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MedStar Health Type 2 Diabetes Pathway to Control (T2DMBC)

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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:
Information provided by (Responsible Party):
Michelle Magee, Medstar Health Research Institute

Tracking Information
First Submitted Date  ICMJE October 4, 2016
First Posted Date  ICMJE October 5, 2016
Results First Submitted Date  ICMJE February 16, 2018
Results First Posted Date  ICMJE July 17, 2020
Last Update Posted Date September 23, 2020
Study Start Date  ICMJE November 2014
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE MedStar Health Type 2 Diabetes Pathway to Control
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Hyperglycemia
Intervention  ICMJE 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2020)
419
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2016)
450
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date June 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02925312
Other Study ID Numbers  ICMJE 2014-191
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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  ICMJE Medstar Health Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michelle F Magee, MD Medstar Health Research Institute
PRS Account Medstar Health Research Institute
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP