Division of General Internal Medicine, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, MD, United States.
Center for Population Health Information Technology, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.
JMIR Res Protoc. 2024 Jul 23;13:e57316. doi: 10.2196/57316.
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).
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.
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.
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.
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.
ClinicalTrials.gov NCT05574699; https://clinicaltrials.gov/study/NCT05574699.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57316.
在考虑对个人寿命和生活质量的影响时，社会需求和健康的社会决定因素（SDOH）比医疗护理重要得多，导致健康状况不佳和预期寿命缩短。将社会需求和 SDOH 数据与临床风险信息整合到电子健康记录（EHR）中内置的操作性临床决策支持（CDS）系统中，是解决与健康相关的社会需求的有效方法。为了实现这一目标，需要开展应用研究，开发 EHR 集成的 CDS 工具和闭环转介系统，并在医疗保健系统和合作的社区组织（CBO）的数字和临床工作流程中实施和测试这些工具和系统。
本研究旨在描述一项混合方法研究的方案，该研究包括一项随机对照试验和一个定性阶段，评估一种 EHR 集成的数字平台识别有社会需求的患者并提供导航服务以及向 CBO 进行闭环转介以满足其社会需求的可行性、可接受性和有效性。
随机对照试验将招募并随机分配居住在巴尔的摩市社会经济困难社区、在单一学术医疗保健机构接受护理的成年患者，他们将在 3 个月的干预（使用数字平台）或 3 个月的对照（标准护理评估和解决社会需求）臂中进行（每个臂 295 例）。为了评估数字平台的可行性和可接受性及其对临床和数字工作流程以及患者护理的影响，我们将与医疗系统（如临床提供者、社会工作者和护理经理）和合作的 CBO 进行焦点小组讨论。结果将是 CDS 工具和闭环转介系统的可接受性、可行性和有效性。
这项临床试验于 2023 年 6 月开始招募参与者，将于 2025 年 3 月完成。初步结果预计将于 2025 年春季公布。我们将每周使用数字平台的频率作为可行性结果指标进行报告。可接受性结果指标将是提供者和患者对表明未来愿意使用该平台的陈述的真实性的反应。有效性将通过跟踪 3 个月内识别的社会需求的变化以及提供的导航服务以及住院和急诊就诊等临床结果来衡量。
这项研究的结果有望帮助我们了解数字干预措施的使用以及在数字和临床工作流程中实施此类干预措施，以增强医疗保健系统和 CBO 与社会需求评估和干预相关的能力。这些结果可能为构建未来的多机构试验提供信息，以测试该干预措施在不同医疗保健系统和护理环境中的有效性。
ClinicalTrials.gov NCT05574699; https://clinicaltrials.gov/study/NCT05574699.
国际注册报告标识符（IRRID）：DERR1-10.2196/57316.
