A Multifactorial Risk Reduction Strategy for Preventing Perineal

A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and Increasing Maternal Safety
at Vaginal Delivery
APPLICATION FORM
Title of Entry: A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and
Increasing Maternal Safety at Vaginal Delivery
Division: Large Hospitals & Health Systems
Category: Patient Safety
Entrant’s Name and Title:
Phone:
Email:
Dr. Joseph Merola, MD, MPH
484-526-4129
[email protected]
Organization:
St. Luke’s University Hospital—Bethlehem Campus
801 Ostrum Street
Bethlehem, PA 18015-1065
Date Implemented:
Date Sustainable Results Achieved:
September 2011
June 2013
Team Members:
Kathy J. Nunemacher, MSN, RN, Coordinator, Clinical Quality Improvement
Staff Members, Obstetrics’ Department
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A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and Increasing Maternal Safety
at Vaginal Delivery
Executive Summary
Opportunity: For several years, a top priority of this institution’s Board of Trustees and Administration
has been to reduce patient harm and elevate patient safety. From a specific obstetric standpoint, pelvic
trauma at obstetric delivery, and its modifiable risk factors, has created considerable opportunities for
improvement for us, with additional room for incremental change. Therefore, renewed multi-factorial
efforts were necessary in the past two years to propel this evidence-based effort, based on a volume of
greater than 26,000 deliveries, to a very successful comparative performance.
Goal and Target Audience: Maternal trauma at vaginal delivery (3rd and 4th degree perineal lacerations,
i.e. AHRQ’s PSIs 18 and 19), is highly correlated with the subsequent morbidities of urinary and fecal
incontinence, pelvic organ prolapse, and sexual dysfunction. Our goal has been to reduce these harm
events by 40% in the two years CY 2012 and 2013 (per CMS), by minimizing known modifiable risk factors.
These efforts should be realistic for all Obstetric services, delivering varied patient volumes, and at all
severity levels.
Evidence: A growing body of high quality evidence has shown a significant correlation between maternal
perineal harm at obstetric vaginal delivery and numerous risk factors, many of which are not modifiable
prior to labor and delivery. However, systematically applied interventions can succeed, i.e. changes in
labor conduct, episiotomy and type, spontaneous (SVD) or operative vaginal delivery (OVD). These all have
issue in this project (utilizing the AHRQ’s PSIs 18 and 19), resulting from specific action planning.
Baseline Data: In this observational effort initial variables included an SVD rate of 88.70%, an OVD rate of
11.30%, along with an overall Cesarean Birth (CB) Rate of 29.40% and a primary CB Rate of 17.10%. Also,
at the onset were an overall episiotomy rate of 14.50%, a midline episiotomy rate of 95.67%, and a
mediolateral episiotomy rate of 4.33%, among total episiotomies. From an outcomes standpoint, the
baseline total OVD and SVD trauma observed rate (or AHRQ’s PSI 18/19 composite) was 12.49%, OVD
trauma rate (or PSI 18) of 28.90% , and SVD trauma rate (or PSI 19) of 9.60%.
.
Interventions: The processes used were (a) cognitive and education and technical training based on high
quality evidence, measurement understanding, and the Joint Commission’s (JC) Ongoing Professional
Practice Evaluations (OPPE). i.e. “reality”- based efforts; (b) protocol development and revision, default
production, consents and checklists, “huddles,”, and “hard-stops”, i.e. “reliability”-based initiatives.
Additionally, there was a strong new focus on a “Just Culture of Safety,” reducing variation among
providers, verbal and written group and individual feedback, and the JC Focused Professional Practice
Evaluations (FPPE), mandatory consultation, re-education, and credentialing changes.
Results: Among process measures (compared to above), the SVD rate was increased from 88.70% in
FY2007 to 94.01% in FYTD 2014, the OVD Rate decreased from 11.30% to 5.99%, and the overall
episiotomy rate was reduced from 14.50% to 3.30%. Additionally, from FY2011 to FYTD 2014 the type of
episiotomy changed, with midline episiotomy falling from 95.70% to 45.50%, and the mediolateral rate
rising from 4.30% to 54.5%. Along with these very dramatic risk factor improvements, there was
considerable and sustained reduction of pelvic trauma in PSI 18 from 28.90% to 8.54%, PSI 19 from 9.60%
to 0.54%, and the PSI 18/19 composite from 12.4% to 1.25%, with no elevation in CB rates.
A. Needs Assessment and Research:
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A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and Increasing Maternal Safety
at Vaginal Delivery
Our original research noted that the specialty of Obstetrics resided in the highest tier of medical liability
claims and awards in the US, with our state of PA the third highest in the nation. With this liability
background, harm issues, and specifically those related to childbirth, bore an added institutional burden.
