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| ID | Type | Description | Link |
|---|---|---|---|
| P50MD017347-03S3 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-level HRSN initiative | Experimental | Eligible patients will receive the HRSN initiative as part of their primary care appointments |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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) |
ELIGIBILITY CRITERIA FOR EHR DATA EXTRACTION
Inclusion Criteria:
ELIGIBILITY CRITERIA FOR PATIENT SURVEYS (subset of EHR data)
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Kripalani, MD, MSc | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37203 | United States |
After study results are posted on clinical trials and published, de-identified data will be available upon requests made to the principal investigator.
After study results are posted on clinical trials and outcomes published in a peer-reviewed journal, until 5 years later
Contact the principal investigator
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
Systolic blood pressure extracted from the EHR where higher values indicate worse hypertension.
| Baseline and 12 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). |
| 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 |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |