Ranee Thakar1, Ipek Gurol-Urganci2,3, Nick Sevdalis4, Magdalena Jurczuk5, Posy Bidwell2, Dorian Martinez2, Louise Silverton6, Jan Van der Meulen3, Daniel Wolstenholme2. 1. Croydon University Hospitals NHS Trust, 530 London Road, Croydon, CR7 7YE, UK. 2. Centre for Quality Improvement and Clinical Audit, Royal College of Obstetricians and Gynaecologists, 10-18 Union Street, London, SE1 1SZ, UK. 3. Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK. 4. Centre for Implementation Science, Health Service and Population Research Department, King's College London, De Crespingy Park, London, SE5 8AF, UK. 5. Centre for Quality Improvement and Clinical Audit, Royal College of Obstetricians and Gynaecologists, 10-18 Union Street, London, SE1 1SZ, UK. mjurczuk@rcog.org.uk. 6. Royal College of Midwives, 10-18 Union Street, London, SE1 1SZ, UK.
Abstract
BACKGROUND: The Obstetric Anal Sphincter Injury (OASI) Care Bundle comprises four primary and secondary prevention practices that target the rising rates of severe perineal tearing during childbirth, which can have severe debilitating consequences for women. The OASI Care Bundle was implemented in 16 maternity units in Britain in the OASI1 project (2017-2018), which demonstrated the care bundle's effectiveness in reducing OASI rates. In OASI2, the care bundle will be scaled up to 20 additional National Health Service (NHS) maternity units in a hybrid effectiveness-implementation study that will examine the effectiveness of strategies used to introduce, implement and sustain the care bundle. METHODS:OASI2 is a two-arm cluster-randomised control trial (C-RCT) of maternity units in England, Scotland and Wales, with an additional non-randomised study arm. C-RCT arm 1 (peer support, n = 10 units) will be supported by 'buddy' units to implement the OASI Care Bundle. C-RCT arm 2 (lean implementation, n = 10 units) will implement without external support. The additional study arm (sustainability, n = 10 units) will include some original OASI1 units to evaluate the care bundle's sustainability and OASI rates over time, from before OASI1 and through the end of OASI2. Units in all three study arms will receive an Implementation Toolkit with training resources and implementation support. The C-RCT arms will be compared in terms of OASI rate reduction (primary effectiveness outcome) and clinicians' adoption of the care bundle (primary implementation outcome). Clinical data will be collated from maternity information systems; implementation data will be collected through validated surveys with women and clinicians, supplemented by qualitative methods. Descriptive statistics and regression modelling will be used for analysis. Emergent themes from the qualitative data will be assessed using framework analysis. DISCUSSION: OASI2 will study the impact of various implementation strategies used to introduce and sustain the OASI Care Bundle, and how these strategies affect the bundle's clinical effectiveness. The study will generate insights into how to effectively scale-up and sustain uptake and coverage of similar interventions in maternity units. A locally adaptable 'implementation blueprint' will be produced to inform development of future guidelines to prevent perineal trauma. TRIAL REGISTRATION: ISRCTN26523605.
RCT Entities:
BACKGROUND: The Obstetric Anal Sphincter Injury (OASI) Care Bundle comprises four primary and secondary prevention practices that target the rising rates of severe perineal tearing during childbirth, which can have severe debilitating consequences for women. The OASI Care Bundle was implemented in 16 maternity units in Britain in the OASI1 project (2017-2018), which demonstrated the care bundle's effectiveness in reducing OASI rates. In OASI2, the care bundle will be scaled up to 20 additional National Health Service (NHS) maternity units in a hybrid effectiveness-implementation study that will examine the effectiveness of strategies used to introduce, implement and sustain the care bundle. METHODS: OASI2 is a two-arm cluster-randomised control trial (C-RCT) of maternity units in England, Scotland and Wales, with an additional non-randomised study arm. C-RCT arm 1 (peer support, n = 10 units) will be supported by 'buddy' units to implement the OASI Care Bundle. C-RCT arm 2 (lean implementation, n = 10 units) will implement without external support. The additional study arm (sustainability, n = 10 units) will include some original OASI1 units to evaluate the care bundle's sustainability and OASI rates over time, from before OASI1 and through the end of OASI2. Units in all three study arms will receive an Implementation Toolkit with training resources and implementation support. The C-RCT arms will be compared in terms of OASI rate reduction (primary effectiveness outcome) and clinicians' adoption of the care bundle (primary implementation outcome). Clinical data will be collated from maternity information systems; implementation data will be collected through validated surveys with women and clinicians, supplemented by qualitative methods. Descriptive statistics and regression modelling will be used for analysis. Emergent themes from the qualitative data will be assessed using framework analysis. DISCUSSION: OASI2 will study the impact of various implementation strategies used to introduce and sustain the OASI Care Bundle, and how these strategies affect the bundle's clinical effectiveness. The study will generate insights into how to effectively scale-up and sustain uptake and coverage of similar interventions in maternity units. A locally adaptable 'implementation blueprint' will be produced to inform development of future guidelines to prevent perineal trauma. TRIAL REGISTRATION: ISRCTN26523605.
Entities:
Keywords:
Implementation; OASI Care Bundle; Obstetric anal sphincter injury; Quality improvement; Scale-up; Severe perineal tear
Authors: Posy Bidwell; Ranee Thakar; Ipek Gurol-Urganci; James M Harris; Louise Silverton; Alexandra Hellyer; Robert Freeman; Edward Morris; Vivienne Novis; Nick Sevdalis Journal: BMJ Open Date: 2020-09-09 Impact factor: 2.692
Authors: Katarina Ekelöf; Elisabeth Sæther; Anna Santesson; Maria Wilander; Katarina Patriksson; Susanne Hesselman; Li Thies-Lagergren; Heike Rabe; Ola Andersson Journal: BMC Pregnancy Childbirth Date: 2022-07-26 Impact factor: 3.105