Clinical trial NCT02925312: MedStar Health Type 2 Diabetes Pathway to Control
Official title: MedStar Pathway to Diabetes Control Demonstration Project: Type 2 Diabetes Boot Camp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Hyperglycemia
Keywords: Diabetes Care Management
Chronic Care Model
Resources Utilization
Hemoglobin A1C
Hospitalizations
Emergency Room Visits
Cost analysis
Return on Investment
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 419
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage Change in Hemoglobin A1C From Baseline to 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
measure: Adherence to Prescribed Diabetes Medications
timeFrame: 90 days
measure: Frequency of Eye Exams
timeFrame: 90 days
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Health Research Institute
name: Michelle F Magee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magee MF, Baker KM, Fernandez SJ, Huang CC, Mete M, Montero AR, Nassar CM, Sack PA, Smith K, Youssef GA, Evans SR. Redesigning ambulatory care management for uncontrolled type 2 diabetes: a prospective cohort study of the impact of a Boot Camp model on outcomes. BMJ Open Diabetes Res Care. 2019 Nov 13;7(1):e000731. doi: 10.1136/bmjdrc-2019-000731. eCollection 2019.
citation: Montero AR, Toro-Tobon D, Gann K, Nassar CM, Youssef GA, Magee MF. Implications of remote monitoring Technology in Optimizing Traditional Self-Monitoring of blood glucose in adults with T2DM in primary care. BMC Endocr Disord. 2021 Nov 10;21(1):222. doi: 10.1186/s12902-021-00884-6.