Bronx A1c: Bring it Down for Health
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      To address and reduce population-attributable risk due to elevated HbA1c, the New York City
      Department of Health and Mental Hygiene (DOHMH) developed an innovative HbA1c registry, which
      requires all major laboratories to report HbA1c results electronically. We propose to utilize
      this registry to conduct a randomized controlled trial addressing the following specific
      aims: 1) to evaluate the incremental effect of a tiered and tailored, patient-centered
      telephone intervention, in English and Spanish, on the mean HbA1c levels beyond that achieved
      with print materials mailed to patients and providers by the DOHMH registry intervention; 2)
      determine what patient demographic and psychosocial factors mediate the effect of the
      interventions; and 3) provide estimates of implementation costs of the tiered, tailored
      telephone intervention for comparison with the print intervention. The study outcome will be
      change in HbA1c values from the registry records from baseline to one-year
      post-randomization. A total of 941 individuals with diabetes will be needed to provide 83%
      power to detect a statistically significant difference (p<0.05) between groups of at least
      0.3% in absolute HbA1c. Intervention cost data will be evaluated for translation of findings
      and scalability. At study end, we will know the extent to which this intervention will
      improve metabolic control in a low-income, multi-ethnic sample who are part of the DOHMH
      HbA1c registry in the South Bronx, New York. These findings will inform public health
      policies and practices in New York City, as well as other urban areas throughout the nation.
    

Detailed description: 
      Metabolic control of diabetes, measured by hemoglobin A1c (HbA1c), reduces the risk of
      microvascular complications. Health care providers frequently do not meet standards for
      managing HbA1c and individuals with diabetes are often not aware of their HbA1c values. To
      address these issues and reduce population-attributable risk due to elevated HbA1c, the New
      York City Department of Health and Mental Hygiene (DOHMH) developed an innovative HbA1c
      registry, which requires all major laboratories to report HbA1c results electronically. We
      propose to utilize this registry to conduct a randomized controlled trial addressing the
      following specific aims: 1) to evaluate the incremental effect of a tiered and tailored,
      patient-centered telephone intervention, in English and Spanish, on the mean HbA1c levels
      beyond that achieved with print materials mailed to patients and providers by the DOHMH
      registry intervention; 2) determine what patient demographic and psychosocial factors mediate
      the effect of the interventions; and 3) provide estimates of implementation costs of the
      tiered, tailored telephone intervention for comparison with the print intervention. The
      individual is the unit of sampling, assignment and analysis. After eligibility is assessed
      and informed consent is obtained by telephone, the individual will be randomly assigned to
      one of the two groups. The patient telephone intervention will focus on collaborative problem
      solving for resolving barriers to medication adherence, improving lifestyle behaviors, and
      communicatiing effectively with their providers. The print materials from the DOHMH will
      communicate HbA1c results to patients and their providers, with strategies to improve them.
      The study outcome will be change in HbA1c values from the registry records from baseline to
      one-year post-randomization. A total of 941 individuals with diabetes will be needed to
      provide 83% power to detect a statistically significant difference (p<0.05) between groups of
      at least 0.3% in absolute HbA1c. Psychosocial data on depression, health behaviors, and risk
      perceptions will be collected by telephone. Intervention cost data will be evaluated for
      translation of findings and scalability. At study end, we will know the extent to which this
      intervention will improve metabolic control in a low-income, multi-ethnic sample who are part
      of the DOHMH HbA1c registry in the South Bronx, New York. These findings will inform public
      health policies and practices in New York City, as well as other urban areas throughout the
      nation.
    

Intervention name(s): telephonic
Intervention type(s): Behavioral
Intervention description(s): Between 4-8 phone calls each year for health behavior counseling to improve HbA1c
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: diabetes; behavioral intervention; HbA1c; health disparities