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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypertension; Type 2 Diabetes; Hyperlipidemia; Health-related Social Problems
• Intervention / Treatment: Other: Multi-level HRSN initiative

• Study Type: Interventional
• Enrollment (Estimated): 4809
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Multi-level HRSN initiative; Eligible patients will receive the HRSN initiative as part of their primary care appointments

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cholesterol	Low-density lipoprotein (LDL) extracted from the electronic health record where higher values indicate worse hyperlipidemia.	Baseline and 12 months post-baseline
Change in blood pressure	Systolic blood pressure extracted from the EHR where higher values indicate worse hypertension.	Baseline and 12 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in medication adherence (survey)	As assessed by the Adherence to Refills and Medications Scale-Diabetes (ARMS-D) with scores ranging from 11-44, where higher scores indicate more problems with medication adherence (worse).	Baseline and 6 months post-baseline
Change in dietary behavior (survey)	As assessed by the short version of the Personal Diabetes Questionnaire scale (PDQ-11) Eating Behavior Problems subscale with scores ranging 1-6, where higher scores indicate more problem eating behaviors (worse).	Baseline and 6 months post-baseline
Change in dietary behavior (survey)	As assessed by the short version of the Personal Diabetes Questionnaire scale (PDQ-11) Use of Information for Decision Making subscale with scores ranging 1-6, where higher scores indicate more use of dietary information for decision making (better).	Baseline and 6 months post-baseline
Change in physical activity (survey)	As assessed by scores on the Exercise Vital Sign (EVS) Tool with scores ranging 0-1,050 minutes or greater per week of moderate to strenuous physical activity.	Baseline and 6 months post-baseline
Change in diabetes distress (survey)	As assessed by the Problem Areas in Diabetes-5 (PAID-5) scale with scores ranging from 0 to 20, where higher scores indicate greater diabetes-related emotional distress (worse).	Baseline and 6 months post-baseline
Change in diabetes self-efficacy (survey)	As assessed by the Perceived Diabetes Self-Management Scale (PDSMS) with scores ranging 8 to 40, where higher scores indicate more self-efficacy (better).	Baseline and 6 months post-baseline
Change in interpersonal processes of care (survey)	As assessed by the Interpersonal Processes of Care (IPC) survey with scores ranging from 1-5 (calculated as the mean of non-missing responses to the corresponding items), where higher scores indicate higher frequency of the labeled interpersonal process (e.g., decided together; lack of clarity). Scoring occurs for 7 interpersonal processes: lack of clarity; elicited concerns, responded; explained results; decided together; emotional support, compassion; discriminated due to race/ethnicity; and disrespectful office staff.	Baseline and 6 months post-baseline
Change in perceived discrimination (survey)	As assessed on the Discrimination in Medical Settings scale with scores ranging from 7-35, where higher scores indicate higher frequency of experiences with discrimination in medical settings.	Baseline and 6 months post-baseline

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Sunil Kripalani, MD, MSc, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2025
• Primary Completion (Estimated): September 4, 2026
• Study Completion (Estimated): September 4, 2026

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): February 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hypertension; Diabetes Mellitus, Type 2; Hyperlipidemias
• Other Study ID Numbers: 241778; P50MD017347-03S3 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
• IPD Sharing Time Frame: After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later
• IPD Sharing Access Criteria: Contact the principal investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No