PACT: cluster randomised controlled trial of the ‘Your Care Needs You!’ intervention
| ISRCTN | ISRCTN17062524 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17062524 |
| IRAS number | 277060 |
| Secondary identifying numbers | CPMS 44559, IRAS 277060 |
- Submission date
- 03/02/2020
- Registration date
- 11/02/2020
- Last edited
- 14/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Going home from hospital can sometimes be a tricky period for people, particularly older people who may have more health problems. This can be made worse when people don’t understand what needs to be done to manage their health. For example, they may not understand their medicines or they may have lost the confidence to move about in their homes because they didn’t move about much when in hospital. Sometimes this leads to unnecessary hospital readmissions. Patients who are more involved in their care in hospital do better when they get home. Researchers have designed an approach called ‘Your Care Needs You!’ which includes a patient booklet, a short film and an enhanced discharge letter. These aim to encourage patients to ‘know more’ and ‘do more’ in hospital so that they are better prepared to manage at home. The study aims to find out if the ‘Your Care Needs You!’ approach reduces hospital readmissions and improved the quality and safety of the transition from hospital to home for older people.
Who can participate?
Patients aged 75 and over who have stayed for at least one night on a participating ward and are going to be discharged to their own home or that of a relative’s
What does the study involve?
The research will take place within 40 wards (across 8 acute NHS Trusts) over a 12-month period. In total, 20 wards are randomly allocated to deliver the ‘Your Care Needs You’intervention and 20 wards deliver care as usual. On the wards that have been selected to use ‘Your Care Needs You’, all patients can have the booklet, see the film and have an enhanced discharge letter. The researchers compare outcomes (such as hospital readmissions or experience of transition to home) for people who receive ‘Your Care Needs You!’ with those who don’t. The evaluation will involve taking informed consent from patients and then asking them to complete some questionnaires by post or with telephone support. There will be three questionnaires, one at around 7 days after discharge, one at 30 days and one at 90 days. The researchers will also ask some patients to take part in an interview to ask them about their experience of the approach.
What are the possible benefits and risks of participating?
There will be no direct benefits for participants because they will only be consenting to complete questionnaires. Patients on the wards selected to give out ‘Your Care Needs You!’ will get the booklet and film etc regardless of whether they decide to take part in the research evaluation. The benefits to taking part in the evaluation might actually be for patients in the future because by taking part in the research the researchers will get data that will tell them if they have improved the patient experience. There are no known risks to taking part in the evaluation.
Where is the study run from?
The study will be run from the Yorkshire Quality and Safety Research Group based in Bradford. The team will be supported by the York Trials Unit. The study will include up to nine NHS Hospital Trusts from the Yorkshire region and between 40 and 50 wards within these Trusts.
1. Hull And East Yorkshire Hospitals NHS Trust
2. York Teaching Hospital NHS Foundation Trust
3. Calderdale and Huddersfield NHS Foundation Trust
4. Barnsley Hospital NHS Foundation Trust
5. Bradford Teaching Hospitals NHS Foundation Trust
6. Doncaster And Bassetlaw Teaching Hospitals NHS Foundation Trust
7. Harrogate And District NHS Foundation Trust
8. Leeds Teaching Hospitals NHS Trust
When is the study starting and how long is it expected to run for?
August 2019 to October 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Jenni Murray
jenni.murray@bthft.nhs.uk
Contact information
Scientific
Research Programme Manager
PACT Research Programme
Yorkshire Quality & Safety Research Group & Patient Safety Translational Research Centre
Bradford Institute for Health Research
Temple Bank House
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
 ORCID ID |
0000-0003-0563-0020 |
|---|---|
| Phone | +44 (0)1274 383667 |
| jenni.murray@bthft.nhs.uk |
Scientific
Yorkshire Quality and Safety Group
Bradford Institute for Health Research
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
| Phone | +44 (0)1274 383465 |
|---|---|
| R.J.Lawton@leeds.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Process of Care, Complex Intervention, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN17062524_PIS_v1_10Oct19.docx |
| Scientific title | A cluster randomised controlled trial to assess the effectiveness and cost-effectiveness of the ‘Your Care Needs You!’ intervention to improve safety and experience of care transitions |
| Study acronym | PACT |
| Study objectives | Transitions of care from hospital to home can be risky, especially for older people with multiple health conditions. Previous research has suggested that the post-discharge period may be improved by better involving patients and families in their care. This study forms part of a programme of research which aims to develop an intervention to improve the safety and experience of transitions from hospital to home for people aged 75 years and over. In this study, a cluster Randomised Control Trial will be conducted to assess the effectiveness of, cost-effectiveness of, and fidelity to the Your Care Needs You! (YCNY) intervention. |
