accompanying bundle booklet - women.wcha.asn.au · 4 wha accompanying bundle booklet 05.07.2018...
TRANSCRIPT
Accompanying Bundle Booklet
2
WHA Accompanying Bundle Booklet 05.07.2018
3
WHA Accompanying Bundle Booklet 05.07.2018
Contents _Toc499219107
BACKGROUND .................................................................................................................................................................. 4
ABOUT INTERVENTIONS BUNDLES ........................................................................................................................... 5
HOW TO USE THIS BOOKLET ....................................................................................................................................... 6
RISK FACTORS .......................................................................................................................................................................................... 7 PATIENT INFORMATION AND CONSENT ................................................................................................................................................ 7
COMPONENTS OF THE INTERVENTIONS BUNDLE ................................................................................................ 8
FOR ALL WOMEN. ............................................................................................................................................................ 9
1. APPLY WARM PERINEAL COMPRESSES DURING THE SECOND STAGE OF LABOUR AT THE COMMENCEMENT OF PERINEAL
STRETCHING. .................................................................................................................................................................................. 9 2. WITH A SPONTANEOUS VAGINAL DELIVERY, USING GENTLE VERBAL GUIDANCE, TO ENCOURAGE A SLOW CONTROLLED
BIRTH OF THE FETAL HEAD AND SHOULDERS: ........................................................................................................................ 10 a. support the perineum with the dominant hand ....................................................................................................... 10 b. apply counter-pressure on the fetal head with the non-dominant hand ...................................................... 10 c. if shoulders do not deliver spontaneously, apply gentle traction to release the anterior shoulder . 10 d. allow the posterior shoulder to be released following the curve of Carus ................................................... 10
WHEN EPISIOTOMY IS INDICATED ......................................................................................................................... 12
3. EPISIOTOMY SHOULD BE PERFORMED: .................................................................................................................................... 12 a. at crowning of the fetal head ........................................................................................................................................... 12 b. using a medio-lateral incision .......................................................................................................................................... 12 c. at a minimum 60 degree angle from the fourchette .............................................................................................. 12
FOR ALL WOMEN .......................................................................................................................................................... 14
4. GENITO-ANAL EXAMINATION NEEDS TO: ................................................................................................................................. 14 a. be performed by an experienced clinician .................................................................................................................. 14 b. include a PR examination on all women, including those with an intact perineum ............................... 14
5. ALL PERINEAL TRAUMA SHOULD BE ......................................................................................................................................... 15 a. graded according to the RCOG grading guideline .................................................................................................. 15 b. reviewed by a second experienced clinician to confirm the diagnosis & grading .................................... 15
WOMEN’S INVOLVEMENT .......................................................................................................................................... 16
ENSURING CONTINUOUS QUALITY IMPROVEMENT .......................................................................................... 17
DATA COLLECTION, FEEDBACK AND EVALUATION .......................................................................................... 18
MEASURES FOR IMPROVEMENT ........................................................................................................................................................... 18 EVALUATION OF THE CARE BUNDLE .................................................................................................................................................... 19 WHAT THIS MEANS FOR YOU AND YOUR TEAM ................................................................................................................................. 20
REFERENCES .................................................................................................................................................................. 21
4
WHA Accompanying Bundle Booklet 05.07.2018
Background
Approximately 75% (n=172,700) of all women who give birth in Australia each year
sustain some form of perineal tear1. More than 3.6% (n=6,365)1 of these women will
sustain third and fourth degree tears which have the potential for long term, or
even lifelong, impact on their wellbeing. Australian data shows a year on year
increase in the number of women who sustain third and fourth degree tears2. This
rising rate of harm from tears is occurring despite a declining vaginal birth rate.
There is considerable variation in rates of third and fourth degree tears between
hospitals. This variation is not specific to different service capabilities. Hospitals
supporting more than 500 births p.a. reported rates of third and fourth degree tear
ranging between 1.3% and 5.6%, with an average of 3.43%3. For hospitals
supporting less than 500 births per annum the rates varied from 0% to 10%, with an
average of 2.46%3. This variability in rates of tears indicates that local practices,
including the grading of tears, have an impact on rates of tears and that there is
potential for improvement to occur.
The consequences of such injuries include both physical and psychological
morbidities4,5. Long-term complications of perineal tears include anal
incontinence, urinary incontinence, chronic pain and dyspareunia6. This trauma
has been shown to have a detrimental psychosocial impact on women requiring
ongoing intervention. It has also been shown that the trauma of sustaining a
perineal tear and its complications can effect subsequent births choices where a
vaginal birth is forsaken, increasing rates of elective caesarean section7.
