Feasibility of Implementing Type One Diabetes Screening in Pediatric Clinics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 9,500
- 主要终点
- Feasibility (Clinician Perspective)
研究概览
简要总结
This study examines how population-based screening for type 1 diabetes (T1D) using islet autoantibodies (i.e., immune system proteins) can be incorporated into pediatric primary care during routine well-child visits. The project evaluates whether this screening approach, supported by the study's implementation approach, is feasible, acceptable, and appropriate for clinicians, parents, and other key constituent groups. The study also explores how often clinicians order the test, how often patients complete it, and how often clinicians document stages of early-stage T1D in the patients' electronic health records. Insights from parents, clinicians, other care team members, pediatric endocrinologists, and national and regional experts will inform future scale-up efforts and practical strategies to improve early detection of T1D in pediatric practices across the United States.
详细描述
Background:
Type 1 diabetes (T1D) is the most common form of diabetes in children and adolescents, affecting approximately 1 in 300 young people in the United States. The disease results from autoimmune destruction of pancreatic β-cells and often progresses silently over months to years before clinical symptoms emerge. Although first-degree relatives have a substantially higher risk of developing T1D, most children diagnosed with T1D do not have a family history of the disease. The presence of multiple islet autoantibodies is associated with an almost certain lifetime risk of insulin-requiring diabetes, and early identification before symptom onset can significantly reduce rates of life-threatening diabetic ketoacidosis (DKA), support structured monitoring, and potentially allow for disease-modifying interventions.
Despite clear benefits, early detection through autoantibody screening is not routinely implemented in U.S. pediatric primary care. Currently, screening largely occurs in research settings, and little is known about how best to integrate universal T1D screening into busy community pediatric practices. Key concerns include workflow burden, clinician capacity, limited availability of pediatric endocrinologists, parent understanding and acceptability, and other structural barriers such as insurance coverage. Emerging recommendations from leading professional organizations worldwide, including the International Society for Pediatric and Adolescent Diabetes and the American Diabetes Association, highlight the potential of population-based screening; however, practical strategies for real-world implementation remain underdeveloped.
This study is designed to generate practice-informed evidence on how universal T1D islet autoantibody screening can be feasibly, acceptably, and appropriately integrated into routine pediatric well-child visits. Guided by implementation science, the study evaluates a set of implementation strategies that includes clinician education, clinician ordering reminders, and facilitation.
Observational Study Model:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Clinics will be encouraged to select screening ages or visits that align with international consensus statements for screening during early childhood, mid-childhood, and preadolescence and routine U.S. well-child visit schedules, and that minimize workflow disruption and maximize screening completion, such as visits that already include blood draws for other routine tests (e.g., lead screening at age 2). Children who have visits at their clinic's selected ages will be eligible to have their data extracted from the electronic health record (EHR)
- •Parents/Caregivers - All parents or legal guardians (hereafter, parents) who attended the well-child visit, who are eligible to have their child's EHR data extracted, and who are over age 18, will be eligible to complete the post-visit survey and interview.
- •Clinicians and Other Care Team Members
- •All pediatric primary care clinicians (i.e., physician [MD, DO], nurse practitioner, physician assistant) at participating clinics will be eligible to complete an interview.
- •All other care team members, including nurses, medical assistants, phlebotomists, and front desk staff at participating clinics will be eligible to complete an interview.
排除标准
- •- Parents who have opted-out of survey recruitment at their clinic will not be eligible for the survey/interview.
结局指标
主要结局
Feasibility (Clinician Perspective)
时间窗: Towards the end of the study (approximately months 12-15)
Feasibility of screening and implementation strategies will be assessed using items adapted from the Feasibility of Intervention Measure (FIM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
Acceptability (Parent Perspective)
时间窗: Throughout study period (15 months)
Parent perspectives on the acceptability (for both clinician recommendation of screening and undergoing a blood draw for screening; parents who received or completed each element will be asked about actual acceptability and those who didn't will be asked about anticipated acceptability). Survey questions will be adapted from the psychometrically validated Acceptability of Intervention Measure (AIM) and rated on a Likert-scale ranging from completely agree (5) to completely disagree (1).
Acceptability (Clinician Perspective)
时间窗: Towards the end of the study (approximately months 12-15)
Acceptability of screening and implementation strategies will be assessed using items adapted from the Acceptability of Intervention Measure (AIM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
Appropriateness (Parent Perspective)
时间窗: Throughout study period (15 months)
Parent perspectives on the appropriateness (i.e., relevance of screening; parents who completed screening will be asked about actual appropriateness and those who didn't will be asked about anticipated appropriateness). Survey questions will be adapted from the psychometrically validated Intervention Appropriateness Measure (IAM) and rated on a Likert-scale ranging from completely agree (5) to completely disagree (1).
Appropriateness (Clinician Perspective)
时间窗: Towards the end of the study (approximately months 12-15)
Appropriateness of screening and implementation strategies will be assessed using items adapted from the Intervention Appropriateness Measure (IAM), administered verbally during interviews and rated on a five-point Likert scale ranging from completely agree (5) to completely disagree (1)
次要结局
- Penetration of T1D Screening(15 months preceding study period and 15 months of study period)
- Reach of T1D Screening(15 months preceding study period and 15 months of study period)
- Clinical Documentation(15 months preceding study period and 15 months of study period)
研究者
Rinad Beidas
Ralph Seal Paffenbarger Professor and Chair, Department of Medical Social Sciences
Northwestern University