MedStar Diabetes Pathway Chart Reviews (MedstarBC2)

Expanded MedStar Diabetes Pathway Ongoing Chart Review Protocol

The MedStar Diabetes Pathway (MDP) is transitioning into a clinical program offered at various MedStar sites. The MDP clinical team is reviewing the data collected during the pilot to improve the program and adapt it to various clinical settings in order to better serve the target patient population. It is imperative to continue reviewing patient clinical outcomes as the program expands in order to insure continuous quality improvement of the program. This will be achieved through chart reviews of patients receiving diabetes care via the MDP and comparison with patients received diabetes standard of care through their primary care physician.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes Mellitus
• Intervention / Treatment: Other: Intensive diabetes education and medication management

Detailed Description

The MedStar Diabetes Pathway (MDP) early pilot program has generated evidence that an innovative technology-enabled "Boot Camp" approach to the delivery of diabetes survival skills education and medication management has a significant impact on glycemic control and healthcare utilization measures. The MDP is a 12 week Diabetes "Boot Camp" technology-enabled intervention which will offer learner-centered survival skills self-management education (DSSE) and algorithm-driven diabetes medications (DM) titration by Endocrinologist-supervised Certified Diabetes Educators (CDE), NPs and PharmDs. The program has been offered at 5 MedStar Medical Group (MMG) Primary Care Practices from November 2014 to February 2016 to high risk adults with uncontrolled type 2 diabetes who have a hemoglobin A1C (A1C) level -a marker of average blood glucose (BG) levels in the 2-3 months prior to the time the test is done- which is at or above 9% - considered to be poor control, and 1 or more additional risk factors for poor health outcomes. The program has been well received by MedStar Primary Care Providers and their diabetes patients. Patients that participated in the MDP achieved significantly higher A1C reduction and decreased risk risk for acute care utilization then matched controls that received standard of care. The pilot evidence demonstrated a significant impact on glycemic control and healthcare utilization measures as the result of a concise, focused DM education and medication management intervention. Building on the success of the MDP Phase 1.0 pilot, the next steps in expanding the program will be as follows:

• Transition of the Pathway from early feasibility pilot to the next phase as an expanded pilot program integrated within the MedStar Health System care delivery network and built upon a sustainable infrastructure across early adopter MMG practice sites.
• Expand recruitment to include high risk patients with uncontrolled type 2 diabetes, including those with a new diagnosis and A1C >9%, who have MedStar Emergency Department and/or Inpatient encounters
• Spread to additional targeted MedStar Primary Care Practices and/or to MedStar Managed Care Plan participants.

Chart reviews and data collection during the expansion phase will be essential to guide the process and allow rapid cycle adjustments to maximize the impact of the program and utilization of resources for the benefit of our patients.

• Study Type: Observational
• Enrollment (Actual): 826

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with uncontrolled type 2 diabetes that meet inclusion and exclusion criteria.

Description

Inclusion Criteria:

• Diagnosis of Type 2 Diabetes, A1C equal or higher than 9%, active patient of medstar health provider, english speaking, willing and able to participate in the program

Exclusion Criteria:

• A1C less than 9%, severe illness that precludes participation such severe congestive heart failure or COPD, advanced kidney disease, recent acute illness such as heart attack or stroke in the past 30 days, active cancer, severe mental illness, high dose steroid, other types of diabetes, pregnant or lactating.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway	Other: Intensive diabetes education and medication management; Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.
Matched controls; patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in A1C	Change in Hemoglobin A1C from baseline to 12-16 weeks for both cases and controls	12-16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk for Emergency Room Visits at 30 Days From Baseline as Measured by Incidence Risk Ratio	Comparison of risk of incurring an emergency room visits at 30 days from baseline for cases and controls. This was done by calculating and comparing the incidence risk ratio for an ER visit for each group and comparing them.	30 days
Risk for Hospitalizations at 30 Days From Baseline	Comparison of risk for experiencing a hospital visit within 30 days from baseline in both group. This was done by calculating the incidence risk ratio for hospitalizations for cases and controls at 30 days from baseline and comparing them.	30 days
Risk for Composite of Emergency Room Visits and Hospitalizations at 30 Days From Baseline	Comparison for risk of experiencing a visit to the emergency room and/or the hospital at 30 days from baseline. This was measured by calculating the Incidence risk ratio for acute care utilization at 30 days from baseline for both cases and controls and comparing them.	30 days
Risk for Emergency Room Visits at 90 Days From Baseline	Comparison of the risk of experiencing an emergency room visit at 90 days from baseline in both groups. This was done by calculating the Incidence risk ratio for an emergency room visit at 90 days for both cases and controls and comparing them	90 days
Risk for Hospitalizations at 90 Days From Baseline	Comparison of the risk for experiencing a hospitalization within 90 days from baseline in both groups. This was done by calculating the Incidence Risk Ratio for hospitalizations for cases and controls within 90 days of baseline and comparing them.	90 days
Composite of Risk for Hospitalizations and Emergency Room Visits Within 90 Days From Baseline	Comparison of the risk for experiencing a hospitalization and/or emergency room visit within 90 days from baseline for both groups. This was done by calculating then comparing the incidence risk ratio for acute care utilization within 90 days from baseline for cases and controls.	90 days

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 22, 2018

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2016-143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No