Social Risk Score + CDS Tool for Chronic Disease
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Johns Hopkins University
Disqualifiers: Children, High income, Non-African American
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
The overarching goal of this project is to leverage health information technology (HIT) to integrate available digital information on social needs to improve care for racial and ethnic minorities and socially disadvantaged populations with chronic diseases. In the previous phases of this project the investigators developed a social risk score to identify social needs among medically under-served patients with special emphasis on application among African American patients with low income and chronic diseases who face social determinants, risk factors, and needs (SDRN) challenges. The investigators also developed a clinical decision support (CDS) tool to present the social risk score to clinical providers and sought feedback from different users on the face and content validity of the CDS tool. In the current project the investigators will run a randomized clinical trial (RCT) study to pilot test the new risk score and CDS tool in selected primary care clinics at Johns Hopkins Health System (JHHS) and in collaboration with selected community-based organizations (CBOs). This system will help identify, manage, and refer patients with both high levels of disease burden and modifiable SDRN challenges.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Social Risk Score + CDS Tool for Chronic Disease treatment?
Research shows that screening for social determinants of health (like financial concerns or social isolation) in clinical settings can identify unmet social needs and improve referrals to appropriate services. This approach has been shown to be feasible and beneficial in improving provider practice and connecting patients with necessary resources, which can positively impact health outcomes.12345
Is the Social Risk Score + CDS Tool for Chronic Disease safe for humans?
How is the Social Risk Score + CDS Tool treatment different from other treatments for chronic disease?
This treatment is unique because it focuses on identifying and addressing social factors that affect health, such as housing and food access, through a screening tool and decision support system, rather than just medical symptoms. It helps healthcare providers connect patients with community resources to address these social needs, which are often overlooked in traditional medical treatments.12101112
Eligibility Criteria
This trial is for adult African-American patients with low income who have chronic diseases like heart failure, diabetes, or high blood pressure. It's not open to children, people of other races, or those with higher incomes.Inclusion Criteria
I am an adult African-American with low income.
Exclusion Criteria
I am an adult.
Individuals with race other than African American
People who make a lot of money.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Implementation
Implementation of the social risk score and CDS tool in selected primary care clinics
4 weeks
Ongoing access through EHR
Randomized Controlled Trial (RCT)
Conduct RCT to assess the impact of the CDS tool on care processes and patient outcomes
3 months
Regular clinic visits as per standard care
Follow-up
3-month follow-up to assess changes in social determinants of health challenges and patient satisfaction
3 months
Telephone survey
Treatment Details
Interventions
- Social Risk Score and CDS Tool (Behavioural Intervention)
- Standard of Care (Other)
Trial OverviewThe study tests a new social risk score and clinical decision support tool against standard care in managing chronic diseases among underserved populations. The goal is to improve care by addressing social needs using health information technology.
Participant Groups
2Treatment groups
Active Control
Group I: ControlActive Control1 Intervention
Patients randomized into the control arm will be provided with the standard-of-care screening, assessment, and addressing social needs in the clinic setting. This would not include any automated mechanism of pre-collected data in the EHR. Currently providers on an ad-hoc basis apply a series of needs-assessment tools including one available within JHHS-EHR. Patients in the control arm that are identified as someone with social needs will then be referred to appropriate services through current standard-of-care mechanisms, this may include a sheet of various educational resources, or a list of organizations that can address the identified social need.
Group II: Social Risk Score and Closed Loop ReferralActive Control1 Intervention
Patients in intervention arm will have a social risk score available through the CDS tool, which the provider can review and decide whether the patient needs more assessment. If the patient is identified as with high social needs based on the risk score in the CDS tool, the providers will refer the patient to social workers/ care managers for further in-depth assessment of the participants social needs at HCC. HCC will reach out to the patients over the phone and will perform an in-depth assessment of the patients social needs. If any social needs are identified and patient agrees to address those needs HCC staff will refer the patient to CBOs.
Social Risk Score and CDS Tool is already approved in United States for the following indications:
🇺🇸 Approved in United States as Social Risk Score and CDS Tool for:
- Identification and management of social needs in medically underserved populations with chronic diseases
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Johns Hopkins Community Physicians - RemingtonBaltimore, MD
Johns Hopkins Community Physicians - EBMCBaltimore, MD
Johns Hopkins GreenSpring StationBaltimore, MD
Johns Hopkins Bayview Medical Center - Comprehensive Care PracticeBaltimore, MD
More Trial Locations
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Who Is Running the Clinical Trial?
Johns Hopkins UniversityLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Addressing Social Determinants of Health in a Clinic Setting: The WellRx Pilot in Albuquerque, New Mexico. [2022]Although it is known that the social determinants of health have a larger influence on health outcomes than health care, there currently is no structured way for primary care providers to identify and address nonmedical social needs experienced by patients seen in a clinic setting. We developed and piloted WellRx, an 11-question instrument used to screen 3048 patients for social determinants in 3 family medicine clinics over a 90-day period. Results showed that 46% of patients screened positive for at least 1 area of social need, and 63% of those had multiple needs. Most of these needs were previously unknown to the clinicians. Medical assistants and community health workers then offered to connect patients with appropriate services and resources to address the identified needs. The WellRx pilot demonstrated that it is feasible for a clinic to implement such an assessment system, that the assessment can reveal important information, and that having information about patients' social needs improves provider ease of practice. Demonstrated feasibility and favorable outcomes led to institutionalization of the WellRx process at a university teaching hospital and influenced the state department of health to require managed care organizations to have community health workers available to care for Medicaid patients.
