Transcript Slide 1

Strategies for prevention of
surgical site infections:
Putting them into context
Lillian S. Kao, MD, MS, FACS
Associate Professor
Co-Director, Center for Surgical Trials and
Evidence-based Practice (C-STEP)
Vice-Chair for Quality, Department of Surgery
University of Texas Health Science Center at Houston
Interventions for SSI
prevention
 Antibiotic prophylaxis
 Hyperoxia
 Normothermia
 Skin preparation
 Euglycemia
 Appropriate hair
 Fluid restriction
removal
 Aseptic techniques
 Etc.
 Wound edge
protectors
Potential Moderators
• Intervention complexity
• Facilitation strategies
• Delivery quality
• Participant
responsiveness
Intervention
Outcomes
FACILITATION STRATEGIES: How do they
affect outcome?
From 2011 TIDIRH conference.
Strategies for implementation
of evidence-based measures
for SSI prevention
 Guidelines/protocols
 Collaboratives
 Checklists
Guidelines: Surgical Care
Improvement Project (SCIP)
SCIP Timeline
2003 Surgical
Infection
Prevention (SIP)
measures became
core measures
2006 Surgical Care
Improvement
Project (SCIP)
measures replaced
SIP measures
2004 Hospitals
began collecting
core measure data
for SIP with patient
discharges
SCIP guideline
Evidence
Prophylactic antibiotic received within 1 hr prior to
incision.
Observational
Prophylactic antibiotic selection for surgical
patients
RCTs + expert
opinion
Prophylactic antibiotics discontinued within 24
hours of surgery end time
Observational
Cardiac surgery patients with controlled 6 am post- Observational, RCTs
operative serum glucose (≤ 200 mg/dL)
Post-operative infection diagnosed at initial
hospitalization
Expert opinion
Surgical patients with appropriate hair removal
RCTs
Colorectal surgical patients with immediate
postoperative normothermia (≥36C)
RCT + observational
SCIP: What is the
evidence?
• Abx timing 68%
• Abx discontinuation
71%
• Normothermia 64%
• SSI 25.6%
Pre-study
baseline
Protocol
• System level
changes to increase
compliance with
guidelines for abx,
normothermia, and
normoglycemia
• Abx timing* 91%
• Abx discontinuation*
93%
• Normothermia 71%
• SSI* 15.9%
Study period
SCIP: Single center successes
Hedrick TL et al. JACS 2005.
SCIP: Multi-center successes
Dellinger EP et al. Am J Surg 2005.
Did SCIP reduce SSIs?
Stulberg JJ et al. JAMA 2010.
Only SCIP-2 compliance correlated
to SSIs
Ingraham AM et al. J Am Coll Surg 2010.
Is SCIP a failure?
 Surgical Site Infection Prevention: Time to Move
Beyond the Surgical Care Improvement Program
– Hawn MT et al. Ann Surg 2011
 Reducing the Risk of Surgical Site Infections: Did
We Really Think SCIP Was Going to Lead Us to
the Promised Land?
– Edmiston CE et al. Surg Infect 2011
 Diminishing surgical site infections after colorectal
surgery with surgical care improvement project: is
it time to move on?
– Larochelle M et al. Dis Colon Rectum 2011
Collaboratives: ACS NSQIP
100
90
80
70
abx timing
60
abx selection
d/c abx
50
normothermia
no shaving
40
oxygenation
glucose control
30
20
10
0
1
2
3
CMMS Demonstration Project
National Surgical Infection
Prevention Collaborative
Dellinger EP et al. Am J Surg 2005.
4
100
80
60
40
20
0
Antimicrobial Prophylaxis Measure
TRAPE Trial:
Cluster RCT
Kritchevsky SB et al. Ann Intern Med 2008.
NSQIP Timeline
2001 ACS
NSQIP
pilot
program
1994 VA
NSQIP was
born
1999 pilot
study of
NSQIP in
non-VA
hospitals
2004 ACS
NSQIP
available to
all private
hospitals
ACS NSQIP – national
validated QI program
Neumayer SSI model for prediction:
High outlier: O/E>1 (and 95% CI excluding 1)
Low outlier: O/E<1 (and 95% CI excluding 1)
Campbell DA Jr et al. J Am Coll Surg 2008.
