Stepped ImplementatioN of Enhanced Recovery in GynaecologY
Go to the SINERGY website.
To 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 breakthrough strategy that is usually applied in large scale improvement projects in the Netherlands.
A cluster randomised controlled trial. Cluster randomisation will be applied at hospital level.
All Dutch hospitals authorised to perform major abdominal surgery in gynaecologic oncology patients in 2013 are eligible for inclusion. Hospitals participating in a structured and documented local perioperative improvement programme during the study period will be excluded to avoid interference between the two programmes. The hospitals that already perform perioperative care according to the ERAS programme and meet predefined criteria of successful management, based on results of the retrospective baseline measurement, will also be excluded from this study.
The intervention group receives an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and builds 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.
In the control arm hospitals receive the traditional breakthrough strategy with educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities.
The primary outcome is length of postoperative hospital stay. Additional outcome measures will be length of recovery, guideline adherence and implementation costs. An effect, economic, and process evaluation will be conducted throughout the trial.
Based on a sample size calculation, seven hospitals with on average 60 patients per hospital would be needed in each study arm to detect a difference of 20% adherence to the benchmark of a postoperative stay of five days or less. We will not select a random sample from the existing population, and we do not expect drop outs among patients as informed consent procedures and filling in questionnaires by patients is not needed. Privacy of patientsí information is protected by coding and processing all data anonymously.
The mean implementation costs per patient will be calculated in both study arms and will be compared by means of bootstrap analysis.
The study will be initiated in 2013 and is planned to take three years.
Month 0-6: preparation of study and recruitment of hospitals
Month 7-8: retrospective baseline measurement
Month 9-20: implementation period
Last year: sustainability meetings, evaluation and report
T. van der Weijden, MD, PhD, Department of Family Medicine, CAPHRI, School for Public Health and Primary Care, Maastricht University Medical Centre
J.M.C. Maessen, PhD, Department of Patient Care, Maastricht University Medical Centre
B.F.M. Slangen, MD, PhD, Department of Obstetrics and Gynaecology, Maastricht University
This study is funded by ZonMw, the Netherlands Organisation for Health Research and Development
J.J.A. de Groot, PhD-student
Maastricht University, CAPHRI, Department of Family Medicine
Phone: 043 3882317