Can Group Visits Improve Outcomes of Veterans With Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00286741
First received: February 1, 2006
Last updated: September 3, 2014
Last verified: September 2014

February 1, 2006
September 3, 2014
June 2006
September 2008   (final data collection date for primary outcome measure)
  • Hemoglobin A1c, Systolic Blood Pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Systolic Blood Pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
proportion of patient with HbA1c less than or equal to 7.0%, proportion of patients with BP less than 130/80
Complete list of historical versions of study NCT00286741 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Cost-effectiveness, proportion of patients with LDL less than 100, health services utilization, quality of life (as measured by DQoL), patient empowerment (as measured by DES).
Not Provided
Not Provided
 
Can Group Visits Improve Outcomes of Veterans With Diabetes
Can Group Visits Improve Outcomes of Veterans With Diabetes

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes
  • Hypertension
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.
  • Experimental: Medical group visits
    Medical group visits
    Intervention: Other: Diabetes Group Management Visits
  • No Intervention: Treatment as Usual control
    control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
239
January 2009
September 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00286741
IIR 03-084
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: David Edelman, MD MHS Durham VA Medical Center
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP