DAMPen-D II: Improving the Detection, Assessment, Management, and Prevention of Delirium in Palliative Care Units: a Cluster Randomised-Controlled Trial, Economic Analysis and Process Evaluation

BACKGROUND

Delirium is highly distressing for patients and families, increases health professionals’ anxiety and stress, and leads to poor clinical outcomes and higher care costs. One-third of people cared for by adult in-patient Palliative Care Units (PCUs) such as hospices have delirium on admission, with a further one-third developing delirium during their stay.

Non-pharmacological interventions reduce delirium risk and are recommended in NICE clinical guidelines. However, there is a major evidence gap about the effectiveness of strategies for implementing guideline-adherent delirium care in PCUs and other settings. AIMS & OBJECTIVES Aim:

To evaluate the effectiveness and cost-effectiveness of a clinical guideline implementation strategy (CLECC-Pal Delirium) to improve the early detection, management and prevention of delirium among palliative care unit (PCU) in-patients. Objectives:

1. To set up (Work Package (WP) 1) and conduct (WP2) a cluster RCT (cRCT) of CLECC-Pal Delirium vs. usual practice with an integrated pilot phase

2. To evaluate the effectiveness and cost-effectiveness of CLECC-Pal Delirium vs. usual practice on reducing the proportion of in-patient delirium days in PCUs in a fully powered cRCT, and to explain the results of the cRCT (WP2)

3. To engage and inform stakeholders about study findings, and explore how the CLECC-Pal Delirium implementation strategy could be adapted for use in other settings (WP3) RESEARCH QUESTIONS In palliative care units (PCUs):

1.What is the effectiveness and cost-effectiveness of CLECC-Pal Delirium vs. usual practice on reducing the proportion of in-patient delirium days?

2.What mechanisms, occurring in which contexts, might explain why different implementation and patient outcomes subsequently occur? 3.How should CLECC-Pal Delirium be tailored for PCUs with different organisational cultures to achieve optimal impact? For other settings:

4.How can CLECC-Pal Delirium be adapted to improve delirium guideline implementation for people receiving palliative care in other high-prevalence settings such as care homes? METHODS AND TIMELINE

Building on the learning from our feasibility study and the feedback of our Public Involvement Group members, we will conduct a cRCT with concurrent economic analysis and process evaluation in 20 PCUs in the United Kingdom. - WP1 (M1-9): Study set-up and PCU engagement - WP2 (M10-48): • Internal pilot (M10-15)

• Adaptive ‘implementation-to-target’ cRCT (M16-42) • Health economic analysis (M16-42) • Process evaluation (M25-48) • cRCT data analysis and reporting, including synthesis of findings (M43-48) - WP3: Knowledge exchange workshops (M37-48) ANTICIPATED IMPACT AND DISSEMINATION

The 12% reduction in PCU delirium days that our study is powered to detect will inform health and care decision-making that will:

1. Decrease unplanned health service utilisation and costs (e.g. hospital care savings of £41.5 million per year if a 12% reduction in PCU delirium days resulted in a similar reduction in unplanned hospital admissions)

2. Improve the quality of life of c.28,000 people in the UK each year who would otherwise experience the distress of delirium whilst a PCU in-patient

3. Improve the wellbeing and ability to maintain economic productivity of the c.112,000 carers (family, friends) who will not be obliged to deal with the damaging sequelae of delirium 4. Improve PCU workforce wellbeing, including improved recruitment and retention