Evaluating the Effectiveness of a Multi-level Health-Related Social Needs Initiative
Enrolling by invitation · Not applicable
Conditions studied: Type 2 Diabetes, Hypertension, Hyperlipidemia, Health-related Social Problems
In brief
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.
Key facts
- Study ID
- NCT06831162
- Run by
- Vanderbilt University Medical Center
- People needed
- 4809
- Starts
- 2025-01-24
- Expected to finish
- 2026-09-04
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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)
Where it is running
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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