Efficacy Study of Diabetes Group Visits

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Initiating Diabetic Group Visits in Newly Diagnosed Diabetics in an Urban Academic Medical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497301
• Other study ID #: IRB00007909
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1C		baseline, 6 months, and 12 months
Secondary	Number of patients that are in compliance with all recommended preventive measures for diabetics	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.	baseline, 6 months, and 12 months
Secondary	Patient satisfaction with diabetes group visits	Will use validated tool: Diabetes Management Evaluation Tool	6 months and 12 months
Secondary	Provider Satisfaction with Diabetes Group Visits		baseline, 6 months, 12 months
Secondary	Difference in costs of delivering care to diabetics through group visits compared to standard individual medical appointments		6 months, 12 months
Secondary	Change in blood pressure		baseline, 6 months, 12 months
Secondary	Change in LDL cholesterol		baseline, 6 months, 12 months