Efficacy Study of Diabetes Group Visits

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Oregon Health and Science University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Holly Milne, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01497301
First received: December 19, 2011
Last updated: December 21, 2011
Last verified: December 2011
  Purpose

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 Intervention
Diabetes Mellitus, Type 2
Behavioral: Group Visits

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Initiating Diabetic Group Visits in Newly Diagnosed Diabetics in an Urban Academic Medical Practice

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Change in Hemoglobin A1C [ Time Frame: baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients that are in compliance with all recommended preventive measures for diabetics [ Time Frame: baseline, 6 months, and 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]
    Will use validated tool: Diabetes Management Evaluation Tool

  • Provider Satisfaction with Diabetes Group Visits [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Difference in costs of delivering care to diabetics through group visits compared to standard individual medical appointments [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change in blood pressure [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]
  • Change in LDL cholesterol [ Time Frame: baseline, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497301

Contacts
Contact: Holly M Milne, MD 503-494-8573 milne@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Holly M Milne, MD    503-494-8573    milne@ohsu.edu   
Sub-Investigator: Holly M Milne, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Scott Fields, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Holly Milne, Clinical Instructor, Department of Family Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01497301     History of Changes
Other Study ID Numbers: IRB00007909
Study First Received: December 19, 2011
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
Diabetes
Group Visit
Shared Medical Appointment

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 29, 2014