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Social Risk Score + CDS Tool for Chronic Disease

N/A
Recruiting
Led By Elham Hatef, MD, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Children are excluded from this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 month follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to improve care for racial/ethnic minorities and socially disadvantaged populations with chronic diseases by leveraging HIT to integrate digital info on social needs.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since this trial involves the use of a risk assessment tool rather than medication, traditional side effects are not applicable. However, there may be indirect impacts on patient care based on the interventions' effectiveness.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am an adult.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the number of social determinants of health (SDOH) challenges identified during the visit at 3-month follow-up telephone survey compared to the baseline visit.
Secondary study objectives
Change in the number of hospitalization events and emergency department (ED) visits between intervention and control arms
Difference in the number of patients with social needs identified in the intervention and control groups
Difference in the number of patients with social needs who receive services at a CBO in intervention and control groups

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,210 Total Patients Enrolled
5 Trials studying Chronic Disease
2,682 Patients Enrolled for Chronic Disease
National Institute on Minority Health and Health Disparities (NIMHD)NIH
434 Previous Clinical Trials
1,378,233 Total Patients Enrolled
5 Trials studying Chronic Disease
2,894 Patients Enrolled for Chronic Disease
Elham Hatef, MD, MPHPrincipal InvestigatorJohns Hopkins University

Media Library

Social Risk Score and CDS Tool Clinical Trial Eligibility Overview. Trial Name: NCT05574699 — N/A
Chronic Disease Research Study Groups: Control, Social Risk Score and Closed Loop Referral
Chronic Disease Clinical Trial 2023: Social Risk Score and CDS Tool Highlights & Side Effects. Trial Name: NCT05574699 — N/A
Social Risk Score and CDS Tool 2023 Treatment Timeline for Medical Study. Trial Name: NCT05574699 — N/A
~104 spots leftby Mar 2025