OPHTHALMIC COMPLICATIONS PREVENTION TRIAL

The goal of this study is to evaluate the efficacy of an inexpensive educational intervention to promote annual ophthalmic screening as recommended by the U.S. Public Health Service and American Diabetes Association. The intervention is directed at low-income Black women with diabetes and comprises a brief personal contact, low-literacy level print materials, and reinforcement through telephone follow-up. Race-specific age-adjusted rates for diabetes mellitus-related deaths are highest for Blacks. From 1980 to 1987, the number of Black females with diabetes increased by 24%, while the number of White females with diabetes remained about the same. In each of these years, the annual prevalence of diabetes (age-standardized to the U.S. population) was higher for Blacks than for Whites and was higher for Black females than for Black males. Further, Black women with diabetes are less likely to receive timely ophthalmic screening than their White counterparts. The proposed intervention strategy is a direct result of research over the last five years by the Diabetes research and Training Center at Albert Einstein College of Medicine, which indicated both a great need for interventions to increase ophthalmic screening in this population, and a need to evaluate the effectiveness of patient education intervention coupled with provider education. The study design is a randomized controlled intervention trial with blinding, with the individual as the unit of sampling, assignment and analysis. A total of 350 low-income Black women will be sampled from a large county hospital and randomized to intervention or control. The study endpoint is receipt of ophthalmic screening, which is defined by consensus criteria at one and two years post-enrollment. Sample size determinations were based on alpha = 0.01, 1 = beta = 0.80, and a 70% screening rate in the intervention group compared to an estimated rate of 50% in the control group. Measures of women's knowledge and beliefs will also be collected. The intervention was designed in a practical way, so if efficacious and safe it can be disseminated, implemented and sustained in existing community programs in our region and elsewhere.