MedStar Health Type 2 Diabetes Pathway to Control

NCT ID: NCT02925312

Last Updated: 2020-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 419 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-12-31

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.

Conditions

Type 2 Diabetes Mellitus; Hyperglycemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Diabetes Pathway

Intervention Type: OTHER

Medication algorithm, survival skills education, enhanced patient-provider communication facilitated by near, real-time blood glucose monitoring

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diabetes Pathway

Medication algorithm, survival skills education, enhanced patient-provider communication facilitated by near, real-time blood glucose monitoring

Intervention Type: OTHER

Other Intervention Names

Diabetes Boot Camp

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Michelle Magee

Director, MedStar Diabetes Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle F Magee, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 31798894 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34758807 (View on PubMed)

Other Identifiers

2014-191

Identifier Type: -

Identifier Source: org_study_id