Hyperglycemia, Type 2 Diabetes Mellitus
Conditions
Keywords
Diabetes Care Management, Chronic Care Model, Resources Utilization, Hemoglobin A1C, Hospitalizations, Emergency Room Visits, Cost analysis, Return on Investment
Brief summary
A Diabetes Institute (MDI), in partnership with key stakeholders-including Primary Care Providers- in a northeastern US regional, mixed-payer healthcare system), seeks to implement an evidence-based, technology-enabled, innovative, and integrated diabetes care management pathway (Boot Camp) for adult patients with uncontrolled type 2 diabetes (A1C\>/=9%) which will demonstrate improvement in diabetes clinical and health resources utilization outcomes.
Detailed description
* The program is designed to integrate type 2 diabetes specialty services into Primary Care practices to support PCPs and their patients in improving a spectrum of diabetes-related outcomes. * High-risk patients from Primary Care practices who have uncontrolled type 2 diabetes and meet the target population inclusion and exclusion criteria will be invited to participate in an intensive and concise BOOT CAMP medication management and education intervention of \ 4-8 weeks duration. * The intervention will consist of three key components: (1) intensive, algorithm-based medication management (Appendix A), based on continuous review and management of blood sugars; (2) survival skills diabetes self-management education based on knowledge deficits identified on the KNOW Diabetes knowledge survey; (3) enhanced patient-provider communication, all provided by Endocrinologist supervised allied health professionals (in this instance CDEs). * Survival skills DSME will focus on nutrition and meal plan basics, blood glucose targets, taking medications as prescribed, hyper- and hypoglycemia recognition and treatment, and when to seek medical help. * The intervention is initiated with one to two face-to-face meetings with the CDE, at which the patient's readiness to change is assessed. * These are followed by virtual meetings though a variety of media based on patient preference and health literacy (largely telephone and text messaging). * Various technology tools are used to facilitate patient engagement, access and attainment of glycemic targets, including smart meters, virtual meeting platforms, web-based education content and surveys administration via tablets, etc. * Near real-time transmission of blood glucose data using a cellular-enabled blood glucose monitoring system sends all glucose results to a web-based dashboard accessed daily by the Boot Camp educators. * Concurrent matched charts of patients receiving standard care at the three MedStar locations will serve as a basis of comparison in assessing the impact of MDI on clinical and education outcomes and process of care. * Based on patient progress towards improved glycemic control, the patient will 'graduate' from the program and the CDE will refer the patient back to their PCP in 8-12 weeks with a full report of medication changes, blood glucose readings and further diabetes management recommendations eg referrals; further DSME, etc.
Interventions
OTHERDiabetes Pathway
Medication algorithm, survival skills education, enhanced patient-provider communication facilitated by near, real-time blood glucose monitoring
Sponsors
Medstar Health Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes for \>=1 year * Active practice patient * A1C \> 9.0% at their last visit to Medical Home, ED or hospital admission plus one more high risk factor (ED visit or hospitalization in past 12 mos) * Primary Care Provider willing to have patient enter the program * Patient is able and willing to participate in the program and exhibits readiness to change DM self-management * Proficient in English
Exclusion criteria
* Known history of DKA * No MedStar PCP visit within past 12 months * Endocrine or Diabetes Education consult referral order in the past 6 months which resulted in Endo visit(s) or DSME visit(s) documented in chart or self-reported by patient during initial screen * Active additional medical issues which in the opinion of the care team would preclude concentrating on BG control and/or would predispose to ED visits and/or hospital admits independent of glycemic control, e.g.: severe CHF, severe COPD; severe mental illness. * Resident of skilled nursing facility, nursing home or receiving home health care services. * Active cancer in the preceding 3 years excluding nonmalignant basal cell cancer * Supraphysiologic doses of glucocorticoids (hydrocortisone \> 30mg/day; prednisone \> 5-6mg daily; dexamethasone \> 2mg daily). * Pregnant or anticipates attempting conception in the following year * Patient and/or custodial caregiver unwilling and/or unable to participate in program-related activities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change in Hemoglobin A1C From Baseline to 3 Months | 3 months | Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of Experiencing a Composite Endpoint of All Cause ED Visits and Hospitalizations at 6 Months Post Intervention vs 6 Months Pre-intervention for Cases and Controls. | 6 months | Health care utilization measure. We compared the risk of experiencing an emergency room and/or hospital visit at 6 months from baseline for both groups. this was done by calculating he Incidence Risk Ratio of ED visits/hospitalizations for intervention and control patients to assess whether the pathway impacted the risk for ED visits/hospitalizations at 6 months from baseline and comparing them. We looked at these measures for the 6-month period that preceded the baseline visit and the 6-month period that followed the baseline visit. |
