Efficacy Study of Diabetes Group Visits
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Visits
Sponsored by

About this trial
This is an interventional health services research trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Group Visit, Shared Medical Appointment
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
Sites / Locations
- Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Standard Individual Medical Appointment
Group Visits
Arm Description
Outcomes
Primary Outcome Measures
Change in Hemoglobin A1C
Secondary Outcome Measures
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.
Patient satisfaction with diabetes group visits
Will use validated tool: Diabetes Management Evaluation Tool
Provider Satisfaction with Diabetes Group Visits
Difference in costs of delivering care to diabetics through group visits compared to standard individual medical appointments
Change in blood pressure
Change in LDL cholesterol
Full Information
NCT ID
NCT01497301
First Posted
December 19, 2011
Last Updated
April 23, 2019
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01497301
Brief Title
Efficacy Study of Diabetes Group Visits
Official Title
Initiating Diabetic Group Visits in Newly Diagnosed Diabetics in an Urban Academic Medical Practice
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes, Group Visit, Shared Medical Appointment
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Individual Medical Appointment
Arm Type
No Intervention
Arm Title
Group Visits
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Group Visits
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1C
Time Frame
baseline, 6 months, and 12 months
Secondary Outcome Measure Information:
Title
Number of patients that are in compliance with all recommended preventive measures for diabetics
Description
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.
Time Frame
baseline, 6 months, and 12 months
Title
Patient satisfaction with diabetes group visits
Description
Will use validated tool: Diabetes Management Evaluation Tool
Time Frame
6 months and 12 months
Title
Provider Satisfaction with Diabetes Group Visits
Time Frame
baseline, 6 months, 12 months
Title
Difference in costs of delivering care to diabetics through group visits compared to standard individual medical appointments
Time Frame
6 months, 12 months
Title
Change in blood pressure
Time Frame
baseline, 6 months, 12 months
Title
Change in LDL cholesterol
Time Frame
baseline, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Fields, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Diabetes Group Visits
We'll reach out to this number within 24 hrs