Type2 Diabetes Mellitus
Conditions
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.
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.
Interventions
OTHERIntensive diabetes education and medication management
Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.
Sponsors
Medstar Health Research Institute
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in A1C | 12-16 weeks | Change in Hemoglobin A1C from baseline to 12-16 weeks for both cases and controls |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk for Hospitalizations at 30 Days From Baseline | 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. |
| Risk for Composite of Emergency Room Visits and Hospitalizations at 30 Days From Baseline | 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. |
| Risk for Emergency Room Visits at 30 Days From Baseline as Measured by Incidence Risk Ratio | 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. |
| Risk for Hospitalizations at 90 Days From Baseline | 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. |
| Composite of Risk for Hospitalizations and Emergency Room Visits Within 90 Days From Baseline | 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. |
| Risk for Emergency Room Visits at 90 Days From Baseline | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 366 |
| 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 | 366 |
| Total | 732 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 94 | 0 |
Baseline characteristics
| Characteristic | Cases | Total | Concurrent Matched Controls |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 73 Participants | 146 Participants | 73 Participants |
| Age, Categorical Between 18 and 65 years | 293 Participants | 586 Participants | 293 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 7 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 362 Participants | 725 Participants | 363 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hemoglobin A1C >/=9% | 11.2 % STANDARD_DEVIATION 1.7 | 11.23 % STANDARD_DEVIATION 1.6 | 11.3 % STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 296 Participants | 580 Participants | 284 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 27 Participants | 18 Participants |
| Race (NIH/OMB) White | 48 Participants | 101 Participants | 53 Participants |
| Region of Enrollment United States | 366 participants | 732 participants | 366 participants |
| Sex: Female, Male Female | 225 Participants | 458 Participants | 233 Participants |
| Sex: Female, Male Male | 141 Participants | 274 Participants | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 460 |
| other Total, other adverse events | 3 / 460 |
| serious Total, serious adverse events | 5 / 460 |
Outcome results
Primary
Percent Change in A1C
Change in Hemoglobin A1C from baseline to 12-16 weeks for both cases and controls
Time frame: 12-16 weeks
Population: Hemoglobin A1C was measured at baseline and at 3 months in both groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cases | Percent Change in A1C | -3.06 % change | Standard Deviation 1.98 |
| Matched Controls | Percent Change in A1C | -1.44 % change | Standard Deviation 2.11 |
Comparison: The study was powered to detect a difference of 0.5% in the change in A1C with SD = 2 with 80\& at alopha = 0.;05 with a sample size of 128 in each group (paired t-test). The study reaches 100% power to detect this observed difference with an alpha level of 0.01.p-value: <0.001t-test, 2 sided
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.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cases | Composite of Risk for Hospitalizations and Emergency Room Visits Within 90 Days From Baseline | 0.49 ratio of risk incidences |
| Matched Controls | Composite of Risk for Hospitalizations and Emergency Room Visits Within 90 Days From Baseline | 0.80 ratio of risk incidences |
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.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cases | Risk for Composite of Emergency Room Visits and Hospitalizations at 30 Days From Baseline | 0.55 ratio of risk incidences |
| Matched Controls | Risk for Composite of Emergency Room Visits and Hospitalizations at 30 Days From Baseline | 0.53 ratio of risk incidences |
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.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cases | Risk for Emergency Room Visits at 30 Days From Baseline as Measured by Incidence Risk Ratio | 0.79 ratio of risk incidences |
| Matched Controls | Risk for Emergency Room Visits at 30 Days From Baseline as Measured by Incidence Risk Ratio | 0.39 ratio of risk incidences |
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
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cases | Risk for Emergency Room Visits at 90 Days From Baseline | 0.62 ratio of risk incidences |
| Matched Controls | Risk for Emergency Room Visits at 90 Days From Baseline | 0.66 ratio of risk incidences |
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.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cases | Risk for Hospitalizations at 30 Days From Baseline | 0.21 ratio of risk incidences |
| Matched Controls | Risk for Hospitalizations at 30 Days From Baseline | 1.14 ratio of risk incidences |
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.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cases | Risk for Hospitalizations at 90 Days From Baseline | 0.23 ratio of risk incidences |
| Matched Controls | Risk for Hospitalizations at 90 Days From Baseline | 1.58 ratio of risk incidences |