A Phase 3 interventional study of Diabetes Group Management Visits in Diabetes and Hypertension, sponsored by US Department of Veterans Affairs. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2019-01-09.
Sponsored by US Department of Veterans Affairs · Phase 3, Interventional, and Treatment
Background: Diabetes is a common, morbid and expensive disease among veterans. Achieving adequate glycemic control and blood pressure control can reduce the devastating complications of diabetes. Because the majority of patients do not achieve adequate control of blood sugar and blood pressure, innovative strategies to improve control are needed. One strategy with great potential for veterans receiving VA care is the group clinic. Group clinics have been developed over the last 5-10 years, and have been shown to improve clinical outcomes and reduce outpatient utilization in geriatric settings. Group medical clinics involve a cohort of 8-20 patients who have 1-2 hour group visits. These clinics are distinguished from traditional group education visits for diabetes by the fact that these visits involve one physician and one or more additional health care professionals, usually a nurse practitioner and/or a pharmacist, and are designed to make management changes for a number of people with the same disease in a short period of time. The effect of group medical clinics on blood sugar, blood pressure, and the cost of diabetes care, is unknown. Objectives: Our primary objectives in this project are to determine the effectiveness and cost-effectiveness of a group visit intervention in improving rates of control of diabetes and high blood pressure in patients with both illnesses.
Background:
Diabetes is a common, morbid and expensive disease among veterans. Achieving adequate glycemic control and blood pressure control can reduce the devastating complications of diabetes. Because the majority of patients do not achieve adequate control of blood sugar and blood pressure, innovative strategies to improve control are needed. One strategy with great potential for veterans receiving VA care is the group clinic. Group clinics have been developed over the last 5-10 years, and have been shown to improve clinical outcomes and reduce outpatient utilization in geriatric settings. Group medical clinics involve a cohort of 8-20 patients who have 1-2 hour group visits. These clinics are distinguished from traditional group education visits for diabetes by the fact that these visits involve one physician and one or more additional health care professionals, usually a nurse practitioner and/or a pharmacist, and are designed to make management changes for a number of people with the same disease in a short period of time. The effect of group medical clinics on blood sugar, blood pressure, and the cost of diabetes care, is unknown.
Objectives:
Our primary objectives in this project were to determine the effectiveness and cost-effectiveness of a group visit intervention in improving rates of control of diabetes and high blood pressure in patients with both illnesses.
Methods:
We performed a two-site, randomized, controlled trial of group medical visits for diabetes management. Patients were patients in primary care at the Durham or Richmond VAMC's who had inadequate control of both their blood sugar and their blood pressure. We excluded patients with life-limiting illness. Patients randomized to the control arm received usual primary care. Patients randomized to the intervention arm were assigned to attend a group medical clinic every two months for one year. In the clinic, a primary care physician, with the assistance of a nurse and a pharmacist, measured blood pressure at the point of care, reviewed blood sugar logs, and then made all necessary medical changes for patients with diabetes. The primary outcomes were hemoglobin A1c and systolic blood pressure. Additional outcomes will be serum LDL-cholesterol, diabetes-specific quality of life, and health services utilization. Formative evaluation was undertaken to determine the mechanism of the intervention and to prepare for more successful dissemination if the intervention is effective. Formal cost analysis will be performed and cost-effectiveness analysis will be undertaken. All outcomes were measured at baseline, and 6 and 12 months after the beginning of the intervention.
Status:
All patient contact complete. Project is in analysis phase.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 239 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
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Exclusion Criteria:
-Primary care provider excludes patient from study, -Patient states that primary care is shared with non-VA primary care provider, -New enrollment in endocrine clinic within the last 6 months, -Patient is reluctant to participate in group visit for any reason, -Reduced life expectancy, as determined by any of the following: -New York Heart Association Class IV congestive heart failure, -Lung disease requiring supplemental oxygen, -End-stage renal disease on dialysis, -Current malignancy with any evidence of disease or currently undergoing chemotherapy or radiation therapy, -Cirrhosis of the liver, or -AIDS (HIV disease does not exclude a patient in the absence of an AIDS diagnosis), -Five or more errors on Short Portable Mental Status Questionnaire, Psychotic illness with hospitalization within three years prior to enrollment
Medical group visits
Other: Diabetes Group Management Visits
control
Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
Hemoglobin A1c
Time frame: 12 months
Systolic Blood Pressure
Time frame: 12 months
Cost-effectiveness, Proportion of Patients With LDL < 100, Health Services Utilization, Quality of Life (as Measured by DQoL), Patient Empowerment (as Measured by DES).
Time frame: one year
| Milestone | Medical Group Visits | Control |
|---|---|---|
| Started | 133 | 106 |
| Completed | 122 | 89 |
| Not completed | 11 | 17 |
| percentage points | Medical Group Visits | Control |
|---|---|---|
| Hemoglobin A1c | 8.4 ± 1.3 | 8.7 ± 1.5 |
| mmHg | Medical Group Visits | Treatment as Usual Control |
|---|---|---|
| Systolic Blood Pressure | 140 ± 14.8 | 147 ± 13.4 |
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Medical Group Visits | — | 59/133 (44.4%) | 122/133 (91.7%) |
| Control | — | 37/106 (34.9%) | 85/106 (80.2%) |
| Event | Medical Group Visits | Control |
|---|---|---|
| All-Cause hospitalizationGeneral disorders | 56/133 | 36/106 |
| DeathGeneral disorders | 3/133 | 1/106 |
| Event | Medical Group Visits | Control |
|---|---|---|
| HypoglycemiaEndocrine disorders | 101/133 | 83/106 |
| LightheadednessVascular disorders | 66/133 | 62/106 |
| Renal insufficiencyRenal and urinary disorders | 71/133 | 51/106 |
| HypotensionVascular disorders | 19/133 | 14/106 |
| Hepatic insufficiencyHepatobiliary disorders | 2/133 | 2/106 |
| Age, Continuous(years) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Mean | 63 ± 9.4 | 60.8 ± 10 | 62.0 ± 9.8 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Female | 6 | 4 | 10 |
| Male | 127 | 102 | 229 |
| Race (NIH/OMB)(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 72 | 71 | 143 |
| White | 57 | 29 | 86 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 6 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 2 | 5 |
| Not Hispanic or Latino | 128 | 103 | 231 |
| Unknown or Not Reported | 2 | 1 | 3 |
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs