Integrating quality and safety thinking into the whole healthcare system

1
Integrating quality and safety thinking into the
whole healthcare system
International Forum on Quality and Safety in
Health Care April 20 2007 Barcelona
Carlo Favaretti, Azienda Provinciale per i
Servizi Sanitari, Italy Göran Henriks, Jönköping
County Council, Sweden Lloyd Provost, Institute
for Healthcare Improvement, USA
2
Questions we try to answer today?

• How can management strength be developed by
  system thinking?
• How can integration and coordination of
  improvement efforts support transformational
  change of a system?
• How does quality and safety work depend on good
  integration of learning, science and practice

3
Questions in the beginning

• What is the purpose of our existence?
• How do you ensure that its the patient
  perspective that are in front of your development
  work?

4
Results (for the Health Care Sytem that you work
in)
Last Quarters result
This years target

• Avergage per capita health expeditures
• Hospital beds per 1,000 inhabitants
• Employee turnover rate
• Overall patient satisfaction score
• Hospital (or system) mortality rate
• Total number of infections in hospital
• Number of patient harmed
• Percent re-admissions
• Average Waiting time for appointment
• Infancy mortality rate (first year of life),
• Mammographic screening adhesion rate,
• Anti-influenza vaccination rate (people over 65),
  
•  

5
System Definitions

• A system is a network of interdependent
  components that work together to try to
  accomplish the aim of the system
• W. Edwards Deming, The New
  Economics, 1993
• A system is an whole which cannot be divided
  into independent parts
• Russell Ackoff, Better management for a
  Changing World
• System an interdependent group of items, people,
  or processes working together toward a common
  purpose.
• Associates in Process Improvement,
  Quality as a Business Strategy, 1987

6
Demings view of Production as a System (1950,
1994)
Stage 0 Generation of ideas
7
Demings view of the Organization as a System
(1950, 1994)
Three Perspectives of the Health Care System
Management Lens (leadership level)
Stage 0 Generation of ideas
Improvement Science Lens
Micro-system Lens (team level)
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Choice of Detail when Describing a System
5-9
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System Principles

• We can think of all work as a process
• A system is an interdependent group of items,
  people, and processes with a common aim
• Every system is perfectly designed to achieve the
  results it achieves
• If each part of a system, considered separately,
  is made to operate as efficiently as possible,
  then the system as a whole will not operate as
  effectively as possible.
• Improvement of a system requires change, but not
  every change is an improvement

10
Demings view of the Organization as a System
(1950, 1994)
Three Perspectives of the Health Care System
Management Lens
Stage 0 Generation of ideas
Improvement Science Lens
Micro-system Lens
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• Do we have a quality strategy?
• If so, what could we do to make it more likely we
  would execute our strategy successfully?

12
Demings view of the Organization as a System
(1950, 1994)
Three Perspectives of the Health Care System
Management Lens (leadership level)
Stage 0 Generation of ideas
Improvement Science Lens
Micro-system Lens (team level)
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Overview

• The context
• The EFQM Excellence Model
• Enabler improvement
• Measuring results
• Innovation and learning

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Overview

• The context
• The EFQM Excellence Model
• Enabler improvement
• Measuring results
• Innovation and learning

15
The Autonomous Province of Trento
Trusts figures

• 7,400 employees (around 4,000 healthcare
  professionals)
• 390 general practitioners and 79 community
  paediatricians (indipendente contractors)
• 2 hub hospitals, 11 healthcare districts (with 5
  more spoke hospitals) and many outpatients
  facilities (more then 2,600 ordinary booking
  lists clinical priorities lists)
• Agreements with outpatients clinics, private
  hospitals and 52 nursing homes
• budget 2005 879 millions euros, in balance