The financial impact on the Australian health care system is also substantial. The
overall inpatient cost is estimated to reach $58 million annually. In addition the
estimated cost of outpatient care of the woman with a perineal tear costs
approximately $6 million every year8. In Australia, WHA members have anecdotally
advised that successful claims are typically between $80,000 and $300,000 each.
Costs of litigation arising from third and fourth degree tears is also a consideration.
While Australian data is scarce, in the United Kingdom it has been reported that
between 2000 and 2010 there were 441 successful claims alleging negligence after
women sustained perineal trauma9. The total value of these claims was estimated
to be £31.2 million, and is reported to relate primarily to third and fourth degree
perineal tears.
In England, the rate of third and fourth degree tears has tripled over the last 10
years, increasing from 1.8% to 5.9% in singleton, term, cephalic, vaginal first births10.
The incidence of perineal tears in the UK is 2.9% (range 0—8%), with an incidence
of 6.1% in primiparous and 1.7% in multiparous women11. As a result of the
increasing rates of perineal trauma, the National Health Service has commenced
a national collaborative improvement project which is progressively being rolled
out in maternity services around the UK in 2016 – 2018.
5
WHA Accompanying Bundle Booklet 05.07.2018
About interventions bundles
The US Institute for Healthcare Improvement (IHI) developed the concept of a
bundle to describe a collection of interventions needed to reliably deliver the
best possible care and safety for patients. They define an interventions bundle as
a set of evidence-based interventions that, when reliably implemented together
will result in significantly improved outcomes than when implemented
individually12.
A bundle should consist of a small number, usually three to five, of evidence
based interventions. Each of these interventions can be separately implemented
in each episode of care. A bundle brings changes together into a package of
interventions that must be followed for every patient, every single time.
Interventions bundles are effective in ensuring evidence base practices are
consistently performed by all staff within a clinical service. Monitoring compliance
with each component of the bundle enables individual unit to assess the impact
of the intervention bundle within their unit. Women should be informed of the
care bundles prior to their birth.
Care Bundle development
An expert panel was formed with representation from around Australia including
midwives, obstetricians, urogynaecologists and consumer representatives. The
panel met on two occasions to evaluate evidence from current systematic
reviews, source articles and best practice methodology to determine the
interventions that could reliably reduce rates of third and fourth degree tears. In
addition to the quality of evidence, other factors were taking into account in the
selection process including patient acceptability and feasibility.
Testing of the interventions bundle then occurred using QI 1, 3, 5 methodology to
evaluate the ability to implement and evaluate the bundle effectiveness. Initial
testing sites provided input which resulted in continuous improvement to bundle
terminology, measurement and supporting resources. The interventions bundle
was well received by obstetricians, urogynaecologists, midwives and consumers.
6
WHA Accompanying Bundle Booklet 05.07.2018
How to use this booklet
This booklet provides information on how to perform all components and
implement the Interventions bundle. The effectiveness of the Bundle is
dependent upon the conscientious application of all components including;
1) the effectiveness of local change leaders,
2) the quality of the educational programme,
3) the compliance with the bundle
The booklet describes the five evidence-based components that form the WHA
National Collaborative Interventions Bundle that when implemented together will
reduce the risk of third and fourth degree tears for women giving birth in
participating hospitals.
Included in the booklet are recommendations on communicating with the woman
about the elements of the bundle and suggested wording for documentation
related to the interventions bundle. The bundle will be supported by an
educational resources package and facilitated coaching by experts in
improvement science that aims to achieve reliable sustained improvements in
patient care.
This booklet is intended for use by all midwives and obstetricians at participating
hospitals and health services. The term ‘clinician’ is used which refers to both
midwives and obstetricians irrespective of the level of experience. Local training
on how to use the care bundle is essential to its success. The accompanying
educational resource package is designed to support participating teams to
increase reliability of implementation. Those championing change within each
service are responsible for ensuring that staff are provided with sufficient training
to enable them to carry out all elements safely and effectively.
The Interventions Bundle is compatible with clinician discretion and does not
replace reasonable clinical judgement. The interventions should be implemented
with consideration of local policies and procedures related to, but not limited to:
operative vaginal births
maternal position
Informed consent
communication
episiotomy
perineal assessment, and
management of tears.
7
WHA Accompanying Bundle Booklet 05.07.2018
Risk Factors
Clinicians must be aware of the risk factors for sustaining a third and fourth degree
perineal tear (included in table 1 below). However, it should also be remembered
that even without these specific risk factors, a woman may sustain a perineal tear
and therefore the Interventions Bundle should still be applied.
Antenatal Risk factors:
Nulliparous
Asian/ Indian ethnicity
Posterior fourchette to mid-anus < 2.5cm
Previous 3rd and 4th degree tear
Previous shoulder dystocia
Intrapartum Risk Factors
This baby in OP position at delivery
Birthweight estimated at delivery > 4 kgs
Shoulder dystocia at delivery
Table 1 Risk factors for third and fourth degree tears14:
Information for Women and consent
An information leaflet for Women has been finalised for use. It is envisaged that it
will be provided to all women at an antenatal appointment between 32-36
weeks. The clinician should explain the Interventions bundle and respond to any
questions or concerns the woman may have. It is envisaged that in the future
copies of this leaflet be displayed and available at services frequented by
prenatal women including ultrasound departments, antenatal clinics and
consultant waiting rooms.
8
WHA Accompanying Bundle Booklet 05.07.2018
COMPONENTS OF THE INTERVENTIONS BUNDLE
Perineal support should be able to be applied in most positions women choose to
adopt for birth. With the exception of a birthing stool or water immersion, all other
positions should allow the clinician to visualise the perineum and use their hands
to support it at the time of birth. Women should be encouraged to mobilize freely
during labour and to choose their preferred position for birth. A woman can be
advised of their increased risk of tears in their chosen position but should not be
FOR ALL WOMEN.
1. Apply warm perineal compresses during the second stage of
labour at the commencement of perineal stretching.
2. With a spontaneous vaginal delivery, using gentle verbal
guidance, to encourage a slow controlled birth of the fetal head
and shoulders:
a. support the perineum with the dominant hand
b. apply counter-pressure on the fetal head with the non-
dominant hand
c. if the shoulders do not deliver spontaneously, apply
gentle traction to release the anterior shoulder
d. Allow the posterior shoulder to be released following the
curve of Carus
WHEN EPISIOTOMY IS INDICATED
3. Episiotomy should be performed:
a. at crowning of the fetal head
b. using a medio-lateral incision
c. at a minimum 60 degree angle from the fourchette NB: An episiotomy is indicated for all women requiring a forceps or vacuum assisted delivery having their
first vaginal birth
FOR ALL WOMEN
4. Genito-anal examination following birth needs to:
a. be performed by an experienced clinician
b. include a PR examination on all women, including those
with an intact perineum
5. All perineal trauma should be
a. graded according to the RCOG grading guideline
b. reviewed by a second experienced clinician to confirm
the diagnosis & grading
a. support the perineum with the dominant hand
9
WHA Accompanying Bundle Booklet 05.07.2018
prevented from adopting this position. If an instrumental delivery is required a
women will need to adopt a suitable position for this to occur.
FOR ALL WOMEN.
1. Apply warm perineal compresses during the second stage of labour
at the commencement of perineal stretching.
Warm packs applied during the second stage of labour reduce the risk of third
and fourth degree tears16 and intrapartum perineal pain16, 17. The use of a
standard hospital perineal pad with water of a safe temperature should be
applied to all women at the commencement of perineal stretching, with the
exception of women having a water birth.
Temperature of the warm compress
Ensure water is the correct temperature by:
1. Adding 300mls of boiling water to 300mls of cold tap water (cold water
should be added first for safety)
Or
2. Using a temperature controlled tap that has been tested to deliver water
between 38-44oC
3. Prior to application test water temperature in the same way a baby’s bath
water is checked
4. Replace water entirely every 15 minutes to ensure a correct temperature is
maintained
5. Do NOT ‘top up’ or add hot water as a correct temperature cannot be
maintained
6. Check the colour of the skin after application for signs of excessive heat.
Communication
Provision of information about the benefits of reducing perineal tears should be
provided. It is important to warn the woman about the risk of overheating and
ask her to report any discomfort. If a women requests to remove the warm
compress at any stage their preferences should be followed. It is reasonable to
suggest reapplying a warm compress at a later stage with consent of the
labouring women. The amount of time the compress was in place and any
reasons for removal should be documented in the patient notes.
It is acceptable to use warm compresses in the presence of an epidural
providing due care in taken to the assessment of the heat of the warm compress
prior to its application as the woman may not be able to necessarily discriminate
the temperature.
