Improving Communication in the Pediatric Intensive Care

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Transcript Improving Communication in the Pediatric Intensive Care

Improving Quality of NICU Care Using State of the
Art Collaborative Quality Improvement Methods
Paul Sharek, MD, MPH
Paul Kurtin, MD
Goals of Webcast
 Introduce CPQCC members to multiple collaborative QI models
 Discuss evidence of outcomes associated with these collaborative
QI models
 Conclude that IHI Collaborative QI model is the most successful
to date
 Describe results of a successful statewide NICU infection
reduction collaborative using IHI model
Welcome from CAN
A message from Dr. Rangasamy Ramanathan…
Outline of Presentation
 Background
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Value of Collaboration
Collaborative Efforts Nationally
Models of Collaboration
Relevant outcomes for IHI model
 Example of 12 month California NICU collaborative using the IHI
model
 Questions and Answers
Stating the Obvious…Why are we here?
 Care about, dedicated to, newborns
 Quality/Safety mandates
 Ethical
 Hospital/Board based accountability
 Regulatory
 Joint Commission
 ABP
 Transparency
 Pay for Performance
Stating the Obvious…Why are we here?
 You all provide high quality care-BUT we can get better!
 We can improve quality collectively
 Interest in statewide QI efforts reflects belief in collaboration
 Noble intentions
 Set example for newborn healthcare within California
 Set example for other states
 Build infrastructure for aggressive quality improvement
Background: Value of Collaboration
 Collaboration: roughly translated means
“laboring together”
Background:
Value of Collaboration: Motivators
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Gap between knowledge and practice
Broad variation in practices is pervasive
Existing professional boundaries inhibit improvement
Outcomes are the result of systems, not just individuals
Literature (slowly but surely…) suggests that improved
practices and outcomes occur
Kilo CM. Pediatrics 1999;103:384-393
Background:
Value of Collaboration: Advantages
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Accelerates improvement (exposes gaps)
Minimizes between-site repetition
Allows functional benchmarking
Allows free exchange of ideas and data
Pools data
Encourages standardization of practices
Provides tacit competition
Complements and supports research
Background:
Value of Collaboration: Disadvantages
 Consensus building can hinder progress
 Structural and / or operating differences between
participating sites
 Misalignment between collaborative and participant
priorities
 Additional effort required to synchronize activities
 Varying levels of commitment leads to challenges in
aggregating the data
 The cost associated with collaborating (travel,
resources)
Background:
Examples of Collaborative efforts underway
 Child Health Corporation of America
(CHCA)
 Adverse Drug Event Rates-Narcotics: DONE
 Central Line Associated BSIs: DONE
 Surgical Site Infection reduction: DONE
 Wait Times in the ED: DONE
 Rapid Response Teams: underway
 Patient progression: underway
Background:
Examples of Collaborative efforts underway
 Vermont Oxford Network (VON) NIC/Q2007
 Daily care
 Nutrition, infection, respiratory care, etc
 Staffing for quality and safety
 Transitions (admit, discharge, transfer)
Background:
Examples of Collaborative efforts underway
 National Association of Children’s Hospitals and Related
Institutions (NACHRI): PICU Catheter Associated BSIs
NACHRI PICU CABSI collaborative (10 mo; n=29): 10.31.07
Background:
Examples of Collaborative efforts underway
 California Children’s Hospital Association
(CCHA): NICU CABSIs
Background:
Models of Collaboration
 Research model (i.e. multi-site trials)
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Project manager
Strict outcomes
Strict interventions
External funding
Finite timeline for intervention
???Sustainability???
