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 was to undertake detailed feasibility work and development of resources for a future definitive cluster randomised controlled trial.

Objectives are related to feasibility, safety and potential efficacy, and sample size estimation.

Methods

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:

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.

A prospective, parallel-group, cluster-randomised controlled feasibility trial in 10 care homes (nursing/residential). It was anticipated that approximately 12-15 residents would be recruited from each care home.

Care home staff introduced the trial concept to eligible residents who, if they were in agreement, spoke to a researcher who obtained their consent to participate. Where a resident lacked capacity consultees were approached, in line with the requirements of the Mental Capacity Act.

Trial researchers administered 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.

Results

A total of 348 residents were screened; 146 were registered (71 UC, 75 SCTP). Forty two were lost by 6 months, largely due to deaths. While data collection from proxy informants was good (>95% expected data), attrition meant that data completion rates did not meet target. Data collection from residents was poor due to high levels of dementia. Intervention uptake was variable – staff attendance at all sessions ranged from 12.5 to 65.8%. There were no safety concerns.

Care home and resident recruitment are feasible, but refinement of data collection approaches and intervention delivery are needed for this trial and care home research more widely.

Outputs

Kelly C, Hulme C, Graham L, Ellwood A, Patel I, Cundill B, Farrin A, Goodwin M, Hull K, Fisher J, Forster A. Inter-rater reliability of care home staff’s proxy judgements with residents’ assessments of their own health-related quality of life: an analysis of the PATCH trial EQ-5D data. Age Ageing, 2021; afab053. https://doi.org/10.1093/ageing/afab053.

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

Graham L, Cicero R, Clarke D, Cundill B, Ellwood A, Farrin A, Fisher J, Goodwin M, Hawkins R, Hull K, Hulme C, Trépel D, Williams R, Forster A. 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. https://doi.org/10.1186/s13063-018-2863-5

Partners & Collaborators

Investigators
Anne Forster, Amanda Farrin, Jill Fisher, Liz Graham, Rebecca Hawkins, Karen Hull, Claire Hulme.

Collaborators
Bradford Teaching Hospitals NHS Foundation Trust, University of Leeds, Leeds Neurophysiotherapy

Timescales

01/10/2016 – 31/03/2019

Funding agency

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).

http://www.csp.org.uk/professional-union/careers-development/funding/csp-charitable-trust-education-awards