Type I or Type II Diabetes (Excludes Gestational Diabetes)
Conditions
Keywords
diabetes
Brief summary
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.
Detailed description
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: 1. clinical markers for diabetes and related metabolic disorders; 2. the cost of care and resource utilization; and 3. patient knowledge and perceived ability to manage diabetes. There is an additional specific aim to assess the pharmacists with respect to satisfaction with the training program and the overall project, the activities conducted in patient sessions, and the time taken to complete the visits in this study.
Interventions
BEHAVIORALPharmacist Counseling
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.
BEHAVIORALEducational materials
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.
Sponsors
Sanofi
Oregon State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diabetes (Type I or Type II) * enrolled in health plan with participating employer * age 18 or older * willing and able to provide informed consent
Exclusion criteria
* gestational diabetes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A-1C From Baseline | baseline and 12 months | Compare changes in Hemoglobin A-1C from baseline between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | baseline and 12 months | 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): 1. LDL 2. HDL 3. Total cholesterol 4. Triglycerides |
| Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months | 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: 1. Total cost of care 2. Costs of diabetes medications 3. Costs of diabetes supplies |
| Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months | 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): 1. Changes from baseline to 12 months for the Diabetes Empowerment Scale (DES). Mean score for 28 items each scored as a Likert scale from 1 to 5. Higher scores correspond to greater empowerment 2. Changes from baseline to 12 months for the Adherence Starts with Knowledge (ASK-20) adherence barrier test total barrier score (TBC). The TBC has a range from 0 to 18 and higher scores correspond to greater barriers. 3. Changes from baseline to 12 months for understanding of diabetes. This is a single question: How would you rate your understanding of diabetes and its treatment? which uses a 7-point scale Likert scale as the response from 1 (poor) to 7 (excellent). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 36 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Total | EMPOWER Group | Usual Care Plus Out-of-pocket Cost Waiver |
|---|---|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 8.1 | 55.6 years STANDARD_DEVIATION 6.8 | 52.6 years STANDARD_DEVIATION 9.2 |
| Depression No | 51 participants | 30 participants | 21 participants |
| Depression Yes | 16 participants | 6 participants | 10 participants |
| Dyslipidemia No | 26 participants | 11 participants | 15 participants |
| Dyslipidemia Yes | 41 participants | 25 participants | 16 participants |
| Education categories At least a masters degree | 3 participants | 3 participants | 0 participants |
| Education categories College graduate | 19 participants | 11 participants | 8 participants |
| Education categories High school graduate | 9 participants | 4 participants | 5 participants |
| Education categories Some college | 32 participants | 15 participants | 17 participants |
| Education categories Unspecified | 4 participants | 3 participants | 1 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 34 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hypertension No | 25 participants | 10 participants | 15 participants |
| Hypertension Yes | 42 participants | 26 participants | 16 participants |
| Income categories $100 000 or more | 12 participants | 10 participants | 2 participants |
| Income categories $15 000 to <$30 000 | 6 participants | 3 participants | 3 participants |
| Income categories $30 000 to <$50 000 | 23 participants | 12 participants | 11 participants |
| Income categories $50 000 to <$100 000 | 21 participants | 10 participants | 11 participants |
| Income categories Unspecified | 5 participants | 1 participants | 4 participants |
| On glucose-lowering therapy No | 15 participants | 8 participants | 7 participants |
| On glucose-lowering therapy Yes | 52 participants | 28 participants | 24 participants |
| On insulin No | 52 participants | 31 participants | 21 participants |
| On insulin Yes | 15 participants | 5 participants | 10 participants |
| On oral agents No | 23 participants | 12 participants | 11 participants |
| On oral agents Yes | 44 participants | 24 participants | 20 participants |
| On other diabetes medications No | 62 participants | 33 participants | 29 participants |
| On other diabetes medications Yes | 5 participants | 3 participants | 2 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 participants | 1 participants | 1 participants |
| Race (NIH/OMB) Asian | 2 participants | 0 participants | 2 participants |
| Race (NIH/OMB) Black or African American | 1 participants | 1 participants | 0 participants |
| Race (NIH/OMB) More than one race | 2 participants | 0 participants | 2 participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 participants | 1 participants | 0 participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) White | 62 participants | 32 participants | 30 participants |
| Sex: Female, Male Female | 33 Participants | 14 Participants | 19 Participants |
| Sex: Female, Male Male | 34 Participants | 22 Participants | 12 Participants |
| Used diabetic supplies No | 39 participants | 26 participants | 13 participants |
| Used diabetic supplies Yes | 28 participants | 10 participants | 18 participants |
| Years since diabetes diagnosis | 9.0 years STANDARD_DEVIATION 9.1 | 9.9 years STANDARD_DEVIATION 10.3 | 8.0 years STANDARD_DEVIATION 7.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 36 |
| serious Total, serious adverse events | 0 / 31 | 0 / 36 |
Outcome results
Primary
Change in Hemoglobin A-1C From Baseline
Compare changes in Hemoglobin A-1C from baseline between the two groups.
