MedStar Health Type 2 Diabetes Pathway to Control

Not Applicable

Completed

Conditions: Type 2 Diabetes Mellitus
Hyperglycemia

Interventions: Other: Diabetes Pathway

Registration Number: NCT02925312

Lead Sponsor: Medstar Health Research Institute

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 419

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Diabetes Pathway	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.

Primary Outcome Measures

Name	Time	Method
Percentage Change in Hemoglobin A1C From Baseline to 3 Months	3 months	Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group

Secondary Outcome Measures

Name	Time	Method
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.	6 months	Health care utilization measure. We compared the risk of experiencing an emergency room and/or hospital visit at 6 months from baseline for both groups. this was done by calculating he Incidence Risk 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 and comparing them. 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	90 days	Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects
Frequency of Eye Exams	90 days	Change in the Proportion of Patients Receiving an Eye Exam in the 6 Months Following the Start of the Intervention as Compared to Baseline and to Concurrent Chart Controls