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| ID | Type | Description | Link |
|---|---|---|---|
| IRB Application 2979 |
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This study will look at the impact of health insurance benefits on self management of diabetes for people with this condition. Studies have shown that when people with diabetes manage their disease better, they stay healthier. Our goal in this study is to help those with diabetes better manage their disease (self-care). We will compare two types of health insurance benefits in this study. We want to see if one set of benefits improves self-care more than the other one.
The objective of this particular study is to determine if the addition of regular pharmacist visits to usual care can improve clinical outcomes in patients with diabetes. The central hypothesis is that a program overseen by community pharmacists that empowers patients to self-manage their diabetes will lead to improved clinical and humanistic outcomes and will be cost-effective. Strong preliminary data collected from other sites suggests that patient empowerment programs are effective at reducing hemoglobin A1C after 12 months and in reducing the total cost of care. This hypothesis will be tested by pursuing three specific aims to evaluate the impact of a pharmacist-administered diabetes patient empowerment program on:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care plus out-of-pocket cost waiver | Active Comparator | Patients received educational materials (handouts) in the mail. This was assumed to be of minimal effectiveness. Patients also received waiver of out-of-pocket expenses for diabetes care. |
|
| EMPOWER | Experimental | Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacist Counseling | Behavioral | Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A-1C From Baseline | Compare changes in Hemoglobin A-1C from baseline between the two groups. | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | Changes from baseline in LDL, HDL, total cholesterol, triglycerides. Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group):
| baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dale F Kraemer, Ph.D. | Oregon State University, College of Pharmacy | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21987530 | Result | Kraemer DF, Kradjan WA, Bianco TM, Low JA. A randomized study to assess the impact of pharmacist counseling of employer-based health plan beneficiaries with diabetes: the EMPOWER study. J Pharm Pract. 2012 Apr;25(2):169-79. doi: 10.1177/0897190011418513. Epub 2011 Oct 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care Plus Out-of-pocket Cost Waiver | Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study. |
| FG001 | EMPOWER Group | Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care Plus Out-of-pocket Cost Waiver | Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Hemoglobin A-1C From Baseline | Compare changes in Hemoglobin A-1C from baseline between the two groups. | Specific employers were recruited and offered waiver of out-of-pocket costs for diabetes-related care to their employees to participate in the study. The number of participants reported reflects only those participants who had both baseline and 12-month lab tests. | Posted | Mean | Standard Deviation | percentage of glycolsylated hemoglobin | baseline and 12 months |
|
Follow-up of approximately one year post-randomization (about 400 days, on average)
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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 | Usual Care Plus Out-of-pocket Cost Waiver | Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dale Kraemer | University of Florida | Dale.Kraemer@jax.ufl.edu |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Educational materials | Behavioral | Patients received educational materials (handouts) in the mail. This was assumed to be of minimal effectiveness. Patients also received waiver of out-of-pocket expenses for diabetes care. |
|
| Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months |
Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are:
|
| baseline to 12 months |
| Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months | Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group):
| From baseline to 12 months |
| BG001 |
| EMPOWER Group |
Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Number | participants |
|
| Education categories | Number | participants |
|
| Income categories | Number | participants |
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| Hypertension | Number | participants |
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| Dyslipidemia | Number | participants |
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| Depression | Number | participants |
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| On glucose-lowering therapy | Number | participants |
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| On oral agents | Number | participants |
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| On insulin | Number | participants |
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| On other diabetes medications | Number | participants |
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| Used diabetic supplies | Number | participants |
|
| Years since diabetes diagnosis | Mean | Standard Deviation | years |
|
| OG001 | Pharmacists Consults Plus Out-of-pocket Cost Waiver | Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management. |
|
|
|
| Secondary | Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | Changes from baseline in LDL, HDL, total cholesterol, triglycerides. Sample sizes for each individual test (usual care plus out-of-pocket cost waiver; EMPOWER group):
| The number of participants reported reflects only those participants who had both baseline and 12-month lab tests. | Posted | Mean | 95% Confidence Interval | mg/dl | baseline and 12 months |
|
|
|
|
| Secondary | Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months | Changes in claims-based economic data on costs of total health care, diabetes medications, and diabetes supplies from baseline to 12 months. Only participants who had a claim in the 12 months prior to baseline were included in these analyses. The resulting sample sizes (usual care plus out-of-pocket cost waiver; EMPOWER group) for these outcomes are:
| Changes in claims-based data from baseline to 12 months among patients with at least one diabetes-related claim at baseline. | Posted | Mean | 95% Confidence Interval | US dollars | baseline to 12 months |
|
|
|
|
| Secondary | Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months | Psycho-social aspects of diabetes knowledge and empowerment. Sample sizes are in parentheses (usual care plus out-of-pocket cost waiver; EMPOWER group):
| The number of participants reported for each outcome reflects those participants who completed both baseline and 12-month surveys. | Posted | Mean | 95% Confidence Interval | units on a scale | From baseline to 12 months |
|
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | EMPOWER Group | Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management. | 0 | 36 | 0 | 36 |
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| Total cholesterol (n: 29; 36) |
|
| triglycerides (n: 29; 36) |
|
| 0.16 |
| No |
| Superiority or Other |
| Comparison of change in total cholesterol from baseline to 12 months between groups. | ANCOVA | 0.14 | No | Superiority or Other |
| Comparison of change in triglycerides from baseline to 12 months between groups. | ANCOVA | 0.92 | No | Superiority or Other |
| Diabetes supplies costs (n: 18; 10) |
|
| Wilcoxon (Mann-Whitney) |
| .6413 |
| No |
| Superiority or Other |
| Analyses not adjusted for other variables. | Wilcoxon (Mann-Whitney) | .4303 | No | Superiority or Other |
| Understanding of Diabetes (n: 29; 35) |
|
| ANCOVA |
| 0.302 |
| No |
| Superiority or Other |
| Comparison of change in Understanding of Diabetes from baseline to 12 months between groups. | ANCOVA | 0.0024 | No | Superiority or Other |