title: Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial.
abstract: BACKGROUND
  This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed.
  
  
  METHODS
  This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is conducted to identify the compliance with the implementation strategy, as well as an economic evaluation to assess the costs. Data sources are registered clinical data and surveys. There is no form of blinding.
  
  
  CONCLUSIONS
  The perioperative setting is an unexplored area with respect to implementation issues. This study is expected to yield important new evidence about the effects of a multifaceted approach on guideline adherence in the perioperative care setting.
  
  
  BACKGROUND
  Dutch trial registry: NTR3568.
authors.affiliation: Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, PO Box 9101, 114 IQ healthcare, 6500, HB, Nijmegen, The Netherlands. Yvette.Emond@radboudumc.nl.|Radboud university medical center, Radboud Institute for Health Sciences, Department of Anesthesiology, Pain and Palliative Care, Nijmegen, The Netherlands. Yvette.Emond@radboudumc.nl.
authors.forename: Yvette E J J M
authors.initials: YE
authors.lastname: Emond
authors.affiliation: Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, PO Box 9101, 114 IQ healthcare, 6500, HB, Nijmegen, The Netherlands. H.Calsbeek@radboudumc.nl.
authors.forename: Hiske
authors.initials: H
authors.lastname: Calsbeek
authors.affiliation: Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, PO Box 9101, 114 IQ healthcare, 6500, HB, Nijmegen, The Netherlands. Steven.Teerenstra@radboudumc.nl.|Radboud university medical center, Radboud Institute for Health Sciences, Dapartment for Health Evidence, section Biostatics, Nijmegen, The Netherlands. Steven.Teerenstra@radboudumc.nl.
authors.forename: Steven
authors.initials: S
authors.lastname: Teerenstra
authors.affiliation: Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, PO Box 9101, 114 IQ healthcare, 6500, HB, Nijmegen, The Netherlands. Gerrit.Bloo@radboudumc.nl.|Radboud university medical center, Radboud Institute for Health Sciences, Department of Anesthesiology, Pain and Palliative Care, Nijmegen, The Netherlands. Gerrit.Bloo@radboudumc.nl.
authors.forename: Gerrit J A
authors.initials: GJ
authors.lastname: Bloo
authors.affiliation: Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, PO Box 9101, 114 IQ healthcare, 6500, HB, Nijmegen, The Netherlands. Gert.Westert@radboudumc.nl.
authors.forename: Gert P
authors.initials: GP
authors.lastname: Westert
authors.affiliation: Radboud university medical center, Radboud Institute for Health Sciences, Department of Anesthesiology, Pain and Palliative Care, Nijmegen, The Netherlands. Johan.Damen@radboudumc.nl.
authors.forename: Johan
authors.initials: J
authors.lastname: Damen
authors.affiliation: Radboud university medical center, Radboud Institute for Health Sciences, Department of Anesthesiology, Pain and Palliative Care, Nijmegen, The Netherlands. Andre.Wolff@radboudumc.nl.
authors.forename: André P
authors.initials: AP
authors.lastname: Wolff
authors.affiliation: Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, PO Box 9101, 114 IQ healthcare, 6500, HB, Nijmegen, The Netherlands. Hub.Wollersheim@radboudumc.nl.
authors.forename: Hub C
authors.initials: HC
authors.lastname: Wollersheim
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005260:Female; D019983:Guideline Adherence / Q000191:economics; D006761:Hospitals / Q000592:standards; D006801:Humans; D008297:Male; D009426:Netherlands; D061214:Patient Safety / Q000191:economics / Q000592:standards*; D019990:Perioperative Care / Q000009:adverse effects / Q000191:economics / Q000379:methods / Q000592:standards*; D011183:Postoperative Complications / Q000517:prevention & control; D017410:Practice Guidelines as Topic