

1055

Participant exclusion criteria

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

31/07/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Nuffield Department of Population Health 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

Current publication and dissemination plan as of 02/06/2020:
We have published the findings for the process evaluation that was embedded in the trial, submitted a manuscript with the main trial findings for consideration and are drafting a manuscript of the findings from the cost-effectiveness analysis

Previous publication and dissemination plan:
Not provided at time of registration

Intention to publish date

31/12/2020

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2017 protocol in https://doi.org/10.1186/s13063-017-2214-y (added 12/05/2020)

Publication citations

Additional files

Editorial Notes

10/07/2020: The following changes were made to the trial record: 1. The overall end date was changed from 31/07/2019 to 31/01/2020. 2. The plain English summary was updated to reflect these changes. 02/06/2020: The following changes were made to the trial record: 1. The publication and dissemination plan was updated. 2. The intention to publish date was changed from 31/12/2019 to 31/12/2020. 12/05/2020: The following changes were made to the trial record: 1. Publication reference added. 2. The trial website was added. 3. The target number of participants was changed from "Planned Sample Size: 1554; UK Sample Size: 1554" to "1055". 4. The trial participating centre address was updated. 5. The plain English summary was added. 10/09/2018: The total target enrollment has been changed from 1554 to 1055. 12/03/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 01/03/2018 to 31/07/2018 2. The overall trial end date was changed from 01/05/2019 to 31/07/2019 3. The Intention to publish date was added. 16/10/2017: The following changes were made to the trial record: 1. The recruitment end date was changed from 07/07/2017 to 01/03/2018. 2. The overall trial end date was changed from 31/10/2016 to 01/05/2019. 17/05/2016: The recruitment end date has been updated from 31/10/2016 to 07/07/2017.