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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway |
| |
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with uncontrolled type 2 diabetes that meet inclusion and exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Michelle F Magee, MD | Medstar Health Research Institute | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cases | patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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A total of 460 patients started the diabetes boot camp (cases) during the study period, but only 366 completed it and were included in the results analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cases | Adult patients with uncontrolled type 2 diabetes mellitus and A1C>/= 9% that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change in A1C | Change in Hemoglobin A1C from baseline to 12-16 weeks for both cases and controls | Hemoglobin A1C was measured at baseline and at 3 months in both groups. | Posted | Mean | Standard Deviation | % change | 12-16 weeks |
|
Adverse events were collected during the 90 days that patients were enrolled in the diabetes boot camp
The definition of adverse events used was the same as from clinicaltrials.gov. Deaths and adverse events were not monitored/assessed for the matched controls as these patients were receiving diabetes standard of care and the matching was performed once the cases had completed the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cases | patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| worsening pre-existing heart failure | Cardiac disorders | Non-systematic Assessment | Patient with preexisting class III/IV heart failure required hospitalization and LVAD placement. Was withdrawn from the boot cam due to extended hospital stay |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic neuropathy | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | New diagnosis of diabetic neuropathy in patients with long standing type 2 DM |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michelle F Magee, Director MedStar Diabetes Institute | MedStar Health | 202-877-2383 | michelle.f.magee@medstar.net |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 1, 2016 | Mar 25, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2016 | Aug 19, 2020 | SAP_001.pdf |
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| 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 |
| Concurrent Matched Controls |
Adult patients with uncontrolled type 2 diabetes and A1C>/=9% that propensity match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis | Count of Participants | Participants |
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| Race (NIH/OMB) | 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis | Count of Participants | Participants |
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| Region of Enrollment | 460 were enrolled but only the 366 patients that completed the boot camp were included in the final analysis of results. | Number | participants |
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| Hemoglobin A1C >/=9% | A total of 460 patients started the diabetes boot camp (cases) during the study period, but only 366 completed it and were included in the results analysis. | Mean | Standard Deviation | % |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | ratio of risk incidences | 30 days |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | ratio of risk incidences | 30 days |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | ratio of risk incidences | 30 days |
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| Secondary | 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 | Posted | Number | 95% Confidence Interval | ratio of risk incidences | 90 days |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | ratio of risk incidences | 90 days |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | ratio of risk incidences | 90 days |
|
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| 0 |
| 460 |
| 5 |
| 460 |
| 3 |
| 460 |
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| Chest pain requiring hospitalization | Cardiac disorders | Non-systematic Assessment | Patient with know history of CHF and CADA. |
|
| New diagnosis of breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | AE classified as unrelated to Boot Camp as patient had not been started on any new medications. Patient self-withdrew from the Boot Camp after receiving diagnosis and was lost to follow up. |
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| Deep vein Thrombosis requiring intervention | Vascular disorders | Non-systematic Assessment | Patient had a history of vascular problems |
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