MedStar Health Type 2 Diabetes Pathway to Control (T2DMBC)

• ClinicalTrials.gov Identifier: NCT02925312
• Recruitment Status: Completed
• First Posted: October 5, 2016
• Results First Posted: July 17, 2020
• Last Update Posted: September 23, 2020
• Sponsor: Medstar Health Research Institute
• Information provided by (Responsible Party): Michelle Magee, Medstar Health Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus; Hyperglycemia	Other: Diabetes Pathway	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 419 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: MedStar Pathway to Diabetes Control Demonstration Project: Type 2 Diabetes Boot Camp
• Study Start Date: November 2014
• Actual Primary Completion Date: June 30, 2016
• Actual Study Completion Date: December 31, 2016

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Percentage Change in Hemoglobin A1C From Baseline to 3 Months [ Time Frame: 3 months ]
   Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group

Secondary Outcome Measures :

1. 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. [ Time Frame: 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.
2. Adherence to Prescribed Diabetes Medications [ Time Frame: 90 days ]
   Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects
3. Frequency of Eye Exams [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, District of Columbia

MedStar Washington Hospital Center

Washington, District of Columbia, United States, 20010

Sponsors and Collaborators

Medstar Health Research Institute

Investigators

• Principal Investigator: Michelle F Magee, MD; Medstar Health Research Institute

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Michelle Magee, Director, MedStar Diabetes Institute, Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT02925312
• Other Study ID Numbers: 2014-191
• First Posted: October 5, 2016
• Results First Posted: July 17, 2020
• Last Update Posted: September 23, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Upon final completion of reporting of main study results the study protocol, SAF, ICF and CSR will be available for 5 years.
• Access Criteria: Deidentified data for scientific use that may contribute to the body of evidence to inform diabetes care management.

Keywords provided by Michelle Magee, Medstar Health Research Institute:

Diabetes Care Management; Chronic Care Model; Resources Utilization; Hemoglobin A1C; Hospitalizations; Emergency Room Visits; Cost analysis; Return on Investment

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases