跳至主要内容
临床试验/NCT04977583
NCT04977583已完成不适用

The Effect of Screening and Referral for Social Determinants of Health on Veterans' Outcomes

VA Office of Research and Development6 个研究点 分布在 1 个国家目标入组 479 人开始时间: 2022年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
479
试验地点
6
主要终点
Number of Participants Who Connected With a New Resource

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Veterans enrolled in one of three VA medical centers:
  • VA Boston Healthcare System
  • Corporal Michael J. Crescenz VA Medical Center (Philadelphia)
  • Ralph H. Johnson VA Medical Center (Charleston)
  • Veterans with, or at risk for, cardiovascular disease (CVD) who had at least 1 PC visit in the prior year
  • CVD patients are defined as those with International Classification of Disease 10 (ICD10) diagnoses indicating:
  • coronary artery disease
  • cerebrovascular disease
  • peripheral artery disease
  • Patients at-risk for CVD are defined as having diagnoses of hypertension, diabetes mellitus (DM), or hyperlipidemia

排除标准

  • Impaired decision-making
  • Illiterate or have limited or no English proficiency

结局指标

主要结局

Number of Participants Who Connected With a New Resource

时间窗: 8 weeks

Defined as participant connecting to one or more resources since the index unmet need screen and assessed via a participant survey administered 8 weeks following the index unmet need screen. The survey will ask: "Since you completed the unmet social need screen on (insert date), were you able to connect with any of the programs or resources for help with (insert need(s) identified)".

Mean Count of Resources Connected To

时间窗: 8 weeks

Defined as a count of resources that a participant connected to since the index unmet need screen and assessed via a participant survey administered 8 weeks following the index unmet need screen. The survey will ask: "Since you completed the unmet social need screen on (insert date), were you able to connect with any of the programs or resources for help with (insert need(s) identified)".

次要结局

  • Unmet Need Reduction - Any(6 months)
  • Emergent Visits (Urgent Care and Emergency Department Visits)(12 months compared to baseline)
  • Medication Adherence(12 months compared to baseline)
  • Clinic Visit Appointment Attendance ("No-show")(12 months compared to baseline)
  • Systolic Blood Pressure (BP)(12 months compared to baseline)
  • Hemoglobin A1c (HbA1c)(12 months compared to baseline)
  • Unmet Need Reduction - Percent(6 months)
  • Diastolic Blood Pressure (BP)(12 months compared to baseline)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验

Unmet Social Needs Study | 临床试验