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

Tracking Information

• First Submitted Date: October 4, 2016
• First Posted Date: October 5, 2016
• Results First Submitted Date: February 16, 2018
• Results First Posted Date: July 17, 2020
• Last Update Posted Date: September 23, 2020
• Study Start Date: November 2014
• Actual Primary Completion Date: June 30, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 22, 2020)

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

Original Primary Outcome Measures (submitted: October 4, 2016)

• Reduction in A1C by > 1% over 3 months [ Time Frame: 3 months ]
  Measure of glycemic control
• Increased adherence to diabetes medications as measured using MMS by 25% from baseline to 3 months for intervention subjects [ Time Frame: 3 months ]
  medication adherence
• Increase the proportion of patients receiving an eye exam by 20% in the 6 months following the start of the intervention as compared to baseline and to concurrent chart controls. [ Time Frame: 6 months ]
  HEDIS measure

Current Secondary Outcome Measures (submitted: September 22, 2020)

• 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.
• 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
• 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

Original Secondary Outcome Measures (submitted: October 4, 2016)

• trend in the composite endpoint of diabetes-related ED visits and hospitalizations compared to both 6 month pre-intervention and among concurrent chart controls. [ Time Frame: 6 months ]
  Health care utilization measure
• - Reduction in self-reported absenteeism (or days missed from usual daily activities) during the intervention period when compared to 6 months prior to enrollment [ Time Frame: 6 months ]
  quality of life

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: MedStar Health Type 2 Diabetes Pathway to Control
• Official Title: MedStar Pathway to Diabetes Control Demonstration Project: Type 2 Diabetes Boot Camp
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Type 2 Diabetes Mellitus
• Hyperglycemia

Intervention

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

Study Arms

• 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.
  Intervention: Other: Diabetes Pathway
• 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.

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 1, 2020): 419
• Original Estimated Enrollment (submitted: October 4, 2016): 450
• Actual Study Completion Date: December 31, 2016
• Actual Primary Completion Date: June 30, 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02925312
• Other Study ID Numbers: 2014-191
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: 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.

• Current Responsible Party: Michelle Magee, Medstar Health Research Institute
• Original Responsible Party: Michelle F. Magee, Medstar Health Research Institute, Director, MedStar Diabetes Institute
• Current Study Sponsor: Medstar Health Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Medstar Health Research Institute
• Verification Date: September 2020