Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-30 @ 9:25 AM
Study NCT ID:
NCT03442595
Status:
COMPLETED
Last Update Posted:
2020-10-20
First Post:
2018-02-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MedStar Diabetes Pathway Chart Reviews
Sponsor:
Medstar Health Research Institute
Organization:
Study Overview
Official Title:
Expanded MedStar Diabetes Pathway Ongoing Chart Review Protocol
Status:
COMPLETED
Status Verified Date:
2020-10
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:
MedstarBC2
Brief Summary:
The MedStar Diabetes Pathway (MDP) is transitioning into a clinical program offered at various MedStar sites. The MDP clinical team is reviewing the data collected during the pilot to improve the program and adapt it to various clinical settings in order to better serve the target patient population. It is imperative to continue reviewing patient clinical outcomes as the program expands in order to insure continuous quality improvement of the program. This will be achieved through chart reviews of patients receiving diabetes care via the MDP and comparison with patients received diabetes standard of care through their primary care physician.
Detailed Description:
The MedStar Diabetes Pathway (MDP) early pilot program has generated evidence that an innovative technology-enabled "Boot Camp" approach to the delivery of diabetes survival skills education and medication management has a significant impact on glycemic control and healthcare utilization measures. The MDP is a 12 week Diabetes "Boot Camp" technology-enabled intervention which will offer learner-centered survival skills self-management education (DSSE) and algorithm-driven diabetes medications (DM) titration by Endocrinologist-supervised Certified Diabetes Educators (CDE), NPs and PharmDs. The program has been offered at 5 MedStar Medical Group (MMG) Primary Care Practices from November 2014 to February 2016 to high risk adults with uncontrolled type 2 diabetes who have a hemoglobin A1C (A1C) level -a marker of average blood glucose (BG) levels in the 2-3 months prior to the time the test is done- which is at or above 9% - considered to be poor control, and 1 or more additional risk factors for poor health outcomes. The program has been well received by MedStar Primary Care Providers and their diabetes patients. Patients that participated in the MDP achieved significantly higher A1C reduction and decreased risk risk for acute care utilization then matched controls that received standard of care. The pilot evidence demonstrated a significant impact on glycemic control and healthcare utilization measures as the result of a concise, focused DM education and medication management intervention. Building on the success of the MDP Phase 1.0 pilot, the next steps in expanding the program will be as follows:
* Transition of the Pathway from early feasibility pilot to the next phase as an expanded pilot program integrated within the MedStar Health System care delivery network and built upon a sustainable infrastructure across early adopter MMG practice sites.
* Expand recruitment to include high risk patients with uncontrolled type 2 diabetes, including those with a new diagnosis and A1C \>9%, who have MedStar Emergency Department and/or Inpatient encounters
* Spread to additional targeted MedStar Primary Care Practices and/or to MedStar Managed Care Plan participants.
Chart reviews and data collection during the expansion phase will be essential to guide the process and allow rapid cycle adjustments to maximize the impact of the program and utilization of resources for the benefit of our patients.
* Transition of the Pathway from early feasibility pilot to the next phase as an expanded pilot program integrated within the MedStar Health System care delivery network and built upon a sustainable infrastructure across early adopter MMG practice sites.
* Expand recruitment to include high risk patients with uncontrolled type 2 diabetes, including those with a new diagnosis and A1C \>9%, who have MedStar Emergency Department and/or Inpatient encounters
* Spread to additional targeted MedStar Primary Care Practices and/or to MedStar Managed Care Plan participants.
Chart reviews and data collection during the expansion phase will be essential to guide the process and allow rapid cycle adjustments to maximize the impact of the program and utilization of resources for the benefit of our patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: