MedStar Health Type 2 Diabetes Pathway to Control (T2DMBC)

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperglycemia; Type 2 Diabetes Mellitus
• Intervention / Treatment: Other: Diabetes Pathway

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.

• Study Type: Interventional
• Enrollment (Actual): 419
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: Diabetes Pathway; Medication algorithm, survival skills education, enhanced patient-provider communication facilitated by near, real-time blood glucose monitoring; Other Names: Diabetes Boot Camp
No Intervention: Matched controls; Patients receive standard of care from their primary care provider. Usual care visits are typically conducted quarterly per national guidelines for management of T2DM in adults, or more frequently as needed.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	6 months
Adherence to Prescribed Diabetes Medications	Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects	90 days
Frequency of Eye Exams	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	90 days

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 30, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Hospitalizations; Chronic Care Model; Cost analysis; Hemoglobin A1C; Diabetes Care Management; Resources Utilization; Emergency Room Visits; Return on Investment
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2014-191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon request to the PI including provision of details of how the IPD will be utilized by the requestor, the study team will decide whether to release the IPD. The study protocol, SAP, ICF and clinical study report will be available.
• IPD Sharing Time Frame: Upon final completion of reporting of main study results the study protocol, SAF, ICF and CSR will be available for 5 years.
• IPD Sharing Access Criteria: Deidentified data for scientific use that may contribute to the body of evidence to inform diabetes care management.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR