Increasing Veterans' Social Engagement and Connectedness — CONNECTED  

Social Isolation Clinical Trial

Official title: Increasing Veterans' Social Engagement and Connectedness

Status Not yet recruiting

Clinical Trial Summary

Social isolation is a negative social determinant of health (SDoH) that affects 1-in-5 adults in the U.S. and 43% of Veterans. Social isolation is estimated to cost the nation $6.7 billion annually in federal healthcare spending. Yet, social isolation has rarely been the direct focus of healthcare interventions. The proposed project is a randomized controlled trial that seeks to test the effectiveness of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among diverse Veteran groups in primary care clinics. CONNECTED involves three key services delivered by peers via telehealth through individual and group sessions over 8 weeks: 1) peer support, which includes person-centered assessment for social isolation, 2) psychosocial interventions to address social isolation, and 3) navigation (i.e., connecting Veterans to social resources). Findings from this study will contribute to the VA's efforts to address SDoH among Veterans and to provide high quality, person-centered, and equitable care to all Veterans.

Clinical Trial Description

Background: Social isolation is a global public health threat and a negative social determinant of health (SDoH) that affects 1 in 5 adults in the U.S. and contributes to $6.7 billion in annual healthcare spending.

Significance: Affecting roughly 43% of Veterans, social isolation is highly prevalent among Veterans, particularly those with a history of mental illness. Social isolation contributes to cardiovascular diseases, dementia, depression, suicidal ideation, and premature death. To date, social isolation remains largely unaddressed as a negative SDoH in healthcare systems. Current efforts to address social isolation are limited by lack of diverse participant samples, rigorous methodologies, and involvement of healthcare systems to systematically assess and reduce social isolation.

Innovation and Impact: To address these gaps, the proposed project will test a novel and feasible program to intervene on social isolation among diverse Veteran populations in the VHA healthcare system. The investigators propose to test the effects of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among Veterans. CONNECTED uses an innovative approach by integrating two existing evidence-based care models: peer services and patient navigation to address social isolation among Veterans in VHA primary care clinics. CONNECTED involves three key services delivered by peer specialists via telehealth over 8 weeks: 1) peer support, which includes person-centered assessment of factors driving social isolation; 2) psychosocial interventions to address Veterans' social isolation (e.g., goal setting, supportive therapy, and group-based social engagement activities); and 3) navigation (i.e., connecting Veterans to social resources in the community and the VHA) to help expand their social networks. Because prior social isolation studies have not prioritized inclusion of younger and racially/ethnically diverse samples, the investigators will over sample these groups using stratified random sampling.

Specific Aims: The investigators aim for a randomized controlled clinical trial comparing CONNECTED to an attention control group. Aim1: Test the effects of CONNECTED on social isolation at 2-, 4-, and 8-months from baseline compared to the control group; Aim2: Test the effects of CONNECTED on secondary, health-related outcomes; and Aim 3: Conduct formative and pre-implementation evaluations to inform future implementation processes.

Methodology: Aims 1 and 2 involve delivering the intervention to (N=264) Veterans in VHA primary care clinics. Data from Aims 1 and 2 will be analyzed using general linear models. In Aim 3, the investigators will describe Veterans (n=20) and providers' experiences (N=10) with the intervention using semi-structured interviews to identify barriers and facilitators to CONNECTED's future implementation. The investigators will also survey peers and peer supervisors (n=20) from VISN10 VA facilities (n=13) and interview a subgroup of survey completers (n=8) to evaluate factors that may affect potential adoption of CONNECTED in VHA and to identify future implementation strategies. Qualitative data from Aim 3 will be analyzed using an inductive/deductive approach.

Next Steps & Implementation: Should this trial be successful the investigators will work with operational partners to implement CONNECTED in the VHA. The next step will also involve the evaluation of CONNECTED's core elements and its implementation in diverse VHA facilities. ;

Related Conditions & MeSH terms

• Social Isolation

• NCT number: NCT06467214
• Study type: Interventional
• Source: VA Office of Research and Development
• Contact: Johanne Eliacin, PhD
• Phone: (317) 988-5298
• Email: johanne.eliacin@va.gov
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: July 1, 2024
• Completion date: June 30, 2028