Clinical Trials Logo

Clinical Trial Summary

The impacts of unmet social needs, such as homelessness, inconsistent access to food, and exposure to violence on health are well-established, especially for cardiovascular disease. A limited but growing body of evidence suggests that screening for and addressing these needs - also referred as social determinants of health -- in clinic settings helps to connect patients to resources to address unmet needs and has the potential to improve health outcomes. Veterans carry a high burden of unmet needs. At present, VA systematically screens for only two unmet needs; homelessness and food insecurity. The investigators propose to assess the efficacy of systematically screening Veterans for nine unmet needs (i.e., housing, food insecurity, utility insecurity, transportation, legal problems, employment, safety, stress, and social isolation), and compare the effect of referral mechanisms of varying intensity on Veterans' connection to resources, reduction of unmet needs, treatment adherence, reduced preventable hospitalizations, and clinical outcomes.


Clinical Trial Description

Background: Despite medical advances, up to 70% of health outcomes are due to social determinants of health (SDoH) - the conditions in which people live and work that shape whether basic needs (e.g., housing, food) are met. These associations are especially well documented for cardiovascular disease (CVD). In response, health policy leaders recommend screening and referral (S&R) for unmet needs in clinical settings, and the American Heart Association recently concluded that the most significant opportunities for reducing CVD death and disability lie with addressing the social determinants of cardiovascular outcomes. A limited but promising evidence base supports these recommendations but more rigorous research is needed to guide how best to intervene on unmet needs that affect health. Significance/Impact: This project addresses the Office of Social Work's priority to link Veterans with resources and services in support of treatment goals, the Office of Patient Centered Care and Cultural Transformation's priority to enhance the physical, emotional, and social well-being of the whole person, the Office of Health Equity's priority to reduce disparities, and the HSR&D priorities of health equity and population health. Our study will provide much-needed evidence to document the burden of Veterans' unmet needs, inform how best to address unmet needs, and assess how such a process can affect adherence (to medications and appointments), utilization, and clinical outcomes. Innovation: VA currently systematically screens for only two unmet needs (homelessness and food insecurity). Identification of other unmet needs (and referral to address them) occurs on an ad hoc basis, with varying approaches among clinics/ clinicians. The investigators will implement comprehensive screening of eight unmet needs and systematic referral, developing tools and processes that, if efficacious, can be implemented within VA (and other) clinical systems. VA is currently funding several studies related to SDoH, but none test interventions that systematically identify a wide range of unmet social needs among Veterans and connect Veterans with identified needs to social service resources. Specific Aims: 1) Describe the burden and distribution of nine unmet needs (i.e., housing; food insecurity; utility insecurity; transportation; legal guidance; employment; safety; and social isolation) among Veterans with or at-risk for CVD, and identify their associations with sociodemographic characteristics, and baseline health-related behaviors and clinical outcomes; 2) Compare the effects of three S&R study intervention conditions of varying intensity on Veterans' connection to new SDoH resources (primary outcome), reduction of unmet needs, adherence, and clinical outcomes, and 3) Identify barriers and facilitators to Veterans' connecting with social services and having needs met, and explanatory factors for observed RCT outcomes. Methodology: The investigators propose a 3-year, two-phased mixed methods study. In Phase One (Aims 1 and 2), the investigators will implement a three-armed randomized controlled trial at three VA sites to compare outcomes among Veterans randomized within each site to one of three study conditions: screening only; screening plus provision of tailored resource sheets; or screening plus resource sheets plus social work support. For each Veteran, the investigators will examine associations of unmet needs with baseline outcomes (Aim 1), and longitudinally examine the impact of each approach on connection to new SDoH resources and follow-up outcomes over a 12-month period (Aim 2). In Phase Two (Aim 3), the investigators will conduct interviews with Veterans and representatives of the VA- and community-based programs to which Veterans are referred because of the trial to identify facilitators and barriers and potential explanatory factors related to the relative success of the interventions. Implementation/Next Steps: If the intervention yields positive results, findings will be used by partners to support more widespread implementation of it throughout VA. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04977583
Study type Interventional
Source VA Office of Research and Development
Contact Deborah A Gurewich, PhD
Phone (857) 364-4044
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date February 1, 2022
Completion date May 31, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Not yet recruiting NCT05041829 - Dietary Sodium Intake and Blood Pressure in Living Kidney Donors N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Active, not recruiting NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Not yet recruiting NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Recruiting NCT03875768 - Nourish: A Digital Health Program to Promote the DASH Eating Plan Among Adults With High Blood Pressure N/A
Active, not recruiting NCT04303468 - Intervention With a GABA Supplement in Prediabetics N/A
Completed NCT03632668 - Evaluating the Pharmacokinetic Interaction Between AD-2071 and AD-2072 Phase 1
Recruiting NCT02699645 - Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial Phase 3
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Recruiting NCT04452331 - Assessing Open Access Audio N/A
Active, not recruiting NCT03660631 - Dissemination of the Cardiovascular Risk Service N/A
Completed NCT03929198 - Translation of Pritikin Program to the Community N/A
Terminated NCT04051957 - Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury Phase 2
Completed NCT00508365 - Evaluation of Potential for Orthostatic Hypotension in Elderly Hypertensives Phase 1
Completed NCT00382564 - Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease N/A
Recruiting NCT05077475 - A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52L in Healthy Volunteers Phase 1