Prevention, Early Identification, and Treatment of Delirium in Older Adults -- Cycle 1 2022

Delirium is an acute, reversible state of disorientation, inattention, and confusion.^1-3 It is caused mainly by acute medical illness, surgery, hospitalization, trauma, or drugs.⁴ It is most common amongst older adults with 60% of delirium being unrecognized.⁵ With the onset of the COVID-19 pandemic, delirium has manifested as an urgent clinical challenge as many symptoms overlap with COVID-19 in older adults.⁶ Delirium ultimately leads to a series of events ending in loss of independence, increased morbidity and mortality, institutionalization, and high health care costs.^7-9 In the United States, more than 2.6 million adults ages 65 and older each year develop delirium and account for an estimated $164 billion in annual health expenditures.^10,11   

Evidence gaps exist in delirium research in the areas of prevention (head-to-head comparisons of single and multicomponent non pharmacologic interventions), evidence for screening tools in different health care settings, and effective implementation and uptake of interventions, and comparisons of pharmacologic and non-pharmacologic interventions on delirium treatment.

Therefore, the Delirium Targeted PCORI Funding Announcement will solicit applications for CER studies that focus on three research areas within delirium research:

• Prevention
• Early Identification
• Treatment

These three areas encompass real-world challenges within delirium research, and applications may focus on one or more of these areas. PCORI is particularly interested in multisite randomized clinical trials. Observational studies may be considered responsive given that the choice of observational design is well justified, and the proposed methods are robust.  Applicants can propose to compare the effectiveness of single and multicomponent non pharmacologic interventions, pharmacological and/or nonpharmacological combination interventions.

The proposed budget for studies under this initiative may be up to $5 million in direct costs for small studies and $10 million in direct costs for large studies, as appropriate.  Applications for the large studies are required to include an implementation aim in addition to comparing the effectiveness of interventions. To that end, to be considered responsive, PCORI encourages applicants applying for the large studies to consider study designs such as hybrid type 1, hybrid type 2 or mixed method approaches.

Additionally, applications focused on the needs of underserved, underrepresented, or historically excluded populations within hospital and long term care settings will be encouraged. Applicants will be asked to propose well justified and validated outcomes that are clinically meaningful, considered important by patients and/or their caregivers, and that are readily measurable within the proposed study period not to exceed 5 years.