10
WHA Accompanying Bundle Booklet 05.07.2018
2. With a spontaneous vaginal delivery, using gentle verbal guidance, to
encourage a slow controlled birth of the fetal head and shoulders:
a. support the perineum with the dominant hand
b. apply counter-pressure on the fetal head with the non-dominant
hand
c. if shoulders do not deliver spontaneously, apply gentle traction
to release the anterior shoulder
d. allow the posterior shoulder to be released following the curve of
Carus
Slowing the birth of the fetal head at the time of crowning may reduce the risk of
perineal trauma16. Techniques to control speed of birth can be performed in most
birthing positions that the woman adopts. The following techniques should be used
for all births to reduce rapid expulsive force and encourage birth to occur in a slow
controlled manner 18:
1) Encourage the woman to minimise active pushing using gentle verbal
guidance. The use of controlled slowed or shallow maternal breathing
should be used to birth the baby slowly.
2) Support of the perineum with the dominant hand (* with the exception of
women having a water birth)
3) Applying counter pressure to the fetal head using the non-dominant hand
to control the fetal head15 (* with the exception of women having a water
birth).It is important for the clinician to evaluate the speed at which the
head is progressing to allow the use of appropriate pressure i.e.to allow
progress but prevent uncontrolled expulsion.
4) Once the head has been delivered, wait for restitution to occur.
5) Continue to support the perineum as you encourage the mum to push
gently to birth the shoulders. In the event that the shoulders do not delivery
spontaneously, remove the dominant hand and apply gentle downward
traction or as appropriate to the women’s position e.g. on all fours traction
is upwards, towards the accoucheur. If she is standing and you are in front
of her, the traction is applied anterior or forward etc.
6) Allow the posterior shoulder to be released following the curve of Carus,
protecting the perineum throughout this step.
7) Support is provided to the baby’s body by moving both hands.
Although access to the perineum is necessary for the achievement of perineal
support at crowning, it should never be a reason to restrict a woman’s movement
during the second stage. The clinician may need to adjust their position in order to
11
WHA Accompanying Bundle Booklet 05.07.2018
allow visualisation and support of the perineum. Perineal support can be provided
in most positions including semi-recumbent, lateral and ‘all fours’ (hands and
knees). There is no clear evidence that any particular position has a significantly
protective effect on the perineum.
Instrumental Assisted Births
Perineal support should also be used during assisted births when using either
forceps or vacuum. In these instances, the technique for perineal support is
modified. If a single clinician is performing the instrumental procedure, at the point
at which the fetal head is extending, then the clinician should change the hand
controlling the instrument from the dominant hand to the non-dominant hand and
use the dominant hand to support the perineum (including after an episiotomy has
been cut) If two clinicians are available during an instrumental birth, the assistant
will apply support from one hand on the perineum during the birth of the fetal head
(including after the episiotomy has been cut) by the instrument of choice. On
crowning, the clinician should control the speed of the birth of the head and
control the delivery of the shoulders.
Communication
The use of verbal guidance to encourage a slow controlled birth should be used
by encouraging women to slow their breathing and control their pushes on
crowning of the fetal head. This allows the perineum to accommodate the gradual
stretching caused by the head, thereby reducing the risk of tearing by
uncontrolled expulsion.
If a woman has chosen a birthing position which restricts access to the perineum
and the clinician has concerns about a women’s individual risk for a third or fourth
degree tear (see risk factors on page 7) they may recommend that the woman
adopts a position which allows for perineal support.
Unless the baby’s condition is critical, once the head is born, the clinician should
encourage the women to refrain from pushing until restitution occurs (external
rotation of the baby’s head and internal rotation of the shoulders). Due to ongoing
risk to the perineum, care should be taken during the birth of the shoulders and
perineal support should be continued as the shoulders are delivered.
IMPORTANT PRINCIPLES ARE:
• Coaching the mum to avoid sudden expulsive push
• Maintaining gradual progress during the birth of the head
• No undue downward traction during delivery of the shoulders
• Support the perineum throughout the whole birth Royal College of Obstetricians and Gynaecologists , OASIS Care Bundle19
12
WHA Accompanying Bundle Booklet 05.07.2018
WHEN EPISIOTOMY IS INDICATED
3. Episiotomy should be performed:
a. at crowning of the fetal head
b. using a medio-lateral incision
c. at a minimum 60 degree angle from the fourchette
There is evidence that selective use of episiotomy reduces the risk of third and
fourth degree tears during instrumental delivery19. All primiparous women,
including women having the first vaginal birth ie VBAC who require a forceps or
vacuum assisted delivery should have an episiotomy.
