Clinical trial NCT04977583: Unmet Social Needs Study
Official title: The Effect of Screening and Referral for Social Determinants of Health on Veterans' Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Hypertension
Diabetes Mellitus
Hyperlipidemia
Keywords: Social Determinants of Health
Veterans
Cardiovascular Diseases
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Boston Healthcare System
name: Ralph H. Johnson VA Medical Center
name: Corporal Michael J. Crescenz VA Medical Center
First posted: 2021-07-27
Enrollment: 479
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators are implementing a three-armed randomized controlled trial (RCT) at three VA sites to compare outcomes among Veterans with one or more unmet social needs randomized within each site to one of three intervention arms. The investigators have the following study arms/conditions: unmet needs screening only by Research Assistant ("Screening" arm"; Screening plus provision of a tailored Resource Sheet listing available resources to address identified needs ("Awareness" arm); Screening plus provision of tailored Resource Sheet plus research team social worker-supported referral to assist with connection to resources to address unmet needs ("Assistance" arm).
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Veterans enrolled in one of three VA medical centers:

  * 1) VA Boston Healthcare System
  * 2) Corporal Michael J. Crescenz VA Medical Center (Philadelphia)
  * 2) 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants Who Connected With a New Resource
timeFrame: 8 weeks
measure: Mean Count of Resources Connected To
timeFrame: 8 weeks
Secondary outcomes:
measure: Unmet Need Reduction - Any
timeFrame: 6 months
measure: Emergent Visits (Urgent Care and Emergency Department Visits)
timeFrame: 12 months compared to baseline
measure: Medication Adherence
timeFrame: 12 months compared to baseline
measure: Clinic Visit Appointment Attendance ("No-show")
timeFrame: 12 months compared to baseline
measure: Systolic Blood Pressure (BP)
timeFrame: 12 months compared to baseline
measure: Hemoglobin A1c (HbA1c)
timeFrame: 12 months compared to baseline
measure: Unmet Need Reduction - Percent
timeFrame: 6 months
measure: Diastolic Blood Pressure (BP)
timeFrame: 12 months compared to baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Deborah A Gurewich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gurewich D, Kressin N, Bokhour BG, Linsky AM, Dichter ME, Hunt KJ, Fix GM, Niles BL. Randomised controlled trial evaluating the effects of screening and referral for social determinants of health on Veterans' outcomes: protocol. BMJ Open. 2022 Sep 23;12(9):e058972. doi: 10.1136/bmjopen-2021-058972.