POISED: Protocol for a multi-site randomized controlled trial of the program of intensive support in emergency departments for care partners of cognitively impaired patients (Preprint)

BACKGROUND Older adults with cognitive impairment have more Emergency Department (ED) visits and 30-day readmissions and are more likely to die after visiting the ED than people without cognitive impairment. ED providers frequently do not identify cognitive impairment in the older adults. Use of cognitive screening tools, in combination with better understanding of root causes for ED visits, could equip healthcare teams with the knowledge they need to develop individually tailored care management strategies for post-ED care. By identifying and directly addressing patients’ and informal caregivers’ (or care partners’) psychosocial and healthcare needs, such strategies could reduce the need for repeat acute care. We use the terms ‘caregiver’ and ‘care partner’ interchangeably. OBJECTIVE This paper describes the protocol for a randomized controlled trial of a new care management intervention, “Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients Trial” (POISED) compared to usual care. We describe the research design, intervention, outcome measures, data collection techniques, and analysis plan. METHODS ED patients >75 years who screen positive for cognitive impairment via either the Mini-Cog or the proxy-reported Short Informant Questionnaire on Cognitive Decline in the Elderly, with a planned discharge to home, are recruited to participate with their identified informal (family or friend) caregiver in a 2-site randomized controlled trial of POISED at New York University Langone Health and Indiana University. The intervention group receives 6 months of care management provided by the POISED Care Team of registered nurses and specialty-trained paraprofessionals, who perform root cause analyses, administer standardized assessments, provide advice, recommend appropriate referrals, and, when applicable, implement dementia-specific co-morbid condition protocols. The control group receives care as recommended at ED discharge (usual care) and are given information about resources for further cognitive assessment. The primary outcome is repeat ED use; secondary outcomes include caregiver activation for patient healthcare management, caregiver depression, anxiety, and experience of social support as important predisposing and time-varying enabling and need characteristics. Data are collected from questionnaires and patient electronic health records. RESULTS Recruitment occurred from March 2018 through May 2021. Study findings will be published in peer-reviewed journals, and presented to peer audiences, decision makers, stakeholders, and other interested persons. CONCLUSIONS The POISED intervention is a promising approach to tailoring care management based on root causes for ED admission of cognitively impaired patients with the aim of reducing readmissions. This trial will provide insights for caregivers and ED and primary care providers on appropriate, personalized, and proactive treatment plans for cognitively impaired older adults. Findings will be relevant to all audiences concerned with quality of life for individuals with cognitive impairment and their caregivers. CLINICALTRIAL ClinicalTrials.gov (NCT03325608) registered on October 30, 2017.