MedStar Diabetes Pathway Chart Reviews

NCT03442595 | Completed Results

• 1 other identifier: 2016-143
• Study Type: observational
• Target: 826
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Percent Change in A1C

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

  12-16 weeks

Secondary Outcomes (6)

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

  30 days

• Risk for Hospitalizations at 30 Days From Baseline

  30 days

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

  30 days

• Risk for Emergency Room Visits at 90 Days From Baseline

  90 days

• Risk for Hospitalizations at 90 Days From Baseline

  90 days

Study Arms (2)

Cases

patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway

Other: Intensive diabetes education and medication management

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

Interventions

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.

Cases

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Limitations and Caveats

By design this was a real-world study and not a randomized controlled trial. The researchers chose a pragmatic study design over an RCT to see if the intervention was effective in real world situations under usual patient care conditions.

Results Point of Contact

• Title: Dr Michelle F Magee, Director MedStar Diabetes Institute
• Organization: MedStar Health

michelle.f.magee@medstar.net

202-877-2383

Study Officials

• Michelle F Magee, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MedStar Diabetes Institute

Study Record Dates

• First Submitted: February 16, 2018
• First Posted: February 22, 2018
• Study Start: July 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: February 28, 2019
• Last Updated: October 20, 2020
• Results First Posted: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share