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The Autonomous Province of Trento
Inhabitants 495,000 Population density
76.3 per sqm Per capita GDP 23,000
euros Unemployement rate () 3.4 Tourist
day stays per year 28 million
( 20 of the average national figure)
(Italy 9.2 )
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The Autonomous Province of Trento
Italy
Birth rate 10.5 x 1,000 Life
expectancy M 76 yrs F 83 yrs Crude
mortality rate 9.3 x 1,000 Infant mortality
rate 2.0 x 1,000 Population gt 65 yrs 18.0
Population gt 75 yrs 8.7
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The Autonomous Province of Trento
Trusts Mission

• Health promotion
• Preventive medicine
• Primary and hospital care
• Rehabilitation
• Psychiatric care

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Overview

• The context
• The EFQM Excellence Model
• Enabler improvement
• Measuring results
• Innovation and learning

20
Governance
EFQM model
APSS approach
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INTEGRATED GOVERNANCE
Systems and processes y which trusts lead, direct
and control their functions in order to achieve
organizational objectives, stafety and quality of
services and in which they relate to patients,
the wider community and partner organizations.
(Governing the NHS a guide for NHS Boards,
2003)
Integrated governance is a co-ordinating
principle....It does not seek to replace or
supersede clinical or financial governance or
any other governance domain. Rather re-energises
their vital importance and the inter-dipendence
and inter-connection between them. (Integrated
Governance Handbook, Department of Health, 2006)
Integrated governance arrangements representing
best practice are in place in all healthcare
organizations and across all healthcare
communities and clinical networks (Standards for
Better Health - Integrated Governance Handbook,
Department of Health, 2006)
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STEPS TO ITEGRATED GOVERNANCE

• Integration risk assessment with the initial
  objective setting process
• Developing an appropriate schem for reporting
  progress against objectives
• Aligning the various governance systems so that
  they complement each other without overlap
• Developing an effective assurance framework

(The voice of NHS management The developement
of integrated governance, 2004)
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THE CHALLENGE....
Bringing togheter various strands of
governance (clinica, financial, human resources,
patients and staff safety, information,
technological, etc.) transitional position
moving beyond the handling of organizational
issues in silos Promoting a new quality
framework based on interrelationship of quality
strands balancing needs and expectations of
competing elements (national v local, quality v
cost, information v sharing individual rights,
past and future demands etc) and stakeholders
expectations
(Integrated Governance Handbook, Department of
Health, 2006)
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The EFQM Excellence Model
Each element is important
RESULTS
ENABLERS
People Results
People
Key Performance Results
Customer Results
Policy and Strategy
Leadership
Processes
Society Results
Partnerships Resources
INNOVATION AND LEARNING
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The EFQM Excellence Model
but the undelying network is also crucial !
ENABLERS
RESULTS
People Results
People
Key Performance Results
Leadership
Customer Results
Policy and Strategy
Processes
Society Results
Partnerships Resources
INNOVATION AND LEARNING
26
The EFQM Excellence Model
ENABLERS
RESULTS
INNOVATION AND LEARNING
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EFQM corporate self assessments
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Il processo chiave LA GESTIONE DEL PERSONALE
LACQUISIZIONE DEL PERSONALE
LA FORMAZIONE DI BASE
LAMMINISTRAZIONE DEL PERSONALE
LA GESTIONE DEGLI INCARICHI
LORGANIZZAZIONE DEL LAVORO
LA GESTIONE DEGLI OBIETTIVI
Il processo chiave LA GESTIONE DEI LIIVELLI DI
ASSISTENZA
LA FORMAZIONE CONTINUA
LA SICUREZZA DEI LAVORATORI
Le ATTIVITÀ TRASVERSALI ai Livelli di assistenza
La gestione del Livello ASSISTENZA
COLLETTIVA
Il processo chiave LA GESTIONE DELLE RISORSE E
DELLE ALLEANZE
La gestione del Livello ASSISTENZA DISTRETTUALE
La gestione del Livello
ASSISTENZA OSPEDALIERA
LA GESTIONE DEGLI IMMOBILI
LA GESTIONE FINANZIARIA
LA GESTIONE DEL SISTEMA INFORMATIVO
LA GESTIONE DELLE ATTREZZ. SANITARIE
LA GESTIONE DEI MATERIALI
LA GESTIONE DEI SERVIZI DI SUPPORTO
Il processo chiave LA GESTIONE DELLA LEADERSHIP
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Overview

