The Patient-Centered Outcomes Research Institute (PCORI) funds patient-centered outcomes research (PCOR), a type of comparative clinical effectiveness research that focuses on outcomes that matter to patients, their caregivers, and their families. PCORI-funded studies must include the perspectives of patients and other healthcare stakeholders.

This Targeted PCORI Funding Announcement (PFA) seeks to fund high-quality studies that compare effectiveness of evidence-based single and/or multicomponent nonpharmacologic, pharmacologic, and/or combination interventions that improve prevention, early identification, or treatment of delirium in older adults. PCORI will accept applications that propose rigorous multisite randomized controlled trials or robust well-justified observational prospective studies. Applicants will be asked to propose well-justified and validated outcomes that are clinically meaningful and considered important by patients and/or their caregivers.

Research Initiative Highlights

Delirium is an acute, reversible state of disorientation, inattention, and confusion. It is caused mainly by acute medical illness, surgery, hospitalization, trauma, or drugs. It is most common amongst older adults, with 60 percent of delirium being unrecognized.

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. Delirium ultimately leads to a series of events ending in loss of independence, increased morbidity and mortality, institutionalization, and high healthcare costs.

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

PCORI’s Targeted PFA is soliciting applications for CER studies that focus on one or more of three research areas within delirium research:

• Prevention
• Early Identification
• Treatment

These three research areas encompass real-world challenges within delirium research. For this reissuance, applications addressing one or more of these three areas will be considered responsive; however, PCORI especially encourages applications in the areas of early identification and treatment. PCORI is particularly interested in multisite randomized controlled trials. Observational studies may be considered responsive if 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 nonpharmacologic, pharmacological, and/or combination interventions.

The proposed budget for studies under this initiative may be up to $5 million in direct costs for small studies and up to $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.

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

For questions regarding this funding announcement, please reach out to sciencequestions@pcori.org.