Time frame: baseline and 12 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care Plus Out-of-pocket Cost Waiver | Change in Hemoglobin A-1C From Baseline | -0.16 percentage of glycolsylated hemoglobin | Standard Deviation 0.42 |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Change in Hemoglobin A-1C From Baseline | -0.50 percentage of glycolsylated hemoglobin | Standard Deviation 0.5 |
Comparison: Null hypothesis is mean change in usual care group equals mean change in Empower group.~Power calculation required 150 per group assuming 25% would withdraw prior to 12 months.p-value: 0.0757ANCOVA
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): 1. Changes from baseline to 12 months for the Diabetes Empowerment Scale (DES). Mean score for 28 items each scored as a Likert scale from 1 to 5. Higher scores correspond to greater empowerment 2. Changes from baseline to 12 months for the Adherence Starts with Knowledge (ASK-20) adherence barrier test total barrier score (TBC). The TBC has a range from 0 to 18 and higher scores correspond to greater barriers. 3. Changes from baseline to 12 months for understanding of diabetes. This is a single question: How would you rate your understanding of diabetes and its treatment? which uses a 7-point scale Likert scale as the response from 1 (poor) to 7 (excellent).
Time frame: From baseline to 12 months
Population: The number of participants reported for each outcome reflects those participants who completed both baseline and 12-month surveys.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care Plus Out-of-pocket Cost Waiver | Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months | Overall Diabetes Empowerment Scale (n: 27; 34) | 0.29 units on a scale |
| Usual Care Plus Out-of-pocket Cost Waiver | Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months | Adherence Starts with Knowledge (ASK-20)(n:28; 31) | 0.25 units on a scale |
| Usual Care Plus Out-of-pocket Cost Waiver | Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months | Understanding of Diabetes (n: 29; 35) | -0.14 units on a scale |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months | Overall Diabetes Empowerment Scale (n: 27; 34) | 0.17 units on a scale |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months | Adherence Starts with Knowledge (ASK-20)(n:28; 31) | -0.65 units on a scale |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Change in Diabetes Knowledge and Empowerment (Patient Self-efficacy) From Baseline to 12 Months | Understanding of Diabetes (n: 29; 35) | 0.54 units on a scale |
Comparison: Comparison of change in Diabetes Empowerment Scale from baseline to 12 months between groups.p-value: 0.785ANCOVA
Comparison: Comparison of change in Adherence Starts with Knowledge (ASK-20) from baseline to 12 months between groups.p-value: 0.302ANCOVA
Comparison: Comparison of change in Understanding of Diabetes from baseline to 12 months between groups.p-value: 0.0024ANCOVA
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): 1. LDL 2. HDL 3. Total cholesterol 4. Triglycerides
Time frame: baseline and 12 months
Population: The number of participants reported reflects only those participants who had both baseline and 12-month lab tests.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care Plus Out-of-pocket Cost Waiver | Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | LDL (n: 27; 35) | 0.1 mg/dl |
| Usual Care Plus Out-of-pocket Cost Waiver | Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | HDL (n: 29; 36) | -3.6 mg/dl |
| Usual Care Plus Out-of-pocket Cost Waiver | Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | Total cholesterol (n: 29; 36) | -5.1 mg/dl |
| Usual Care Plus Out-of-pocket Cost Waiver | Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | triglycerides (n: 29; 36) | -5.8 mg/dl |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | triglycerides (n: 29; 36) | -8.9 mg/dl |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | LDL (n: 27; 35) | -3.9 mg/dl |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | Total cholesterol (n: 29; 36) | -11.6 mg/dl |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Changes From Baseline in LDL, HDL, Total Cholesterol, Triglycerides | HDL (n: 29; 36) | -6.3 mg/dl |
Comparison: Comparison of change in LDL from baseline to 12 months between groups.p-value: 0.44ANCOVA
Comparison: Comparison of change in HDL from baseline to 12 months between groups.p-value: 0.16ANCOVA
Comparison: Comparison of change in total cholesterol from baseline to 12 months between groups.p-value: 0.14ANCOVA
Comparison: Comparison of change in triglycerides from baseline to 12 months between groups.p-value: 0.92ANCOVA
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: 1. Total cost of care 2. Costs of diabetes medications 3. Costs of diabetes supplies
Time frame: baseline to 12 months
Population: Changes in claims-based data from baseline to 12 months among patients with at least one diabetes-related claim at baseline.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care Plus Out-of-pocket Cost Waiver | Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months | Total health care costs (n: 31; 36) | -89 US dollars |
| Usual Care Plus Out-of-pocket Cost Waiver | Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months | Diabetes medication costs (n: 24; 28) | 516 US dollars |
| Usual Care Plus Out-of-pocket Cost Waiver | Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months | Diabetes supplies costs (n: 18; 10) | 237 US dollars |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months | Total health care costs (n: 31; 36) | 1612 US dollars |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months | Diabetes medication costs (n: 24; 28) | 450 US dollars |
| Pharmacists Consults Plus Out-of-pocket Cost Waiver | Changes in Economic Outcomes (Total Cost of Care, Cost of Diabetes Medications, Cost of Diabetes Supplies) From Baseline to 12 Months | Diabetes supplies costs (n: 18; 10) | 191 US dollars |
Comparison: Comparison of change in cost of total health care from baseline to 12 months between groups. Analyses not adjusted for other variables.p-value: 0.3856Wilcoxon (Mann-Whitney)
Comparison: Comparison of change in cost of diabetes medications from baseline to 12 months between groups. Analyses not adjusted for other variables.p-value: 0.6413Wilcoxon (Mann-Whitney)
Comparison: Analyses not adjusted for other variables.p-value: 0.4303Wilcoxon (Mann-Whitney)