NCT02925312已完成不适用
MedStar Pathway to Diabetes Control Demonstration Project: Type 2 Diabetes Boot Camp
Medstar Health Research Institute2 个研究点 分布在 1 个国家目标入组 419 人开始时间: 2014年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 419
- 试验地点
- 2
- 主要终点
- Percentage Change in Hemoglobin A1C From Baseline to 3 Months
研究概览
简要总结
A Diabetes Institute (MDI), in partnership with key stakeholders-including Primary Care Providers- in a northeastern US regional, mixed-payer healthcare system), seeks to implement an evidence-based, technology-enabled, innovative, and integrated diabetes care management pathway (Boot Camp) for adult patients with uncontrolled type 2 diabetes (A1C>/=9%) which will demonstrate improvement in diabetes clinical and health resources utilization outcomes.
详细描述
- The program is designed to integrate type 2 diabetes specialty services into Primary Care practices to support PCPs and their patients in improving a spectrum of diabetes-related outcomes.
- High-risk patients from Primary Care practices who have uncontrolled type 2 diabetes and meet the target population inclusion and exclusion criteria will be invited to participate in an intensive and concise "BOOT CAMP" medication management and education intervention of ~4-8 weeks duration.
- The intervention will consist of three key components: (1) intensive, algorithm-based medication management (Appendix A), based on continuous review and management of blood sugars; (2) survival skills diabetes self-management education based on knowledge deficits identified on the KNOW Diabetes knowledge survey; (3) enhanced patient-provider communication, all provided by Endocrinologist supervised allied health professionals (in this instance CDEs).
- Survival skills DSME will focus on nutrition and meal plan basics, blood glucose targets, taking medications as prescribed, hyper- and hypoglycemia recognition and treatment, and when to seek medical help.
- The intervention is initiated with one to two face-to-face meetings with the CDE, at which the patient's readiness to change is assessed.
- These are followed by virtual meetings though a variety of media based on patient preference and health literacy (largely telephone and text messaging).
- Various technology tools are used to facilitate patient engagement, access and attainment of glycemic targets, including smart meters, virtual meeting platforms, web-based education content and surveys administration via tablets, etc.
- Near real-time transmission of blood glucose data using a cellular-enabled blood glucose monitoring system sends all glucose results to a web-based dashboard accessed daily by the Boot Camp educators.
- Concurrent matched charts of patients receiving standard care at the three MedStar locations will serve as a basis of comparison in assessing the impact of MDI on clinical and education outcomes and process of care.
- Based on patient progress towards improved glycemic control, the patient will 'graduate' from the program and the CDE will refer the patient back to their PCP in 8-12 weeks with a full report of medication changes, blood glucose readings and further diabetes management recommendations eg referrals; further DSME, etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes for >=1 year
- •Active practice patient
- •A1C > 9.0% at their last visit to Medical Home, ED or hospital admission plus one more high risk factor (ED visit or hospitalization in past 12 mos)
- •Primary Care Provider willing to have patient enter the program
- •Patient is able and willing to participate in the program and exhibits readiness to change DM self-management
- •Proficient in English
排除标准
- •Known history of DKA
- •No MedStar PCP visit within past 12 months
- •Endocrine or Diabetes Education consult referral order in the past 6 months which resulted in Endo visit(s) or DSME visit(s) documented in chart or self-reported by patient during initial screen
- •Active additional medical issues which in the opinion of the care team would preclude concentrating on BG control and/or would predispose to ED visits and/or hospital admits independent of glycemic control, e.g.: severe CHF, severe COPD; severe mental illness.
- •Resident of skilled nursing facility, nursing home or receiving home health care services.
- •Active cancer in the preceding 3 years excluding nonmalignant basal cell cancer
- •Supraphysiologic doses of glucocorticoids (hydrocortisone > 30mg/day; prednisone > 5-6mg daily; dexamethasone > 2mg daily).
- •Pregnant or anticipates attempting conception in the following year
- •Patient and/or custodial caregiver unwilling and/or unable to participate in program-related activities
结局指标
主要结局
Percentage Change in Hemoglobin A1C From Baseline to 3 Months
时间窗: 3 months
Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group
次要结局
- Risk of Experiencing a Composite Endpoint of All Cause ED Visits and Hospitalizations at 6 Months Post Intervention vs 6 Months Pre-intervention for Cases and Controls.(6 months)
- Adherence to Prescribed Diabetes Medications(90 days)
- Frequency of Eye Exams(90 days)
研究者
Michelle Magee
Director, MedStar Diabetes Institute
Medstar Health Research Institute
研究点 (2)
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