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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06831162
Enrollment
4809
Registered
2025-02-17
Start date
2025-01-24
Completion date
2026-09-04
Last updated
2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health-related Social Problems, Hyperlipidemia, Hypertension, Type 2 Diabetes

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.

Interventions

OTHERMulti-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

Vanderbilt University Medical Center
Lead SponsorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

ELIGIBILITY CRITERIA FOR EHR DATA EXTRACTION Inclusion Criteria: * 18 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) Inclusion Criteria: * 18 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Change in glycemic controlBaseline and 12 months post-baselineHemoglobin A1c extracted from the electronic health record where higher values indicate worse glycemic control.

Secondary

MeasureTime frameDescription
Change in cholesterolBaseline and 12 months post-baselineLow-density lipoprotein (LDL) extracted from the electronic health record where higher values indicate worse hyperlipidemia.
Change in blood pressureBaseline and 12 months post-baselineSystolic blood pressure extracted from the EHR where higher values indicate worse hypertension.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSunil Kripalani, MD, MSc

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026