Efficacy Study of Diabetes Group Visits

NCT ID: NCT01497301

Last Updated: 2019-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-12-31

Brief Summary

Much evidence exists that new, more effective methods of delivering care to diabetics are necessary. In our current system of delivering care, diabetes care is often done in the context of multiple other issues addressed during a regular office visit. Providers often lack the time to properly educate patients on diabetes self management topics. This project hopes to show that group visits can improve clinical outcomes, patient satisfaction, provider satisfaction, and patient's self management knowledge, while decreasing cost. This group visit method can make care more patient-centered and team based which is in alignment with our organization's goal of becoming a true patient centered medical home. If successful, this could expand to our other family medicine clinic sites and provide a valuable learning opportunity for the family medicine residents at OHSU.

The investigators will first identify newly diagnosed diabetics (diagnosed within the last 12 months) at the South Waterfront and Gabriel Park family medicine clinics using EPIC. The investigators will invite those diabetics identified from the South Waterfront clinic to participate in 6 group visits that will follow a curriculum that the investigators created based on the National Standards for Diabetes Self Management Education and the ACP Diabetes Care Guide. This curriculum will address basic pathophysiology of diabetes, the "ABCs to Better Diabetic Care" as defined by the ACP Diabetes Care Guide, setting goals, nutrition, exercise, diabetic medications, and complications of diabetes. This intervention group will be compared to a control cohort identified at the Gabriel Park clinic that will continue to receive standard diabetes care from their primary physician. The investigators will look at and compare clinical outcomes (Hemoglobin A1C, blood pressure (BP), and LDL cholesterol levels), adherence to recommended preventive measures for diabetics (foot exams, eye exams, yearly microalbumin, and immunizations), patient and provider satisfaction, as well as cost. Cost data will be collected using EPIC to look at the costs involved in group visits compared to the cost of delivering diabetic care through the standard individual medical appointment. The investigators may also use EPIC to look at utilization of specialty services, emergency room visits, and inpatient admissions and compared utilization across groups.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard Individual Medical Appointment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group Visits

Group Type: ACTIVE_COMPARATOR

Group Visits

Intervention Type: BEHAVIORAL

During group visits, there will be discussions regarding the basic pathophysiology of diabetes, the "ABCs to Better Diabetic Care" as defined by the ACP Diabetes Care Guide, setting goals, nutrition, exercise, diabetic medications, and complications of diabetes. Patients will have blood drawn to measure hemoglobin A1C and lipids. They will be educated on self glucose monitoring so they will undergo finger sticks to measure their own glucose. BP measurements, monofilament foot exams, and urine collection for microalbumin will also occur during the study. They may also receive immunizations. A consent form for participation in the group visits, including undergoing the above procedures will be reviewed at our first group visit and signed by all participants.

Interventions

Group Visits

During group visits, there will be discussions regarding the basic pathophysiology of diabetes, the "ABCs to Better Diabetic Care" as defined by the ACP Diabetes Care Guide, setting goals, nutrition, exercise, diabetic medications, and complications of diabetes. Patients will have blood drawn to measure hemoglobin A1C and lipids. They will be educated on self glucose monitoring so they will undergo finger sticks to measure their own glucose. BP measurements, monofilament foot exams, and urine collection for microalbumin will also occur during the study. They may also receive immunizations. A consent form for participation in the group visits, including undergoing the above procedures will be reviewed at our first group visit and signed by all participants.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis of diabetes mellitus, type 2 after 11/01/2010
• English speaking

Exclusion Criteria

• Dementia
• Unable to come to all 6 preschedule group visits

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Holly Hofkamp

Clinical Instructor, Department of Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Scott Fields, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB00007909

Identifier Type: -

Identifier Source: org_study_id