Condition category
Not Applicable
Date applied
03/01/2018
Date assigned
12/01/2018
Last edited
15/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
NHS general hospitals have more than two million unplanned admissions of people aged 65 and older every year. These patients typically spend more time in hospital than those aged under 65. Long hospital stays are bad for older patients: they can get new illnesses like infections and lose their independence. They are also bad for the NHS which has a shortage of hospital beds. Psychological problems, like dementia, confusion, depression and anxiety, are common in older patients and these are an important cause of long hospital stays. These problems are often not identified in busy hospital wards where the focus is on patients’ physical illnesses. The aim of this study is to find out whether adding a new approach (sometimes called Proactive Liaison Psychiatry) to the identification and management of psychological problems reduces the time that older people spend in acute general hospital wards.

Who can participate?
Patients aged 65 and older who have been admitted to acute wards in hospitals in Oxfordshire, Cambridgeshire and Devon

What does the study involve?
Participants are randomly allocated to receive either usual care, or usual care plus the new approach (which involves seeing a doctor, nurse or occupational therapist who specialises in psychological problems in the medically ill). The study looks at whether the new approach reduces the time that patients spend in hospital and whether it improves their quality of life and independence. Patients, carers and healthcare professionals are also interviewed to learn about their experiences of the new approach.

What are the possible benefits and risks of participating?
Taking part involves participants talking with the research team and allowing them access to their information. They may see an additional doctor or nurse who specialises in psychological problems. However, it is not known whether this will help them get home more quickly; that is why this study is happening. The aim of the study is to find out how best to care for patients in the future.

Where is the study run from?
1. John Radcliffe Hospital (UK)
2. Horton Hospital (UK)
3. Royal Devon and Exeter Hospital (UK)
4. Addenbrooke’s Hospital (UK)

When is the study starting and how long is it expected to run for?
April 2017 to March 2020

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

Who is the main contact?
Dr Jane Walker

Trial website

https://oxfordpsychologicalmedicine.org/research/thehomestudy/

Contact information

Type

Scientific

Primary contact

Dr Jane Walker

ORCID ID

http://orcid.org/0000-0003-1938-1141

Contact details

Psychological Medicine Research Group
University of Oxford Department of Psychiatry
Oxford
OX3 7JX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

36034

Study information

Scientific title

The HOME Study: a study comparing two different ways of looking after older people in hospitals to see if we can improve how quickly they go home

Acronym

The HOME Study

Study hypothesis

NHS general hospitals have more than two million unplanned admissions of people aged 65 and older every year. These patients typically spend more time in hospital than those aged under 65. Long hospital stays are bad for older patients: they can get new illnesses like infections and lose their independence. They are also bad for the NHS which has a shortage of hospital beds. Psychological problems, like dementia, confusion, depression and anxiety, are common in older patients and these are an important cause of long hospital stays. These problems are often not identified in busy hospital wards where the focus is on patients’ physical illnesses.

In this study, the trialists will research whether adding a new approach (sometimes called Proactive Liaison Psychiatry) to the identification and management of psychological problems reduces the time that older people spend in acute general hospital wards.

Ethics approval

Oxford C REC, 02/11/2017, ref: 17/SC/0497

Study design

Randomised; Both; Design type: Treatment, Diagnosis, Process of Care, Psychological & Behavioural, Complex Intervention, Management of Care, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Specialty: Ageing, Primary sub-specialty: Ageing; UKCRC code/ Disease: Generic Health Relevance/ No specific disease

Intervention

The trialists will recruit approximately 3,588 patients aged 65 and older, who have been admitted to acute wards in hospitals in Oxfordshire, Cambridgeshire and Devon. Half of the study participants will get usual NHS care. This means that they will be looked after by doctors, nurses and other staff in the usual way during their hospital stay. The other half will get usual NHS care and they will also see a doctor or nurse who specialises in psychological problems – they will talk to them to find out if they have problems such as worries or confusion that might delay their discharge from hospital and will make a plan to help them with these. The trialists will study whether the new approach reduces the time that patients spend in hospital and whether it improves their quality of life and independence. They will also interview patients, carers and healthcare professionals to learn about their experiences of the new approach.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Number of days spent as an inpatient in a general hospital in the month (30 days) post-randomisation; Timepoint(s): 30 days

Secondary outcome measures

Current secondary outcome measures as of 15/02/2018:
1. Cognitive function, measured using MOCA-T at 1 and 3 months
2. Independent functioning, measured using Barthel Index of Activities of Daily Living at 1 and 3 months
3. Health-related quality of life, measured using EQ-5D-5L at 1 and 3 months
4. Symptoms of anxiety and depression, measured using PHQ-4 at 1 and 3 months
5. Overall quality of life, measured using study-specific item at 1 and 3 months
6. Patient’s experience of hospital stay, measured using study-specific item at 1 month
7. Patient’s view on the length of their hospital stay, measured using study-specific item at 1 month
8. Discharge destination
9. Secondary healthcare use (including total length of index admission, number of readmissions, number of days in hospital) in the year post-randomisation
10. Death in the year post-randomisation

Previous secondary outcome measures:
1. Cognitive function, measured using MOCA-T at 1 and 3 months
2. Independent functioning, measured using Barthel Index of Activities of Daily Living at 1 and 3 months
3. Health-related quality of life, measured using EQ-5D-5L at 1 and 3 months
4. Symptoms of anxiety and depression, measured using PHQ-4 at 1 and 3 months
5. Overall quality of life, measured using study-specific item at 1 and 3 months
6. Patient’s experience of hospital stay, measured using study-specific item at 1 and 3 months
7. Patient’s view on the length of their hospital stay, measured using study-specific item at 1 and 3 months
8. Discharge destination
9. Secondary healthcare use (including total length of index admission, number of readmissions, number of days in hospital) in the year post-randomisation
10. Death in the year post-randomisation

Overall trial start date

01/04/2017

Overall trial end date

31/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

To be included in the study patients must:
1. Be an inpatient in an acute ward
2. Have been admitted non-electively
3. Be aged 65 or older
4. Be expected (by their clinical team) to remain an inpatient for at least 2 days from the time of baseline assessment
5. Be able to give informed consent or if unable to give consent, a consultee advises that study participation is appropriate

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 3588; UK Sample Size: 3588

Participant exclusion criteria

Patients will be excluded if:
1. They are moribund (defined as when the clinicians caring for a patient estimate that they are likely to die before discharge from hospital)
2. Their participation in the study is judged to be clinically or practically inappropriate (e.g. patient visiting from overseas)
3. They have already been enrolled in the study
4. They have already been referred to the usual liaison psychiatry team.
5. They have been a general hospital inpatient continuously for 1 week at the time of the baseline assessment
6. They do not read or speak English

Recruitment start date

12/02/2018

Recruitment end date

11/02/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

John Radcliffe Hospital
Oxford
OX3 9DU

Trial participating centre

Horton Hospital
Banbury
OX16 9AL

Trial participating centre

Royal Devon and Exeter Hospital
Exeter
EX2 5DW

Trial participating centre

Addenbrooke’s Hospital
Cambridge
CB2 0QQ

Sponsor information

Organisation

University of Oxford

Sponsor details

University of Oxford Research Services
Clinical Trials and Research Governance
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 15/11/16

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Protocol will be published on the NIHR website and in a journal. Planned publication of study results in a high-impact peer reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/02/2018: The target number of participants has been updated from 3244 to 3588. The secondary outcome measures have been updated.