An episiotomy should be performed at a 60-degree angle on the woman’s right as
the baby’s head is crowning. Due to stretching and distortion of the perineum
during the second stage, an episiotomy cut at less than 60o results in a episiotomy
suture line closer to 45o angle, which has been shown to increase the risk of a third
and fourth degree tear20. All midwives and obstetricians should have the
performance of an episiotomy within their scope of practice.
Episiotomy should only be considered after clinical assessment of the fetal and
maternal risks for multiparous women and for women not requiring forceps or
vacuum assisted deliveries.
It is important to remember that 16% of women report severe pain levels during
perineal procedures21. It is therefore important to ensure adequate pain relief prior
to and during the procedure (e.g. lignocaine infiltration, nitrous gas inhalation, or
epidural):
1) Explain the rational for performing the episiotomy and obtain the woman’s
informed consent
2) Ensure adequate analgesia and check that it is effective prior to procedure
3) Cut an episiotomy by starting at the fourchette and directing the incision
away from the perineal midline at an angle of 60 degrees22.
Tools should be used and training provided to facilitate achievement of the 60
degree angle. Alternatively if available the use of scissors that indicate the correct
episiotomy angle can be used29.
In the context of this care bundle, episiotomy is indicated in cases of suspected or
confirmed fetal compromise, delayed second stage of labour, instrumental
delivery, and in cases when a severe perineal tear is judged to be imminent (feel
digitally for remaining space/stretch), for example where the blood flow to the
perineum is significantly reduced, or if 'button-holing' is occurring during the
second stage of labour.
13
WHA Accompanying Bundle Booklet 05.07.2018
Communication
It is important that the clinician communicates the reason why an episiotomy is
being considered with the woman. For example, if the episiotomy is being
performed when there are no immediate concerns about fetal wellbeing and the
episiotomy is only being performed in an attempt to protect the perineum, the
woman should be made aware of the equivocal nature of the evidence for this
intervention.
As with any intervention, the woman should give her agreement before an
episiotomy is performed.
14
WHA Accompanying Bundle Booklet 05.07.2018
FOR ALL WOMEN
4. Genito-anal examination needs to:
a. be performed by an experienced clinician
b. include a PR examination on all women, including those with an
intact perineum
Accurate diagnosis and effective care of perineal injuries requires systematic
perineal assessment23. Following ALL BIRTHS, a thorough examination of the
perineum should be carried out by an experienced clinician. This assessment
must include a rectal examination as recommended by NICE 24 and should be
carried out even when the perineum appears intact as visual examination alone
often results in underestimation of the degree of trauma25.
It is often difficult to determine if the internal anal sphincter is damaged. Careful
inspection by an experienced clinician is required. We recommended that a rectal
examination is performed using the following technique25.
1. Insert the index finger into the anus and ask the woman to squeeze:
The separated ends of a torn external anal sphincter will retract
backwards and a distinct gap will be felt anteriorly
When regional analgesia affects muscle power, assess for gaps or
inconsistencies in the muscle bulk of the sphincter by placing the
index finger in the anal canal and the thumb in the vagina and
palpate by performing a ‘pill-rolling motion’
2. Assess the anterior rectal wall for overt or occult tears by palpating and
gently stretching the rectal mucosa with the index finger
Any tears should be classified according to the RCOG and documented in the
client notes.
Communication
The clinician should explain to the women the reason why the examination is being
performed and how they will do it. The clinician should ensure that the woman is
comfortable with adequate analgesia .e.g entonox. Consideration of the cultural
needs of the women and their right to privacy should be considered. The woman’s
preferred support person should be present if she desires this, to provide support to
the woman and her baby.
If a tear is identified, and following its appropriate repair, a detailed discussion and
the provision of written information is required. Follow up should be offered for any
women assessed as receiving a third or fourth degree tear.
15
WHA Accompanying Bundle Booklet 05.07.2018
5. All perineal trauma should be
a. graded according to the RCOG grading guideline
b. reviewed by a second experienced clinician to confirm the
diagnosis & grading
Perineal injuries sustained during childbirth are most often classified by the
degree to which the perineum tears. It is important that assessment and grading
is performed by an experienced clinician trained in perineal assessment and alert
to risk factors25. A second clinician should review any tear to confirm the
diagnosis and the extent of the injury25. Refer to table 2 below regarding grading
of tears.
Table 2. Grading of perineal tears
Degree of perineal tear13
First-degree tear: Injury to perineal skin and/or vaginal mucosa.
Second-degree tear: Injury to perineum involving perineal muscles
but not involving the anal sphincter.
