跳至主要内容
临床试验/NCT03084900
NCT03084900已完成不适用

Patient-Centered Decision Support to Improve Diabetes Management in Pre-Teens and Adolescents With Type 1 Diabetes

Indiana University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年7月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
HbA1c value

研究概览

简要总结

Investigators propose to study an intervention that will provide patient-centered, automated decision support to diabetes providers with the goals of improving adherence to medical recommendations (both patients and providers), improving self-management, and ultimately improving health outcomes.

详细描述

Investigators propose to study an intervention that will provide patient-centered, automated decision support to diabetes providers with the goals of improving adherence to medical recommendations (both patients and providers), improving self-management, and ultimately improving health outcomes. Computer decision support systems (CDSS) have scientifically demonstrated advantages for improving care, and the potential to revolutionize diabetes care because they allow for increased reactive and proactive contact with the health care team, real-time adherence support, and intensification of treatment. In this study,investigators will implement the ADA recommended standards of care using a CDSS developed by the research group - the Child Health Improvement through Computer Automation (CHICA) system.9 One of the greatest strengths of the CHICA system is its ability to implement evidence-based recommendations from authoritative sources, in this case the ADA, in a format that integrates easily into routine care. A second strength of the CHICA system is its ability to screen for patient-centered concerns, including barriers to optimal care such as literacy, socioeconomic issues (i.e., food insecurity, housing insecurity, etc.), and mental health issues (i.e., depression). The provider is alerted, and safety mechanisms are set in motion (i.e., referral to mental health provider, etc.) to address identified issues. In order to ensure that we design the most effective CDSS intervention possible, the study team, in collaboration with the Patient Engagement Core (PEC) of the Indiana Clinical and Translational Science Institute, will partner with adolescents, parents, and other stakeholders in a way that exceeds standard expectations for the engagement of these parties in research. Investigators have experience working directly with patients to elucidate patient-centered outcomes, identify determinants of adherence, and to co-design interventions that are inherently more patient-centered.10-14 By combining a patient-centered design approach along with CDSS investigators will be able to individually tailor recommendations to meet the real needs of patients, taking into account the adolescent patient's perspective and input. This truly innovative approach will offer improved technology-based support systems for diabetes management along with attention to patient-centered goals using co-designed interventions for diabetes self-management.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Adolescents with type 1 diabetes
  • Parents of adolescents with type 1 diabetes
  • Friends/siblings of adolescents with type 1 diabetes
  • Community partners who work with adolescents with type 1 diabetes
  • Diabetes care providers

排除标准

  • 未提供

研究组 & 干预措施

Patient-Centered Decision Support

Experimental

Intervention - computer decision support in diabetes clinic. Investigators will use a computerized decision support system to aid clinicians to provide standard of care management while introducing patient-centered guidelines and outcomes measures. The intervention is the use of an electronic decision support tool. The decision support tool consists of a series of questions answered by the patients that will then allow the health care provider to address specific needs during the visit.

干预措施: Arm 1 (Other)

Standard Care

No Intervention

Standard pediatric diabetes care will be compared to the computerized decision support system.

结局指标

主要结局

HbA1c value

时间窗: 4 years

Measure of HbA1c value for youth subjects

次要结局

  • Hypoglycemia(4 years)
  • DKA(4 years)

研究者

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

Tamara S. Hannon

Associate Professor

Indiana University

研究点 (2)

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