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van CCT (UK)

van CCT (UK)

Stepped implementation of Enhanced Recovery After Surgery in major gynaecological surgery

- candidate number15067
- NTR NumberNTR4058
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jul-2013
- Secondary IDs837003002 ZonMW
- Public TitleStepped implementation of Enhanced Recovery After Surgery in major gynaecological surgery
- Scientific TitleA cluster randomised controlled trial of a stepped implementation strategy that aims at the normalisation of the Enhanced Recovery After Surgery programme in major gynaecological surgery
- hypothesisTo implement the Enhanced Recovery After Surgery (ERAS) programme in elective gynaecological surgery on large scale in an (cost) effective manner is challenging. The traditional used breakthrough method for health care improvement on large scale showed at the best moderately positive effects and requires considerable investments in professional time and energy. The objective of this study is to compare the breakthrough programme with a new stepped approach designed to deliver an optimal effect of implementation efforts at the lowest possible costs.. It is hypothesised that the stepped implementation strategy is more effective compared to the traditional breakthrough methodology for the nationwide uptake of evidence based best practice.
- Healt Condition(s) or Problem(s) studiedGynaecological oncology, Elective abdominal surgery, Perioperative care
- Inclusion criteriaAll Dutch hospitals that are authorised in 2013 to perform major abdominal surgery in gynaecologic oncology patients are eligible for inclusion.
- Exclusion criteriaThe hospitals that are already participating in a structured and documented local perioperative improvement programme will be excluded from this study to avoid interference between programmes.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2013
- planned closingdate1-nov-2014
- Target number of participants14
- InterventionsThe intervention group receives an innovative stepped implementation 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.
- Primary outcomeThe primary outcome is length of postoperative hospital stay.
- Secondary outcomeAdditional outcome measures will be length of recovery, guideline adherence and implementation costs. An effect, economic, and process evaluation will be conducted throughout the trial.
- Timepoints- Retrospective baseline measurement
- Prospective monitoring of patient characteristics, process indicators and outcome measures during the one year implementation period.
- Evaluation of the effectiveness of both strategies every three months after every step or teaching session and at the end of the project. The timing of the teaching sessions of the breakthrough project will be synchronously with the timing of implementation steps.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe Enhanced Recovery After Surgery (ERAS) programme is an evidence-based perioperative management programme that aims at an early recovery after major surgical trauma and consequently at a reduced length of hospitalisation. The ERAS programme proved to be safe and is already standard care in colorectal surgery for many years. This study focuses on large scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands.
- Main changes (audit trail)
- RECORD2-jul-2013 - 15-jul-2013

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