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Jama-Journal of the American Medical Association ; 327(3):286-286, 2022.
Article in English | Web of Science | ID: covidwho-1695638
Journal of Investigative Medicine ; 69(5):1087, 2021.
Article in English | EMBASE | ID: covidwho-1343971


Introduction/Background This pragmatic cluster randomized clinical trial (cRCT) enrolls patients with multiple chronic diseases (MCDs) who are at highest risk for destabilization (unplanned hospitalizations, increased disability). Patients with multiple chronic diseases are often excluded from clinical trials because of their multiple medical conditions and worse health outcomes, which significantly confound Results. Few evidenced- based strategies exist to comprehensively address the needs of these patients. Objective(s) Among 1920 adult patients with multiple chronic diseases defined as a Charlson Comorbidity Index (CCI) > 4, who are established primary care patients of 16 Federally Qualified Health Centers (FQHCs) in NYC (n=8) and Chicago (n=8), which serve predominantly low income, Black and Latino patients, this pragmatic cluster RCT evaluates the comparative effectiveness of two approaches to preventing significant destabilization ('tipping points') that leads to unplanned hospitalization and increased disability. Methods Federally Qualified Health Centers (FQHCs, n=16) are cluster-randomized to: 1) Patient Centered Medical Home (PCMH) (Usual Care);or 2) PCMH plus a Health Coach (PCMH + HC) intervention that employs a positive affect/ self-affirmation strategy to motivate patients to set life goals, improve self-management and handle psychosocial and other stressors (Experimental). Primary and secondary outcomes include: unplanned hospitalizations and emergency department (ED) visits aggregated by PCORnet Clinical Research Networks, Health Information Exchange (New York City), and hospital alerts (Chicago), at baseline, 6, 12, 24-months and changes in disability. With the COVID-19 pandemic, we shifted to remote recruitment, and added oral consenting, egift cards and mailed letters. Results The PCMH + HC arm is designed to identify and prevent destabilization leading to hospitalization or ED visits that are more often triggered by psychosocial issues-family, community and environmental-than by medical issues. The study is powered to detect a 33% relative reduction in% hospitalized (a 5% absolute reduction) in PCMH + HC compared to PCMH only. Additionally, we expect that reducing hospitalization will result in reduced disability. Conclusion This intervention is designed to help participants manage life events that lead to 'tipping points' or overwhelming situations that result in unplanned hospitalizations and increased disability. FQHCs with PCMH recognition focus on care coordination. Patients need assistance to deal with many social and health related challenges they face and need help in communicating with health care providers and navigating a complex health care system. The PCMH + HC intervention will determine if adding health coaches helps patients to better manage their sources of stress, improve self-care and reduce unplanned hospitalizations. The impact of COVID-19 on changes to study processes and patient outcomes will be examined.