MedStar Health Type 2 Diabetes Pathway to Control (T2DMBC)
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|ClinicalTrials.gov Identifier: NCT02925312|
Recruitment Status : Completed
First Posted : October 5, 2016
Results First Posted : July 17, 2020
Last Update Posted : July 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus Hyperglycemia||Other: Diabetes Pathway||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||419 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||MedStar Pathway to Diabetes Control Demonstration Project: Type 2 Diabetes Boot Camp|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||June 30, 2016|
|Actual Study Completion Date :||December 31, 2016|
Patients receive the full diabetes pathway intervention consisting of: individualized diabetes self-management education and support; T2DM meds management by clinician-supervised diabetes educators using an evidence-based algorithm and FDA approved anti-hyperglycemic agents; near, real-time blood glucose monitoring, delivered via a combination of two in-person and weekly remote (telephone/text) visits.
Other: Diabetes Pathway
Medication algorithm, survival skills education, enhanced patient-provider communication facilitated by near, real-time blood glucose monitoring
Other Name: Diabetes Boot Camp
No Intervention: Matched controls
Patients receive standard of care from their primary care provider. Usual care visits are typically conducted quarterly per national guidelines for management of T2DM in adults, or more frequently as needed.
- Mean Change in Hemoglobin A1C From Baseline to 3 Months [ Time Frame: 3 months ]Comparison of the absolute reduction in A1C from baseline to 3 months between the intervention and the control group
- Trend in the Composite Endpoint of All Cause ED Visits and Hospitalizations as Compared to the 6 Month Pre-intervention Period vs the 6 Months After the Start of the Intervention. This Was Measured for in Intervention and Concurrent Chart Controls. [ Time Frame: 6 months ]Health care utilization measure. We looked at the Incidence Rate Ratio of ED visits/hospitalizations for intervention and control patients to assess whether the pathway impacted the risk for ED visits/hospitalizations at 6 months from baseline. We looked at these measures for the 6-month period that preceded the baseline visit and the 6-month period that followed the baseline visit.
- Adherence to Prescribed Diabetes Medications [ Time Frame: 90 days ]Increased Adherence to Diabetes Medications as Measured Using MMS by 25% From Baseline to 3 Months for Intervention Subjects
- Frequency of Eye Exams [ Time Frame: 90 days ]Increase the Proportion of Patients Receiving an Eye Exam by 20% in the 6 Months Following the Start of the Intervention as Compared to Baseline and to Concurrent Chart Controls
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02925312
|United States, District of Columbia|
|MedStar Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Michelle F Magee, MD||Medstar Health Research Institute|