| Ethics approval(s) | Current ethics approval as of 07/08/2020: Approved 31/01/2020, amendment 1 approved 27/04/20202, North East – Newcastle and North Tyneside 2 REC (NHSBT Newcastle Blood Donor Centre, Holland Dr, Newcastle upon Tyne NE2 4NQ, UK; Tel: +44 (0)207 1048091, +44 (0)207 104 8222; Email: nrescommittee.northeast-newcastleandnorthtyneside2@nhs.net), REC ref: 20/NE/0020 Previous ethics approval: Approved 31/01/2020, North East – Newcastle and North Tyneside 2 REC (NHSBT Newcastle Blood Donor Centre, Holland Dr, Newcastle upon Tyne NE2 4NQ, UK; Tel: +44 (0)207 1048091, +44 (0)207 104 8222; Email: nrescommittee.northeast-newcastleandnorthtyneside2@nhs.net), REC ref: 20/NE/0020 |
| Health condition(s) or problem(s) studied | Care transitions |
| Intervention | Current interventions as of 07/08/2020: The research will take place within 40 wards (across 8 acute NHS Trusts) over a 12 month period. In total, 20 wards will deliver the intervention and 20 wards will deliver care as usual. A minimum of 1000 patients will provide informed consent to complete a questionnaire at three timepoints post-discharge and for routine data about their care to be collected from medical records. Data from the questionnaires will be used to measure the effectiveness of the YCNY intervention at improving quality and experience of transitions, quality of life, health care utilisation and 60/90 day unplanned readmission rates (secondary outcomes). The researchers will also obtain anonymised ward level data for 5,440 patients discharged from participating wards during the period of recruitment to assess the effectiveness of YCNY in reducing 30-day unplanned readmission rates (primary outcome). A process evaluation assessing intervention fidelity and mechanisms of action/contextual factors influencing intervention delivery, will also be conducted. In eight intervention wards, a subset of 24-30 of these patients (with/without carers) will also consent to a qualitative evaluation of the intervention (interviews and observations). Up to 45 staff will be interviewed to gain their views on the intervention and explore contextual factors. Previous interventions: The research will take place within 40 wards (across 8 acute NHS Trusts) over a 12 month period. In total, 20 wards will deliver the intervention and 20 wards will deliver care as usual. A minimum of 782 patients will provide informed consent to complete a questionnaire at three timepoints post-discharge and for routine data about their care to be collected from medical records. Data from the questionnaires will be used to measure the effectiveness of the YCNY intervention at improving quality and experience of transitions, quality of life, health care utilisation and 60/90 day unplanned readmission rates (secondary outcomes). The researchers will also obtain anonymised ward level data for 7,000 patients discharged from participating wards during the period of recruitment to assess the effectiveness of YCNY in reducing 30-day unplanned readmission rates (primary outcome). A process evaluation assessing intervention fidelity and mechanisms of action/contextual factors influencing intervention delivery, will also be conducted. In eight intervention wards, a subset of 24-30 of these patients (with/without carers) will also consent to a qualitative evaluation of the intervention (interviews and observations). Up to 45 staff will be interviewed to gain their views on the intervention and explore contextual factors. |
| Intervention type | Behavioural |
| Primary outcome measure | 30-day hospital emergency readmissions, measured using routinely collected data on 30 unplanned hospital readmissions |
| Secondary outcome measures | 1. Quality and experience of care transition for patients, measured using Partners at Care Transitions Measure (PACT-M) at 7 days, 30 days and 90 days post discharge 2. Difficulties that patients experienced in hospital that could affect them after discharge, measured using Post Hospital Syndrome questionnaire at 7 days post discharge 3. Quality of life, measured using EuroQol 5-Dimension Health Questionnaire (5 levels) (EQ5D-5L) and Proxy EQ5D-5L at 7 days, 30 days and 90 days post discharge 4. Healthcare resource use measured using unvalidated questions about services used since discharge at 7 days, 30 days and 90 days post discharge 5. Utility of the intervention measured using unvalidated questions asking about the intervention at 7 days post discharge 6. Unplanned readmissions at 60 and 90 days, measured using routinely collected data |
| Overall study start date | 01/08/2019 |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 75 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1000 consented, 5440 non-consented; UK Sample Size: 1000 consented, 5440 non-consented |
| Key inclusion criteria | 1. Aged 75 and over 2. Anticipated to be discharged to their own home or that of a relative’s (this can include a period of rehabilitation after hospital discharge) 3. Stayed for at least one night on a participating ward 4. Ability to read and understand English or has a carer that can read and understand English 5. Willing and able to give informed consent (or personal consultee if lacking in mental capacity) |
