title: Study protocol for "Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET)": a pragmatic trial comparing implementation strategies.
abstract: BACKGROUND
  Little research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies' effectiveness in the community health center setting.
  
  
  METHODS
  This cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics' ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the "how" and "why" underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in "real-world" practices.
  
  
  CONCLUSIONS
  Having a better understanding of how different strategies support implementation efforts could positively impact the field of implementation science, by comparing practical, generalizable methods for implementing clinical innovations in community health centers. Bridging this gap in the literature is a critical step towards the national long-term goal of effectively disseminating and implementing effective interventions into community health centers.
  
  
  BACKGROUND
  ClinicalTrials.gov, NCT02325531.
authors.affiliation: Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227, USA. Rachel.Gold@kpchr.org.|OCHIN, Inc., 1881 SW Naito Parkway, Portland, OR, 97201, USA. Rachel.Gold@kpchr.org.
authors.forename: Rachel
authors.initials: R
authors.lastname: Gold
authors.affiliation: Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227, USA. Celine.b.hollombe@kpchr.org.
authors.forename: Celine
authors.initials: C
authors.lastname: Hollombe
authors.affiliation: Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227, USA. Arwen.E.bunce@kpchr.org.
authors.forename: Arwen
authors.initials: A
authors.lastname: Bunce
authors.affiliation: OCHIN, Inc., 1881 SW Naito Parkway, Portland, OR, 97201, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Nelson
authors.affiliation: Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227, USA. James.v.davis@kpchr.org.
authors.forename: James V
authors.initials: JV
authors.lastname: Davis
authors.affiliation: OCHIN, Inc., 1881 SW Naito Parkway, Portland, OR, 97201, USA. cowburns@ochin.org.
authors.forename: Stuart
authors.initials: S
authors.lastname: Cowburn
authors.affiliation: Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227, USA. Nancy.Perrin@kpchr.org.
authors.forename: Nancy
authors.initials: N
authors.lastname: Perrin
authors.affiliation: OCHIN, Inc., 1881 SW Naito Parkway, Portland, OR, 97201, USA. DevoeJ@ohsu.edu.|Oregon Health Science University, 3181 S.W. Sam Jackson Park Rd., Portland, OR, 97239, USA. DevoeJ@ohsu.edu.
authors.forename: Jennifer
authors.initials: J
authors.lastname: DeVoe
authors.affiliation: OCHIN, Inc., 1881 SW Naito Parkway, Portland, OR, 97201, USA. mossmann@ochin.org.
authors.forename: Ned
authors.initials: N
authors.lastname: Mossman
authors.affiliation: Kaiser Permanente Care Management Institute, 1 Kaiser Plaza, 16 L, Oakland, CA, 94612, USA. bruce.d.boles@kp.org.
authors.forename: Bruce
authors.initials: B
authors.lastname: Boles
authors.affiliation: Mid-Atlantic Permanente Research Institute, 2101 East Jefferson Street 3 West, Rockville, MD, 20852, USA. michael.horberg@kp.org.
authors.forename: Michael
authors.initials: M
authors.lastname: Horberg
authors.affiliation: College of Communication Arts and Sciences, Michigan State University, 404 Wilson Road, 473, East Lansing, MI, 48824, USA. dearjim@msu.edu.
authors.forename: James W
authors.initials: JW
authors.lastname: Dearing
authors.affiliation: Multnomah County Public Health Department, 426 SW Stark St, 8th Floor, Portland, OR, 97204, USA. victoria.c.jaworski@multco.us.
authors.forename: Victoria
authors.initials: V
authors.lastname: Jaworski
authors.affiliation: Oregon Health Science University, 3181 S.W. Sam Jackson Park Rd., Portland, OR, 97239, USA. cohendj@ohsu.odu.
authors.forename: Deborah
authors.initials: D
authors.lastname: Cohen
authors.affiliation: Kaiser Permanente Northwest Center for Health Research, 3800 N. Interstate Avenue, Portland, OR, 97227, USA. David.H.Smith@kpchr.org.
authors.forename: David
authors.initials: D
authors.lastname: Smith
mesh_terms: D002318:Cardiovascular Diseases / Q000188:drug therapy* / Q000453:epidemiology; D003151:Community Health Centers / Q000458:organization & administration* / Q000592:standards; D003920:Diabetes Mellitus / Q000453:epidemiology; D004059:Diffusion of Innovation; D057286:Electronic Health Records / Q000458:organization & administration; D055317:Evidence-Based Practice; D019983:Guideline Adherence; D006801:Humans; D007318:Inservice Training / Q000458:organization & administration; D065186:Interrupted Time Series Analysis; D017410:Practice Guidelines as Topic; D015397:Program Evaluation; D019984:Quality Indicators, Health Care; D017010:Reminder Systems; D012107:Research Design