Research project
The PATCH Study - Package for Residents in Care Homes: a Cluster Randomised Controlled Feasibility Trial
- Start date: 1 October 2016
- End date: 31 March 2019
- Partners and collaborators: Bradford Teaching Hospitals NHS Foundation Trust, University of Leeds, Leeds Neurophysiotherapy
- Co-investigators: Anne Forster, Amanda Farrin, Jill Fisher, Liz Graham, Rebecca Hawkins, Karen Hull, Claire Hulme
Description
Background
Residents of care homes are amongst the frailest in our population. As most residents have a mix of co-morbidities and dementia is prevalent, providing appropriate care is challenging. Our Cochrane Review of rehabilitation in long-term care reported that it is possible to improve physical activity in this population, but interventions are often time limited and resource intensive. A more sustainable approach is to enhance the confidence, skills and abilities of care home staff in postural awareness and physical activity. To address this, a group of physiotherapists developed and implemented a tailored, manualised, competency-based training programme (the Skilful Care Training Package). Preliminary work in one care home suggested benefit. The PATCH trial involved detailed feasibility work in preparation for a large cluster-randomised controlled trial.
Aims & Objectives
The overarching aim is to undertake detailed feasibility work and development of resources for the future definitive cluster randomised controlled trial. This will investigate the clinical and cost effectiveness of the Skilful Care Training Package (SCTP) compared to Usual Care (UC) when delivered in residential and nursing care homes.
Objectives relate to feasibility, safety and potential efficacy, and sample size estimation.
Feasibility objectives are:
1. To ascertain recruitment and retention rates at the level of the care home, staff and residents;
2. To assess feasibility of delivering the Skilful Care Training Package;
3. To develop methods to assess compliance with, and adherence to, the skilful care training package;
4. To assess feasibility and acceptability of follow up (retention of participants and completeness of data);
5. To explore and clarify procedures to collect anonymised data at the level of the home;
6. To assess the feasibility and methods of collecting resource and outcome data;
7. To assess the appropriateness of outcome measures (ease of use, sensitivity and relevance; confirmation of validity) to inform choice of primary and secondary outcomes for the definitive trial.
Safety and potential efficacy objectives are:
8. To monitor relevant adverse events and to confirm how best to collect these;
9. To assess evidence of proof of concept relating to potential efficacy.
Scientific objectives are:
10. To ascertain the number of care homes and residents needed for a definitive trial;
11. To estimate the intra-class correlation coefficient for the selected primary outcome from the trial data and from other literature and data sources.
12. Process evaluation work will enable us to:
13. Gain an understanding of the barriers and enablers to delivering and implementing the Skilful Care Training Package in care homes to optimise implementation in the definitive trial;
14. Obtain an understanding of care home staff and trainers’ views of the programme to inform refinement for the definitive trial.
15. Obtain an insight from residents as to the acceptability of the intervention to inform refinement for the definitive trial.
Methods
This is a prospective, parallel-group, cluster randomised controlled feasibility trial in 10 care homes (nursing/residential). It is anticipated that approximately 12-15 residents will be recruited from each care home.
Care home staff will introduce the trial concept to eligible residents who will then, if they are in agreement, speak to a researcher who will obtain their consent to participate. Where a resident lacks capacity consultees will be approached, in line with the requirements of the Mental Capacity Act.
Trial researchers will undertake baseline assessments with care home managers, residents and staff, and thereafter will register all consenting residents to the project. Care homes will be randomised (after completion of all baseline assessments) on a 1:1 basis to either receive the SCTP or to continue with UC only.
Care home managers, staff and residents will be followed up at three and six months post-randomisation. Researchers will administer questionnaires to staff and residents, as well as collect data from care notes. In addition, staff will complete self-reported measures at each time point.
Care home staff will, of necessity, be aware of intervention allocation but collection of outcomes by researchers will be undertaken blind to this knowledge wherever possible.
Grant applicants:
Anne Forster, Amanda Farrin, Jill Fisher, Liz Graham, Rebecca Hawkins, Karen Hull, Claire Hulme.
Funding agency
Chartered Society of Physiotherapy Charitable Trust
Further information
For further information contact Anne Forster or Liz Graham
This work was supported by a Grant from the Chartered Society of Physiotherapy Charitable Trust (Grant no. OPA/14/03).
Publications and outputs
Graham L, Cicero R, Clarke D, et al. PATCH: posture and mobility training for care staff versus usual care in care homes: study protocol for a randomised controlled trial. Trials 2018;19(1):521
Further information
For further information please contact Professor Anne Forster (a.forster@leeds.ac.uk) or Liz Graham (liz.graham@bthft.nhs.uk) Telephone: 01274 383443