• The context
• The EFQM Excellence Model
• Enabler improvement
• Measuring results
• Innovation and learning

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ENABLER IMPROVEMENT
Continuous enablers improvement to develop
integrated governance
1. Strategic planning
2. Aligning reporting mechanisms
3. Budgeting process

• Managing of demand and supply

5. Health technology assessment

• Risk management

7. Continuos Education and staff evaluation

• Services and care domains integration

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Enabler improvement - 1 STRATEGIC PLANNING
STRATEGIC DIRECTIONS

• Health promotion within health promoting settings
• Continuous quality improvement
• Coherent managerial action

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Enabler improvement -2 STRATEGIC PLANNING
Key actions for the ongoing development of the
plan
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Enabler improvement - 2 REPORTING MECHANISMS
Stake holders reporting and accountability
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Enabler improvement 3a BUDGETING PROCESS
BUDGETING YEARLY ACTIVITY PROGRAM The budget
is the tool for integrating the most important
processes

• Activities and resources
• Clinical and organizational processes
• Actors heads of department and staff, doctors,
  nurses and other professionals
• Routines and innovation

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Enabler improvement 3b BUDGETING PROCESS
ACTIVITIES to perform and available RESOURCES
SECTORAL PLANS
OPERATIONAL BUDGET
BALANCE SHEETS
PROJECTS PORTFOLIO

• Patients safety
• Workers safety
• Education
• Building
• Devices
• Informatics
• Human resources
• Goods and services

• Budget sheets
• APSS
• central directorates
• hospital and districts
• and structural dipartments
• operational unit and
• services

• Activity plan
• Yearly and multi-years provisional balance
• sheet
• CEO report on yearly
• and multi-years
• provisional balance

Main corporate projects (informatics, building,
Autonomous Province of Trento objectives,
riorganizations, ecc.)
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Enabler improvement 4 MANAGING OF DEMAND AND
SUPPLY

• Segmenting and scheduling outpatients access to
  services according to their clinical needs. The
  system, succesfully established involving general
  practitioners and specialists, is in place for
  all disciplines. Have been set omogenous waiting
  groups of 3, 10 or 40 days according to the
  clinical urgency for more then 70 different
  services
• Incresing of supply in critical areas
• Monitoring of booked services (centralised call
  center/web site booking system for outpatients
  services)
• Appropriatness improvement initiatives
• Clinical pathways in the management of some
  chronic and neoplastic conditions
• Strenghtening of health care services at district
  level
• Telemedicine

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Enabler improvement 5 TECHNOLOGY ASSESSMENT
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Enabler improvement 6 RISK MANAGEMENT
Performed activites

• Observatory for monitoring and prevention of
  healthcare civil liablity risks
• Guidelines on information and patient informed
  consensus spreading and implementation of
  clinical address papers (guidelines, prcedures,
  clinical pathways,..)
• Trust surveys to analyse risk related to
  structural aspects and devices
• Trust committee on patients safety and
  subsequent yearly sectoral plans
• strategie comuni di comportamento among all the
  different trust committee omitati involved by
  risk management activities
• Improvement of documental system
• Continuous Education
• Organizational experimentations (es.
  distribuzione dei farmaci in reparto).

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Enabler improvement - 7 CONTINUOS EDUCATION AND
STAFF EVALUATION
framework for clinicians evaluation
Report on personal clinical activities and
credit of CME
consistent with EFQM enablers
EFQM personal assessment
Leadership
Policy and Strategy
CEO reappoints or moves down
People
EVALUATION
Partnerships Resources
Processes
Annual budget results
The EFQM assessment scheme is coherent with the
professional job description
Disciplinary actions
40
Enabler improvement 9 SERVICE AND CARE DOMAINS
INTEGRATION
TOWARDS A BETTER INTEGRATION...