Background: Models of Collaboration
 IHI model (adopted by CHCA, NACHRI, NICHQ,
CCHA, Ohio Children's Hospital Association, etc)
 Change package available (literature)
 Personnel:
 Centralized project manager
 Centralized content experts (subject and quality)
 Site project manager
 Site MD champion
 Site senior leader
 Outcomes: collaborative and local
 Interventions: locally chosen from change package
 Timeline: approx 1 year
Background: Models of Collaboration
 VON model
 Change package +/- available (literature, vs build as you go)
 Focus groups-identify issues of local interest and migrate to similar
centers
 Personnel:
 Centralized project manager: NONE
 Centralized content experts (subject and quality): +/ Site project manager: VARIABLE
 Site MD champion: HOPEFULLY
 Site senior leader: NOT AGGRESSIVELY PURSUED
 Outcomes: collaborative and local
 Interventions: locally chosen from change package
 Timeline: approx 2 years
Background: Models of Collaboration
 CPQCC model
 Change package available: ON LINE TOOLKIT
 Personnel:
 Centralized project manager: NONE
 Centralized content experts (subject and quality): +/-
 Site project manager: VARIABLE
 Site MD champion: HOPEFULLY
 Site senior leader: NOT ACTIVELY PURSUED
 Outcomes: local, AND PUBLICLY AVAILABLE
 Interventions: locally chosen from change package
 Timeline: not well defined
Results:
Value of Collaboration: Outcomes VON model
 NIC/Q collaborative (1995-97)
 Decreased CLD rates by 28% (n=4 centers)
 Decreased CONS rates by 25% (n=6 centers)
 Decreased costs
 10% (CLD focus group)
 19% (infection focus group)
 Other collaboratives since: NIC/Q2000, NIC/Q2002,
NIC/Q2005
 1 publication (n=6 centers): decreased CONS from 24.6% (1997) to
16.4% (2000). Kilbride, Wirtschafter, Powers, Sheehan
Results:
Value of Collaboration: Outcomes CPQCC model
 Antenatal steroid administration rate increased from
76% of 1524 infants in 1998 to 86% of 1475 infants in
2001 (P < .001). Wirtschafter, Danielsen, Main, Korst,
Gregory,Wertz, Stevenson, Gould. (n=25 centers)
Results:
Value of Collaboration: Outcomes IHI model
 Decreased mortality from CABG by 24% (New England CABG
collaborative)
 Lots of publications with increased efficiency (wait times, length
of stay, etc)
 Decreased ADE rates due to narcotics (CHCA)
 by 56% -see graph
 79% participating hospitals with reduction
Value of Collaboration: Outcomes
CHCA ADEs from Narcotics Collaborative
Reported per 1000 narcotic DOSES (12 teams)
60
Baseline weighted average = 35.8
50
40
30
*
20
10
2006/04
2006/03
2006/02
2006/01
2005/12
2005/11
2005/10
2005/09
2005/08
2005/07
2005/06
2005/05
2005/04
2005/03
2005/02
2005/01
0
Last 5 months weighted average = 20.1
2004/12
ADEs per 1000 Narcotic Doses
70
M onth
Note: some teams reported ADEs per 1,000 narcotic doses while others
reported them per 1,000 narcotic days
Value of Collaboration: Outcomes
CHCA ADEs from Narcotics Collaborative
Reported per 1000 narcotic DAYS (7 teams)
140
120
100
*
80
Baseline weighted average = 119.8
60
40
20
2006/03
2006/02
2006/01
2005/12
2005/11
2005/10
2005/09
2005/08
2005/07
2005/06
2005/05
2005/04
2005/03
2005/02
2005/01
0
Last 5 months weighted average =76.2
2004/12
ADEs per 1000 Narcotic Days
160
M onth
Note: some teams reported ADEs per 1,000 narcotic doses while others
reported them per 1,000 narcotic days.
