Many African-Americans and Latinos with diabetes do not achieve the recommended goals for normal blood sugar, blood pressure, or cholesterol level, placing them at high risk for complications. This study will evaluate the impact of a novel intervention designed to improve lifestyle behaviors and medication adherence, and intensify therapy to reach goals. The first component of the intervention includes a clinic-based pharmacist disease management program. The program includes detailed patient assessments, physician- approved treatment plans, patient education and support services to enhance medication adherence. In addition, this program includes intensification of medication therapy to improve blood sugar, blood pressure, and cholesterol levels to reach recommended goals. The second component of the intervention includes health promoters (HPs), or community-based lay health workers. Health promoters are commonly found in minority communities and provide assistance for neighbors overcoming language, cultural, and other barriers to conventional health care services. They may provide autonomy support and solve problems related to medication adherence barriers. Furthermore, health promoters may complement pharmacist activities by improving access to medications, assisting in continuity of care with providers, monitoring response to therapy, and reinforcing educational messages. The proposed study will determine whether the addition of health promoters to clinic based pharmacist service delivery improves care. The study will involve the recruitment of 300 African-American and Latino adults with uncontrolled diabetes through the University of Illinois Medical Center in Chicago and randomization to one of two groups: (1) pharmacist management (Pharm) for 12 months;or (2) pharmacist management with HP support (Pharm+HP) for 12 months. Cross-over will occur at 12 months such that the Pharm group will be intensified by the addition of HP support and HP support will be phased out from the Pharm+HP group to assess maintenance.
The specific aims i nclude: (1) To evaluate the effectiveness of Pharm+HP compared with Pharm alone on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels;(2) To evaluate the maintenance of improved diabetes behaviors as well as clinical outcomes by phasing out HP support from the Pharm+HP group after year 1;(3) To evaluate the intensification offered by adding an HP after one year of Pharm alone;and (4) To evaluate the cost and cost-effectiveness of Pharm+HP and Pharm alone.

Public Health Relevance

This research evaluates a diabetes management intervention designed to improve medication adherence and intensify therapy to reach goals in blood sugar, blood pressure, and cholesterol levels. This study will determine the benefit and cost of adding community health promoters to pharmacist disease management services. If there is benefit, then this approach may help reduce the burden of diabetes and its related complications among minorities with diabetes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK091347-03
Application #
8459005
Study Section
Dissemination and Implementation Research in Health Study Section (DIRH)
Program Officer
Hunter, Christine
Project Start
2011-05-01
Project End
2016-02-29
Budget Start
2013-03-01
Budget End
2014-02-28
Support Year
3
Fiscal Year
2013
Total Cost
$648,972
Indirect Cost
$235,801
Name
University of Illinois at Chicago
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
098987217
City
Chicago
State
IL
Country
United States
Zip Code
60612
Sharp, Lisa K; Tilton, Jessica J; Touchette, Daniel R et al. (2018) Community Health Workers Supporting Clinical Pharmacists in Diabetes Management: A Randomized Controlled Trial. Pharmacotherapy 38:58-68
Locatelli, Sara M; Sharp, Lisa K; Syed, Saming T et al. (2017) Measuring Health-related Transportation Barriers in Urban Settings. J Appl Meas 18:178-193
Syed, Samina T; Sharp, Lisa K; Kim, Yoonsang et al. (2016) Relationship Between Medication Adherence and Distance to Dispensing Pharmacies and Prescribers Among an Urban Medicaid Population with Diabetes Mellitus. Pharmacotherapy 36:590-7
Rojas, Enrique; Gerber, Ben S; Tilton, Jessica et al. (2015) Pharmacists' perspectives on collaborating with community health workers in diabetes care. J Am Pharm Assoc (2003) 55:429-33
Sharp, Lisa K; Fisher, Edwin B; Gerber, Ben S (2015) Background and rationale for the Society of Behavioral Medicine's position statement: expand United States health plan coverage for diabetes self-management education and support. Transl Behav Med 5:354-6
Lora, Claudia M; Sokolovsky, Alexander W; Touchette, Daniel R et al. (2013) ACE inhibitor and ARB medication use among Medicaid enrollees with diabetes. Ethn Dis 23:189-95
Syed, Samina T; Gerber, Ben S; Sharp, Lisa K (2013) Traveling towards disease: transportation barriers to health care access. J Community Health 38:976-93
Gerber, Ben S; Rapacki, Lauren; Castillo, Amparo et al. (2012) Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with diabetes. BMC Public Health 12:891