Development and evaluation of the OASI Care Bundle: A quality improvement project

to reduce the rates of severe perineal trauma

Posy Bidwell & Alexandra Hellyer

What is an OASI?

An obstetric anal sphincter injury (OASI) is any degree of injury to the anal sphincter muscle sustained during childbirth.

Consequences

• Anal and urinary incontinence, chronic pain, infection

• Multiple attendances for hospital and community treatment

• Caesarean section for subsequent births

• Dyspareunia (painful sexual intercourse)

• Psychosocial disorders (including PTSD)

‘I have permanent

damage to my bowel, pelvic floor and nerve in

my left bum cheek’

‘My experience postnatally has made me terrified when I hear of

others who are about to give birth’

‘I don’t feel as if I’ll ever

be ok’

Why are we doing this?

Rates of OASI in the UK have risen over the last ten years from 1.8% to 5.9%, amounting

to 70,000 women being

affected during this period1

Long-term consequences can be debilitating causing complex

physical and psychosocial burdens which severely impact a

woman’s quality of life, as well a financial burden to the NHS 3

For many women there is no clear reason why they

sustain an OASI. However, underlying problems such as

inconsistencies in practice (e.g. ‘hands on’

or ‘hands poised’) have been identified as

contributing factors

1. GUROL-URGANCI, I. et al. Third- and fourth-degree perineal tears among primiparous women in England between 2000 and 2012: time trends and risk factors BJOG 2013; 120: 1516-25. 2. ABBOTT, D. et al. Obstetric anal sphincter injury. BMJ 2010; 341.

3. PRIDDIS, H. S. Autoethnography and severe perineal trauma—an unexpected journey from disembodiment to embodiment. BMC Women's Health 2015 ; 15: 88

Risk factors for OASI2

Nulliparity

South Asian ethnicity

Induction of labour

Birthweight > 4kg

Persistent occiptio-posterior

position

Prolonged second stage

Instrumental delivery

Evidence of successful interventions

• Norwegian experience that 50% of tears can be prevented through1

• Perineal support

• Women moving freely during birth and pushing in a comfortable position

• Women adopting a position during the last minutes of pushing to allow visualisation of the perineum and perineal support technique

• Mediolateral episiotomy on indication only

• Experiences in the UK • Croydon and Plymouth adopted similar package of interventions to Norway

• Decreased by 23% and 31%, respectively2,3

1Laine K et al. Incidence of obstetric anal sphincter injuries after training to protect the perineum. BMJ Open. 2012. 2Hollands H (personal communication 18 May 2015).

3Naidu M et al. Reducing obstetric anal sphincter injuries using perineal support a preliminary experience. Female Pelvic Medicine & Reconstructive Surgery. 20 (Supplement 1):S1-S40, July/August 2014.

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OASIS (%), all vaginal deliveries

Denmark

Sweden

Norway

Finland

Ullevål

Fredrikstad

Laine K et al. AOGS 2012

Laine K et al. EJOGRB 2009

The Scandinavian success story

Development of the OASI Care

Bundle

May 2014:

Summit held to discuss the increase in OASI. RCM & RCOG write a

joint statement of support for this work.

October 2014:

Working group of experts from RCM,

RCOG & LSHTM formed. Systematic

review of intrapartum interventions to reduce

OASI

November 2014:

OASI Care Bundle group discusses the

evidence and the acceptability and feasibility of each

identified intervention

March 2015:

OASI Care Bundle group participates in a consensus meeting to agree the elements of

the care bundle

January 2016:

Pilot study of the OASI Care Bundle in two

maternity units

May 2016:

Funding obtained from The Health Foundation

to upscale the OASI Care Bundle to sixteen

units as part of a quality improvement programme to reduce

OASI rates

What is a Care Bundle?

A care bundle is a small set of evidence-based interventions for a defined patient segment or population and care setting that, when implemented together, will result in significantly better outcomes than when implemented individually.

Institute for Healthcare Improvement

What does the OASI Care Bundle involve?

Inform the woman about OASI and what can be done

to minimize her risk.

When indicated, episiotomy should be performed

mediolaterally at a 60-degree angle at crowning.

Documented use of manual perineal protection (MPP):

- For spontaneous births, MPP should be used unless the woman objects, or her chosen birth position doesn’t allow for it. - For assisted births MPP should always be used.

Following birth, the perineum should be examined and any tears graded according to the RCOG guidance. The

examination should include a per rectum check even

when the perineum appears intact.

1

2

3

4

Implementation

What does implementation involve?

Multi-disciplinary skills development

module

Awareness Campaign

The Care Bundle

Local Champions attend a Skills Development Day • Training in interventions • Guidance and support in rolling out in their units Training materials provided: • e.g. videos, visual aids

• 4 evidence-based interventions that, when implemented together, will result in significantly better outcomes than when implemented individually.

