Ignite Creation Date:
2024-05-06 @ 9:12 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02925312
Status:
COMPLETED
Last Update Posted:
2020-09-23
First Post:
2016-10-04
Brief Title:
MedStar Health Type 2 Diabetes Pathway to Control
Sponsor:
Medstar Health Research Institute
Organization:
Medstar Health Research Institute
Study Overview
Official Title:
MedStar Pathway to Diabetes Control Demonstration Project Type 2 Diabetes Boot Camp
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T2DMBC
Brief Summary:
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 A1C9 which will demonstrate improvement in diabetes clinical and health resources utilization outcomes
Detailed Description:
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None