Third-degree tear: Injury to perineum involving the anal sphincter
complex:
Grade 3a tear: Less than 50% of external anal sphincter (EAS)
thickness torn.
Grade 3b tear: More than 50% of EAS thickness torn.
Grade 3c tear: Both EAS and internal anal sphincter (IAS) torn.
Fourth-degree tear: Injury to perineum involving the anal sphincter
complex (EAS and IAS) and anorectal mucosa.
For grading purposes an episiotomy should NOT be graded as a second degree
perineal tear.
A perineal tear that goes beyond the planned episiotomy incision, should be
recorded as an episiotomy with extension and graded according to the degree
of perineal trauma.
For example;
1) A women who has been given an episiotomy prior to vaginal birth and
ends up with a tear that exposes the fat in ischio-rectal fossa with both
sphincters intact, should be graded as both an episiotomy with extension
and a grade 2 tear.
2) A women who has a planned episiotomy who has both EAS and internal
anal sphincter (IAS) torn should be graded as both an episiotomy with
extension and a grade 3c tear.
3) An episiotomy that does not extend should be graded as No Tear.
16
WHA Accompanying Bundle Booklet 05.07.2018
Where indicated repair should occur as soon as practicable after birth. There
should be consideration of the needs of the women and support of uninterrupted
skin-to-skin contact post birth with the risk of infection and blood loss. It is
important that staff are trained in the diagnosis and repair of tears. Senior
obstetricians should be consulted for any grade 3 or 4 injuries. Refer to local
procedures techniques for perineal repair.
Communication
Following perineal examination, a discussion with the woman of the findings and
proposed treatment should occur. Written information should also be provided
and an appropriate level of follow up arranged.
Women’s involvement
It is important that all women giving birth in your maternity unit are aware of the
interventions bundle and how this influences their care. An information leaflet has
been developed that should be provided at an antenatal visit from 32-36 weeks.
It will also be provided as part of the interventions bundle paperwork to help inform
the women at the time of delivery if feasible. It will be important to discuss the
interventions bundle with the woman: identify any potential risk factors; outline how
the bundle will influence their care; and answer any questions they may have.
The involvement of women in the process of quality improvement is very important
to ensure techniques implemented are acceptable to the patient population. The
WHA involved female consumers in many aspects of planning and development
of the Collaborative. Feedback was particularly valuable in the development of
educational resources and the development of the evaluation framework.
17
WHA Accompanying Bundle Booklet 05.07.2018
Ensuring Continuous Quality Improvement
To improve healthcare and the way it is delivered, change must occur. Not all
changes result in improvement, but all improvement starts with acknowledging
that change is needed. Reliable processes are those that occur every time, for
every woman, tailored to each woman’s preferences. When using intervention
bundles and all-or-none measurements, care is changed in important ways27. This
includes:
challenging the assumption that evidence-based care is being delivered
reliably
promoting awareness that the entire care team work together in a system
designed for reliability
promoting the use of improvement methods to redesign care processes27
The use of quality improvement methods to facilitate the implementation of the
interventions bundle in your maternity unit will be supported through training in
improvement methodology and 1:1 coaching.
Changes do not need to be implemented in their entirety overnight. ‘Plan Do Study
Act’ (PDSA) cycles are used to test changes, to assess their impact and to ensure
that new ideas improve quality and safety of care before implementation on a
wider scale28. In this project, facilitated PDSA cycles will be used to support your
team with the implementation of the bundle in your maternity unit. This means that
we will introduce the care bundle to a small cohort of women initially, then review
and modify the approach before implementing it with a larger group of women,
and so forth until the intervention is fit for purpose and implementation among all
agreeing women. Incremental roll-out allows for the introduction of new systems
without disrupting existing systems28.
18
WHA Accompanying Bundle Booklet 05.07.2018
Data collection, feedback and evaluation
Measures for improvement
Measurement is critical to quality improvement and allows us to determine
whether changes made result in benefit or improvement.
Many quality improvement initiatives involve making changes to processes, and
performing them in a consistent and reliable way, in order to positively influence
outcome and establish reliable sustained improvements29. Balancing measures are
used to monitor whether a change that is designed to improve one part of the
system has unforeseen impacts on another part of the system29.
This Collaborative aims to improve outcomes for women by reducing the rate of
avoidable third and fourth degree tears. A set of measures will be used in this
Collaborative to evaluate the care bundle used to try to achieve this aim [Figure
1]. Your team will learn more about project measures, how they will be collected,
and how to use the measures to support change and improvement in your
maternity unit in Learning Set 1.
