An interventional study of Algorithm driven medication titration and Monitoring in Diabetes Mellitus and Cardiovascular Diseases, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-11.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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
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.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 250 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Diabetic veterans with HbA1c >7.0% and at least one of the following:
Exclusion Criteria:
Algorithm driven medication titration, Behavioral: Monitoring, Behavioral: Group support, Behavioral: Self efficacy
Other: Algorithm driven medication titration · Behavioral: Monitoring · Behavioral: Group support · Behavioral: Self efficacy
Patient continues on usual care for diabetes
Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes
Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals
Peer support are provided in the group setting
Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision
Hemoglobin A1c
Hemoglobin A1c levels at 6 months
Time frame: 6 months
Hemoglobin A1c
hemoglobin A1c levels at 13 months
Time frame: 13 months
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
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
| Milestone | Pharmacist-led Group Medical Visits | Usual Care |
|---|---|---|
| Started | 117 | 133 |
| Completed | 97 | 117 |
| Not completed | 20 | 16 |
Hemoglobin A1c levels at 6 months
| percent Hemoglobin A1c | Pharmacist-led Group Medical Visits | Usual Care |
|---|---|---|
| Hemoglobin A1c | 7.8 ± 1.2 | 8.1 ± 1.4 |
hemoglobin A1c levels at 13 months
| percent Hemoglobin A1c | Pharmacist-led Group Medical Visits | Usual Care |
|---|---|---|
| Hemoglobin A1c | 7.9 ± 1.3 | 8.0 ± 1.4 |
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.
| Scores of SF-36v | Pharmacist-led Group Visits | Usual Care |
|---|---|---|
| Baseline Physical Composite Summary Score | 39.2 ± 9.7 | 39.3 ± 9.8 |
| 13 Months Physical Composite Scores | 39.6 ± 10.5 | 39.1 ± 9.7 |
| Baseline Mental Composite Summary Score | 48.8 ± 11.0 | 50.4 ± 11.7 |
| 13 Months Mental Composite Summary Score | 50.1 ± 10.5 | 51.0 ± 11.0 |
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.
| United States Dollar | Pharmacist-led Group Medical Visits | Usual Care |
|---|---|---|
| baseline or time "0" | 22062 ± 67524 | 15200 ± 23812 |
| Study period - 13 months prior to baseline | 4656 ± 31881 | 2645 ± 25580 |
| 13 months after study - study period | -1575 ± 30774 | 2360 ± 23708 |
| 13 months after study - 13 months before baseline | 4220 ± 31091 | 5752 ± 29690 |
Collected over 13 months of the study period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pharmacist-led Group Medical Visits | — | 38/117 (32.5%) | 5/117 (4.3%) |
| Usual Care | — | 44/133 (33.1%) | 7/133 (5.3%) |
| Event | Pharmacist-led Group Medical Visits | Usual Care |
|---|---|---|
| hospitalizationGeneral disorders | 26/117 | 21/133 |
| ER visitsGeneral disorders | 24/117 | 24/133 |
| DeathGeneral disorders | 2/117 | 4/133 |
| Event | Pharmacist-led Group Medical Visits | Usual Care |
|---|---|---|
| HyperglycemiaEndocrine disorders | 3/117 | 6/133 |
| Hypoglycemia,Endocrine disorders | 2/117 | 1/133 |
| Age, Continuous(years) | Pharmacist-led Group Medical Visits | Usual Care | Total |
|---|---|---|---|
| Mean | 65.8 ± 8.7 | 65.0 ± 9.8 | 65.4 ± 9.3 |
| Sex: Female, Male(Participants) | Pharmacist-led Group Medical Visits | Usual Care | Total |
|---|---|---|---|
| Female | 112 | 128 | 240 |
| Male | 5 | 5 | 10 |
| Race/Ethnicity, Customized(participants) | Pharmacist-led Group Medical Visits | Usual Care | Total |
|---|---|---|---|
| Caucasian | 88 | 104 | 192 |
| African American | 12 | 15 | 27 |
| Asian Pacific Islander | 15 | 8 | 23 |
| Hispanic | 0 | 4 | 4 |
| Unknown | 2 | 2 | 4 |
| Hemoglobin A1c(percent Hemoglobin A1c) | Pharmacist-led Group Medical Visits | Usual Care | Total |
|---|---|---|---|
| Mean | 8.2 ± 1.5 | 8.2 ± 1.3 | 8.2 ± 1.4 |
| Systolic Blood Pressure(mmHg) | Pharmacist-led Group Medical Visits | Usual Care | Total |
|---|---|---|---|
| Mean | 136.5 ± 19.0 | 136.2 ± 17.4 | 136.3 ± 18.1 |
| LDL cholesterol(mg/dL) | Pharmacist-led Group Medical Visits | Usual Care | Total |
|---|---|---|---|
| Mean | 87.6 ± 29.8 | 93.7 ± 33.7 | 91.0 ± 32.1 |
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