Improving Metformin Utilization And Diabetes Control Through Patient-Centered Outcomes Research

通过以患者为中心的结果研究提高二甲双胍的利用率和糖尿病控制

• 批准号: 9294937
• 负责人: James H Flory
• 金额: $ 15.19万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9294937
• 关键词: Improving; Metformin; Utilization; Diabetes; Control

 DESCRIPTION (provided by applicant): This is a K08 initial application for Dr. James Flory, an endocrinologist and young investigator pursuing patient-oriented comparative effectiveness research on the care of type 2 diabetes mellitus (T2DM). A K08 award will provide him with the means to acquire skills in three key career development areas: 1) clinical epidemiology, 2) qualitative research, and 3) clinical trial design. By acquiring these skills, Dr. Flory will fulfil his long-term career goal of becoming an independent clinical investigator. Dr. Flory has a primary mentor, Dr. Alvin Mushlin, who is a leading epidemiologist and internist with extensive experience mentoring K-grant awardees. He will also work with a co-mentor, Dr. Sean Hennessy, a leading pharmacoepidemiologist. In addition, Dr. Flory has two key collaborators: Dr. Joshua Richardson, an expert in the application of qualitative research to biomedical informatics, and Dr. David Brillon, an endocrinologist and clinical researcher specializing in diabetes. The motivating clinical problem for this proposal is the fact that although metformin is the first-line drug therapy for T2DM and confers unequalled long-term clinical benefits, it is under-utilized. In particular, 16% of patients discontinue metformin at 6 months and close to a third discontinue it at one year. Dr. Flory's central hypothesis is that much of this non-persistence (i.e., early discontinuation) is due to patient-centered factors specific to metformin and that better prescribing practices and prescriber-patient communication can enhance metformin persistence. To test this hypothesis and translate it into a pragmatic intervention, Dr. Flory proposes to collect epidemiologic and qualitative data on metformin non-persistence and then design and pilot an intervention in a small pragmatic clinical trial. These activities will la the groundwork for a large-scale pragmatic randomized trial to be proposed in an R01 application during the K08 award period. Aim 1 will test the hypothesis that metformin non-persistence is common and leads to observably worse short-term clinical outcomes. Aim 2 will test the hypothesis that non-persistent patients and their providers will offer potentially modifiable reasons for metformin non-persistence. Aim 3 will test the hypothesis that a pragmatic clinical trial of a patient-centered intervention to reintroduce metformin to previously non-persistent patients is feasible and likely to result in increased appropriate use of metformin to treat T2DM. The proposed research is significant because positive results will lead to identification of an intervention to allow more patients to benefit from metformin. Negative results would provide information on the nature of metformin non-persistence and lay groundwork for alternative approaches to optimizing care of these patients.

 描述（由应用程序提供）：这是对詹姆斯·弗洛里（James Flory）博士的初步申请。 K08奖将为他提供在三个关键职业发展领域获得技能的手段：1）临床流行病学，2）定性研究和3）临床试验设计。通过获得这些技能，Flory博士将实现他成为独立临床研究者的长期职业目标。弗洛里（Flory）博士的主要心态，阿尔文·穆斯林（Alvin Mushlin）博士，他是一位领先的流行病学家和实习生，拥有丰富的心态K-Grant获奖者。他还将与一位领先的药物ePIDEMIXOSTER SEAN HENNENSSY博士合作。此外，弗洛里（Flory）博士还有两个主要合作者：约书亚·理查森（Joshua Richardson）博士，他是定性研究在生物医学信息中的应用专家，而专门从事糖尿病的内分泌学家和临床研究人员戴维·布里隆（David Brillon）博士。该提案的动机临床问题是，尽管二甲双胍是T2DM的一线药物治疗，并且赋予了无与伦比的长期临床益处，但它的利用不足。特别是，有16％的患者在6个月时停止二甲双胍，在一年后接近三分之一。弗洛里博士的中心假设是，这种非持久性（即早期停用）的大部分是由于特定于二甲双胍的因素而引起的，并且更好地开处方的做法和处方药的通信可以增强二甲双胍的持久性。为了检验这一假设并将其转化为务实的干预措施，Flory博士提议收集有关二甲双胍非持久性的流行病学和定性数据，然后设计和试点介入一项小型务实临床试验。这些活动将为在K08奖励期内在R01申请中提出的大规模实用随机试验的基础。 AIM 1将检验以下假设：二甲双胍非持久性很常见，并导致明显的短期临床结果。 AIM 2将检验以下假设：非持久患者及其提供者将为二甲双胍非持久性提供可能修改的理由。 AIM 3将检验以下假设：以患者为中心的干预措施的务实临床试验可行，可将二甲双胍重新引入以前的非持久患者是可行的，并且可能会增加适当地使用二甲双胍治疗T2DM。拟议的研究很重要，因为积极的结果将导致鉴定干预措施，以使更多的患者从二甲双胍中受益。负面结果将提供有关二甲双胍非持久性的性质的信息，并为优化对这些患者的护理的替代方法提供了基础。