19
WHA Accompanying Bundle Booklet 05.07.2018
Evaluation of the care bundle
To better understand whether changes are resulting in improvement to outcomes,
we will also ask teams to collect data on maternal characteristics (e.g. age, BMI,
parity) and intra partum care (induction of labour, mode of delivery, epidural use
and shoulder dystocia) to adjust for case mix and risk factors. Rates of Caesarean
section will also be examined.
Implementation outcomes will be evaluated through evidence of integration of
the care bundle into routine practice i.e. reliability and sustainability, as well as an
assessment of acceptability and feasibility of the interventions.
Evaluation measures for Collaborative
Risk Factors Antenatal
Parity Mode of birth
Asian/ Indian ethnicity Epidural analgesia
Posterior fourchette to mid-
anus < 2.5cm
Episiotomy rate
Previous 3rd degree tear Caesarean section rate
Previous shoulder dystocia
Intrapartum Risk Factors
Length of 2nd stage
(primp/Multip)
O-P position at birth Number of deliveries/ unit
Shoulder dystocia at birth
Birthweight at delivery > 4kgs
Compliance
Compliance with Implementation of Bundle
Provision of patient information leaflet (%
Women who receive)
Post partum referral for third or fourth degree
tear
Figure 1
Type What is measured? Frequency of reporting
Outcome Rate of third and fourth degree
perineal tears in vaginal births
Monthly
Process % Compliance with each
component of bundle
% Compliance with all
components of bundle
Weekly
Balancing Caesarean Section Rate
Episiotomy Rate
Monthly
20
WHA Accompanying Bundle Booklet 05.07.2018
What this means for you and your team
The Collaborative implementation period will run from November 2017 through to
December 2018. During this time, your team will be asked to submit de-identified
patient data. An excel data template is available for baseline data collection. This
template will automatically generate run charts and pareto charts which will be
used by the Improvement Advisor to guide your initial coaching session.
A separate template (that auto-generates charts) will be provided for continuous
data collection to monitor ongoing improvement. The Improvement Advisor will
refer to these on a monthly basis. The charts can also be used to provide feedback
to staff in your birthing unit and other key people in your organisation, including
your executive sponsor.
A clinician operated quality improvement platform (QUIDS) is available to support
the quality improvement activities, create driver diagrams, record PDSA and share
learning/experiences across the participating hospitals.
Implementation outcomes will be evaluated through evidence of integration of
the care bundle into routine practice i.e. reliability and sustainability of system
improvement, as well as an assessment of acceptability and feasibility of the
interventions.
Monitoring and feedback during roll-out
A process of continuous data collection, evaluation and feedback will be used to
support implementation within participating hospitals. A clinician operated data
platform will be utilised that supports entry of de identified patient data. The data
platform allows real time evaluation of run charts and facilitates the preparation
of monthly reports. Monthly reporting will be utilised by clinical units to feedback
improvement on key process and outcome measures to clinical teams and
Executive sponsors.
21
WHA Accompanying Bundle Booklet 05.07.2018
References
1. AIHW. (2016a). Australia's mothers and babies 2014 - in brief. Perinatal statistics
seriers no. 32. Cat no. PER 87. AIHW: Canberra. Retrieved from Perineal status,
2016.
2. AIHW. (2016b). National Hospital Morbidity Database - Procedures and healthcare
interventions (ACHI 8th edition), Australia, 2013-14. Canberra: Australian Institue of
Health and Welfare, 2016
3. WHA. (2016). Benchmarking maternity care data 2015-16 [unpublished].
Canberra: Women's Healthcare Australasia, 2016.
4. Beckmann, M. M., & Stock, O. M. Antenatal perineal massage for reducing
perineal trauma. Cochrane Database of Systematic Reviews, 2013.
5. Farrar, D., Tuffnell, D. J., & Ramage, C. Interventions for women in subsequent
pregnancies following obstetric anal sphincter injury to reduce the risk of recurrent
injury and associated harms. Cochrane Database of Systematic, 2014.
6. Haadem K, Dahlstrom JA, Ling L and Ohrlander S. Anal sphincter function after
delivery rupture. Obstetrics and Gynaecology, 1987. 70 (1):53-6.
7. Evans C, Archer R, Forrest A and Barrington J. Management of obstetric anal
sphincter injuries (OASIS) in subsequent pregnancy. Journal of Obstetrics and
Gynaecology. 2014, 34(6):486-8.
8. WHA. (2017). WHA Activity and Costing Reports 2015-16 – Women’s Hospitals CEO’s
[unpublished]. Canberra: Women's Healthcare Australasia, 2017.
