title: A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial.
abstract: BACKGROUND
  Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands.
  
  
  METHODS
  All Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary outcome is length of postoperative hospital stay. Additional outcome measures are length of recovery, guideline adherence, and mean implementation costs per patient.
  
  
  CONCLUSIONS
  This study takes up the challenge to evaluate an efficient strategy for large-scale implementation. Comparing effectiveness and costs of two different approaches, this study will help to define a preferred strategy for nationwide dissemination of best practices.
  
  
  BACKGROUND
  Dutch Trial Register NTR4058.
authors.affiliation: Department of Family Medicine, CAPHRI, School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. jeanny.degroot@maastrichtuniversity.nl.|Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands. jeanny.degroot@maastrichtuniversity.nl.
authors.forename: Jeanny Ja
authors.initials: JJ
authors.lastname: de Groot
authors.affiliation: Department of Family Medicine, CAPHRI, School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. jose.maessen@mumc.nl.|Department of Quality and Safety, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands. jose.maessen@mumc.nl.
authors.forename: José Mc
authors.initials: JM
authors.lastname: Maessen
authors.affiliation: Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands. brigitte.slangen@mumc.nl.|GROW, School for Oncology and Developmental Biology, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands. brigitte.slangen@mumc.nl.
authors.forename: Brigitte Fm
authors.initials: BF
authors.lastname: Slangen
authors.affiliation: Department of Methodology and Statistics, CAPHRI, School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. bjorn.winkens@maastrichtuniversity.nl.
authors.forename: Bjorn
authors.initials: B
authors.lastname: Winkens
authors.affiliation: Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, P.O. Box 5800, 6202 AZ, Maastricht, the Netherlands. c.dirksen@mumc.nl.
authors.forename: Carmen D
authors.initials: CD
authors.lastname: Dirksen
authors.affiliation: Department of Family Medicine, CAPHRI, School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. trudy.vanderweijden@maastrichtuniversity.nl.
authors.forename: Trudy
authors.initials: T
authors.lastname: van der Weijden
mesh_terms: D002985:Clinical Protocols; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D009426:Netherlands; D019990:Perioperative Care / Q000379:methods; D011182:Postoperative Care / Q000379:methods*; D016730:Program Development; D058996:Quality Improvement / Q000458:organization & administration