SSIs improved in ACS NSQIP participating hospitals
Hall BL et al. Ann Surg 2009.
World Health Organization
(WHO) Checklist
Before and After Data
25
20
%
15
10
5
0
1
Mortality before
1
Mortality after
0
Morbidity before 11.6
Morbidity after
7
2
1.1
0.3
7.8
6.3
3
0.8
1.4
13.5
9.7
4
1
0.6
7.5
5.5
5
1.4
0
21.4
5.5
6
3.6
1.7
10.1
9.7
7
2.1
1.7
12.4
8
8
1.4
0.3
6.1
3.6
WHO Checklist reduced mortality and
morbidity in 8 hospitals worldwide
Haynes et al. NEJM 2009.
Total
1.5
0.8
11
7
World Health
Organization
Checklist
%
Mortality and Process Measures
100
90
80
70
60
50
40
30
20
10
0
1
2
3
4
Mortality before
1
1.1 0.8
1
Mortality after
0
0.3 1.4 0.6
Process measures before 94.1 3.6 30.8 67.1
Process measures after 94.2 55.3 51 63.7
5
1.4
0
0
0
6
7
8
9
3.6 2.1 1.4 1.5
1.7 1.7 0.3 0.8
1.4 46.7
0
34.2
18.1 92.1 51.7 56.7
Process measures unchanged but mortality
decreased?
Haynes et al. NEJM 2009.
%
Morbidity and Process Measures
100
90
80
70
60
50
40
30
20
10
0
1
2
3
4
5
6
7
8
9
Morbidity before
11.6 7.8 13.5 7.5 21.4 10.1 12.4 6.1
11
Morbidity after
7
6.3 9.7 5.5 5.5 9.7
8
3.6
7
Process measures before 94.1 3.6 30.8 67.1
0
1.4 46.7
0
34.2
Process measures after 94.2 55.3 51 63.7
0
18.1 92.1 51.7 56.7
Processes measures unchanged but
morbidity decreased?
Haynes et al. NEJM 2009.
Quality of the
evidence
Lack of
effectiveness of
strategy
Quality of
implementation
For one or
more
interventions
For the
implementation
strategy
Context
Why is there variation in the effectiveness
of the implementation strategies?
Quality of the evidence
Surgical Site Infection Rate .
SCIP-1: Prophylactic antibiotic
received within 1 hour prior to incision
6%
5%
4%
Incision
3%
2%
1%
0%
>2
2
1
0
1
2
3
4
5
6
7
8
Hours before or after incision (Time 0)
Classen DC et al. NEJM 1992.
9
10 >10
In adjusted model,
timing had a linear
effect.
Antibiotic receipt
after surgery did not
increase SSIs.
Hawn MT et al. JAMA Surg 2013.
Studies on SCIP implementation:
antibiotic prophylaxis
2% 2%
RCT
Stepped wedge
47%
49%
Time series
Uncontrolled
before and after
Levy SM et al (unpublished data)
SCIP 1
Mean
Regression to the mean
Levy SM et al (unpublished data).
SCIP 2
SSIs
?
Levy SM et al (unpublished).
Are there effective strategies
for changing practice?
Strategy
# reviews
# studies Conclusions
Education with different
strategies
8
5-63
Mixed effects, dependent on
combo
Performance feedback
16
3-37
Mixed effects, best for test
ordering
Computerized decision
support
5
11-98
Mostly effective for drug dosing
& prevention
Continuous QI
1
55
Limited effects, mostly single
site non-RCTs
Financial interventions
6
3-89
Mainly on prescribing
Combined
16
2-39
More effective than single. Not
confirmed recent reviews.
Grol and Grimshaw. Lancet, 2003.
Implementation: does it matter?
