Objectives and brief methodology
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. We have undertaken a Cochrane Review of rehabilitation in long-term care in which we reported that it was possible to improve physical activity in this population but interventions were 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 have developed and implemented a tailored manualised competency-based training programme (Skilful Care Training Package). Preliminary work suggested benefit, which supported the undertaking of a detailed feasibility trial in preparation for a large cluster randomised controlled trial.
Aims & Objectives
The overarching aim was to undertake detailed feasibility work and development of resources for a future definitive cluster randomised controlled trial – to 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 related 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:
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
This was a prospective, parallel group, cluster randomised controlled feasibility trial in 10 care homes (nursing/residential), which aimed to recruit approximately 12-15 residents from each home. Residents with and without capacity were included in the trial in line with the requirements of the Mental Capacity Act.
Trial researchers completed baseline assessments with care home managers, residents and staff, and thereafter registered all consenting residents to the project. Care homes were 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 were followed up at three and six months post-randomisation. Researchers administered questionnaires to staff and residents, and collected data from care notes. In addition, staff completed self-reported measures at each time point.
Care home staff were, of necessity, aware of intervention allocation but collection of outcomes by researchers was undertaken blind to this knowledge wherever possible
Partners & Collaborators
Anne Forster, Amanda Farrin, Jill Fisher, Liz Graham, Rebecca Hawkins, Karen Hull, Claire Hulme.
Bradford Teaching Hospitals NHS Foundation Trust, University of Leeds, Leeds Neurophysiotherapy
The trial successfully completed in March 2019. Results can be found
Graham L, Ellwood A, Hull K, Fisher J, Cundill B, Holland M, Goodwin M, Clarke D, Hawkins R, Hulme C, Patel I, Kelly C, Williams R, Farrin A, Forster A. Posture and mobility training package for care home staff: results of a cluster randomised controlled feasibility trial (the PATCH trial). Age Ageing 2020;49(5)821–828. https://doi.org/10.1093/ageing/afaa046
01/10/2016 – 31/03/2019
Chartered Society of Physiotherapy Charitable Trust
This work was supported by a Grant from the Chartered Society of Physiotherapy Charitable Trust (Grant no. OPA/14/03).