Unmet Social Needs Study
The Effect of Screening and Referral for Social Determinants of Health on Veterans' Outcomes
1 other identifier
interventional
479
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2021
CompletedFirst Posted
Study publicly available on registry
July 27, 2021
CompletedStudy Start
First participant enrolled
April 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedResults Posted
Study results publicly available
July 30, 2024
CompletedApril 30, 2025
April 1, 2025
1.1 years
July 16, 2021
May 23, 2024
April 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants Who Connected With a New Resource
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)".
8 weeks
Mean Count of Resources Connected To
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)".
8 weeks
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (3)
Screening
EXPERIMENTALParticipants 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.
Awareness
EXPERIMENTALParticipants 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.
Assistance
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Impaired decision-making
- Illiterate or have limited or no English proficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- VA Boston Healthcare Systemcollaborator
- Ralph H. Johnson VA Medical Centercollaborator
- Corporal Michael J. Crescenz VA Medical Centercollaborator
Study Sites (3)
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817, United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104-4551, United States
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703, United States
Related Publications (2)
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.
PMID: 36153033RESULTGurewich 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.
PMID: 39849274DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Grant Huang
- Organization
- Department of Veterans Affairs
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah A Gurewich, PhD
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2021
First Posted
July 27, 2021
Study Start
April 29, 2022
Primary Completion
June 9, 2023
Study Completion
December 15, 2023
Last Updated
April 30, 2025
Results First Posted
July 30, 2024
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Quantitative data meeting VA standards for disclosure to the public will be made available within one year of publication. The quantitative analytical datasets and statistical code used in the publication will be retained for 6 years, in accordance with VA record retention policy.
- Access Criteria
- Quantitative data sets will be made available to investigators whose proposed use of the data have been approved by an independent review committee identified for that purpose. The proposed analyses must be for individual participant data meta-analysis.
The investigators will share final quantitative data sets underlying all publications resulting from the proposed research, after deidentification. A limited data set will be created and shared pursuant to a Data Use Agreement appropriately limiting use if the data set and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or reidentify) any individual whose data are included in the dataset. Prior to distribution, a local privacy officer will certify that the all datasets contain no protected health information. The PI will maintain a crosswalk between the analytical data set(s) and the public release data sets so that a VA-approved auditor or the PI could conduct or facilitate validation if needed. Qualitative data will not be shared. The sensitive nature of the study data precludes asking participants to consent and grant HIPAA authorization for sharing.