Can Group Visits Improve Outcomes of Veterans With Diabetes

Hypertension Clinical Trial

Official title:

Can Group Visits Improve Outcomes of Veterans With Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286741
• Other study ID #: IIR 03-084
• Status: Completed
• Phase: Phase 3
• Start date: June 2006
• Est. completion date: January 2009

Study information

• Verified date: December 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: January 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Hypertension

Intervention

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.

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina
United States	Hunter Holmes McGuire VA Medical Center, Richmond, VA	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

References & Publications (5)

Crowley MJ, Melnyk SD, Coffman CJ, Jeffreys AS, Edelman D. Impact of baseline insulin regimen on glycemic response to a group medical clinic intervention. Diabetes Care. 2013 Jul;36(7):1954-60. doi: 10.2337/dc12-1905. Epub 2013 Feb 7. — View Citation

Crowley MJ, Melnyk SD, Ostroff JL, Fredrickson SK, Jeffreys AS, Coffman CJ, Edelman D. Can group medical clinics improve lipid management in diabetes? Am J Med. 2014 Feb;127(2):145-51. doi: 10.1016/j.amjmed.2013.09.027. Epub 2013 Oct 15. — View Citation

Edelman D, Dolor RJ, Coffman CJ, Pereira KC, Granger BB, Lindquist JH, Neary AM, Harris AJ, Bosworth HB. Nurse-led behavioral management of diabetes and hypertension in community practices: a randomized trial. J Gen Intern Med. 2015 May;30(5):626-33. doi: — View Citation

Edelman D, Fredrickson SK, Melnyk SD, Coffman CJ, Jeffreys AS, Datta S, Jackson GL, Harris AC, Hamilton NS, Stewart H, Stein J, Weinberger M. Medical clinics versus usual care for patients with both diabetes and hypertension: a randomized trial. Ann Inter — View Citation

Jackson GL, Edelman D, Olsen MK, Smith VA, Maciejewski ML. Benefits of participation in diabetes group visits after trial completion. JAMA Intern Med. 2013 Apr 8;173(7):590-2. doi: 10.1001/jamainternmed.2013.2803. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c		12 months
Primary	Systolic Blood Pressure		12 months
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).		one year