Diabetes, Hypertension
Conditions
Keywords
Diabetes, Hypertension, Randomized controlled trials, cost-effectiveness, health services
Brief summary
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.
Detailed description
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.
Interventions
OTHERDiabetes Group Management Visits
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.
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Primary care at one of two participating sites, * HbA1c \>= 7.5%, Systolic BP \> 140 OR Diastolic BP \> 90 on 2 consecutive measurements
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin A1c | 12 months |
| Systolic Blood Pressure | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness, Proportion of Patients With LDL < 100, Health Services Utilization, Quality of Life (as Measured by DQoL), Patient Empowerment (as Measured by DES). | one year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Medical group visits
Diabetes Group Management Visits: 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. | 133 |
| Arm 2 control | 106 |
| Total | 239 |
Baseline characteristics
| Characteristic | Total | Arm 1 | Arm 2 |
|---|---|---|---|
| Age, Continuous | 62.0 years STANDARD_DEVIATION 9.8 | 63 years STANDARD_DEVIATION 9.4 | 60.8 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 231 Participants | 128 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 143 Participants | 72 Participants | 71 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) White | 86 Participants | 57 Participants | 29 Participants |
| Sex: Female, Male Female | 10 Participants | 6 Participants | 4 Participants |
| Sex: Female, Male Male | 229 Participants | 127 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 122 / 133 | 85 / 106 |
| serious Total, serious adverse events | 59 / 133 | 37 / 106 |
Outcome results
Primary
Hemoglobin A1c
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Group Visits | Hemoglobin A1c | 8.4 percentage points | Standard Deviation 1.3 |
| Control | Hemoglobin A1c | 8.7 percentage points | Standard Deviation 1.5 |
p-value: 0.15Mixed Models Analysis
Primary
Systolic Blood Pressure
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medical Group Visits | Systolic Blood Pressure | 140 mmHg | Standard Deviation 14.8 |
| Control | Systolic Blood Pressure | 147 mmHg | Standard Deviation 13.4 |
p-value: 0.03Mixed Models Analysis
Secondary
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
Population: Analysis was not performed - project staff and data no longer available.