A Review of Tools to Screen for Social Determinants of Health in the United States: A Practice Brief. [2021]Increasingly, health care institutions are called on to address social determinants of health (SDH) given the connection to morbidity and mortality across populations. However, widespread implementation of screening for health-related social conditions (HRSC) is lagging. It is estimated that half of patients who have such needs may be missed by failure to screen routinely. Health care institutions face gaps in information related to screening tools. A review of tools that screen for HRSC at the individual level is needed to share readily available and applicable tools for integration in various settings, to communicate how tools are typically administered, and to assess whether tools capture domains corresponding with Institute of Medicine (IOM) core measures. To address these gaps, an unsystematic rapid review of the literature was conducted. In addition to peer-reviewed literature, Google, PubMed, and CINAHL databases and grey literature were searched with a focus on lead agencies or scholars in the field. English language publications from 2008-2018 with content related to SDH or health-related social condition screening tools were included. Nine commonly applied tools were selected and reviewed for content, setting, and method of administration. Fifteen common domains were identified and assessed for alignment with IOM recommendations and correspondence with the construct of social stability. This review consolidates essential information about HRSC screening tools in 1 place and provides practice, policy, and research recommendations to improve HRSC screening. This review is a practice brief that can help health care institutions and clinicians implement screening and interventions related to HRSC.
Screening for Social Determinants of Health Among Medicare Beneficiaries in Primary Care During the Covid-19 Pandemic in Prince George's County, Maryland. [2023]Primary care providers in Prince George's County, Maryland reported inconsistencies in their ability to identify and refer patients with social care needs. This project aimed to improve health outcomes of Medicare beneficiaries by implementing social determinant of health (SDOH) screening to identify unmet needs and improve rates of referral to appropriate services. Buy-in was achieved from providers and frontline staff via stakeholder meetings at a private primary care group practice. The Health Leads questionnaire was modified and integrated into the electronic health record. Medical assistants (MA) were trained to conduct screening and initiate care plan referrals prior to visits with the medical provider. During implementation, 96.25% of patients (n = 231) agreed to screening. Of these, 13.42% (n = 31) screened positive for at least one SDOH need, and 48.39% (n = 15) reported multiple social needs. Top needs included social isolation (26.23%), literacy (16.39%), and financial concerns (14.75%). All patients screening positive for one or more social needs were provided referral resources. Patients who identified as being of Mixed or Other race had significantly higher rates of positive screens (p = 0.032) compared to Caucasians, African Americans, and Asians. Patients were more likely to report SDOH needs during in-person visits (17.22%) compared to telehealth visits (p = 0.020). Screening for SDOH needs is feasible and sustainable and can improve the identification of SDOH needs and resource referrals. A limitation of this project was the lack of follow-up to determine whether patients with positive SDOH screens had been successfully linked to resources after initial referral.
Implementing screening for social determinants of health using the Core 5 screening tool. [2021]Social determinants of health (SDOH) have been documented to underpin 80% of overall health and are being increasingly recognised as key factors in addressing tertiary health outcomes. Yet, despite the widespread acceptance of the association of SDOH with health outcomes, more than two-thirds of hospitals do not screen for social risk factors that indicate individual-level adverse SDOH. Such screening for social risk factors represents the first step in connecting patients with resources and documents the prevalence of social needs. The aim of this project was to implement the Core 5 social risk screening tool and evaluate its efficacy and usability in identifying social risk factors in a presurgical spine population. Prior to this implementation, screening for social risk had not been performed. The Model for Improvement provided a framework for implementing and evaluating the Core 5 social risk screening tool. Methods included implementation of a patient self-report social risk screening tool, referral workflow to connect patients with needed resources and evaluation of staff feasibility in using the Core 5 tool. The results indicated that the screening tool identified patients with social risk factors and staff reported perceptions of efficacy and usability in clinical workflow. Overall, 52 of 88 (59%) of subjects in the presurgical spine population were effectively screened. Of these, five patients (10%) had identified social needs that needed to be addressed prior to surgery. The staff usability survey for the Core 5 tool demonstrated high acceptance and usability, with an average score of 4.4 (out of 5). Future work should evaluate the efficacy of the screening tool in other ambulatory and tertiary settings.
Collecting and applying data on social determinants of health in health care settings. [2022]Despite strong evidence linking patients' social circumstances to their health, little guidance exists for health care practitioners and institutions on addressing social needs in clinical settings. Current approaches to social determinants generally focus on population-level and policy interventions; these overlook individual and clinical innovations within health care that can address patients' social circumstances. This article proposes a framework for how social determinants interventions in the health care system can be construed across 3 tiers-patient, institution, and broader population-and describes ways to collect data and target interventions at these levels.
