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临床试验/NCT06831162
NCT06831162Enrolling By Invitation不适用

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

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 4,809 人开始时间: 2025年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
4,809
试验地点
1
主要终点
Change in glycemic control

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

Multi-level HRSN initiative

Experimental

Eligible patients will receive the HRSN initiative as part of their primary care appointments

干预措施: Multi-level HRSN initiative (Other)

结局指标

主要结局

Change in glycemic control

时间窗: Baseline and 12 months post-baseline

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

次要结局

  • Change in cholesterol(Baseline and 12 months post-baseline)
  • Change in blood pressure(Baseline and 12 months post-baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sunil Kripalani

Principal Investigator

Vanderbilt University Medical Center

研究点 (1)

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