Nonadherence to medications is common among patients with diabetes and contributes to suboptimal control of glycemic and lipid plasma levels. Adherence is not routinely measured in clinical practice because no valid, feasible methods have been readily available. The lack of medication adherence information contributes to clinician failure to identify and address patient nonadherence and to clinical inertia and poor health outcomes. Existing electronic prescribing systems hold the potential to display medication adherence information. We propose a 2-arm cluster-randomized trial to test the effectiveness of providing PCPs with both adherence measurements and an adherence clinic to improve adherence to diabetic and lipid-lowering drugs. This adherence clinic will consist of a pharmacist and nurse trained in motivational interviewing (Ml) techniques to improve adherence to medications. Adherence indices will be generated by linking e-prescribing information with pharmacy data. The trial will be conducted among 1,436 patients with diabetes and poor blood glycemic and/or lipid control. Primary care providers will be randomized to 1 of the following 2 study arms: 1) usual care--PCPs will write prescriptions electronically but will not be provided patient adherence information or Ml support;and 2) intervention--PCPs will be provided adherence information and adherence prompts electronically plus physicians and patients will receive support from an adherence clinic. Our intervention uses as theoretical behavioral framework elements of the Chronic Care Model, Self-Determination Theory, and the Health Belief Model. The study will use qualitative methods to guide intervention design and implementation and will include both process evaluation and treatment fidelity measures. The intervention will be tailored to patients'adherence and goal levels. Outcomes will include adherence to diabetes and lipid-lowering medications;cholesterol and glycated hemoglobin plasma levels (primary outcome);patients and providers'acceptance and satisfaction;and cardiovascular morbidity- mortality (exploratory outcome). The study will also evaluate the cost effectiveness of the intervention. Patients will be followed for 36 months. Analyses will control for cluster randomization effects. The introduction of sustainable medication adherence monitoring in clinical practice holds great potential to improve health outcomes among patients with diabetes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project (R01)
Project #
5R01DK064695-08
Application #
7857949
Study Section
Health Services Organization and Delivery Study Section (HSOD)
Program Officer
Hunter, Christine
Project Start
2003-08-05
Project End
2013-05-31
Budget Start
2010-06-01
Budget End
2013-05-31
Support Year
8
Fiscal Year
2010
Total Cost
$317,165
Indirect Cost
Name
Henry Ford Health System
Department
Type
Schools of Medicine
DUNS #
073134603
City
Detroit
State
MI
Country
United States
Zip Code
48202
Lanfear, David E; Gibbs, Joseph J; Li, Jia et al. (2017) Targeted Metabolomic Profiling of Plasma and Survival in Heart Failure Patients. JACC Heart Fail 5:823-832
Zhou, Kaixin; Yee, Sook Wah; Seiser, Eric L et al. (2016) Variation in the glucose transporter gene SLC2A2 is associated with glycemic response to metformin. Nat Genet 48:1055-1059
Wells, Karen E; Cajigal, Sonia; Peterson, Edward L et al. (2016) Assessing differences in inhaled corticosteroid response by self-reported race-ethnicity and genetic ancestry among asthmatic subjects. J Allergy Clin Immunol 137:1364-1369.e2
Pladevall, Manel; Divine, George; Wells, Karen E et al. (2015) A randomized controlled trial to provide adherence information and motivational interviewing to improve diabetes and lipid control. Diabetes Educ 41:136-46
Yessayan, L; Shafiq, A; Peterson, E et al. (2015) Race, Calcineurin Inhibitor Exposure, and Renal Function After Solid Organ Transplantation. Transplant Proc 47:2968-72
El-Refai, Mostafa; Hrobowski, Tara; Peterson, Edward L et al. (2015) Race and association of angiotensin converting enzyme/angiotensin receptor blocker exposure with outcome in heart failure. J Cardiovasc Med (Hagerstown) 16:591-6
Velez, Mauricio; Peterson, Edward L; Wells, Karen et al. (2015) Association of antidiabetic medications targeting the glucagon-like peptide 1 pathway and heart failure events in patients with diabetes. J Card Fail 21:2-8
Padhukasahasram, Badri; Reddy, Chandan K; Levin, Albert M et al. (2015) Powerful Tests for Multi-Marker Association Analysis Using Ensemble Learning. PLoS One 10:e0143489
Lanfear, David E; Li, Jia; Abbas, Raza et al. (2015) Genetic Factors Influencing B-type Natriuretic Peptide-Mediated Production of Cyclic Guanosine Monophosphate and Blood Pressure Effects in Heart Failure Patients. J Cardiovasc Transl Res 8:545-53
Bunyavanich, Supinda; Schadt, Eric E; Himes, Blanca E et al. (2014) Integrated genome-wide association, coexpression network, and expression single nucleotide polymorphism analysis identifies novel pathway in allergic rhinitis. BMC Med Genomics 7:48

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