Bronx A1c: Bring it Down for Health
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/27/2018 |
| Start Date: | September 2008 |
| End Date: | June 2012 |
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.
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.
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.
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.
Inclusion Criteria:
- Subjects will be those patients with diabetes who speak English and/or Spanish and
reside in the South Bronx.
- Subjects will be adults, > 18 years, with diabetes, who become part of the NYC
registry by virtue of having a reported HbA1c >7% to the DOHMH.
- The sampling frame for this study comprises virtually all adults with diabetes in the
South Bronx.
Exclusion Criteria:
- Age < 18 years
- A1c < = 7 %
- Refuses informed consent and HIPAA consent
- Cognitive dysfunction as assessed by telephone
- Does not read or speak English or Spanish
- No diabetes
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