Similarly, we became aware, from our large collaborative data alliance, that our own institutional
performance in PSIs 18 and 19 was worse than the median, with ample room for improvement, along with
the production of excellent performance and outcomes. Additional urging and support came from such
bodies as the CMS Partnership for Patients (PfP), the AHRQ, our Hospital Engagement Network (HEN), and
the Institute for Healthcare Improvement in its “Idealized Design for Perinatal Care,” and reliability science
approaches.
This evidence was reinforced by the rich obstetric safety literature, noting great inter-obstetrician and
institutional behaviors in the conduct of labor and delivery. There was also a strong relationship between
pelvic (perineal) trauma at vaginal delivery and immediate, short term and possibly longer term maternal
morbidity. The latter resided in pelvic support problems (uterovaginal prolapse), urinary and bowel
incontinence, and sexual dysfunction disorders.1,2 While numerous risk factors for vaginal delivery trauma
have been suggested, many were either not modifiable, or at least not modifiable at the time of labor and
delivery (e.g. maternal weight and BMI, fetal size especially macrosomia, diabetes mellitus, and maternal
gravity). Those, however, that had both a strong association with trauma and were modifiable included
the conduct of labor, SVD vs. OVD, and the use of episiotomy and its type.3,4,
It became apparent that, starting with our baseline data, and approaching these identifiable risk factors
with standard, broad and then more innovative strategies, both risk and the stated harm outcomes could
be reduced significantly.
B. Baseline Data:
Study period - FY2007 to FYTD2014 (7 years, 8 months)
 Total Births from FY2007 to FYTD2014 – 26,781
 Total Vaginal Deliveries - 18,077
 PSI 18 Rate – 28.90%
 PSI 19 Rate - 9.60 %
 PSI 18 + 19 Rate – 12.49%
 SVD Rate – 88.70%
 OVD Rate –11.30
 Episiotomy Overall Rate – 14.50%
 Midline Episiotomy Proportion - 95.70%
 Mediolateral Episiotomy Proportion - 4.30%
 Overall Cesarean Section Rate – 29.40%
 Primary Cesarean Birth Rate – 17.10%
1
MacCleod, et al. Europ J Obstet Gynecol Reprod Biol. 2009:136.
Kudish, et al. Int J Gynaecol Obstet. 2008:102.
3
Williams, et al. J Clin Nursing.2007:16
4
DeVogel, et al. Amer J Obstet Gynecol.2012:206
2
C. Strategies, Implementation Plan, and Interventions:
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A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and Increasing Maternal Safety
at Vaginal Delivery
The Strategic Intent was to positively and incrementally change the outcomes in the data noted above,
utilizing an incremental, three-phased, and multifactorial change agenda, creating “highly significant”
improvement in each metric.
The overall structure of the agenda resembles a modification of the Marx Model5 for a “Just Culture of
Safety5. Figure 1 represents a diagrammatic representation of process flow, while the tabular Figure 2
details the Reality, Reliability and Just Culture of Safety components representing in the varied
interventions.
The Reality (and Reducing Human Error) actions had at their core the understanding of the goal,
cognitive and procedural education, understanding of the evidence, establishing measurement
awareness, and baseline profiling of the department via Ongoing Professional Practice Evaluations (OPPE).
In search of further Reliability (and Avoiding “At Risk” Behaviors), remediation, continued evidence
revision, more specific OPPE benchmarking and personal profiling all arose in Column II. Here, two “hard
stop” approaches are newly applied: The first was in the form of an OVD Time Out, modeled after the OR
Time Out. In each non-emergent OVD, a “time out” occurs with the operating obstetrician, resident,
bedside nurse, and patient. The planned procedure, benefits and risks are reviewed. Compliance has been
100%. The second innovation, a “Second Stage Huddle,” occurs following the first two hour pushing
process, subsequent to complete cervical dilatation, and followed again by another huddle at every
hourly interval of the second stage. Again, with patient involvement, a conscious and deliberate planned
approach, with expectations, is carried out by the team. A third effort within this area has been a formal
nurse-mediated project to encourage “non-directed” pushing, wherein the time-honored and family
coaching of pushing is replaced by a permissive attitude, with the patient voluntarily determining the
timing of, and energy she should dedicate to, pushing efforts6.
With an increasingly more challenging change agenda, a Just Culture of Safety was increasingly sought,
with the necessity on occasion to the actions in Column III. (Dealing with Unheeding Behaviors). Here,
more pointed written and verbal urging or counseling ensued, along with a FPPE utilization, cognitive and
technical remediation, proctoring, and temporarily or permanently altering privileging in obstetrics.
