title: Rationale, design, and implementation of a cluster randomized trial using certified diabetes educators to intensify treatment for glycemia, blood pressure and lipid control: REMEDIES 4D.
abstract: BACKGROUND
  Evidence supports that adequate treatment of hyperglycemia, hypercholesterolemia, and hypertension can reduce morbidity and mortality in people with diabetes, however achieving treatment goals remains elusive. The majority of diabetes care occurs in the primary care setting; however there are often missed opportunities for timely intervention during office visits. This paper describes a systematic redesign of current diabetes treatment in primary care by implementing evidence-based protocols.
  
  
  METHODS
  This is a cluster randomized controlled trial using certified diabetes educators (CDEs) to intensify therapeutic management. Fifteen primary care practices from the University of Pittsburgh Medical Center were recruited. Practices were randomized to intervention (implementation of diabetes management protocols) or usual care. Eligibility criteria included diagnosis of type 2 diabetes at least one year prior to baseline and an A1C ≥ 7%, LDLc ≥ 100 mg/dl or blood pressure ≥ 130/80 mmHg which were the goal levels established by the American Diabetes Association at study inception. Treatment was intensified according to preapproved protocols. Participants also received diabetes education during their visits. Research assessments were done at baseline, three, six and twelve months. Clinical visits were scheduled between research visits, as needed, to adjust medications. Primary outcomes were achievement of glycemic, blood pressure, or lipid control goals. Secondary outcomes included quality of life, medication and diabetes care satisfaction, medication adherence, and cost-effectiveness.
  
  
  CONCLUSIONS
  Results from this study will provide the evidence to support expanded roles for CDEs in primary care. Using this model to deliver diabetes care may offer a more cost-effective approach for diabetes management.
authors.affiliation: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States. Electronic address: edcjan@pitt.edu.
authors.forename: Janice C
authors.initials: JC
authors.lastname: Zgibor
authors.affiliation: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States.
authors.forename: Shihchen
authors.initials: S
authors.lastname: Kuo
authors.affiliation: Physician Services Division, University of Pittsburgh Medical Center, Pittsburgh, PA, United States; University of Pittsburgh, Pittsburgh, PA, United States.
authors.forename: Sharlene
authors.initials: S
authors.lastname: Emerson
authors.affiliation: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States.
authors.forename: Patricia
authors.initials: P
authors.lastname: Gittinger
authors.affiliation: Physician Services Division, University of Pittsburgh Medical Center, Pittsburgh, PA, United States; University of Pittsburgh, Pittsburgh, PA, United States.
authors.forename: Francis X
authors.initials: FX
authors.lastname: Solano
authors.affiliation: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States.
authors.forename: Debra
authors.initials: D
authors.lastname: Tilves
authors.affiliation: Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, United States.
authors.forename: Maura
authors.initials: M
authors.lastname: Maloney
authors.affiliation: Department of Internal Medicine, Charles R. Drew University, Los Angeles, CA, United States.
authors.forename: Mayer B
authors.initials: MB
authors.lastname: Davidson
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose; D001794:Blood Pressure; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology / Q000628:therapy*; D019468:Disease Management; D050171:Dyslipidemias / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D006442:Glycated Hemoglobin; D006304:Health Status; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology; D008055:Lipids / Q000097:blood; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D011320:Primary Health Care / Q000458:organization & administration*; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D012959:Socioeconomic Factors
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D008055:Lipids
keywords: Clinical inertia; Diabetes education; Primary care; Protocols; Treatment intensification; Type 2 diabetes