1033 — Research Protocol: A mixed-methods RCT to assess unmet social need intervention among Veterans with cardiovascular disease

Lead/Presenter: Deborah Gurewich,  COIN - Bedford/Boston
All Authors: Gurewich DA (Center for Healthcare Organization and Implementation Research, Boston)), Kressin, N (Boston University School of Medicine, General Internal Medicine, Boston) Bokhour, B (Center for Healthcare Organization and Implementation Research, Bedford) Linsky, A (Center for Healthcare Organization and Implementation Research, Boston) Dichter, M (Center on Health Equity Research and Promotion, Philadelphia) Hunt, KJ (Health Equity and Rural Outreach Innovation Center, Charleston) Fix, GM (Center for Healthcare Organization and Implementation Research, Bedford) MacLaren, RZ (Center for Healthcare Organization and Implementation Research, Boston) Niles, B (National Center for PTSD, Behavioral Sciences Division, Boston)

Objectives:
Health policy leaders recommend screening and referral (SandR) for unmet social needs (e.g., food, housing) in clinical settings, and the American Heart Association recently concluded that the most significant opportunities for reducing cardiovascular (CVD) death and disability lie with addressing the social determinants of CVD outcomes. A limited but promising evidence base supports these recommendations, but more rigorous research is needed to guide health care-based SandR efforts. This study will assess the efficacy of SandR on Veterans’ connections to new resources to address social needs, reduction of unmet needs, and health-related outcomes (adherence, utilization, and clinical outcomes).

Methods:
This is a 1-year mixed-methods randomized controlled trial at three VA sites, enrolling Veterans with CVD and CVD-risk. Enrollment commenced on May 2, 2022. Veterans experiencing one or more social needs are being randomized within each site (N = 880, 293 per site) to one of thee study arms representing referral mechanisms of varying intensity: screening only; screening and provision of resource sheet(s); screening and provision of resource sheet(s) plus social work assistance. For each Veteran, we will examine associations of unmet social needs with health-related outcomes at baseline, and longitudinally compare the impact of each approach on connection to new resources (primary outcome) and follow-up outcomes over a 12-month period. Additionally, qualitative interviews with Veterans and other key stakeholders will be conducted to identify potential explanatory factors related to the relative success of the interventions.

Results:
The study, designed before COVID, is being implemented during COVID. Design modifications, made to accommodate the changing operating environment (e.g., what had been in an-clinic intervention is now entirely a remote intervention) will be reported. Preliminary results document the prevalence of unmet needs at three large urban VA Medical Centers; final study results will provide much-needed evidence to inform how best to address unmet needs and assess how such a process can affect adherence, utilization, and clinical outcomes.

Implications:
If any of our intervention study arms demonstrate greater improvements in one or more study outcomes overall, these findings can be tested and spread through future implementation research and processes. The addition of our stakeholder interviews is unique to most clinical trials and will help to identify barriers and facilitators to future implementation, including potential modifications to the intervention. Further, our focus on the sentinel condition of CVD may help bridge the substantial sociodemographic gap in life expectancy related to CVD, and our methods can be used to examine the effects of interventions to address unmet needs on other conditions.

Impacts:
To our knowledge, there have been no randomized controlled trials demonstrating the impact of systematic SandR for unmet needs on patients’ connection to resources or other utilization and health outcomes in the general adult ambulatory care setting, let alone among Veterans. Because there is no definitive guidance on how best to screen for and address unmet needs in clinical settings, this study addresses a key barrier to implementing SandR for social determinants in health care delivery systems.