The PiTSTOP study: a feasibility cluster randomized trial of delirium prevention in care homes for older people

Background and objectives: delirium is a distressing but potentially preventable condition common in older people in long-term care. It is associated with increased morbidity, mortality, functional decline, hospitalization and significant healthcare costs. Multicomponent interventions, addressing delirium risk factors, have been shown to reduce delirium by one-third in hospitals. It is not known whether this approach is also effective in long-term care. In previous work, we designed a bespoke delirium prevention intervention, called 'Stop Delirium!' In preparation for a definitive trial of Stop Delirium, we sought to address key aspects of trial design for the particular circumstances of care homes. Design: a cluster randomized feasibility study with an embedded process evaluation. Setting and participants: residents of 14 care homes for older people in one metropolitan district in the UK. Intervention: Stop Delirium!: a 16-month-enhanced educational package to support care home staff to address key delirium risk factors. Control homes received usual care. Measurements: we collected data to determine the following: recruitment and attrition; delirium rates and variability between homes; feasibility of measuring delirium, resource use, quality of life, hospital admissions and falls; and intervention implementation and adherence. Results: two-thirds (215) of eligible care home residents were recruited. One-month delirium prevalence was 4.0% in intervention and 7.1% in control homes. Proposed outcome measurements were feasible, although our approach appeared to underestimate delirium. Health economic evaluation was feasible using routinely collected data. Conclusion: a definitive trial of delirium prevention in long-term care is needed but will require some further design modifications and pilot work.