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Testing Methods in the Real World

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Testing Methods in the Real World


Testing Methods in the Real World

Care home managers are often keen to engage with educational interventions that will benefit staff development and improve resident care. PiTStop! (Pilot trial of Stop Delirium! in older people) trial aimed to test the methods for a full trial of Stop Delirium!, an enhanced educational programme that seeks to reduce the poor outcomes associated with delirium through early detection, treatment and prevention. This case study details the experience of the PiTStop! research team and provides learning points for others wishing to conduct a research project in a care home


Delirium, also known as Acute Confusional State, is a distressing disorder common among older people and people with dementia. Delirium is more common in those admitted to hospital from care homes, so it makes sense to target interventions to prevent delirium in care homes. By increasing staff skills and confidence in identifying and addressing the underlying causes of delirium, the quality of life for residents can be improved. PiTStop! aims to develop the methods to test the effectiveness of providing an enhanced educational package to care home staff led by a specialist practitioner through a cluster randomised control trial.

Approaches that worked well

• Initial identification: The research team identified care homes through links with Bradford District Care Trust, Older People’s Community Teams, Bradford Care Homes Forum, care home managers, and NHS Bradford & Airedale, alongside internet search engines. Care homes run by the local authority were excluded. Care homes were initially contacted by letter.

• Engaging with staff and residents: The researcher offered all homes an ‘awareness-raising’ session, usually coinciding with resident’s and relative’s meetings in the homes. One or two lay representatives from the implementation team also attended. There was time after the meetings for any individual concerns or questions to be addressed privately. The team also addressed people’s concerns around consenting residents. The meetings were also a chance for residents to have some social interaction, as the team were able to spend time ‘chatting’ if necessary.

“We have mixed with residents, relatives and care staff in order to answer queries about the research. The opportunity to discuss research with lay people made them feel more at ease and more willing for their relatives to be part of the research programme.” Ernie Lloyd and Anne Grice, Lay members on the implementation team

  • Highlighting benefits to care homes: All homes, whether in control or intervention arms, were offered the intervention (control homes would receive it after the trial). All the participating homes received an ENRICH certificate showing their commitment to improvement through research participation, which was positively acknowledged by the CQC. The care homes were also offered £400 in recognition for their time.
  • Flexible and responsive scheduling: planned training time was often subject to change at the last minute to accommodate care home schedules and researchers were required to be flexible with their time. On some occasions this meant working in the evening and at weekends.
  • Real time data uploads: all activity data was uploaded daily so the PI could see how recruitment was progressing in real time. The use of the SharePoint Portal allowed the research team to easily access documentation remotely e.g. information leaflets, training documents or standard operating procedures related to the trial.

“Involvement of carers on our implementation team and advisory board has been a real strength of the study…their ability to communicate with residents and other carers has been invaluable in promoting PiTStop.” Dr Najma Siddiqi – Principal Investigator

Barriers to success

There was often a six month lead in time between care homes registering interest in taking part and the Research Ethics Committee (REC) and site approvals being in place. This meant that some homes circumstances had changed they and were no longer able to participate in the study. Care home managers gave these reasons for not wanting to participate after initial contact:

• Lack of interest/staff already having knowledge and skills around delirium

• Other research or initiatives taking place in the home e.g. working towards gold standard end of life care

• Pressures of workload and change of management.

Lessons Learned

The project could not commence until REC and site approvals were in place before recruiting homes that had already expressed an interest in the study. This affected the recruitment of homes. Future studies should consider securing these approvals before approaching homes for ‘expressions of interest’ so that fieldwork can commence as soon as possible.

• Using skilled researchers1 with clinical backgrounds and experience of older people and/ or mental health was important in the engagement of both residents and staff.

• Care home staff accompanied residents during the recruitment and consent process, on the premise that having someone familiar to them would make the process easier for residents. This worked well for the most part. However, at times staff did not seem to understand the requirement for informed consent. Training on informed consent in research would help care home staff better support recruitment.

• Staff were largely informed of the study through the care home management, which did not always work well. Some staff misunderstood the purpose of the study and imparted incorrect information to residents, which impeded recruitment. An information leaflet addressed to all staff, not only the care home managers, would improve care home staff engagement.

• Allowing researchers to work autonomously was essential in getting recruitment underway and ensuring progress.

• Formal supervisory meetings alongside, informal ‘coffee catch-up’ sessions were organised at regular intervals to de-brief on the visits and share learning experiences amongst the team. This also helped relieve the pressure of working in what is sometimes an emotionally challenging environment.

• Care home managers felt that there is little distinction between populations of residential and nursing homes and both should be considered for inclusion in future care home research on delirium.

• Involving lay people on the implementation team helped residents and family carers to feel at ease and more willing to be part of the research programme.

• Some care homes offered open access to the researchers whilst others allowed afternoon visits only. This meant that the researchers had to carefully schedule their appointments to optimise use of their time and the research budget. If research could not take place, time was spent, software testing and training. A rigid, uniform approach to all care homes seems to be ineffective.

• Recruiting residents nearer the time of the outcomes measurement might reduce loss to follow-up through the long intervention period. This would also reduce the time burden on staff and residents

Further Information

A report on the feasibility study of Stop Delirium! can be found at: delirium-information/health-professionals/stopdelirium-project/

Researchers training comprised:

• Safeguarding adults from abuse and neglect

• Orientation to care home settings through shadowing an older peoples advocate

• Introduction to the Mental Capacity Act (MCA), 2005

• Workshop around the MCA in practice delivered by a 3rd sector older people’s advocate

• Workshop in the use of the Confusion Assessment Measure (CAM) and Delirium Rating Scale (DRS) delivered by a consultant geriatrician

• Shadowing ward rounds to observe the CAM and DRS tools in practice.


Contact Details

Case Study Lead: Anne Heaven


ENRICH toolkit: