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Enrolling by Invitation

NCT Number: NCT06831162

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.

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Key information

Conditions

Type 2 Diabetes Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Health-related Social Problems Hyperlipidemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Change in glycemic control

    Time frame: Baseline and 12 months post-baseline

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

Secondary outcomes

  1. Change in cholesterol

    Time frame: Baseline and 12 months post-baseline

    Low-density lipoprotein (LDL) extracted from the electronic health record where higher values indicate worse hyperlipidemia.

  2. Change in blood pressure

    Time frame: Baseline and 12 months post-baseline

    Systolic blood pressure extracted from the EHR where higher values indicate worse hypertension.

Other outcomes

  1. Change in medication adherence (survey)

    Time frame: Baseline and 6 months post-baseline

    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).

  2. Change in dietary behavior (survey)

    Time frame: Baseline and 6 months post-baseline

    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).

  3. Change in dietary behavior (survey)

    Time frame: Baseline and 6 months post-baseline

    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).

  4. Change in physical activity (survey)

    Time frame: Baseline and 6 months post-baseline

    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.

  5. Change in diabetes distress (survey)

    Time frame: Baseline and 6 months post-baseline

    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).

  6. Change in diabetes self-efficacy (survey)

    Time frame: Baseline and 6 months post-baseline

    As assessed by the Perceived Diabetes Self-Management Scale (PDSMS) with scores ranging 8 to 40, where higher scores indicate more self-efficacy (better).

  7. Change in interpersonal processes of care (survey)

    Time frame: Baseline and 6 months post-baseline

    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.

  8. Change in perceived discrimination (survey)

    Time frame: Baseline and 6 months post-baseline

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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