Clinical Trials Directory

Trials / Completed

CompletedNCT02925312

MedStar Health Type 2 Diabetes Pathway to Control

MedStar Pathway to Diabetes Control Demonstration Project: Type 2 Diabetes Boot Camp

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
419 (actual)
Sponsor
Medstar Health Research Institute · Academic / Other
Sex
All
Age
21 Years – 75 Years
Healthy volunteers
Not accepted

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 (A1C\>/=9%) 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 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.

Conditions

Interventions

TypeNameDescription
OTHERDiabetes PathwayMedication algorithm, survival skills education, enhanced patient-provider communication facilitated by near, real-time blood glucose monitoring

Timeline

Start date
2014-11-01
Primary completion
2016-06-30
Completion
2016-12-31
First posted
2016-10-05
Last updated
2020-09-23
Results posted
2020-07-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02925312. Inclusion in this directory is not an endorsement.