ARISE (Achieving Routine Intervention and Screening for Emotional health)

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ABSTRACT Diabetes mellitus (DM) affects 30 million people in the U.S. African-Americans and Hispanics are 1.4 and 1.2 times more likely to have DM compared to non-Hispanic whites. Diabetes distress—stress, fear, and guilt related to managing diabetes—is linked to poor glycemic control and disproportionately affects African Americans and Hispanic adults with type 2 diabetes mellitus (T2DM). The American Diabetes Association (ADA) has published guidelines promoting screening for and addressing diabetes distress (DD) as a critical part of clinical care. However, only 24% of adults with diabetes report their health care team asked them how diabetes affected their lives. Efforts to systematically identify and address DD could be an important strategy to improve diabetes outcomes among disadvantaged populations and address diabetes disparities. Community health centers (CHCs) can be important partners in this effort; CHCs provide primary care for 2.5 million adults with diabetes. More than 70% of CHC patients have income below 100% of the federal poverty level and 57% are people of color. No studies have systematically implemented DD screening and treatment interventions into a real-world primary care setting or used a guideline based approach. To fill this gap, we developed the ARISE (Achieving Routine Intervention and Screening for Emotional health) intervention. Based on published guidelines, ARISE incorporates validated screening instruments, draws from interventions shown to improve DD and is individualized to patients’ domains of DD. ARISE includes a standardized process for screening adult patients with T2DM for DD, training for health center staff on how to address distress in the patient encounter, and an algorithm for action steps and referrals based on the domains identified as sources of distress. This study aims to compare ARISE to enhanced usual care (didactic training for health care teams on DD) in CHCs using a type I hybrid effectiveness-implementation design via a cluster randomized pragmatic trial. First, we will adapt ARISE into clinical workflows in two CHCs (one urban and one rural) using the Form and Function domains of the Complex Health Intervention Framework. Using the lessons learned from the adaptation, we will conduct a cluster randomized pragmatic trial across 12 CHCs (six ARISE and six enhanced usual care) to test ARISE vs. enhanced usual care among adult patients with T2DM and A1c>8%. Primary outcome will be change in A1C from baseline to 12-months between arms. Secondary outcomes will include change in DD from baseline to 6-months within the ARISE arm and change in patients’ systolic blood pressure, low density lipoprotein (LDL), and body mass index (BMI) across the two arms. We will assess the adoption, implementation, and maintenance of the ARISE intervention. We will use knowledge gained to develop best practices for CHCs across the country that are charged with caring for the largest share of America’s medically vulnerable patients with T2DM.