The development of a non-pharmacological intervention for delirium management in critically ill patients

Abstract

Delirium is common in Intensive Care Unit (ICU) patients with incidence up to 74 % in the United Kingdom and is associated with increased mortality and morbidity. Multicomponent non-pharmacological interventions are beneficial in the prevention and treatment of delirium in older hospitalised patients however, there is a lack of evidence for their efficacy in critically ill patients. The studies in this thesis investigate which non-pharmacological interventions are effective for the prevention/ treatment of delirium in critically ill patients.

The aim of this research project was to develop a non-pharmacological intervention that could be easily delivered by nursing staff in ICU as part of their current role. The objectives were to determine best evidence from experts and stakeholders on what is practical and if one intervention should be used or a package of interventions, define each component of the intervention and how this can be delivered, develop an implementation plan and protocol for a feasibility study and apply for ethical approval. To achieve these objectives, I followed the MRC guidance on the development of complex interventions and the methods are described here in three parts;

(i) Systematic review and meta-analysis: I followed the Cochrane methodology and included qualitative and quantitative studies. This was a novel approach to determine which interventions were effective in reducing the incidence and/or duration of delirium in critically ill patients,

(ii) Consensus meeting of international delirium experts to discuss the results of the systematic review and identify interventions that might work well in a multicomponent design. An expert panel was conducted where experts discussed in-depth a range of interventions that were indicated in a systematic review and meta-analysis to be potentially beneficial.

(iii) Focus group interviews with ICU staff, ICU survivors and their relatives to determine acceptability and feasibility of the interventions for inclusion in a multicomponent intervention. Key stakeholders discussed in depth a prototype for a multicomponent intervention incorporating education, sedation minimisation, physical and occupational therapy and optimisation of the environment.

The DIGNIFY study is the first to develop a multicomponent non-pharmacological intervention for delirium management in critically ill patients following the Medical Research Council (MRC) framework for the development of complex interventions. This novel study recognised the complexities of developing and implementing a non-pharmacological intervention and sought to address these in the intervention design. This was achieved by including expert opinion and stakeholder veto for interventions that were not deemed feasible. The complexities of the ICU environment were also considered and the template for intervention description and replication (Tidier) framework was used to describe the intervention in its entirety and an implementation plan was devised that considered the ICU context. A thorough analysis of the busy environment, resource and organisation constraints was used to devise an implementation plan that would allow dedicated staff to implement the intervention.
Results from the systematic review of RCTs revealed limited evidence to support non-pharmacological interventions. Results from non-randomised studies were more promising and demonstrated a low-quality signal for improved delirium outcomes associated with education and family participation, sedation minimisation, physical therapy and environmental interventions. Experts felt physical therapy would have to be limited to around the bed mobilisation due to limited resources in UK ICU’s and felt pharmacist buy-in would also be limited with current resources. Staff interviews were largely supportive of the interventions brought forward. ICU survivors and their families placed huge importance on the participation of families, education and communication training or staff. The resultant evidenced based and stakeholder approved intervention incorporated;

1) an education programme for staff to facilitate buy-in from staff and family participation in care
2) an advisory protocol to limit sedatives and improve pain management
3) a physical therapy programme in liaison with the physiotherapy team that was incremental in nature
4) an environmental protocol which focused on structured orientation, communication training and resources, a structured sleep protocol and cognitive stimulation exercises delivered by family members and/or staff.

In summary, this PhD is vital for informing future work in this area due to the extensive work on intervention description using the TIDieR framework and implementation planning including development of a protocol, training manual and implementation strategy. All of this was undertaken in preparation for a single centre feasibility study for which ethical approval has been obtained. This study will be undertaken separate to this PhD thesis and could be taken forward to an RCT.

Date of Award	Dec 2021
Original language	English
Awarding Institution	Queen's University Belfast
Supervisor	Danny McAuley (Supervisor), Mike Clarke (Supervisor) & Bronagh Blackwood (Supervisor)