The Effectiveness of Improving Compliance With Diabetic Preventative Services and Modifying Vascular Risk
Condition: Diabetes
Study type: Interventional

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.
    

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.
    

Intervention name(s): Educational presentation, group discussion, questionnaires
Intervention type(s): Behavioral
Keywords: Diabetes prevention