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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at 3 month follow-up

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at 3 month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and at 3 month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 3 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the number of social needs identified during the visit

Secondary outcome measures

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

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,265 Previous Clinical Trials

14,822,601 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,215,759 Total Patients Enrolled

Elham Hatef, MD, MPHPrincipal InvestigatorJohns Hopkins University

Media Library

Social Risk Score and CDS Tool Clinical Trial Eligibility Overview. Trial Name: NCT05574699 — N/A

Congestive Heart Failure Research Study Groups: Control, Social Risk Score and Closed Loop Referral

Congestive Heart Failure 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for participants in this research?

"As per the clinicaltrials.gov database, this study is actively seeking participants; it was initially registered on May 1st of 2023 and its details were recently revised on May 10th of that same year."

Answered by AI

What is the projected scope of participants for this experiment?

"Affirmative. According to the entry on clinicaltrials.gov, this research project is actively seeking participants and was first listed on May 1st 2023 with its most recent update being made 10 days later. 600 individuals need to be recruited from 3 different healthcare facilities."

Answered by AI