Integrating Social and Medical Care: Could it Worsen Health and Increase Inequity? [2023]As a result of a large and compelling body of evidence documenting the impacts of social determinants, such as income and education, on health outcomes, health care systems are beginning to incorporate social and economic risk data into health care delivery decisions. But there is a risk that some of these efforts could worsen health and widen health inequities. We highlight 3 examples- including recent policy changes in Medicaid, social needs, informed risk prediction models, and advances in precision medicine-where the inclusion of social risk information threatens to reduce care quality or health care access for some groups of patients. A new dialog is needed about both the opportunities and potential consequences of bringing information about patients' social circumstances into a market-based health care system.
Identifying individual social risk factors using unstructured data in electronic health records and their relationship with adverse clinical outcomes. [2022]To determine the prevalence of individual-level social risk factors documented in unstructured data from electronic health records (EHRs) and the relationship between social risk factors and adverse clinical outcomes.
Partner-developed electronic health record tools to facilitate social risk-informed care planning. [2023]Increased social risk data collection in health care settings presents new opportunities to apply this information to improve patient outcomes. Clinical decision support (CDS) tools can support these applications. We conducted a participatory engagement process to develop electronic health record (EHR)-based CDS tools to facilitate social risk-informed care plan adjustments in community health centers (CHCs).
Sensitivity and Specificity of Real-World Social Factor Screening Approaches. [2022]Health care organizations are increasingly documenting patients for social risk factors in structured data. Two main approaches to documentation, ICD-10 Z codes and screening questions, face limited adoption and conceptual challenges. This study compared estimates of social risk factors obtained via screening questions and ICD-10 Z diagnoses coding, as used in clinical practice, to estiamtes from validated survey instruments in a sample of adult primary care and emergency department patients at an urban safety-net health system. Financial strain, transportation barriers, food insecurity, and housing instability were independently assessed using instruments with published reliability and validity. These four social factors were also being collected by the health system in screening questions or could be mapped to ICD-10 Z code diagnosis code concepts. Neither the screening questions nor ICD-10 Z codes performed particularly well in terms of accuracy. For the screening questions, the Area Under the Curve (AUC) scores were 0.609 for financial strain, 0.703 for transportation, 0.698 for food insecurity, and 0.714 for housing instability. For the ICD-10 Z codes, AUC scores tended to be lower in the range of 0.523 to 0.535. For both screening questions and ICD-10 Z codes, the measures were much more specific than sensitive. Under real world conditions, ICD-10 Z codes and screening questions are at the minimal, or below, threshold for being diagnostically useful approaches to identifying patients' social risk factors. Data collection support through information technology or novel approaches combining data sources may be necessary to improve the usefulness of these data.
Addressing social risk factors in the inpatient setting: Initial findings from a screening and referral pilot at an urban safety-net academic medical center in Virginia, USA. [2022]Social Determinants of Health (SDOH) impact health outcomes; thus, a pilot to screen for important SDOH domains (food, housing, and transportation) and address social needs in hospitalized patients was implemented in an urban safety-net academic medical center. This study describes the pilot implementation and examines patient characteristics associated with SDOH-related needs. An internal medicine unit was designated as a pilot site. Outreach workers approached eligible patients (n = 1,135) to complete the SDOH screening survey at time of admission with 54% (n = 615) completing the survey between May 2019 and July 2020. Data from patient screening survey and electronic health records were linked to allow for examination of associations between SDOH needs for food, housing, and transportation and various demographic and clinical characteristics of patients in multivariate logistic regression models. Of 615 screened patients, 45% screened positive for any need. Of 275 patients with needs, 33% reported needs in 2, and 34% - in 3 domains. Medicaid beneficiaries were more likely than patients with private health insurance to screen positive for 2 and 3 needs; Black patients were more likely than White patients to screen positive for 1 and 3 needs; Patients with no designated primary care physician status screened positive for 1 need; Patients with a history of substance use disorder screened positive for all 3 needs. SDOH screening assisted in addressing social risk factors of inpatients, informed their discharge plans and linkage to community resources. SDOH screening demonstrated significant correlations of positive screens with race/ethnicity, insurance type, and certain clinical characteristics.
A Framework for Evaluating Social Determinants of Health Screening and Referrals for Assistance. [2022]Many health systems screen patients for social determinants of health and refer patients with social needs to community service organizations for assistance. We developed a framework based on sequential steps to evaluate this process.
Developing a screening tool to recognise social determinants of health in Australian clinical settings. [2020]Objective and importance of study: The importance of social determinants for individual health recovery outcomes is well recognised in public health. However, no succinct social health screening (SHS) tool exists that has been developed with information from clinicians and patients. This proof-of-concept study asked health consumer advocates, patients and clinicians about their attitudes towards social determinants of health (SDH) and the usefulness of an SHS tool for collecting these data for use in clinical settings. We then developed a streamlined SHS tool to bring this knowledge to clinicians, and conducted a proof-of-concept trial to check its acceptability with patients and clinicians.