JMIR Publications

ABSTRACT

Background:

Social needs and social determinants of health (SDOH) significantly outrank medical care when considering the impact on a person’s length and quality of life, resulting in poor health outcomes and worsening life expectancy in the U.S., especially among racial and ethnic minority populations and those with low income. Integrating social needs and social determinants of health (SDOH) data along with clinical risk information within operational clinical decision support (CDS) systems built into electronic health records (EHRs) is an essential approach to addressing health disparities and providing equitable healthcare. To achieve this goal applied research is needed to identify optimal solutions for the effective collection and application of social needs and SDOH information within EHRs; develop EHR-integrated CDS tools and closed-loop referral systems; and implement the CDS tools and closed-loop referral systems in the digital and clinical workflows at healthcare systems and collaborating community-based organizations (CBOs).

Objective:

To describe the protocol for a mixed methods study including a randomized controlled trial (RCT) and a qualitative phase assessing the feasibility, acceptability, and effectiveness of an EHR-integrated CDS tool to identify patients with social needs and provide navigation services and closed-loop referrals to CBOs.

Methods:

The RCT will enroll and randomize adult African-American patients living in low-income neighborhoods in Baltimore City receiving care at a single academic healthcare institution in the 3-month intervention (using the CDS tool and closed-loop referral) or the 3-month control (standard-of-care screening, assessment, and addressing of social needs) arms (n=295 per arm). To evaluate the feasibility and acceptability of the CDS tool and its impact on the clinical and digital workflow and patient care we will conduct focus groups with the care teams at the healthcare system and collaborating CBOs. The primary outcomes will be the acceptability, feasibility, and effectiveness of the CDS tool and closed-loop referral system.

Results:

This clinical trial opened to enrollment in June 2023 and will be completed in March 2025. Initial results are expected to be published in Spring 2025. We will report feasibility outcome measures as weekly use rates of the CDS tool. The acceptability outcome measure will be the provider’s and patient’s responses to the truthfulness of a statement indicating a willingness to use the tool in the future. Effectiveness will be measured by tracking 3-month clinical outcomes such as patterns of healthcare utilization including hospitalization and emergency department visits.

Conclusions:

The results of this investigation are expected to contribute to our understanding of the use of digital interventions and the implementation of such interventions in digital and clinical workflows to enhance the healthcare system and CBO ability related to social needs assessment and intervention. These results may inform the construction of a future multi-institutional trial designed to test the effectiveness of this intervention across different healthcare systems and care settings. Clinical Trial: This trial is registered through the NIH on clnicaltrials.gov (NCT05574699).