Evaluating the Effectiveness of a Multi-level Health-Related Social Needs Initiative

NCT06831162 | Enrolling By Invitation

• 2 other identifiers: 241778P50MD017347-03S3
• Study Type: interventional
• Target: 4,809
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in glycemic control

  Hemoglobin A1c extracted from the electronic health record where higher values indicate worse glycemic control.

  Baseline and 12 months post-baseline

Secondary Outcomes (2)

• Change in cholesterol

  Baseline and 12 months post-baseline

• Change in blood pressure

  Baseline and 12 months post-baseline

Other Outcomes (8)

• Change in medication adherence (survey)

  Baseline and 6 months post-baseline

• Change in dietary behavior (survey)

  Baseline and 6 months post-baseline

• Change in dietary behavior (survey)

  Baseline and 6 months post-baseline

Study Arms (1)

Multi-level HRSN initiative

EXPERIMENTAL

Eligible patients will receive the HRSN initiative as part of their primary care appointments

Other: Multi-level HRSN initiative

Interventions

Multi-level HRSN initiative OTHER

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.

Multi-level HRSN initiative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Completed the health-related social needs (HRSN) screener as part of a primary care visit
• Diagnosed with type 2 diabetes, plus hypertension and/or hyperlipidemia as reflected by ICD-10 billing codes
• Receive care at one of six partner Vanderbilt University Medical Center primary care clinics: South One Hundred Oaks, North One Hundred Oaks, Green Hills, Hillsboro Medical Group, Melrose, Bellevue
• ELIGIBILITY CRITERIA FOR PATIENT SURVEYS (subset of EHR data)
• years of age or older
• Completed the HRSN screener as part of a primary care visit
• Diagnosed with type 2 diabetes
• Receive care at one of six partner Vanderbilt University Medical Center primary care clinics: South One Hundred Oaks, North One Hundred Oaks, Green Hills, Hillsboro Medical Group, Melrose, Bellevue
• English-speaking

You may not qualify if:

• Blindness
• Hearing impairment
• Conditions that would interfere with survey completion (e.g., significant dementia, active psychosis or mania)
• Being near the end of life (hospice or home hospice)

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Sunil Kripalani, MD, MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 17, 2025
• Study Start: January 24, 2025
• Primary Completion (Estimated): September 4, 2026
• Study Completion (Estimated): September 4, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later
• Access Criteria: Contact the principal investigator

Locations

US (1)