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临床试验/NCT07196007
NCT07196007尚未招募不适用

Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings

Mary Lacy1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2026年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
12,000
试验地点
1
主要终点
Number of participants screened for social needs

研究概览

简要总结

This study is a hybrid type 2 design to evaluate the effectiveness and implementation of a community-clinical linkage intervention in primary clinics to address unmet social needs for patients with diabetes living in rural communities. The study will take place in two rural communities in Kentucky, one in eastern Kentucky and one in western Kentucky.

详细描述

This study will convene clinical and community partners to complete a rapid process improvement workshop (RPIW) to co-create scalable strategies to address unmet social needs and to implement the developed strategy in primary care clinics in two rural communities in Kentucky. Results from the RPIW will be used to design an implementation template with specific implementation strategies tailored to each unique community-clinical linkage (CCL). While implementation strategies will be tailored to each CCL, the overarching intervention components for all CCL include: 1) patient navigators; 2) health information technology; and 3) quality improvement support to clinical and community partners. The finalized intervention will then be rolled out across partner clinics using a parallel-group cluster design that facilitates pragmatic randomization. The effect of the intervention on referrals will be assessed by comparing referrals between intervention and control clinics. Secondary effectiveness outcomes include status of social needs (improved or not), patient-reported quality of life, and diabetes control (A1c < 9.0% controlled vs A1c =9% uncontrolled). To evaluate implementation outcomes, we will use a mixed methods approach to examine process factors that affect reach, acceptance, and fidelity of the CCL intervention. This approach allows us to examine which strategies can be replicated and scaled up for implementation in other communities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
是

入选标准

  • •Clinic/Staff Inclusion Criteria:
  • •staff at the intervention or comparison clinic
  • •Participant Inclusion Criteria:
  • •age 18 or older,
  • •is a patient at the intervention or comparison clinic
  • •diagnosed with diabetes
  • •Clinic/Staff

排除标准

  • •staff not at the intervention or comparison clinic
  • •Participant Exclusion Criteria:
  • •being under the age of 18,
  • •not a patient at the intervention or comparison clinic
  • •not diagnosed with diabetes

研究组 & 干预措施

Usual Screening Patients with Diabetes for Unmet Social Needs Plus a Community-Clinical Intervention

Experimental

The intervention will be developed by community-clinical partners and then implemented in primary care clinics in two rural communities in Kentucky. Intervention components include patient navigation using a Community Health Worker (CHW), health information technology (HIT) and quality improvement (QI) support to both clinical and community partners. Patients who screen positive for unmet social needs will work with CHWs to be connected to community organizations. The HIT support component includes implementing the Kentucky Health Information Exchange referral communication tool between clinics and community organizations and using the Kynect resource directory to refer patients to location-specific social services and community resources. The QI component includes identifying a quality improvement team and site champion, one-on-one calls with a QI advisor, action periods to test QI strategies, and support to validate health outcomes and social needs screening data.

干预措施: Community-Clinical Intervention (Behavioral)

Usual Care

No Intervention

Clinics randomized to the control arm will receive usual care

结局指标

主要结局

Number of participants screened for social needs

时间窗: Baseline, month 6 and month 12

Number of participants screened for social needs intervention compared to control

Number of referrals to community based organization by primary care clinic

时间窗: Baseline, month 6 and month 12

Number of referrals to community based organization in intervention compared to control

次要结局

  • Change in Status of social needs(Baseline, month 6 and month 12)
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) -29(Baseline, month 6 and month 12)
  • Percent of participants with A1c greater than or equal to 9.0%(Baseline, month 6 and month 12)

研究者

发起方
Mary Lacy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mary Lacy

Assistant Professor

University of Kentucky

研究点 (1)

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