Potential Moderators
• Intervention complexity
• Facilitation strategies
• Delivery quality
• Participant
responsiveness
Intervention
Adherence
• Content
• Coverage
• Frequency
• Duration
“Fidelity”
Outcomes
Adapted from: Carroll C, Patterson M, Wood S, Booth A, Rick J, Balain S. A
conceptual framework for implementation fidelity.
Imp Sci 2007;2:40
From 2011 TIDIRH conference.
Antibiotic prophylaxis compliance:
documented versus observed
Criteria
Abx
Type
(100)
Incorrect 3% (3)
Correct
Dose
(100)
Interval
(100)
Redose
(14)
24% (24) 28% (28) 93% (13)
97% (97) 76% (76) 72% (72) 7% (1)
Overall (100):
All guidelines followed:
48.0% (48)
Guidelines violated:
52.0% (52)
Levy SM et al (Unpublished data).
All-or-none phenomenon
Stulberg JJ et al. JAMA 2010.
Checklist compliance
137/137 cases had
documentation of
checklist use
100.00%
80.00%
% Yes
60.00%
40.00%
20.00%
0.00%
Timeout
Done After
Prep and
Drape?
Essential
Parties
Present?
Team
Pt Name and Incision Site
Members
Procedure Confirmed (if
Identified? Confirmed? applicable)?
WHO
Checklist
Team
Antibiotics
Essential
Correct
Anticipated Anticipated
Confirm
Member Administered Imaging
Implants Case Length Risk of Blood Sterility
Concerns
(if
Displayed (if Confirmed (if Determined?
Loss
Indicator?
Addressed? applicable)? applicable)? applicable)?
Determined?
MHH Checklist
Levy SM et al. Surgery 2012.
All Quiet
During
Timeout?
RE-AIM
Framework
Reach
Maintenance
Implementation
Efficacy
Adoption
www.re-aim.org
Do we need to RE-AIM our
SCIP efforts?
Metric
N (% of
studies*)
Reach
Described or mentioned nonparticipants in intervention group
8 (18)
Efficacy
Measured and reported SSIs
7 (16)
Adoption
Described participant adoption of
intervention
Described setting adoption of
intervention
12 (27)
Implementation
Discussed implementation barriers
17 (38)
Maintenance
Discussed strategy for sustainability
9 (20)
* out of 45 studies
Levy SM et al (unpublished).
14 (31)
Context: Does it matter?
PARIHS framework
How to
evaluate
the
evidence
to guide
QI
efforts?
What is the
optimal
method to
facilitate
the
process?
How to evaluate and
change the context?
Kitson et al. Implementation Science 2008.
CONTEXT
Patient Safety Practice
Results
Effectiveness
Harms
Implementation
Adoption &
Spread
AHRQ Publication No. 11-0006-EF Dec 2010
CONTEXT
Results
Effectiveness
Harms
Patient Safety Practice
Implementation
Adoption &
Spread
criteria
Evaluation
what works in what context
Constructs
Logic Model
Internal
Validity
External
Validity
AHRQ Publication No. 11-0006-EF Dec 2010
Synthesis
ORGANIZATION
QI TEAM
MICROSYSTEM
Triggering
Event
Team Leadership
QI Leadership
Team Diversity
Subject Matter Expert
QI Leadership
QI Workforce
Focus,
Resource
Availability,
Data Infrastructure
Decision-Making
Process,
Team Norms,
QI Skill
QI Culture
Motivation
QI Capability
System &
Process
Changes
QI Culture
QI Maturity
Physician Involvement
Payment Structure
Outcome
Improvements
Prior QI Experience
Team Tenure
Dotted lines represent
probationary
relationships (consensus
not obtained)
Model for Understanding Success in Quality (MUSIQ)
Kaplan, HC et al. BMJ Qual Saf, 2011.
High-priority contexts
1. External factors
CONTEXT
Patient Safety
Practice
2. Organizational
structural characteristics
3. Teamwork, leadership,
and patient safety
culture
4. Management tools
Shekelle PG et al. Ann Intern Med 2011.
Why did these hospitals stay the
same or worsen over time?