Results:
Value of Collaboration: Outcomes IHI model
 Decreased mortality from CABG by 24% (New England CABG
collaborative)
 Lots of publications with increased efficiency (wait times, length
of stay, etc)
 Decreased ADE rates due to narcotics (CHCA)
 by 56% -see graph
 79% participating hospitals with reduction
 Decreased CABSI rates (CHCA):
 By 31%-see graph
 62% participating hospitals with reduction
0
31% aggregate reduction in BSI rate (p<0.05)
6
2005/12
2005/11
2005/10
2005/09
2005/08
2005/07
2005/06
2005/05
2
2005/04
2005/03
2005/02
2005/01
2004/12
2004/11
2004/10
2004/09
2004/08
2004/07
10
2004/06
12
2004/05
2004/04
2004/03
2004/02
2004/01
BSI Rate per 1000 Line Days
Baseline weighted average = 6.93
8
Better
Value of Collaboration: Outcomes
CHCA Catheter-Associated BSI Rate Collaborative
16
14
*
4
3 month weighted average = 4.79
Results:
Value of Collaboration: Outcomes IHI model
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Decreased mortality from CABG by 24% (New England CABG collaborative)
Lots of publications with increased efficiency (wait times, length of stay, etc)
Decreased ADE rates due to narcotics (CHCA)
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Decreased CABSI rates (CHCA):
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by 56% -see graph
79% participating hospitals with reduction
By 31%-see graph
62% participating hospitals with reduction
Decreased CABSI rates (Michigan collaborative n=103 ICUs)
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82% reduction in mean CABSIs in 1st 3 months, sustained
100% reduction in median CABSIs
Value of Collaboration: Outcomes IHI model
An evidence based intervention resulted in a large and
sustained reduction of CABSIs that was maintained
throughout the 18 month study period
Results:
Value of Collaboration: Outcomes IHI model
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Decreased mortality from CABG by 24% (New England CABG collaborative)
Lots of publications with increased efficiency (wait times, length of stay, etc)
Decreased ADE rates due to narcotics (CHCA)
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Decreased CABSI rates (CHCA):
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By 31%-see graph
62% participating hospitals with reduction
Decreased CABSI rates (Michigan collaborative n=103 ICUs)
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by 56% -see graph
79% participating hospitals with reduction
82% reduction in mean CABSIs in 1st 3 months, sustained
100% reduction in median CABSIs
Decreased CABSI rates (NACHRI)
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70% reduction in first 6 months
NACHRI Collaborative: Outcomes
CABSI Rates
“…in the first 6 months of the 3 year project, 29
participating hospital units have slashed their
infection rates by close to 70%...”
NACHRI PICU CABSI collaborative (10 mo; n=29): 10.31.07
complete
The Quality Challenge: Models of Collaboration-IHI
model
underway
Call for Participation
Jan 08
05
Jan
Participant Enrollment
Select
Topic-N.I.
Sep 07
Expert
Meeting
Dec 07
Feb 08
Participant Pre-Work
P
A
Develop
Framework
& Changes
Charter (aim,
goals)
Change package
Measurement
strategy
S
2.29.07
A
AP2
S
LS 1
P
A
AP1D
P
AP3
D
S
LS 2
LS 3
Sep 08?
Jan 09?
D
Project
Deliverable
Sustain &
Spread
Supports
Conference calls
Web sessions
Listserv
Learning Sessions
Monthly Team Reports
References
 The Breakthrough Series: IHI’s Collaborative Model for Achieving Breakthrough
Improvement. IHI Innovation Series white paper. Boston: Institute for Healthcare
Improvement; 2003. (Available on www.IHI.org)
 Pronovost P, Needham D, Berenholtz S, et al. An intervention to reduce
catheter related blood stream infections in the ICU. NEJM.2006;355:2725-32
 Kilo CM. Pediatrics 1999;103:384-393
 Horbar JD, Regowski J, Plsek PE, et al. Collaborative Quality Improvement for
Neonatal Intensive Care. Pediatrics.2001;107:14-22
 Kilbride HW, Wirtschafter DD, Powers RRJ, Sheehan MB. Implementation of
evidence based potentially better practices to decrease nosocomial infections.
Pediatrics.2003;111:e519-33
 Wirtschafter DD, Danielsen BH, Main EK, et al. Promoting antenatal steroid use
for fetal maturation: results from the California Perinatal Quality Care
Collaborative. J Pediatr. 2006;148:606-612
California-based NICU Collaborative to
Decrease CABSIs
Paul Kurtin, MD
Reducing Catheter-Related Blood Stream Infections
in Thirteen California Regional/Surgical Neonatal
Intensive Care Units
Paul Kurtin, MD
Chief Quality and Safety Officer
Rady Children’s Hospital San Diego
California Children’s Services/California Children’s Hospitals Association NICU
Improvement Initiative
13 sites in California. 8 Children’s Hospitals,
4 UC Hospitals, Sutter Health
Aim: to reduce/eliminate CR-BSIs in NICU patients
Metrics: infections/1000 catheter days stratified by weight,
days between infections
Methods: improvement collaborative microsystem assessment,
site visits
Partner with CPQCC
Why This Project?
