CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 479 enrolled
Drug / intervention
Unmet Need Screening +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04977583
NCT04977583N/ACompleted

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

VA Office of Research and Development·interventional·Posted Jul 27, 2021·Updated Apr 30, 2025

In Brief

A clinical study evaluating Unmet Need Screening, Unmet Need Referral - Resource Sheet, and 1 other intervention for Cardiovascular Disease and 3 related conditions. Completed, enrolled 479 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 27, 2021
Enrollment StartApr 29, 2022
Primary CompletionJun 9, 2023
Study CompletionDec 15, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.9 years ago

Interventions

Unmet Need Screeningbehavioral

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 Sheetbehavioral

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 Assistancebehavioral

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.