| Key exclusion criteria | Current participant exclusion criteria as of 07/08/2020: 1. Patients who have previously been recruited to the study (e.g. during a different admission or on a different ward) 2. Patients / Consultees who require an interpreter (e.g. because they are unable to read or understand English). 3. Patients who live out of the area included in the study 4. Patients who are expected to be transferred to another acute hospital/trust prior to discharge 5. Admitted for psychiatric reasons (other than dementia/delirium) 6. Nursing/residential home resident or planning to be discharged to a nursing / residential home on a permanent basis 7. Identified as being at the end of their life / subject to fast-track discharge to palliative care 8. Unable to give informed consent and where a suitable personal consultee cannot be identified, or if no one is prepared to act as a consultee for the patient Previous participant exclusion criteria: 1. Out of area patients and/or patients who are to be transferred to another hospital 2. Admitted for psychiatric reasons (other than dementia/delirium) 3. Nursing/residential home resident or planning to be discharged to a nursing/residential home on a permanent basis 4. Less than one overnight stay (on the participating ward) 5. Identified as being at the end of their life/subject to fast-track discharge to palliative care 6. Unable to read and understand English and without a carer who can read and understand English 7. Unable to give informed consent and where a suitable personal consultee cannot be identified, or if no one is prepared to act as a consultee for the patient 8. On an acute medical admission unit and to be transferred to another ward within the hospital |
| Date of first enrolment | 16/11/2020 |
| Date of final enrolment | 31/03/2023 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
-
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Mrs Jane Dennison
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
England
United Kingdom
| Phone | +44 (0)1274 382575 |
|---|---|
| Jane.Dennison@bthft.nhs.uk |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Peer reviewed scientific journals 2. Internal report 3. Conference presentation 4. Publication on website |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from The York Trials Unit |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version v1 | 10/10/2019 | 11/02/2020 | No | Yes |
| Protocol file | version v1 | 12/12/2019 | 11/02/2020 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 14/10/2023 | 16/10/2023 | Yes | No | |
| Statistical Analysis Plan | version 1 | 11/02/2020 | 12/08/2024 | No | No |
| Basic results | 12/11/2024 | No | No |
Additional files
- ISRCTN17062524_PROTOCOL_v1_12Dec19.docx
- Uploaded 11/02/2020
- ISRCTN17062524_PIS_v1_10Oct19.docx
- Uploaded 11/02/2020
- ISRCTN17062524_SAP_v1_11Feb2020.pdf
- ISRCTN17062524 BasicResults.pdf
Editorial Notes
14 /11/2024: The study participating centres Hull And East Yorkshire Hospitals NHS Trust, York Teaching Hospital NHS Foundation Trust, Calderdale and Huddersfield NHS Foundation Trust, Barnsley Hospital NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, Doncaster And Bassetlaw Teaching Hospitals NHS Foundation Trust, Harrogate And District NHS Foundation Trust and Leeds Teaching Hospitals NHS Trust and the country of recruitment United Kingdom - England were removed.
12/11/2024: The basic results have been uploaded as an additional file.
15/10/2024: The following changes were made to the trial record:
1. The participant level data sharing statement was added.
2. The intention to publish date was changed from 01/10/2024 to 31/03/2025.
12/08/2024: Statistical analysis plan added.
16/10/2023: Publication reference added.
06/03/2023: The contact confirmed the record is up to date.
20/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 31/03/2023.
2. The overall end date was changed from 31/07/2023 to 31/10/2023.
3. The intention to publish date was changed from 01/07/2024 to 01/10/2024.
4. The plain English summary was updated to reflect these changes.
07/11/2022: The recruitment end date has been changed from 30/11/2022 to 31/12/2022.
02/11/2021: The following changes have been made:
1. The recruitment end date has been changed from 16/11/2021 to 30/11/2022.
2. The overall trial end date has been changed from 31/03/2022 to 31/07/2023 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/06/2023 to 01/07/2024.
07/08/2020: The following changes have been made:
1. The recruitment start date has been changed from 15/05/2020 to 16/11/2020.
2. The recruitment end date has been changed from 30/05/2021 to 16/11/2021.
3. The target number of participants has been changed from "Planned Sample Size: 822; UK Sample Size: 822" to "Planned Sample Size: 1000 consented, 5440 non-consented; UK Sample Size: 1000 consented, 5440 non-consented".
4. The total target enrolment has been changed from 822 to 1000.
5. The ethics approval has been updated.
6. The interventions have been updated.
7. The participant exclusion criteria have been updated.
11/02/2020: Uploaded protocol Version 1, 12 December 2019 (not peer reviewed). The participant information sheet has been uploaded.
03/02/2020: Trial's existence confirmed by the NIHR.
