In what is, to our knowledge, the largest RCT conducted of a staff training and non-pharmacological intervention for people with dementia living in nursing homes, we have demonstrated that the WHELD intervention confers a statistically significant improvement in QoL over 9 months. There was also a statistically significant benefit regarding agitation and overall neuropsychiatric symptoms over the 9-month period. Whilst the effect sizes were small, the benefits in agitation and neuropsychiatric symptoms were comparable to (agitation) or better than (NPI-NH) the benefits seen with antipsychotic drugs. There was also a significant increase in the proportion of positive care interactions between care staff and residents with dementia, with a moderate effect size. Importantly, the benefits were achieved in the context of a cost saving and used a model that can readily be implemented in nursing homes. Antipsychotic drug use was stable in both treatment groups across the study, and the WHELD treatment intervention did not reduce antipsychotic use (baseline frequency was very low).
Despite the importance of QoL, few trials have examined the impact of interventions on this outcome. In this study, the WHELD intervention conferred a statistically significant improvement in QoL over 9 months, building on a previous proof-of-concept study of WHELD. That study reported a reduction in QoL following antipsychotic review that was mediated by social interaction within the context of an overall PCC training paradigm for care staff. We would speculate that the added benefit was probably a reflection of the structured approach to promoting pleasant activities involving social interaction. The subsequent optimisation of the WHELD intervention maintained benefit but reduced overall cost, making it a cost-effective programme for delivery in care homes. A sub-group analysis focusing on people with mild to moderate, moderately severe, and severe dementia indicated that benefits on QoL were more robust in people with moderately severe dementia.
Agitation is a frequent and distressing symptom for people with dementia living in nursing homes. Benefits from pharmacological treatment with atypical antipsychotics are limited to modest improvements in aggression, and the significant advantage on the CMAI for the WHELD intervention compared to control is comparable to the modest treatment advantage for atypical antipsychotics from a meta-analysis of previous RCTs. In addition, the use of atypical antipsychotics is limited by the significant adverse effects of these medications in people with dementia. Recent studies have begun to suggest that other pharmacological therapies such as citalopram and dextromethorphan may confer significant benefit for the treatment of agitation, but further studies are needed. There was also a statistically significant benefit in overall neuropsychiatric symptoms conferred by the WHELD intervention compared to TAU, suggesting a breadth of benefit beyond just reducing agitation.
Although comparable to the effect sizes of atypical antipsychotics, the standardised effect sizes of benefit for WHELD were small in the context of a clinical intervention. The benefits did however include benefits in QoL, which have not been demonstrated with pharmacological interventions. Although there is no established threshold for a clinically meaningful benefit in QoL, any statistically significant benefit is important given the absence of any benefit in previous studies. In addition, the intervention was not just delivered to people with clinically significant neuropsychiatric symptoms, but conferred benefit amongst a broader population of people with dementia living in care homes. Whilst the effect sizes would be considered marginal in terms of a clinically significant benefit, we believe that the benefits to the broader population of people with dementia in care homes make this a meaningful benefit in the quality of care.
This study is consistent with the evidence base but provides important and novel data within the literature. Our results also compare favourably to those of the small number of published intervention studies that have focused on promoting PCC, none of which have reported benefits in QoL. The findings are particularly favourable when compared with those of trials of antipsychotic medications, which show only very modest benefits over 12 weeks in the context of significant harms. In addition, the current study shows cost advantages over usual care, which has not been demonstrated, to our knowledge, with any previous drug or non-drug intervention.
Elements of the WHELD intervention, such as social interaction and pleasant events, have previously been demonstrated to improve agitation in modest-sized RCTs. Incorporating them within a coherent framework such as WHELD enables straightforward and affordable implementation of these approaches in clinical and care practice. Interestingly, there was a low baseline use of antipsychotic medications (<10%) in this study, reflecting the major changes in clinical practice and the reductions in antipsychotic use that have been achieved for people with dementia in the last decade. In contrast to our previous factorial RCT of the WHELD intervention, no significant reduction in antipsychotic use was achieved, and antipsychotic use was stable in both groups. This is likely attributable to a combination of the low baseline levels of antipsychotic prescription and the more limited education programme for primary care physicians within the current study than in the previous factorial RCT, and highlights the potential additional value of primary care education programmes in parallel to care home training.
This study was a robust, well-powered RCT evaluating the sustained impact of combining PCC and evidence-based non-pharmacological interventions for people with dementia in nursing homes. The study had good retention of surviving participants compared to most studies conducted in nursing home settings. The intervention evaluated was pragmatic, fully manualized, and designed so that it can be easily disseminated and implemented in routine clinical practice. There were also limitations. Antipsychotic review was based on augmenting processes within care homes to trigger medical review and did not in this study involve proactive primary care education. In addition, although the study used a well-validated method, evaluating QoL in people with dementia is challenging and all methods have some limitations. High mortality rates are usual in studies of frail groups of individuals living in care homes, but lead to high non-completion rates and present some challenges for data analysis and interpretation. One of the original secondary outcomes was to evaluate the impact of the intervention on the care home environment. The selected scale focused mainly on the physical building rather than other aspects of the environment, and the programme management group therefore decided to omit this measure at 9-month follow-up as it was unlikely that substantial building renovations had taken place in any of the participating care homes.
A key issue for future studies is the sustainability of the intervention, particularly with turnover of staff, including the WHELD champions. To be sustainable, the WHELD intervention needs to be firmly embedded within the care home culture, and it will be important for further research to identify the optimal approach to maintain benefits. As WHELD is largely verbally based, it will also be important to further evolve interventions more tailored to the needs of people with more severe dementia.
