The Effectiveness of Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00204282
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 23, 2013
Information provided by (Responsible Party):
University of Chicago

Brief Summary:

The purpose of the study is to evaluate the feasibility and efficacy of group visits led by nurse practitioners in improving diabetic preventive services and vascular risk. Diabetes is notable for its high burden on the health of urban populations, a rich literature supporting evidenced based care, and great opportunities to apply systemic primary care interventions to reduce its toll. Extensive literature demonstrates sub-optimal care in the community as well as in academic centers. Addressing the needs of patients with diabetes is challenging in the primary-care environment and nurse case management and disease-specific group visits which focus on education and self-management skills have been shown to be useful adjuncts to traditional outpatient care.

The study will attempt to demonstrate that nurse practitioner run group visits, during which the NP will provide didactic education, facilitate group interaction, and arrange referrals and laboratory testing as appropriate, will improve compliance with established American Diabetes Association guidelines for screening and preventive care and in doing so lower cardiovascular risk. Satisfaction with care, quality of life, and diabetic knowledge will be assessed before and after the patients complete the program. In addition, we will attempt to characterize barriers to care for patients who were formerly established with a primary care physician in the Primary Care Group, but who have not received diabetic care there for at least one year.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Educational presentation, group discussion, questionnaires Not Applicable

Detailed Description:

Patients who are 40 to 79 years old, and who have had at least three visits with a primary care physician will be the focus of the study. Patients will be recruited by letter, co-signed by the PCP and the study P1 A second letter will be sent 2 weeks after the first. After an intake visit, random allocation will divide 150 patients into 2 arms, one a series of 3 NP-led group classes and the other, usual care. Baseline data, including blood pressure control, foot and retinal examination rates, serum lipids, Alc, microalbumin, pneumococcal vaccination, smoking status and counseling, and ASA and lipid medication use will be assessed at enrollment and again at completion of the study. In addition patients will complete a diabetic knowledge scale, quality of life assessment (SF- 12) and ADA patient satisfaction survey. Several measures will be gathered both by chart review and oral administration of the CDC's BRFSS 2002 diabetes module survey, permitting cross validation. Statistical analysis of the differences between proportions (2x2 for independent samples) will be performed using chi-square. Preliminary power analysis (Power Precision; Biostat, Englewood, NJ) suggests adequate power (using Fisher's exact test, alpha beta 0.1, assuming reasonably achievable effect sizes) for at least several intermediate outcomes.

Patients in the 'group visit' arm are expected to attend three 90-minute educational group visits over six months, with group visits directed by a nurse practitioner. Patients will be asked to attend three sessions (8-10 patients in each) within six months. All patients will continue to see their primary care physicians as scheduled. The focus of the visits will be on diabetic and vascular risk goals, dietary education, and self-management skills. A graphical 'Diabetic Health Tracker' modified from Chapin et al will be provided to group class attendees; such an intervention may improve vascular risk endpoints. The group visit provider team will have the ability to make referrals, administer recommended vaccines, and adjust medications in consultation with the primary care physician; NPs will also make phone contact with the class group members between visits to report results and help assure follow-up; such case management functions may also improve outcomes. Additional telephone outreach will be made to patients who both: 1) do respond to the 2 recruiting letters, and 2) who have not been seen in the past 12 months in order review barriers to care. A brief phone screen for depression will be considered given data linking depression to non-adherence.

As the burden of chronic illness rises along with healthcare costs, innovative approaches are required. Diabetes care has been repeatedly identified by government and private payers as area of focus and perhaps even a future subject for "pay for performance". We hope our study can contribute to better diabetic care and, in the longer term, to improved patient health.

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Official Title: The Effectiveness of Nurse Practitioner Led Group Visits in Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk
Study Start Date : August 2003
Study Completion Date : December 2005

Primary Outcome Measures :
  1. Nurse practitioner run group visits will improve compliance with established American Diabetes Association guidelines for screening and preventive care

Secondary Outcome Measures :
  1. Compliance with established American Diabetes Association guidelines for screening and preventive care will lower cardiovascular risk

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All diabetic patients age 40-79 who are followed in the Primary Care Group for Type 2 diabetes and who have seen their PCP at least 3 times in order to establish regular care

Exclusion Criteria:

  • Patients younger than 40 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00204282

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Andrew Davis, M.D. University of Chicago

Adams K and Corrigan J, eds. Priority Areas for National Action: Transforming Health Care Quality, Institute of Medicine, National Academy of Sciences, Washington, DC; 2003
American Diabetes Association: clinical practice recommendations. Standards of medical for patients with diabetes mellitus. Diabetes Care 2003; 26:(suppl 1):533-50
Hawryluk M: CMS project to measure physician quality of care. Am Med News. American Medical Association. February 2003

Responsible Party: University of Chicago Identifier: NCT00204282     History of Changes
Other Study ID Numbers: 12567A
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 23, 2013
Last Verified: September 2013

Keywords provided by University of Chicago:
Diabetes prevention