Clinical trial NCT06831162: Evaluating the Effectiveness of a Multi-level Health-Related Social Needs Initiative
Official title: Evaluating the Effectiveness of a Multi-level Health-Related Social Needs Initiative
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Type 2 Diabetes
Hypertension
Hyperlipidemia
Health-related Social Problems
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-02-17
Enrollment: 4809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be receiving care from one of six Vanderbilt University Medical Center primary care clinics: South One Hundred Oaks, North One Hundred Oaks, Green Hills, Hillsboro Medical Group, Melrose, Bellevue. Vanderbilt University Medical Center primary care clinics are located in Nashville, TN.

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.


Eligibility 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, 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
* 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)

Primary outcomes:
measure: Change in glycemic control
timeFrame: Baseline and 12 months post-baseline
Secondary outcomes:
measure: Change in cholesterol
timeFrame: Baseline and 12 months post-baseline
measure: Change in blood pressure
timeFrame: Baseline and 12 months post-baseline
Other outcomes:
measure: Change in medication adherence (survey)
timeFrame: Baseline and 6 months post-baseline
measure: Change in dietary behavior (survey)
timeFrame: Baseline and 6 months post-baseline
measure: Change in dietary behavior (survey)
timeFrame: Baseline and 6 months post-baseline
measure: Change in physical activity (survey)
timeFrame: Baseline and 6 months post-baseline
measure: Change in diabetes distress (survey)
timeFrame: Baseline and 6 months post-baseline
measure: Change in diabetes self-efficacy (survey)
timeFrame: Baseline and 6 months post-baseline
measure: Change in interpersonal processes of care (survey)
timeFrame: Baseline and 6 months post-baseline
measure: Change in perceived discrimination (survey)
timeFrame: Baseline and 6 months post-baseline
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sunil Kripalani, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: