PACT: Cluster RCT of the ‘Your Care Needs You!’ intervention
Research type
Research Study
Full 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.
IRAS ID
277060
Contact name
Rebecca Lawton
Contact email
Sponsor organisation
Bradford Teaching Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN17062524
Duration of Study in the UK
1 years, 7 months, 28 days
Research summary
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, cost-effectiveness of and fidelity to the Your Care Needs You! (YCNY) intervention. 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 time points 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).
We 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 sub-set 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 be interviewed to gain their views on the intervention and explore contextual factors.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0020
Date of REC Opinion
26 Feb 2020
REC opinion
Further Information Favourable Opinion