Unmet Social Needs Study

NCT ID: NCT04977583

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 479 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-29
• Study Completion Date: 2023-12-15

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.

Conditions

Cardiovascular Disease; Hypertension; Diabetes Mellitus; Hyperlipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Screening

Participants in this arm will be screened for unmet social needs and receive a post card that includes a list of generic VA crisis and homeless hotlines.

Group Type: EXPERIMENTAL

Unmet Need Screening

Intervention Type: BEHAVIORAL

Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.

Awareness

Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, and receive a Resource Sheet tailored to the unmet needs identified in the unmet need screen. The Resource Sheet will include the names of available resources within the VA and/or local community that can help to address the identified need(s) and contact information and hours of operation.

Group Type: EXPERIMENTAL

Unmet Need Screening

Intervention Type: BEHAVIORAL

Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.

Unmet Need Referral - Resource Sheet

Intervention Type: BEHAVIORAL

Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.

Assistance

Participants in this arm will be screened for unmet social needs, receive a post card that includes a list of generic VA crisis and homeless hotlines, receive a tailored Resource Sheet, and be offered assistance from a Social Worker. If accepted, the SW will contact the participant and work with them over a period of 8 weeks to help facilitate their connection to resources than can help to address the unmet need(s) identified in the unmet need screen.

Group Type: EXPERIMENTAL

Unmet Need Screening

Intervention Type: BEHAVIORAL

Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.

Unmet Need Referral - Resource Sheet

Intervention Type: BEHAVIORAL

Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.

Unmet Need Referral Assistance

Intervention Type: BEHAVIORAL

Participants receive assistance from a Social Worker (SW) to facilitate connection to resources that can help to address unmet need(s) identified in the index screen. Assistance includes 1) conducting a standardized bio-psychosocial assessment; 2) motivational interviewing methods to uncover details of the Veteran's unmet needs and identify barriers to resolving the unmet needs, and; 3) developing an action plan for the Veteran to connect with resources and address needs. The SW will conduct initial follow-up by phone one week after the interview/action plan development, with planned subsequent phone outreach every two weeks for up to seven weeks.

Interventions

Unmet Need Screening

Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the "index screen". The index screen occurs prior to randomization.

Intervention Type: BEHAVIORAL

Unmet Need Referral - Resource Sheet

Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.

Intervention Type: BEHAVIORAL

Unmet Need Referral Assistance

Participants receive assistance from a Social Worker (SW) to facilitate connection to resources that can help to address unmet need(s) identified in the index screen. Assistance includes 1) conducting a standardized bio-psychosocial assessment; 2) motivational interviewing methods to uncover details of the Veteran's unmet needs and identify barriers to resolving the unmet needs, and; 3) developing an action plan for the Veteran to connect with resources and address needs. The SW will conduct initial follow-up by phone one week after the interview/action plan development, with planned subsequent phone outreach every two weeks for up to seven weeks.

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Boston Healthcare System

FED

Sponsor Role: collaborator

Ralph H. Johnson VA Medical Center

FED

Sponsor Role: collaborator

Corporal Michael J. Crescenz VA Medical Center

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah A Gurewich, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 36153033 (View on PubMed)

Gurewich D, Hunt K, Bokhour B, Fix G, Friedman H, Li M, Linsky AM, Niles B, Dichter M. Screening and Referral for Social Needs Among Veterans: A Randomized Controlled Trial. J Gen Intern Med. 2025 Aug;40(11):2732-2739. doi: 10.1007/s11606-024-09105-x. Epub 2025 Jan 23.

Reference Type: DERIVED

PMID: 39849274 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IIR 19-013

Identifier Type: -

Identifier Source: org_study_id