Cardiovascular Diseases, Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Clinical pharmacists, guideline adherence, group medical visits, behavioral modification, pharmacotherapy
Brief summary
This is a multi-site open label randomized controlled study of patients with type 2 diabetes undergoing pharmacist-led group medical visits that include education by a multi-disciplinary personnel, behavioral modification and pharmacotherapy case management vs. usual care
Detailed description
Project Background: Diabetes, hypertension, and dyslipidemia are chronic diseases that can lead to heart attack and stroke, and require interventions at patient and organizational levels to promote sustainable lifestyle and medication changes for cardiac risk reduction that are costly. Group intervention has emerged as a potentially cost-saving patient-centered approach to help achieve the necessary lifestyle and medication changes for the treatment of some chronic diseases, but its efficacy in absence of direct physician participation is not well demonstrated in diabetes. Our preliminary data have shown that our pharmacist-based, group diabetes management program at the Providence VAMC has achieved significant improvements in glycemic control and variable success toward improvement in blood pressure and lipid control in type 2 diabetic patients, through education, behavioral intervention and aggressive pharmacotherapy in 4 weekly group sessions. However, we do not know the long-term sustainability of this intervention, the exportability, the costs to the VA and the health-related quality-of-life implications of patients enrolled in our programs. Project Objectives: To assess whether a non-physician-based, group diabetes behavioral and pharmacotherapy intervention program for 12 months will: 1. improve cardiac risk factors, 2. improve health-related quality-of-life, 3. add only minimal institutional cost; when compared to usual care in veterans with type 2 diabetes. Project Methods: We propose a 3-site randomized-controlled study to test the efficacy of a pharmacist-based, group diabetes behavioral and pharmacotherapy intervention program (treatment arm) for 13 months vs. usual care (control arm) in achieving cardiac risk reduction in type 2 diabetic patients with Hemoglobin A1c \>7% and at least one other cardiac risk factor such as smoking, hyperlipidemia or hypertension not at national guideline recommended goals. The interventions in the treatment arm will consist of two phases. Phase 1 (intensive intervention) consists of weekly group sessions of education by a nurse, a physical therapist, and a dietician; and behavioral modification and medication titration by a clinical pharmacist targeting the control of glycemia, smoking, blood pressure, and lipids for 4 weeks. Phase 2 consists of quarterly booster sessions for 1 year to prevent relapse. Patients in the control arm will continue on usual care. Our study endpoints will be the difference between the 2 groups after 13 months of study enrollment in: 1) hemoglobin a1c, blood pressure, LDL cholesterol and smoking 2) health-related quality of life (SF-36V) scores, and 3) healthcare costs from the VA perspective. A total of 250 patients will be enrolled from 3 VAMC sites and followed for 13 months.
Interventions
OTHERAlgorithm driven medication titration
Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
BEHAVIORALMonitoring
Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
BEHAVIORALGroup support
Peer support are provided in the group setting
BEHAVIORALSelf efficacy
Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diabetic veterans with HbA1c \>7.0% and at least one of the following: * being a smoker (any cigarette smoking \< 30 days) * having an LDL \>100 mg/dl or a blood pressure \>130/80 mm Hg documented in at least two occasions within the last 6 months * able to participate and discuss their DM and cardiac risk control in a group setting and sign informed consent
Exclusion criteria
* patients without eligible cardiac risk factors within the last 6 months * those who are unable to attend the group sessions * or disease conditions such as psychiatric instability (acutely suicidal, psychotic) or organic brain injury that preclude them from performing DM self-care * patients with conditions that would preclude them from standard algorithm-based medication dose titrations such as those who are pregnant or with complex co-morbidities as defined by New York Heart Association Class 3 or 4 heart failure, liver cirrhosis, end-stage renal disease on dialysis and end-stage cancer will be excluded from the study * all women of childbearing age will have a pregnancy test before study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1c | 6 months | Hemoglobin A1c levels at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment | Baseline and 13 months | Medical Outcomes Study 36-Item Short Form Survey (SF-36) is a popular, multi-purpose health status survey that addresses quality of life from physical and mental health perspectives. SF-36v is the survey adapted for veterans. Items are summed and averaged in two subscores, the Physical Composite Summary Score and the Mental Composite Summary Score, and scaled to a range of 0 to 100, with lower scores denoting poorer health. |
| Health-care Costs to the VHA | 13 months (during study) and 13 months (after the study) = 26 months | The reported values represent the Total VHA expenditure per person. Institutional costs from health service utilization on the study patients during and 13 months after the intervention. Baseline is considered time 0. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pharmacist-led Group Medical Visits Pharmacist-led group medical visits which consists of medication titration and behavioral modification
Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
Group support: Peer support are provided in the group setting
Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision | 117 |
| Usual Care Patients continued on usual care without pharmacist-led group medical visits | 133 |
| Total | 250 |
Baseline characteristics