| Adherence to Prescribed Diabetes Medications | 90 days | Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects |
| Frequency of Eye Exams | 90 days | Change in the Proportion of Patients Receiving an Eye Exam in the 6 Months Following the Start of the Intervention as Compared to Baseline and to Concurrent Chart Controls |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Patients receive the full diabetes pathway intervention
Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication | 121 |
| Matched Controls patients receive standard of care | 294 |
| Total | 415 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 25 | 0 |
Baseline characteristics
| Characteristic | Intervention | Matched Controls | Total |
|---|---|---|---|
| Age, Customized age between 21 and 75 | 121 Participants | 294 Participants | 415 Participants |
| Sex: Female, Male Female | 67 Participants | 162 Participants | 229 Participants |
| Sex: Female, Male Male | 54 Participants | 132 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 121 | 0 / 294 |
| serious Total, serious adverse events | 0 / 121 | 0 / 294 |
Outcome results
Primary
Percentage Change in Hemoglobin A1C From Baseline to 3 Months
Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group
Time frame: 3 months
Population: Boot camp completers during the study period were compared to concurrent, propensity-matched chart controls.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Percentage Change in Hemoglobin A1C From Baseline to 3 Months | 3.08 percentage | Standard Deviation 2.01 |
| Matched Controls | Percentage Change in Hemoglobin A1C From Baseline to 3 Months | 1.64 percentage | Standard Deviation 1.97 |
Comparison: The study was powered to detect a difference of 0.5 in the change in HbA1c with SD=2 with 80% power at alpha=0.05 with a sample size of 128 in each group (paired t-test). Differences in patient characteristics and the unadjusted differences in the outcome measures between the intervention and control groups were tested using linear mixed models, McNemar tests and conditional logistic models due to matching.p-value: 0.05McNemar
Secondary
Adherence to Prescribed Diabetes Medications
Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects
Time frame: 90 days
Population: This outcome measure was eliminated during the course of the study and data was not collected
Secondary
Frequency of Eye Exams
Change in the Proportion of Patients Receiving an Eye Exam in the 6 Months Following the Start of the Intervention as Compared to Baseline and to Concurrent Chart Controls
Time frame: 90 days
Population: Technology to perform eye exams in primary care offices was not deployed as had been anticipated, therefore data was not collected for this outcome
Secondary
Risk of Experiencing a Composite Endpoint of All Cause ED Visits and Hospitalizations at 6 Months Post Intervention vs 6 Months Pre-intervention for Cases and Controls.
Health care utilization measure. We compared the risk of experiencing an emergency room and/or hospital visit at 6 months from baseline for both groups. this was done by calculating he Incidence Risk Ratio of ED visits/hospitalizations for intervention and control patients to assess whether the pathway impacted the risk for ED visits/hospitalizations at 6 months from baseline and comparing them. We looked at these measures for the 6-month period that preceded the baseline visit and the 6-month period that followed the baseline visit.
Time frame: 6 months
Population: Poisson Regression Models of all utilizations (ED + hospitalization) at 6-month visits by Study Groups: Incidence rate ratios (IRRs) reported. In the six months after enrollment, controls are expected to have 0.646 admissions on average, and cases are expected to have 56.8% of the number of admissions that the controls had, or a reduction of 43.2%
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Risk of Experiencing a Composite Endpoint of All Cause ED Visits and Hospitalizations at 6 Months Post Intervention vs 6 Months Pre-intervention for Cases and Controls. | 0.568 ratio of risk incidences |
| Matched Controls | Risk of Experiencing a Composite Endpoint of All Cause ED Visits and Hospitalizations at 6 Months Post Intervention vs 6 Months Pre-intervention for Cases and Controls. | 0.646 ratio of risk incidences |