OASI2: Evaluation of strategies for care bundle implementation
Research type
Research Study
Full title
OASI2: a hybrid effectiveness implementation RCT to inform scale up of care bundle to reduce obstetric anal sphincter injury (OASI) caused during childbirth
IRAS ID
282750
Contact name
Ranee Thakar
Contact email
Sponsor organisation
Croydon Health Services NHS Trust
Duration of Study in the UK
1 years, 0 months, 31 days
Research summary
The OASI Care Bundle is a set of four interventions meant to reduce the risk of Obstetric Anal Sphincter Injury (OASI). OASIs can have severe, debilitating consequences for women including psychosocial problems and incontinence. The bundle’s clinical effectiveness was demonstrated in the preceding OASI1 study. In this study, OASI2, we will examine different implementation approaches to determine the minimum requirements for successful and sustainable scale-up of the OASI Care Bundle in NHS maternity units. We will identify what is necessary for successful adoption of interventions into routine maternity care and how to maintain their long term sustainability. \n\nParticipants in the OASI2 study are (1) midwives and obstetricians from NHS maternity units across England, Scotland and Wales that are participating in OASI Care Bundle implementation, and (2) women who give birth in participating units. Clinicians will share their perceptions of the care bundle and its implementation process, while women will share how the care bundle impacted their birth experience. \n\n10 maternity units that participated in the preceding OASI1 study have been invited to take part in the ’sustainability arm’ in OASI2. These 10 units are committed to sustaining the care bundle in their units and providing implementation support to other units. 20 new sites have been randomised into the ‘peer implementation’ or ‘lean implementation’ study arms. Peer implementation units receive continuous external implementation support from the sustainability units. Units in the lean implementation arm will not receive external support beyond the implementation toolkit that is provided to all units by the Project Team. The majority of implementation efforts will be carried out in the one-month transition period preceding the 12-month implementation period (November 2020-October 2021)\n\nOASI2 is a hybrid effectiveness-implementation trial that will measure both clinical and implementation outcomes. The co-primary outcomes are OASI rates, and adoption of the care bundle.
REC name
Social Care REC
REC reference
20/IEC08/0029
Date of REC Opinion
1 Dec 2020
REC opinion
Further Information Favourable Opinion