Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity and Improve Adherence in Patients with Hypertension - Project Summary/Abstract Food insecurity (FI) affects 20% of the 116 million people in the US with hypertension (HTN). FI is associated with poor adherence to evidence-based HTN treatments, worse blood pressure control, and a higher risk of mortality. Interventions used to address FI in clinical care settings include 1) providing information about community resources, 2) utilizing community health workers, and 3) delivering medically-tailored meals. Although there is evidence for each of these interventions, people differ in the support they need to reduce FI and little is known about which interventions work best, or for whom. Rather than use a single FI intervention, adaptively allocating interventions could be a more effective, equitable, and efficient approach to improve food security, treatment adherence, and blood pressure for the large, vulnerable population affected by FI and HTN. Our objectives are to 1) determine which initial FI intervention more effectively improves adherence and blood pressure and 2) for those who do not respond to the initial intervention, evaluate how best to provide additional support. We will conduct a Sequential Multiple Assignment Randomized Trial (SMART) in partnership with Atrium Health Wake Forest Baptist, an academic medical center that serves communities in North Carolina with high rates of FI and HTN. In the SMART, patients with uncontrolled HTN and FI will be randomized to 1 of 2 first-stage FI interventions: 1) resource information or 2) community health worker support. Participants who do not have an improvement in blood pressure after 3 months will be re-randomized to 1 of 2 second-stage interventions for an additional 3 months: 1) community health worker support or 2) medically-tailored meals. In Aim 1, we will determine which first-stage FI intervention is more effective in improving adherence and blood pressure. In Aim 2, we will evaluate which FI intervention is the best next step for those who do not respond to the initial intervention. In Aim 3, we will explore how, why, and under what circumstances participants achieved improvements to the first- and second-stage interventions by conducting semi-structured interviews with participants and evaluating for potential predictors of heterogeneity in response to each intervention. The proposed research complements NHLBI’s NOSI (NOT-OD-21-100) to “overcome barriers to adherence to evidence-based guidelines” and “address social determinants that contribute to disparities in adherence.” This will be the first study to evaluate an adaptive intervention to enhance adherence to HTN treatments, by addressing FI. Given the growing interest among health systems in addressing FI as part of clinical care, an efficacious adaptive intervention could be broadly disseminated across healthcare settings. An adaptive FI intervention could reduce the costs and burden to patients and providers by providing no more treatment than is needed for patients who respond to a less intensive approach and redirecting the saved resources to patients who need a more intensive approach. Our team of established investigators has successfully used the methods proposed and has the full support of the health system where the study will occur.