As noted above, the evidence is clear that more judicious use of episiotomy and OVD significantly
decrease pelvic harm at vaginal delivery. Therefore, at all times, and central to all action
planning a varied, and increasingly vigorous approach was apparent in the goal of (1) reducing episiotomy
usage, (2) using a mediolateral, rather than midline, episiotomy, particularly in OVD. (3) reducing OVD use
(4) in necessary OVD, reducing forceps and relatively increasing vacuum use, and finally (5) “strongly
discouraging” the use of multiple instruments in OVD, i.e. forceps plus vacuum.
5
Marx, D. The Just Culture Community, 2007.
Balogash, A, et al. Non-Coached Pushing in the Second Stage of Labor. AWHONN Presentation, 2012.
6
In addition, meticulous attention was paid to the rates of pelvic/perineal trauma in the form of 3rd and
4 degree lacerations that ensued, as results. The most vigorous and restrictive definition of 3rd degree
laceration was utilized in coding for these lacerations, i.e. if any portion of the rectal sphincter was
th
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A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and Increasing Maternal Safety
at Vaginal Delivery
involved. This has been variously applied, but will become uniform with the renewed definition via the
Revitalize program of the American Congress of Obstetrics and Gynecology in the July, 2014 Current
Opinion7 .Similarly, the Leapfrog Group definition for the enumeration of “episiotomy” (exempting cases
with shoulder dystocia) was utilized..
This initiative is most closely aligned with an observational prospective cohort study; “p” values were
calculated by “t-test”, used for level of significance, with certain data similarly subjected to linear
regression analysis and R2 determination for fit.
D. Initiative Success and Evidence of Sustained Improvement
The aforementioned relationship between the multiple risk factors and perineal trauma at vaginal
delivery serves as the basis for the results, and statistical analysis of, the outcomes and risk factors.
The graph in Figure 3. , reveals the marked overall reduction in PSI total 18/19 from 12.49% to 1.26%
(with p=<.0001) over the study period, while associated episiotomy and OVD rates showed considerable
and similar decline. , Notably individual reduction in PSI 18 (trauma with OVD) was similarly dramatic
(28.90% to 8.54% or p=<.0001), and for PSI 19 (trauma with SVD) was 9.60% to 0.54%, (p=< .0001) for the
same period. On the same graph, the drop in OVD decreased from 11.3% to 5.99%, while the proportion
of SVD, a positive trend, rose from 88.70 to 94.01% over the period.
Figure 4. reveals the linear regression slope and R2 value for the same outcome data with R2=0.8905,
recognizing very good predictability.
In turn, Figure 5. notes the crossing values, where the nature of episiotomy quite positively changed
significantly where mediolateral episiotomy rates rose (4.30% to 54.50%, or p=<.0001) and damaging
midline episiotomy rates dropped (95.70% to 45.50%, or p=<.0001). These both represent very important
risk factor alterations in reducing trauma per the literature, and a strong initiative of the latter phase of
the project. Importantly these arose in an overall climate of reduced episiotomy (14.50% to 3.30%, also
with p=.0001) since 2,007.
Figure 6. notes the institutional “observed” values for PSIs 18/19 in relation to those as would be
“expected” by the AHRQ data. Notably, during 2011 and beyond, after multiple years of reduction, the
institutional values finally were reduced beyond those expected by the AHRQ.
Additionally, one concern, and frequently asked question, is what happens to Cesarean Birth rates,
during a time of restrictive OVD and other labor interventions in order to reduce pelvic trauma? Figure
7. importantly notes that there was virtually no change in the CB rate, and in fact at small reduction in the
primary CB Rate from 2007 to 2014. This occurred, even in a decade when, for multiple reasons, national
CB rates have been climbing.
7
Lemieux, L. American Congress of Obstetrics and Gynecology, ReVitalize Definitions. Personal
Communication, April, 2014.
Finally, the control chart depicted in Figure 8. provides an overall sense of the initiatives outlined in
Figure 2 and its explanatory text. It matches the material success over the seven years and >26,000
obstetric delivery time period, with special attention to the final two year period.
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A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and Increasing Maternal Safety
at Vaginal Delivery
Sustained Improvement
Referring again to Figure 8. one notes a “plateau” in the middle years of the project. While at a very
respectable rate around of 4% having been attained, and having been reduced from greater than 12% for
PSI18/19 combined since 2007, there was the question of whether we might accomplish more. Indeed,
with the new initiatives (particularly the OPPE/FPPE, encouragement of mediolateral episiotomy instead
of midline, and the “non-directed” pushing efforts, a final surge to the low number of 1.2% was begun. In
actuality, a 67% change was achieved from the 3rd quarter of CY 2011 to the 3rd quarter of 2013 and
sustainment has not only been shown, but improved further for the following 9 months, with the most
recent composite rate of 1.26% for PSI 18/19.