 CR-BSIs are a lose-lose-lose event
 NICUs are very high cost units for payers
 Baseline data suggested room for improvement: 1)
compared to CDC national data and 2) wide in-state
variation
 While not perfect, evidence to support potential
interventions does exist
SMART AIM
 Reduce catheter-related blood stream infections in NICU
patients weighing … by 25-50% by June 30,2007
Getting Started: What We Know
CR-BSI’s can be reduced/eliminated through the use of a
‘bundle’ of interventions
1. Hand hygiene
2. Maximum barrier precautions
3. Chlorhexidine skin antisepsis
4. Optimal site selection
5. Daily review of line necessity
Most infections related to maintenance rather than insertion
What We Don’t Know and Need to Find Out
 Is the bundle transferable to NICU patients?
Chlorhexidine for infants < 2 months
Optimal site selection
 What is the definition of a CR-BSI?
Clinical sepsis? Contaminants?
Number and volume of blood specimens?
 CPQCC ‘tool kit’ (www.CPQCC.org)
 No perfect closed system (especially umbilical lines)
Getting Started
 Build the ‘burning platform’ by documenting opportunities for
improvement (Will)
 Focus on the what needs to be done and be flexible with the
how to do it (Ideas)
 Help sites identify interventions to try via literature, experts,
and networking (Execute)
Key Measures
 Creating a Baseline
 Infections/1000 catheter days
 Days between infections
 Central catheter days as a % of total bed days
Improvement Process
 Local Champions: physician, nurse, administrative
 Agree to share unblinded data
 Agree that results can NOT be used for advertising or
competition
 Only aggregated results will be made public
 Password protected web site
 Respected content experts: D. Wirtschafter, MD; J.
Pettit, MSN, NNP
Improvement Process
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Frequent phone with sites
Frequent phone calls with project team
Frequent feedback of results
Site visits
PDSA cycles (what v. how)
Create a community of practice with active sharing and
discovery
Key Activities -Tests of Change
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Update and gain consensus on definitions and tool kit
Share experience with chlorhexidine
‘Extended’ hand hygiene for staff and parents
‘Stop the line’
Visual display of results in staff lounge (days since last
infection)
Key Activities-Tests of Change
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Dedicated line insertion and maintenance teams/kits
Educate/collaborate outside of NICU
RCA for each infection
Build the fishbone
Results
 Overall CR-BSIs were reduced by 29%. Varied by site and
weight group
 Approximately $3.4M was saved by avoiding infections
 Many sites set personal records for days without an
infection, often exceeding 100 days
 Sites improved as high functioning microsystems (culture of
safety survey)
Results
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Improved hand hygiene
Wider use of chlorhexidine
Improved configurations of lines especially umbilical lines
Creation of dedicated line teams
Collaboration with areas outside of NICU, especially
radiology and anesthesia
Sustaining Results-Structure
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New employee orientation and training
Skill labs, DVDs, hand hygiene campaign
New P&Ps
New lines
Educate outside of NICU
Visual display of data
Continue to share results
Business case for quality?
Key Resources
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Enthusiasm of participants
State support and active involvement
Hospital/CEO support
Guidelines to work from
Turning Points
§ Turning point: energy and sharing during the calls and the
willingness of the sites to do small tests of change
§ “Been there, done that”--> Wow, we’re glad we tried that
new approach
Improving Care for Hospitalized Children
If not us, who…and if not now, when?
Questions?
Please type in your questions using the Q & A feature
at the bottom right of your screen
Note: you will not be able to ask questions over the phone
We look forward to
working with YOU!!
