NCT04977583

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
479

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

April 29, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

July 30, 2024

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

July 16, 2021

Results QC Date

May 23, 2024

Last Update Submit

April 14, 2025

Conditions

Keywords

Social Determinants of HealthVeteransCardiovascular Diseases

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

EXPERIMENTAL

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.

Behavioral: Unmet Need Screening

Awareness

EXPERIMENTAL

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.

Behavioral: Unmet Need ScreeningBehavioral: Unmet Need Referral - Resource Sheet

Assistance

EXPERIMENTAL

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.

Behavioral: Unmet Need ScreeningBehavioral: Unmet Need Referral - Resource SheetBehavioral: Unmet Need Referral Assistance

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.

AssistanceAwarenessScreening

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.

AssistanceAwareness

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.

Assistance

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Study Sites (3)

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

Boston, Massachusetts, 02130-4817, United States

Location

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

Philadelphia, Pennsylvania, 19104-4551, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

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.

  • 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.

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionDiabetes MellitusHyperlipidemias

Condition Hierarchy (Ancestors)

Vascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDyslipidemiasLipid Metabolism Disorders

Results Point of Contact

Title
Dr. Grant Huang
Organization
Department of Veterans Affairs

Study Officials

  • Deborah A Gurewich, PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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).
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

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.

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.

Locations