Evaluating the Effectiveness of a Multi-level Health-Related Social Needs Initiative
NCT06831162 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4809
Last updated 2026-03-11
Summary
The goal of this study is to evaluate the effectiveness of a multi-level health-related social needs (HRSN) initiative among adult patients diagnosed with type 2 diabetes, plus hypertension or hyperlipidemia. The multi-level initiative includes HRSN data collection, training and tools for health care professionals, care coordinator support, and community resources. Patients with type 2 diabetes plus hypertension or hyperlipidemia will be screened for HRSN as part of the primary care clinic intake process to assess if patients have any social needs (like difficulty with getting food, housing, or transportation). If patients screen positive for having social needs, then patients will be offered support, which can include help from primary care providers with adjusting a patient's disease management plan, referrals to care coordinators to provide additional assistance in addressing social needs, and information about community organizations that offer resources for social needs. The initiative will be integrated as a system change across VUMC adult primary care practices.
The investigators will use a prospective, single-arm clinical trial to evaluate effects on clinical outcomes for 12 months. Data will be extracted from the EHR on adult patients diagnosed with type 2 diabetes, and either hypertension or hyperlipidemia. The investigators hypothesize that the initiative will reduce the impact of HRSN on clinical outcomes over the study period. The investigators will also administer surveys to a subgroup of patients to examine trends in self-reported psychosocial and behavioral measures over the course of the initiative.
Conditions
- Type 2 Diabetes
- Hypertension
- Hyperlipidemia
- Health-related Social Problems
Interventions
- OTHER
-
Multi-level HRSN initiative
The multi-level health-related social needs (HRSN) initiative includes multiple components aimed at assessing and addressing HRSN in clinical practice: HRSN screening, EHR tools for clinical decision support, training and tools for health care providers to address HRSN, care coordinator support for patient outreach, and community resources for referral and support.
Sponsors & Collaborators
-
National Institute on Minority Health and Health Disparities (NIMHD)
collaborator NIH -
Vanderbilt University Medical Center
lead OTHER
Principal Investigators
-
Sunil Kripalani, MD, MSc · Vanderbilt University Medical Center
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-24
- Primary Completion
- 2026-09-04
- Completion
- 2026-09-04
Countries
- United States
Study Locations
More Related Trials
-
Social Network Analysis to Identify Community Health Workers
NCT04210024 ·Status: COMPLETED ·Phase: NA
-
Exercise and Type 2 Diabetes: Gender and Endothelial Function
NCT01993121 ·Status: COMPLETED ·Phase: NA
-
Reducing Total Cardiovascular Risk in an Urban Community
NCT00241904 ·Status: COMPLETED ·Phase: PHASE4
-
Scaling Telehealth Models to Improve Co-morbid Diabetes and Hypertension in Immigrant Populations (Phase II)
NCT06542939 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
Improving Hypertension Control
NCT01910857 ·Status: COMPLETED ·Phase: NA
-
Computer-assisted Diabetes Self-management Interventions
NCT00006163 ·Status: COMPLETED ·Phase: PHASE4
-
Cholesterol, Hypertension and Glucose Education Study
NCT00815789 ·Status: COMPLETED ·Phase: NA
-
Activate Tennessee: A CHW-Supported Program for Patient Activation
NCT07279415 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Team Lifestyle Immersion Hypertension Control Project
NCT07201948 ·Status: RECRUITING ·Phase: NA
-
Health Promoters and Pharmacists in Diabetes Team Management
NCT01498159 ·Status: COMPLETED ·Phase: NA
-
Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations
NCT03802825 ·Status: COMPLETED ·Phase: NA
-
The Effectiveness of Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk
NCT00204282 ·Status: COMPLETED ·Phase: NA
-
Increasing Uptake of EHR-enabled Population Health Outreach Strategies to Improve Diabetes Screening
NCT05730582 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
The National Diabetes Prevention Program in Rural Communities
NCT05387434 ·Status: COMPLETED ·Phase: NA
-
Understanding Health Care Information for African Americans With High Blood Pressure
NCT01389037 ·Status: COMPLETED ·Phase: NA
-
Improving Diabetes Care Collaboratively in the Community
NCT00359996 ·Status: COMPLETED ·Phase: NA
-
Implementing WHO HEARTS-D Guidelines in Bangladesh for Diabetes Control and Prevention
NCT07155902 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
The Reach and Effectiveness of Technology-enhanced Diabetes Prevention Programs
NCT02162901 ·Status: COMPLETED ·Phase: NA
-
Diabetes Reversal Online Program and Study (DROP Study)
NCT05572502 ·Status: RECRUITING ·Phase: NA
-
Implementing Scalable, PAtient-centered, Team-based, Technology-enabled Care for Adults With Type 2 Diabetes (iPATH)
NCT06251323 ·Status: RECRUITING ·Phase: NA
-
Diabetes and Hypertension Self Management Program
NCT06034548 ·Status: COMPLETED ·Phase: NA
-
Managing Diabetes to Gain Opportunities for a More Active Life
NCT03692208 ·Status: COMPLETED ·Phase: NA
-
Supporting Self-Management of Healthy Behaviors in Diabetes, Kidney Disease, and Hypertension
NCT05565716 ·Status: COMPLETED ·Phase: NA
-
Racial/Ethnic Differences in Trust/Mistrust and Its Effect on Diabetes Outcomes
NCT00383110 ·Status: COMPLETED
-
Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes
NCT05161897 ·Status: COMPLETED ·Phase: NA