| Characteristic | Usual Care | Total | Pharmacist-led Group Medical Visits |
|---|---|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 9.8 | 65.4 years STANDARD_DEVIATION 9.3 | 65.8 years STANDARD_DEVIATION 8.7 |
| Hemoglobin A1c | 8.2 percent Hemoglobin A1c STANDARD_DEVIATION 1.3 | 8.2 percent Hemoglobin A1c STANDARD_DEVIATION 1.4 | 8.2 percent Hemoglobin A1c STANDARD_DEVIATION 1.5 |
| LDL cholesterol | 93.7 mg/dL STANDARD_DEVIATION 33.7 | 91.0 mg/dL STANDARD_DEVIATION 32.1 | 87.6 mg/dL STANDARD_DEVIATION 29.8 |
| Race/Ethnicity, Customized African American | 15 participants | 27 participants | 12 participants |
| Race/Ethnicity, Customized Asian Pacific Islander | 8 participants | 23 participants | 15 participants |
| Race/Ethnicity, Customized Caucasian | 104 participants | 192 participants | 88 participants |
| Race/Ethnicity, Customized Hispanic | 4 participants | 4 participants | 0 participants |
| Race/Ethnicity, Customized Unknown | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 128 Participants | 240 Participants | 112 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 5 Participants |
| Systolic Blood Pressure | 136.2 mmHg STANDARD_DEVIATION 17.4 | 136.3 mmHg STANDARD_DEVIATION 18.1 | 136.5 mmHg STANDARD_DEVIATION 19 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 117 | 7 / 133 |
| serious Total, serious adverse events | 38 / 117 | 44 / 133 |
Outcome results
Primary
Hemoglobin A1c
Hemoglobin A1c levels at 6 months
Time frame: 6 months
Population: At the 6 month visit, some patients dropped out of the study or died.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist-led Group Medical Visits | Hemoglobin A1c | 7.8 percent Hemoglobin A1c | Standard Deviation 1.2 |
| Usual Care | Hemoglobin A1c | 8.1 percent Hemoglobin A1c | Standard Deviation 1.4 |
Primary
Hemoglobin A1c
hemoglobin A1c levels at 13 months
Time frame: 13 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pharmacist-led Group Medical Visits | Hemoglobin A1c | 7.9 percent Hemoglobin A1c | Standard Deviation 1.3 |
| Usual Care | Hemoglobin A1c | 8.0 percent Hemoglobin A1c | Standard Deviation 1.4 |
Secondary
Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment
Medical Outcomes Study 36-Item Short Form Survey (SF-36) is a popular, multi-purpose health status survey that addresses quality of life from physical and mental health perspectives. SF-36v is the survey adapted for veterans. Items are summed and averaged in two subscores, the Physical Composite Summary Score and the Mental Composite Summary Score, and scaled to a range of 0 to 100, with lower scores denoting poorer health.
Time frame: Baseline and 13 months
Population: 117 patients randomized to Pharmacist-led Group Medical Visits, 2 patients died before study end date and 18 patients dropped out.133 patients randomized to Usual care, 4 patients died before study end date and 12 patients dropped out.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pharmacist-led Group Medical Visits | Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment | Baseline Physical Composite Summary Score | 39.2 Scores of SF-36v | Standard Deviation 9.7 |
| Pharmacist-led Group Medical Visits | Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment | 13 Months Physical Composite Scores | 39.6 Scores of SF-36v | Standard Deviation 10.5 |
| Pharmacist-led Group Medical Visits | Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment | Baseline Mental Composite Summary Score | 48.8 Scores of SF-36v | Standard Deviation 11 |
| Pharmacist-led Group Medical Visits | Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment | 13 Months Mental Composite Summary Score | 50.1 Scores of SF-36v | Standard Deviation 10.5 |
| Usual Care | Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment | 13 Months Mental Composite Summary Score | 51.0 Scores of SF-36v | Standard Deviation 11 |
| Usual Care | Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment | Baseline Physical Composite Summary Score | 39.3 Scores of SF-36v | Standard Deviation 9.8 |
| Usual Care | Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment | Baseline Mental Composite Summary Score | 50.4 Scores of SF-36v | Standard Deviation 11.7 |
| Usual Care | Change From the Baseline in the Hr-QOL as Assessed by SF-36V at 13 Months of Study Enrollment | 13 Months Physical Composite Scores | 39.1 Scores of SF-36v | Standard Deviation 9.7 |
Secondary
Health-care Costs to the VHA
The reported values represent the Total VHA expenditure per person. Institutional costs from health service utilization on the study patients during and 13 months after the intervention. Baseline is considered time 0.
Time frame: 13 months (during study) and 13 months (after the study) = 26 months
Population: 117 patients randomized to Pharmacist-led Group Medical Visits. 133 patients were randomized to Usual care.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pharmacist-led Group Medical Visits | Health-care Costs to the VHA | baseline or time 0 | 22062 United States Dollar | Standard Deviation 67524 |
| Pharmacist-led Group Medical Visits | Health-care Costs to the VHA | Study period - 13 months prior to baseline | 4656 United States Dollar | Standard Deviation 31881 |
| Pharmacist-led Group Medical Visits | Health-care Costs to the VHA | 13 months after study - study period | -1575 United States Dollar | Standard Deviation 30774 |
| Pharmacist-led Group Medical Visits | Health-care Costs to the VHA | 13 months after study - 13 months before baseline | 4220 United States Dollar | Standard Deviation 31091 |
| Usual Care | Health-care Costs to the VHA | 13 months after study - 13 months before baseline | 5752 United States Dollar | Standard Deviation 29690 |
| Usual Care | Health-care Costs to the VHA | baseline or time 0 | 15200 United States Dollar | Standard Deviation 23812 |
| Usual Care | Health-care Costs to the VHA | 13 months after study - study period | 2360 United States Dollar | Standard Deviation 23708 |
| Usual Care | Health-care Costs to the VHA | Study period - 13 months prior to baseline | 2645 United States Dollar | Standard Deviation 25580 |