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
| ISRCTN | ISRCTN86120296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86120296 |
| Secondary identifying numbers | 36034 |
- Submission date
- 03/01/2018
- Registration date
- 12/01/2018
- Last edited
- 12/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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 the hospital and whether it improves their quality of life and independence. Patients, carers and healthcare professionals are also interviewed to learn about their experiences with 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 October 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Jane Walker, jane.walker@psych.ox.ac.uk (UK)
Contact information
Scientific
Psychological Medicine Research Group
University of Oxford Department of Psychiatry
Oxford
OX3 7JX
United Kingdom
 ORCID ID |
0000-0003-1938-1141 |
|---|
Study information
| Study design | Randomized complex intervention with qualitative component study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN86120296_PIS_V2.0_17Oct2017.pdf |
| 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 |
| Study 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(s) | Approved 02/11/2017, Oxford C REC (Health Research Authority (Bristol), Ground Floor, Temple Quay House, 2 The Square, BS1 6PN, Bristol, UK; +44 (0)207 1048144, (0)207 1048241, (0)207 1048289; oxfordc.rec@hra.nhs.uk), ref: 17/SC/0497 |
| Condition | Older people admitted to hospital |
| 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 |
| 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 17/10/2022: 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, length of index admission truncated at 30 days, number of readmissions, number of days in hospital) in the year post-randomisation 10. Death in the year post-randomisation Previous 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 study start date | 01/04/2017 |
| Overall study end date | 31/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 3588; UK Sample Size: 3588 |
| Total final enrolment | 2744 |
| 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 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 | 05/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
OX3 9DU
United Kingdom
OX16 9AL
United Kingdom
EX2 5DW
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
University/education
University of Oxford Research Services
Clinical Trials and Research Governance
Joint Research Office, Block 60, Churchill Hospital
Oxford
OX3 7LE
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | Current IPD sharing statement as of 30/03/2023: The datasets generated during and/or analysed during the current study are not expected to be made available because these include identifiable information and, under the terms of our agreement with NHS Digital, the use of these data is restricted to The HOME Study researchers and for the purposes of HOME Study analyses. Previous IPD sharing statement: The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V2.0 | 17/10/2017 | 12/01/2018 | No | Yes |
| Protocol article | protocol | 07/08/2019 | 27/08/2019 | Yes | No |
| Statistical Analysis Plan | statistical and economic analysis plan | 04/05/2020 | 06/05/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 10/08/2024 | 12/08/2024 | Yes | No |
Additional files
- ISRCTN86120296_PIS_V2.0_17Oct2017.pdf
- Uploaded 12/01/2018
Editorial Notes
12/08/2024: Publication reference added.
18/03/2024: The intention to publish date was changed from 31/03/2024 to 31/12/2024.
18/09/2023: The intention to publish date has been changed from 30/03/2026 to 31/03/2024.
30/03/2023: The individual participant data (IPD) sharing statement and summary have been changed.
17/03/2023: The following changes have been made and the plain English summary updated accordingly:
1. The overall trial end date has been changed from 30/03/2022 to 31/10/2022.
2. The intention to publish date has been changed from 30/03/2023 to 30/03/2026.
09/11/2022: Internal review.
17/10/2022: The secondary outcome measures have been updated.
30/12/2021: The following changes have been made:
1. The overall trial end date has been changed from 30/12/2021 to 30/03/2022 and the plain English summary updated accordingly.
2. The intention to publish date has been changed from 30/06/2022 to 30/03/2023.
27/09/2021: The following changes have been made:
1. The overall trial end date has been changed from 30/09/2021 to 30/12/2021 and the plain English summary has been updated to reflect this change.
2. The intention to publish date has been changed from 31/03/2021 to 30/06/2022.
21/09/2021: Internal review.
06/05/2020: Publication reference added.
07/04/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/03/2020 to 05/03/2020.
2. The total final enrolment was added.
27/08/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2019 to 31/03/2020.
2. The overall trial end date was changed from 31/03/2020 to 30/09/2021.
3. Publication reference added.
25/04/2019: The condition has been changed from "Specialty: Ageing, Primary sub-specialty: Ageing; UKCRC code/ Disease: Generic Health Relevance/ No specific disease" to "Older people admitted to hospital" following a request from the NIHR.
26/03/2019: The recruitment end date was changed from 11/02/2019 to 31/12/2019.
15/02/2018: The target number of participants has been updated from 3244 to 3588. The secondary outcome measures have been updated.