Please contact us with any questions:
Paul Sharek, MD, MPH: [email protected]
Paul Kurtin, MD: [email protected]
www.cpqcc.org
Appendices
“Methods”
The Details of the IHI Model
The Quality Challenge: Models of CollaborationIHI model
Call for Participation
Jan 05
05
Jan
Participant Enrollment
Select
Topic
Sep 04
Sep
Expert
Meeting
Dec 04
Dec
04
Feb05
05
Feb
A
P
Participant Pre-Work
Develop
Framework
& Changes
Charter (aim,
goals)
Change package
Measurement
strategy
D
S
P
A
AP1
Project
Deliverable
AP2
S
D
LS 1
LS 2
LS 3
Apr 05
Sep 05
Feb 06
Sustain &
Spread
Supports
Conference calls
Listserv
Monthly Team Reports
Web sessions
Learning Sessions
The Quality Challenge: Models of CollaborationIHI model
Call for Participation
Jan 05
05
Jan
Participant Enrollment
Select
Topic
Sep 04
Sep
Expert
Meeting
Dec 04
Dec
04
Feb05
05
Feb
A
P
Participant Pre-Work
Develop
Framework
& Changes
Charter (aim,
goals)
Change package
Measurement
strategy
D
S
P
A
AP1
Project
Deliverable
AP2
S
D
LS 1
LS 2
LS 3
Apr 05
Sep 05
Feb 06
Sustain &
Spread
Supports
Conference calls
Listserv
Monthly Team Reports
Web sessions
Learning Sessions
Key Elements of the IHI Model
 1. Topic selection
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Ripe for improvement
Existing knowledge sound, but not widely used
Better results have been demonstrated in real world settings
Current defect rates affect many patients, or few patients
profoundly
The Quality Challenge: Models of CollaborationIHI model
Call for Participation
Jan 05
05
Jan
Participant Enrollment
Select
Topic
Sep 04
Sep
Expert
Meeting
Dec 04
Dec
04
Feb05
05
Feb
A
P
Participant Pre-Work
Develop
Framework
& Changes
Charter (aim,
goals)
Change package
Measurement
strategy
D
S
P
A
AP1
Project
Deliverable
AP2
S
D
LS 1
LS 2
LS 3
Apr 05
Sep 05
Feb 06
Sustain &
Spread
Supports
Conference calls
Listserv
Monthly Team Reports
Web sessions
Learning Sessions
Key Elements of the IHI Model
 2. Faculty Recruitment
 5-15 experts in relevant disciplines
 Subject matter experts
 Application experts
 Individual clinicians demonstrating breakthrough performance in their
own practice
 Chair and expert faculty create content
 Aims
 Measurement strategies
 Evidence-based changes
 Improvement advisor teaches and coaches teams on improvement methods
and how to apply locally
The Quality Challenge: Models of CollaborationIHI model
Call for Participation
Jan 05
05
Jan
Participant Enrollment
Select
Topic
Sep 04
Sep
Expert
Meeting
Dec 04
Dec
04
Feb05
05
Feb
A
P
Participant Pre-Work
Develop
Framework
& Changes
Charter (aim,
goals)
Change package
Measurement
strategy
D
S
P
A
AP1
Project
Deliverable
AP2
S
D
LS 1
LS 2
LS 3
Apr 05
Sep 05
Feb 06
Sustain &
Spread
Supports
Conference calls
Listserv
Monthly Team Reports
Web sessions
Learning Sessions
Key Elements of the IHI Model
 3. Enrollment and Team Composition
 Multidisciplinary teams in organization with charge:
 Learn from the collaborative process
 Conduct small scale tests of change
 Senior leaders:
 Guide
 Support
 Encourage
 Responsible
 Prework conference calls
 Clarify process, roles, expectations
The Quality Challenge: Models of CollaborationIHI model
Call for Participation
Jan 05
05
Jan
Participant Enrollment
Select
Topic
Sep 04
Sep
Expert
Meeting
Dec 04
Dec
04
Feb05
05
Feb
P
A
Participant Pre-Work
Develop
Framework
& Changes
Charter (aim,
goals)
Change package
Measurement
strategy
P
A
S AP1 D
Project
Deliverable
AP2
S
D
LS 1
LS 2
LS 3
Apr 05
Sep 05
Feb 06
Sustain &
Spread
Supports
Conference calls
Listserv
Monthly Team Reports
Web sessions
Learning Sessions
Key Elements of the IHI Model
 4. Learning Sessions
 Face to face meetings (3)
 Bring together multidisciplinary teams and experts
 Session #1:
 vision for ideal care
 Discuss change package
 Improvement advisor discuss “model for improvement”
 Session #2 and #3
 Team members learn more from each other
 Workshop
 Storyboard
 Informal dialogue and exchange
The Quality Challenge: Models of CollaborationIHI model
Call for Participation
Jan 05
05
Jan
Participant Enrollment
Select
Topic
Sep 04
Sep
Expert
Meeting
Dec 04
Dec
04
Feb05
05
Feb
P
A
Participant Pre-Work
Develop
Framework
& Changes
Charter (aim,
goals)
Change package
Measurement
strategy
S
AP1
P
A
D
Project
Deliverable
AP2
S
D
LS 1
LS 2
LS 3
Apr 05
Sep 05
Feb 06
Sustain &
Spread
Supports
Conference calls
Listserv
Monthly Team Reports
Web sessions
Learning Sessions
Key Elements of the IHI Model
 5. Action Periods