9. NHS Litigation Authority. Ten Years of Maternity Claims. An Analysis of NHS
Litigation Authority Data. London, 2012.
10. Gurol-Urganci I, Cromwell DA, Edozien LC, Mahmood TA, Adams EJ, Richmond
DH, et al. Third-and fourth-degree perineal tears among primiparous women in
England between 2000 and 2012: time trends and risk factors. British Journal of
Obstetrics and Gynaecology, 2013. 120 (12):1516-25.
11. Thiagamoorthy G, Johnson A, Thakar R and Sultan AH. National survey of perineal
trauma and its subsequent management in the United Kingdom. International
Urogynecology Journal, 2014. 25 (12):1621-7.
12. Institute for Healthcare Improvement. Bundle up for safety [cited 2015 26 June
2017]. Available from:
http://www.ihi.org/resources/Pages/ImprovementStories/BundleUpforSafety.aspx.
13. Royal College of Obstetrics and Gynaecology (RCOG). The Management of
Third-and Fourth-Degree Perineal Tears. Green-top guideline No. 29. London:
Royal College of Obstetricians and Gynaecologists, 2015
14. Dahlen H, Ryan M, Homer C, Cooke M. An Australian prospective cohort study of
risk factors for severe perineal trauma during childbirth. Midwifery. 2006; 23:196-
203. 6.
15. Aasheim V, Nilsen ABVika, Lukasse M, Reinar L. Perineal techniques during the
second stage of labour for reducing perineal trauma. Cochrane Database of
Systematic Reviews. 2011; Issue 3.
16. Albers L, Borders N. Minimising genital tract trauma and related pain following
spontaneous vaginal birth. Journal of Midwifery Womens Health. 2007; 52:246-253
17. Dahlen H, Homer C, Cooke M, Upton A, Nunn R, Brodrick B. ‘Soothing the ring of
fire’: Australian women’s and midwives’ experience of using perineal warm packs
in the second stage of labour. Midwifery. 2009; 25:e39-e48.
18. Basu M, Smith D, Edwards R. Can the incidence of obstetric anal sphincter injury
be reduced? The STOMP experience. European Journal of Obstetrics &
22
WHA Accompanying Bundle Booklet 05.07.2018
Gynecology and Reproductive Biology. 2016 Jul 31;202:55-9.Jiang H, Qian X,
Carroli G, Garner P. Selective versus routine use of episiotomy for vaginal birth. The
Cochrane Library. 2017.
19. Royal College of Obstetricians and Gynaecologists(RCOG), OASIS Care Bundle;
Implementation guide for maternity units in the roll-out phase, London UK, 2016.
20. Kalis V, Landsmanova J, Bednarova B, Karbanova J, Laine K and Rokyta Z.
Evaluation of the incision angle of mediolateral episiotomy at 60 degrees.
International Journal of Gynaecology and Obstetrics, 2011. 112(3):220-4.
21. Sanders J, Campbell R, Peters T. Effectiveness of pain relief during perineal
suturing. British Journal of Obstetrics and Gynaecology. 2002; 129:1066- 8
22. Sultan AH and Kettle C. Diagnosis of perineal trauma. In: Sultan AH, Thakar R,
Fenner D, Editors. Perineal and anal sphincter trauma. London: Springer; 2007. p.
13-9
23. Langley V, Thoburn A, Shaw S, Barton A. Second degree tears: to suture or not? A
randomised controlled trial. British Journal of Midwifery. 2006; 14(9):550-4.
24. NICE. Intrapartum care: Care of healthy women and their babies during
childbirth. Clinical guideline [CG190], National Institute for Clinical Excellence;
2014.
25. Stevenson L. Guideline for the systematic assessment of perineal trauma. British
Journal of Midwifery. 2010; 18(8):498-501.
26. Resar R, Griffin F, Haraden C and Nolan T. Using care bundles to improve health
care quality. Institute for Healthcare Improvement, 2012.
27. Fereday S. A guide to quality improvement methods. Healthcare Quality
Improvement Partnership, 2015.
28. Langley GJ, Moen RD, Nolan KM, Nolan TW, Norman CL, Provost LP. The
improvement guide: a practical approach to enhancing organizational
performance. John Wiley & Sons; 2009.
29. Freeman RM, Hollands HJ, Barron LF and Kapoor DS. Cutting a mediolateral
episiotomy at the correct angle: evaluation of a new device, the Episcissors-60.
Medical devices, 2014. 7:23-8.
23
WHA Accompanying Bundle Booklet 05.07.2018