Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings
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
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
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
Mary Lacy
Assistant Professor
University of Kentucky
