Efficacy Study of Diabetes Group Visits

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Group Visits

• Registration Number: NCT01497301
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2011-12-21
• Study First Posted: 2011-12-22
• Study Start: 2012-02
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Visits	Group Visits	-

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1C	baseline, 6 months, and 12 months

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction with diabetes group visits	6 months and 12 months	Will use validated tool: Diabetes Management Evaluation Tool
Change in blood pressure	baseline, 6 months, 12 months
Change in LDL cholesterol	baseline, 6 months, 12 months
Number of patients that are in compliance with all recommended preventive measures for diabetics	baseline, 6 months, and 12 months	Recommended preventive measures for diabetics include yearly foot exams, yearly eye exams, yearly microalbumin. This also includes yearly immunization with influenza vaccine and immunization with pneumococcal vaccine once before age 65 and once after age 65.
Provider Satisfaction with Diabetes Group Visits	baseline, 6 months, 12 months
Difference in costs of delivering care to diabetics through group visits compared to standard individual medical appointments	6 months, 12 months

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States