This application addresses the gap between the demonstrated efficacy of behavioral interventions for adults with diabetes and what is achievable in real-world clinical practice. We propose to integrate two efficacious adjuncts to routine diabetes care: 1) self-management interventions, targeting treatment adherence, and 2) cognitive behavioral skills approaches, aimed at reducing emotional distress, a common and under-recognized aspect of living with diabetes. If widely disseminated, these interventions have the potential for significant public health impact. Our objective is to evaluate the effectiveness f a cost-conscious, comprehensive approach to improving diabetes outcomes. In partnership with the New York City Department of Health and Mental Hygiene, we will deliver the intervention to eligible patients through an existing and sustainable program focused on the improvement of health outcomes for individuals with diabetes and other chronic illnesses. This program supports electronic medical record (EMR) systems development and quality improvements in participating practices throughout NYC. The program employs prevention outreach specialists to identify high- risk patients with gaps in care via EMR data and, in consultation with care providers, contact these patients via telephone to re-engage them with care. We will use this existing program to examine the following specific aims: 1) to conduct an effectiveness trial evaluating the impact of comprehensive telephonic self-management support (Tele-SMS) on HbA1c (primary outcome), distress, treatment adherence, lipids, and blood pressure (secondary outcomes); 2) to apply RE-AIM to evaluate dissemination and implementation and facilitate translation to other sites; and 3) to obtain information on the cost of implementing Tele-SMS relative to treatment benefits. Individuals receiving care at primary care practices will be randomly assigned to one of two arms, Tele-SMS or enhanced usual care. Tele-SMS will focus on problem solving for barriers to medication adherence, improving lifestyle behaviors, and communicating effectively with providers. Additionally, it will involve the use of specific communication strategies to enhance the expression and normalization of emotional distress and ambivalence and, for patients experiencing significant distress, will provide instruction and practice with cognitive behavioral skills. Further, a formalized process for information exchange with care providers will be implemented to address clinical inertia and encourage guideline-concordant care of diabetes and depression, when indicated. Enhanced usual care participants will receive routine care plus print self- management support materials. A total of 875 individuals with diabetes will provide 83% power to detect a significant difference (p<0.05) between groups of at least 0.5% in absolute HbA1c. A full RE-AIM evaluation will be conducted and intervention cost data will be evaluated for translation of findings and scalability. Results will inform public health policies and practices in New York City, as well as other urban areas throughout the nation and could make a significant step towards closing the translation gap in comprehensive diabetes care.
Research conducted over the last two decades has made it clear that: 1) successful self-management of diabetes can reduce risk for complications and maintain quality of life, 2) many individuals with diabetes struggle with self-management and significant emotional distress. This project aims to address these related problems with a cost-conscious and sustainable program of telephonic support delivered by health educators to patients in primary care. If successful in improving diabetes outcomes, this program could be widely disseminated and would have a significant impact on public health.
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