Piloting a Clinical Decision Support Tool to Identify Patients With Social Needs and Provide Navigation Services and Referral to Community-Based Organizations: Protocol for a Randomized Controlled Trial.

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. Integrating social needs and SDOH data along with clinical risk information within operational clinical decision support (CDS) systems built into electronic health records (EHRs) is an effective approach to addressing health-related social needs. To achieve this goal, applied research is needed to develop EHR-integrated CDS tools and closed-loop referral systems and implement and test them in the digital and clinical workflows at health care systems and collaborating community-based organizations (CBOs).

Objective: This study aims to describe the protocol for a mixed methods study including a randomized controlled trial and a qualitative phase assessing the feasibility, acceptability, and effectiveness of an EHR-integrated digital platform to identify patients with social needs and provide navigation services and closed-loop referrals to CBOs to address their social needs.

Methods: The randomized controlled trial will enroll and randomize adult patients living in socioeconomically challenged neighborhoods in Baltimore City receiving care at a single academic health care institution in the 3-month intervention (using the digital platform) or the 3-month control (standard-of-care assessment and addressing of social needs) arms (n=295 per arm). To evaluate the feasibility and acceptability of the digital platform and its impact on the clinical and digital workflow and patient care, we will conduct focus groups with the care teams in the health care system (eg, clinical providers, social workers, and care managers) and collaborating CBOs. The 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 digital platform. 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 platform in the future. Effectiveness will be measured by tracking a 3-month change in identified social needs and provided navigation services as well as clinical outcomes such as 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 health care 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 health care systems and care settings.

Trial Registration: ClinicalTrials.gov NCT05574699; https://clinicaltrials.gov/study/NCT05574699.

International Registered Report Identifier (irrid): DERR1-10.2196/57316.