Hall BL et al. Ann Surg 2009.
QI is local
 “What was it about the ‘best performer’ here that
accounted for the remarkable success? Or
conversely, why were some hospitals struggling?”
Campbell DA Jr. J Am Coll Surg 2009.
Hospital performance (SCIP 1/2) was
associated with risk of adverse
events
Ingraham AM et al. J Am Coll Surg 2010.
Measuring safety culture (SAQ)
Scale
Definition
Example item
Teamwork
climate
perceived quality of collaboration
between personnel
Our doctors and nurses
work together as a well
coordinated team
Job
satisfaction
positivity about the work experience
I like my job
Perceptions of approval of managerial action
management
Management supports
my daily efforts
Safety climate
perceptions of a strong and proactive
organizational commitment to safety
I would feel perfectly
safe being treated here
Working
conditions
perceived quality of the work
environment and logistical support
Our levels of staffing are
sufficient to handle the
number of patients
Stress
recognition
acknowledgement of how
performance is influenced by
stressors
I am less effective at
work when fatigued
Sexton B et al. BMC Health Services
Research 2006.
Changes in SAQ after checklist
implementation
Haynes AB et al. BMJ Qual Saf 2011.
How do we change context (to
improve QI efforts)?
CUSP applied to SSI Prevention
Component
Method
Science of safety
education
Introductory talk to explain the approach to addressing
safety at a local level
Staff safety
assessment
Two question survey to team members asking: How will an
SSI develop in the next patient? What can we do to
prevent an SSI?
Senior executive
partnership
Senior executive attends CUSP meetings, making
resources available to address safety concerns and assist
with system-wide barriers
Learning from defects
Teams are trained to use a structured tool to learn from
defects
Implement teamwork
and communication
tools
Review unit-level safety data (e.g., SSI) monthly and
develop local QI initiatives to improve teamwork,
communication and address identified hazards
Wick EC et al. J Am Coll Surg, 2012.
30
27.3
25
20
18.2
16.9
13.6
15
9
10
4
5
1.4
0.6
0
Overall SSI
Superficial SSI
Preintervention
Deep SSI
Organ Space
Postintervention
Colorectal Surgery SSI Rates Before and After
CUSP-Based Bundle SSI Prevention Intervention
Wick EC et al. J Am Coll Surg, 2012.
Multi-faceted intervention
Workshops
to improve
OR safety
culture
Checklist
modification
by invested
stakeholders
Levy SM et al. Surgery (in press).
Assignment
of checklist
responsibility
SAQ Changes
100%
80%
81%84%
79%80%
82%86%
60%
60%
71%
60%
39%
40%
20%
0%
Safety Culture
Teamwork
Pre-Intervention
Speaking Up Safety Rounds Other Aspects
of Safety
Post-Intervention
Culture
Levy SM et al (unpublished data).
Checkpoint Adherence
100%
80%
60%
40%
20%
0%
Pre-Intervention (n=142)
Post-Intervention (n=362)
Levy SM et al. Surgery (in press).
Summary
 No one intervention or implementation strategy is
universally effective.
 The effectiveness of “proven” interventions to
reduce SSIs depends upon the fidelity of
implementation and local context.
 A multi-faceted, safety-centered approach to
changing context can improve QI success.
Conclusions
 Better methods are necessary for identifying
which components in a bundle/protocol/etc. are
most effective and which are minimally effective
or ineffective.
 Studies on improving compliance with evidence-
based practices should measure and report on
the quality of implementation. Better internal and
external validity are needed.
Conclusions
 Further study is necessary to be able to better
measure contextual factors and to determine
which factors are associated with effective
implementation of evidence-based practices.
 Strategies for efficiently and effectively changing
context to improve implementation, such as
CUSP, are needed.
Acknowledgements
 Kevin P. Lally, MD, MS
 KuoJen Tsao, MD
 Shauna Levy, MD
 Heather Kaplan, MD, MPH
 Jason Etchegaray, PhD
 Eric Thomas, MD, MPH
Questions?
[email protected]