This project demonstrates the value of a very successful and important obstetric safety initiative. A high
level of significant progress is demonstrated by a multifactorial risk management strategy. Its final and
renewed effort over the last two years has helped us to reach the CMS goal of >40% reduction in that two
year period, while reaching at least the top quartile percentile in our own data alliance. Above all, it has
allowed laboring patients in our institution to enjoy a remarkably improved process for protecting them
from needless harm, and improved post-partum, and later, pelvic morbidity.
Applicability to Other Institutions
As noted in the Executive Summary, there is no intervention in this continuum that could not be replicated
at any institution providing labor and delivery care…from small to large delivery services, and caring for
all socioeconomic cohorts, and severities of disease. These interventions are understandable, can be
implemented with systematic forethought and planning, and quite simple tracking mechanisms. In so
doing, those also struggling with improving safety and changing culture could be similarly successful.
Diagrams, Tables and Graphs
Figure 1: Overview of Process Flow
Figure 2: Actions in Continuum of Safety
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A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and Increasing Maternal Safety
at Vaginal Delivery
And Interventions
Figure 3. Overall Episiotomy Rates, Operative Vaginal Delivery Rates, and
Episiotomy Rates in Relation to Perineal Trauma Reduction FY2007 to FYTD 2014
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A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and Increasing Maternal Safety
at Vaginal Delivery
16%
Obstetric Department: Perineal Trauma Reduction
14%
Project
12%
Percent
10%
8%
6%
4%
2%
0%
1.26%
FY07
FY08
Baseline
FY09
FY10
FY11
Cycle 1
PSI 18/19 (Perineal Trauma) 12.49% 10.65% 6.23%
FY12
FY13
FYTD 14
Cycle 2
5.62%
3.73%
3.76%
3.41%
1.26%
Episiotomy Rate
14.50% 14.20% 11.30% 11.80% 8.30%
6.10%
4.60%
3.30%
OVD Rate
11.30% 11.40% 8.60%
7.00%
6.90%
6.00%
Based on separate t test for percentages :Statistically significant results achieved in all 3 categories comparing 2007 to 2013 results p<0.0001
Figure 4. Linear Regression and R2
PSI 18/10 Trend
8.20%
8.40%
Figure 5. Midline vs. Mediolateral Value for combined
0.14
0.12
Episiotomy Trends
Percent
PSI 18-19 Rate FY 07
to FY 14
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0.1
0.08
F20
11
R² = 0.8906
0.06
0.04
PSI 18-19
Rate
0.02
FY 07 (mar-jun)
FY 08
FY 09
FY 10
FY 11
FY 12
FY 13
FY 14 (jul-mar)
0
F20
12
F20
13
F20
14
to
dat
e
% midline
95.70% 71.40% 56.80% 45.50%
Episiotomy
%
mediolateral 4.30% 28.60% 43.20% 54.50%
Episotomy
Overall
Episotomy
rate
8.30% 6.10% 4.60% 3.30%
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A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and Increasing Maternal Safety
at Vaginal Delivery
Figure 6. Cesarean Birth Rates across the Project Period 2007 to 2014
Median Rates:
National Primary
C/S rate - 32.8%
Primary C/S
rate - 21.9%
PCO2 rate - 26%
Healthy People
2020 - 26.4%
Leapfrog Proposed
Cesarean Section Trends
40%
35%
30%
25%
20%
15%
Percent
10%
5%
0%
F2007
F2008
F2009
F2010
F2011
F2012
F2013
F2014
to date
Cesarean Section % 29.40%
32.00%
34.80%
34.80%
31.80%
32.20%
33.10%
30.50%
Primary Section %
19.20%
20.30%
20.20%
18.20%
17.70%
18.30%
16.50%
17.10%
Figure 7. PSI 18/19 Insitutional “Observed” vs. AHRQ “Expected” Rates, FY 2007 to FYTD
14.0%
Patient Safety Indicators: PSI 18/19 Pelvic Trauma Vaginal
12.63% Delivery with and without instrumentation
12.0%
10.0%
8.0%
6.59%
5.62%
6.0%
3.53%
4.0%
3.41%
3.63%
3.38%
1.26%
2.0%
0.0%
Expected Observed Expected Observed Expected Observed Expected
2014
Baseline
FY07
309/2446
Cycle 1
FY10
103/2763
Cycle 2
Fiscal YearsFY13
86/2525
Cycle 3
FY14 1Q-2Q
23/1822
Figure 8. Control Charge for Entire Project with Overall Sense of Timing for
Interventions
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A Multifactorial Risk Reduction Strategy for Preventing Perineal Trauma and Increasing Maternal Safety
at Vaginal Delivery
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