title: Will Mobile Diabetes Education Teams (MDETs) in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial.
abstract: BACKGROUND
  There is evidence to suggest that delivery of diabetes self-management support by diabetes educators in primary care may improve patient care processes and patient clinical outcomes; however, the evaluation of such a model in primary care is nonexistent in Canada. This article describes the design for the evaluation of the implementation of Mobile Diabetes Education Teams (MDETs) in primary care settings in Canada.
  
  
  METHODS
  This study will use a non-blinded, cluster-randomized controlled trial stepped wedge design to evaluate the Mobile Diabetes Education Teams' intervention in improving patient clinical and care process outcomes. A total of 1,200 patient charts at participating primary care sites will be reviewed for data extraction. Eligible patients will be those aged ≥18, who have type 2 diabetes and a hemoglobin A1c (HbA1c) of ≥8%. Clusters (that is, primary care sites) will be randomized to the intervention and control group using a block randomization procedure within practice size as the blocking factor. A stepped wedge design will be used to sequentially roll out the intervention so that all clusters eventually receive the intervention. The time at which each cluster begins the intervention is randomized to one of the four roll out periods (0, 6, 12, and 18 months). Clusters that are randomized into the intervention later will act as the control for those receiving the intervention earlier. The primary outcome measure will be the difference in the proportion of patients who achieve the recommended HbA1c target of ≤7% between intervention and control groups. Qualitative work (in-depth interviews with primary care physicians, MDET educators and patients; and MDET educators' field notes and debriefing sessions) will be undertaken to assess the implementation process and effectiveness of the MDET intervention.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01553266.
authors.affiliation: Ryerson University, School of Nutrition, 350 Victoria Street, Toronto, ON M5B 2 K3, Canada. egucciar@ryerson.ca
authors.forename: Enza
authors.initials: E
authors.lastname: Gucciardi
authors.forename: Mariella
authors.initials: M
authors.lastname: Fortugno
authors.forename: Stacey
authors.initials: S
authors.lastname: Horodezny
authors.forename: Wendy
authors.initials: W
authors.lastname: Lou
authors.forename: Souraya
authors.initials: S
authors.lastname: Sidani
authors.forename: Sherry
authors.initials: S
authors.lastname: Espin
authors.forename: Fiona
authors.initials: F
authors.lastname: Webster
authors.forename: Baiju R
authors.initials: BR
authors.lastname: Shah
mesh_terms: D015415:Biomarkers / Q000097:blood; D019033:Delivery of Health Care, Integrated; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis / Q000628:therapy*; D006442:Glycated Hemoglobin / Q000378:metabolism*; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D033183:Interdisciplinary Communication; D009864:Ontario; D010043:Outcome and Process Assessment, Health Care; D010348:Patient Care Team; D010353:Patient Education as Topic; D011320:Primary Health Care; D011369:Professional-Patient Relations; D015397:Program Evaluation; D058996:Quality Improvement; D012107:Research Design; D012648:Self Care; D012944:Social Support; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human