Efficacy Study of Diabetes Group Visits

Sponsor
Oregon Health and Science University (Other)
Overall Status
Completed
CT.gov ID
NCT01497301
Collaborator
(none)
22
1
2
34
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Group Visits
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Initiating Diabetic Group Visits in Newly Diagnosed Diabetics in an Urban Academic Medical Practice
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Individual Medical Appointment

Active Comparator: Group Visits

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Hemoglobin A1C [baseline, 6 months, and 12 months]

Secondary Outcome Measures

  1. 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.

  2. Patient satisfaction with diabetes group visits [6 months and 12 months]

    Will use validated tool: Diabetes Management Evaluation Tool

  3. Provider Satisfaction with Diabetes Group Visits [baseline, 6 months, 12 months]

  4. Difference in costs of delivering care to diabetics through group visits compared to standard individual medical appointments [6 months, 12 months]

  5. Change in blood pressure [baseline, 6 months, 12 months]

  6. Change in LDL cholesterol [baseline, 6 months, 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon Health and Science University Portland Oregon United States 97239

Sponsors and Collaborators

  • Oregon Health and Science University

Investigators

  • Principal Investigator: Scott Fields, MD, Oregon Health and Science University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Holly Hofkamp, Clinical Instructor, Department of Family Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01497301
Other Study ID Numbers:
  • IRB00007909
First Posted:
Dec 22, 2011
Last Update Posted:
Apr 25, 2019
Last Verified:
Apr 1, 2019
Keywords provided by Holly Hofkamp, Clinical Instructor, Department of Family Medicine, Oregon Health and Science University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2019