Can Group Visits Improve Outcomes of Veterans With Diabetes
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00286741 |
|
Recruitment Status :
Completed
First Posted : February 3, 2006
Results First Posted : September 11, 2014
Last Update Posted : January 9, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Hypertension | Other: Diabetes Group Management Visits | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 239 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Can Group Visits Improve Outcomes of Veterans With Diabetes |
| Study Start Date : | June 2006 |
| Actual Primary Completion Date : | September 2008 |
| Actual Study Completion Date : | January 2009 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Medical group visits
Medical group visits
|
Other: 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. |
|
No Intervention: Treatment as Usual control
control
|
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286741
| United States, North Carolina | |
| Durham VA Medical Center, Durham, NC | |
| Durham, North Carolina, United States, 27705 | |
| United States, Virginia | |
| Hunter Holmes McGuire VA Medical Center, Richmond, VA | |
| Richmond, Virginia, United States, 23249 | |
| Principal Investigator: | David Edelman, MD MHS | Durham VA Medical Center, Durham, NC |
| Responsible Party: | US Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00286741 |
| Other Study ID Numbers: |
IIR 03-084 |
| First Posted: | February 3, 2006 Key Record Dates |
| Results First Posted: | September 11, 2014 |
| Last Update Posted: | January 9, 2019 |
| Last Verified: | December 2018 |
|
Diabetes Hypertension Randomized controlled trials cost-effectiveness health services |
|
Hypertension Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Vascular Diseases Cardiovascular Diseases |