• A Care Bundle Guide is provided

Such as posters, pens, balloons, memory aids,

newsletter

The intervention will be facilitated by: 1. Local clinical champions (one midwife and one obstetrician from each unit). They will champion the project including: ensuring that staff have completed the multi-disciplinary skills development module, monitoring local compliance with the care bundle, reporting on unit-level OASI rates, and participating in shared learning days with the other units in their block.

2. Leadership and support from professional organisations will be provided by the Royal College of Obstetricians and Gynaecologists (RCOG) and the Royal College of Midwives (RCM) who will actively promote the project and will provide a joint statement endorsing the use of care bundle. In addition, the professional and educational networks of the Colleges will be actively used to support the skills development module.

3. Continuous monitoring and feedback will allow participant units to measure their progress, by reporting their OASI rates, compliance with the care bundle, and uptake of the skills development module. Units will participate in shared learning days with other units to provide a forum to discuss the project as it progresses.

Theory of Change

Project set-up 2016 2017 2018

Region 1 Transition Implementation

Region 2

Region 3

Region 4

Evaluation Implementation outcomes Clinical outcomes

Dissemination

Planning Transition Implementation

Skills development

day

Shared learning day

Overall programme plan St

ages

in e

ach

re

gio

n

Where we are now

Evaluation

Study design

• Stepped-wedged design. Short-term exposure with continuous recruitment; women who have a vaginal birth become eligible and will receive the care bundle when the attending clinician has been trained to use it

• Stepped wedge is the most appropriate study design as the intervention aims to improve quality of care using a Care Bundle which brings together evidence-based practice1

• Implementation is staggered randomly in phases, allowing robust evaluation to take place

1. Hargreaves JR et al. Five questions to consider before conducting a stepped wedge trial. Trials, 2015. 16: 350

• Each region will be rolled out over a 3-month period. An estimated 3,280 women will be added per region over a 12 month period (totaling 32,800)

Number of eligible women in each time period

Was this a vaginal birth?

Was this birth eligible for use of the care

bundle?

Was this birth compliant with all four elements of the care

bundle?

Yes – eligible

No - not eligible

No – not eligible

A

C

B

Answer question B

Answer question C

Water birth or birthing stool

A caesarean section was performed

Was the clinician trained in using the care bundle?

All 4 elements of the care bundle used, if clinically

appropriate?

Eligibility and compliance

No – not

complaint

Yes – compliant to

the care bundle

Yes – eligible

Primary outcome: • Analysed retrospectively using anonymised patient-level

data (18 months) from local maternity information systems (MIS).

Secondary outcomes: • Quantitative and qualitative data used to provide

information about barriers and enablers with uptake and scaling-up interventions

• Implementation outcomes will be evaluated to assess acceptability, feasibility, coverage and sustainability of the intervention as well as the implementation strategies.

Evaluation of implementation outcomes

Standardised delivery of the evidence based

intervention

Improved knowledge, awareness & skills

Continued uptake & sustainability of the

intervention

Acceptability Satisfaction with

intervention

Feasibility Extent to which

intervention can be applied

Coverage Extent to which population

receive the intervention

Sustainability Extent to which

intervention is maintained

Clinicians at sites (128) • Readiness for change (RfC)

questionnaire prior to focus group

• Focus groups

Women (20) • Interviews

• Routine monitoring of basic data

Champions (64) • Readiness for change (RfC)

questionnaire prior to roll-out • Focus groups at the end of

transition phase • Follow-up interviews

Evaluation timeline

Planning Roll-out Implementation

Skills development

Shared learning day

Stag

es

in

eac

h b

lock

Feedback (champions)

Routine monitoring of basic data

Interviews (champions)

Focus groups & RfC measure

(clinicians)

Focus groups (champions)

Interview & RfC measure (champions)

Interviews with women

The importance of partnership

Women have said ‘oh, it’s really good to know that you

are doing something about it’

‘She [the head of midwifery] is

showing her support’

‘People are keen to share their

successes’

‘Powerful to have the support of the

RCM and the RCOG’

‘It feels nice when we work

together‘ ‘Taking part means

more evidence and I think people want to be part of that’

What have we learned so far?

Importance of

units being receptive to

change

Current

environment of unit, their research

capacity and their staffing

structures

Implementing change takes

time

Good feedback

mechanisms

Importance of engagement

local champions – vital for success

Crucial to have

top level support

‘Change is a big thing’

Acknowledgements

• The OASI Care Bundle Quality Improvement Project is hugely grateful to the champions at each of the 16 units, for their hard work and dedication to improving outcomes for women.

• The OASI Care Bundle Project is fully funded by The Health Foundation, UK

• Any questions, please contact: Dr Posy Bidwell, Research Fellow: pbidwell@rcog.org.uk

Alexandra Hellyer, Project Manager: ahellyer@rcog.org.uk