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Teams test and implement changes locally
Data collection
Submit monthly progress reports for entire collaborative to review
Supported by
 Conference calls
 Peer site visits
 Web-based discussions (list serve)
 Learn from experts AND themselves
 Goal: build collaboration and support the sites as they try out new ideas
(even at a distance)
The Quality Challenge: Models of CollaborationIHI model
Call for Participation
Jan 05
05
Jan
Participant Enrollment
Select
Topic
Sep 04
Sep
Expert
Meeting
Dec 04
Dec
04
Feb05
05
Feb
A
P
Participant Pre-Work
Develop
Framework
& Changes
Charter (aim,
goals)
Change package
Measurement
strategy
S
A
AP1D
P
Project
Deliverable
AP2
S
D
LS 1
LS 2
LS 3
Apr 05
Sep 05
Feb 06
Sustain &
Spread
Supports
Conference calls
Listserv
Monthly Team Reports
Web sessions
Learning Sessions
Key Elements of the IHI Model
 Model for Improvement
 4 key elements of successful process improvement
 Specific and measurable aims
 Measures of improvement over time
 Key changes
 Series of testing cycles
Institute for Healthcare Improvement
Model for Improvement
Setting Aims
Improvement requires setting aims. The aim should be
time-specific and measurable; it should also define the
specific population of patients that will be affected.
Establishing Measures
Teams use quantitative measures to determine if a
specific change actually leads to an improvement.
Selecting Changes
All improvement requires making changes, but not all
changes result in improvement. Organizations therefore
must identify the changes that are most likely to result in
improvement.
Testing Changes
The Plan-Do-Study-Act (PDSA) cycle is shorthand for
testing a change in the real work setting — by planning
it, trying it, observing the results, and acting on what is
learned. This is the scientific method used for actionoriented learning
Key Elements of the IHI Model
 Critical Lessons Learned (as per IHI)
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Aggressive Pre-work
Prioritize best practices in change package
Senior Leader involvement
Monthly reports
 Required data submission
 1 page summaries to Senior leaders
 Critical Lessons Learned (as per Paul)
 Senior leader critical
 Monthly conf calls and reports critical
 Availability of QI expertise on calls/list serve critical
Senior Leader Report-Example
Senior Leader Report-Example
Senior Leader Report-Example
Models: pros and cons
Research Model
Pros
 Rigorous
 Personnel with
defined/reimbursed roles#
 Well defined methodology
- Interventions
- Measures#
- Communication#
Cons
 Inflexible at the site level*
 No other interventions
allowed*
 Sustainability more difficult
given lack of flexibility
 IRB*
 Consent forms
 Financial sustainability*
# associated with success, P4Q study * Significant barrier, P4Q study
Models: pros and cons
IHI Model
Pros
Change package defined
Personnel with defined roles
 Well respected, effective QI
methodology
- Interventions
- Measures#
- Communication structure#
Senior leader involvement#
1 year timeline
Flexible at site level
Centrally driven
Data analysis/collection central
Cons
 Personnel usual take on as an “add
on” project
 Requires complete focus and
commitment
Not cheap
# associated with success, P4Q study * Significant barrier, P4Q study
Models: pros and cons
VON Model
Pros
Flexible at site level and collaborative
level#
Learning opportunities when sites
build change package collectively
Inexpensive (less personnel, less
central oversight)
Cons
 Change package not always defined
 No centralized project manager
 Not always a content expert involved
 Senior leaders not routinely in the
loop*
 Personnel usual take on as an “add
on” project
 Publication opportunities not as
robust
 Experience suggests inconsistent
improvement
# associated with success, P4Q study * Significant barrier, P4Q study
Models: pros and cons
CPQCC Model
Pros
Flexible at site level and collaborative
level#
Inexpensive (less personnel, less
central oversight)
Toolkit with change package in place
Centralized data warehouse
Cons
 No mandate to complete (voluntary)
 No centralized project manager
 Content expert involved not always
available
 Senior leaders not routinely in the loop*
 Personnel usual take on as an “add on”
project
 Publication opportunities not as robust
 Experience suggests inconsistent
improvement
 No consistent communication strategy*
# associated with success, P4Q study * Significant barrier, P4Q study