Comparative Effectiveness of Two Approaches to Diabetes Management in the Uninsured
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The results of the pre-pilot and pilot studies will be used to determine the feasibility of a
      fully powered trial that will test the effectiveness of two different approaches to diabetes
      management in an uninsured diabetic population who receives their care from a community based
      free clinic, namely nurse-directed interdisciplinary care management compared to peer-led
      self management. Effective programs for the uninsured diabetic will benefit both the
      individual and society by preventing serious illness, decreasing mortality and disability,
      decreasing medical debt, stimulating economic growth, improving business productivity,
      reducing job lock, decreasing health disparities, improving quality of life, and reducing
      cost shifting by decreasing uncompensated care. Findings will be generalizable to uninsured
      and insured patients across a wide spectrum of chronic conditions.
    

Detailed description: 
      The randomized pre-pilot and pilot studies will inform the design of a fully powered trial
      that will test the effectiveness of a nurse-led interdisciplinary care management
      intervention (CM) for improving hemoglobin A1c in uninsured diabetic patients who receive
      their primary medical care from a community-based free clinic compared to similar patients
      who undergo peer-led self management (SM). The comparative effectiveness of these approaches
      has not been tested in a randomized trial.

      To ensure the success of the pilot study the investigators will perform a 6 month pre-pilot
      study using 10 patients per group. This pre-pilot will be used to establish protocols
      covering enrollment, HIPAA, consent, interventions and outcome measurement. The subsequent 1
      year pilot will be used to demonstrate feasibility, estimate recruitment, attendance and
      follow up, refine inclusion criteria, provide power analysis, optimize the interventions and
      determine appropriate secondary outcomes for a fully powered trial. For the pilot, thirty
      patients will be randomized to the CM intervention for the first 6 months. Major components
      of the nurse-led CM model include: 1) assessment and goal setting for self-management; 2)
      education for self efficacy and productive clinical encounters; 3) access to specialist care
      via an interdisciplinary team; 4) evidence-based treatment recommendations responsive to
      patients' goals; and 5) care coordination by a nurse care manager. From 6-12 months patients
      will return to usual clinic care.

      The 30 patients randomized to the SM group will be invited to attend weekly peer-led SM
      training broadly based on the Stanford University Diabetes Self-management Program's Train
      the Trainer Model. The training will occur over 6 weeks and will cover topics common to most
      chronic disease SM programs including: goal setting, self-management of chronic conditions,
      making action plans, feedback and problem solving, handling emotions, symptom management
      techniques, communication with health care providers, medications and making treatment
      decisions. The peer advisors and a nurse will then lead 1 hour monthly group sessions for the
      remainder of the first 6 months for review/revision of action plans, review of self
      management techniques and ongoing social persuasion and modeling. From 6-12 months patients
      will return to usual clinic care.

      For the pilot, outcome measures will be obtained at 6 and 12 months. For this pilot, the
      investigators will not test any hypotheses. Instead, effect sizes and confidence intervals
      will be calculated for each outcome. These results will be used for power analysis. The
      results will also allow us to see which interventions are most effective on which outcomes
      and allow us to optimize the interventions to have the greatest impact on the primary
      outcome, hemoglobin A1c. Cost effectiveness will be determined in a fully powered trial.
    

Intervention name(s): nurse-led care management or peer-led self management
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research