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Completed

NCT Number: NCT03442595

MedStar Diabetes Pathway Chart Reviews

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.

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Key information

Conditions

Type2 Diabetes Mellitus

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensive diabetes education and medication management

Other

Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.

Primary outcomes

  1. Percent Change in A1C

    Time frame: 12-16 weeks

    Change in Hemoglobin A1C from baseline to 12-16 weeks for both cases and controls

Secondary outcomes

  1. Risk for Emergency Room Visits at 30 Days From Baseline as Measured by Incidence Risk Ratio

    Time frame: 30 days

    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.

  2. Risk for Hospitalizations at 30 Days From Baseline

    Time frame: 30 days

    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.

  3. Risk for Composite of Emergency Room Visits and Hospitalizations at 30 Days From Baseline

    Time frame: 30 days

    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.

  4. Risk for Emergency Room Visits at 90 Days From Baseline

    Time frame: 90 days

    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

  5. Risk for Hospitalizations at 90 Days From Baseline

    Time frame: 90 days

    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.

  6. Composite of Risk for Hospitalizations and Emergency Room Visits Within 90 Days From Baseline

    Time frame: 90 days

    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.

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

Expanded MedStar Diabetes Pathway Ongoing Chart Review Protocol

Acronym: MedstarBC2

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Feb 22, 2018
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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