• Partnership agreement with nursing homes
  (providing assisted living services)
• Shared disease management pathways among
  hospitals, primary care, rehabilitation centres
  and nursing homes
• Agreement with local councils and subsequent
  activities for Integration of health and social
  care for targeted patients groups at community
  level
• Education and health promotion intiatives
  involving trust preventive services, local
  goverment institutions, schools and no profit
  organizations
• Partnership with accredited private health
  providers (ambulatory services, hospitals and
  nursing homes) and citiziens and patients
  associations
• Personalized integrated home care services
• Broad public health and socio-cultural
  development projects and activities involving the
  trust and other local community stakeholder

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Overview

• The context
• The EFQM Excellence Model
• Enabler improvement
• Measuring results
• Innovation and learning

42
MEASURING RESULTS
Continuous improvement in measuring results

• performance results
• stakeholders satisfaction
• Integrating clinical governace dashboard
  information
• Clinical indicators and ability to drill down the
  information

...The goal in creating performance mnagement
systems must be to provide the board with
relevati and meaningful information that can be
quickly assimilated and understood... (Integrated
Governance Handbook, Department of Health, 2006)
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Measuring results - 1a PERFORMANCE RESULTS
PHARMACEUTICAL CONSUMPTION
44
Measuring results 1b PERFORMANCE RESULTS
MULTIDIMENSIONAL ASSESSMENT UNIT (MAU)
Patients evaluated during 2005 3.082
since 07-01-2001
45
ENVIRONMENTAL WASTE/MANAGEMENT
Measuring results 1c PERFORMANCE RESULTS
Monthly hospital wastes in Kilograms
Monthly hospital stay days
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Measuring results 2a STAKEHOLDERS SATISFACTION
Survey by phone interview in 2002 and 2006
(1,500 people sample)

• Waiting lists management should consider
  clinical priority indications, not only first
  come first served principle
• 2002 93.8 agrees (quite or strongly agrees)
• 2006 85.4 agrees (quite or strongly agrees)
• Clinical priority system based on Omogeneous
  Waiting Groups in place everywhere since 2004
  (neary 42,000 services with clinical priority
  delivered)

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Measuring results 2b STAKEHOLDERS SATISFACTION
INTEGRATED SURVEYS
opinions of employees and citizens on Trusts
health services are concordant but employees
believe that citizens are too critical
Example opinions on quality of Trusts health
services
48
Measuring results 2c STAKEHOLDERS SATISFACTION
District care
Hospital care
public health care
from Claims Report 2005
49
Measuring results 2d STAKEHOLDERS SATISFACTION
STAFF SATISFACTION
50
Measuring results 3a INTEGRATION CLINICAL
GOVERNANCE DASHBOARD INFORMATION
OMOGENEOUS WAITING GROUPS VISITS sampling audit
on 1,360 service prescriptions (2005) X-Ray and
others imaging exams
X-Ray
CT Scan
28
40
72
60
MRI
Ultrasonography
23
39
61
77
51
Measuring results 3b INTEGRATION CLINICAL
GOVERNANCE DASHBOARD INFORMATION
CLINICAL INDICATORS
ASSISTENZA OSPEDALIERA International Quality
Indicatori Project (IQIP)
Il grafico mostra landamento del tempo che i
pazienti trascorrono in pronto soccorso per le
procedure assistenziali (IQIP indicators)

• Each ward or health care delivery unit has chosen
  at least one clinical indicator used also for the
  budgeting process

52
Overview

• The context
• The EFQM Excellence Model
• Enabler improvement
• Measuring results
• Innovation and learning

53
Overview

• The context
• The EFQM Excellence Model
• Enabler improvement
• Measuring results
• Innovation and learning

54
INNOVATION AND LEARNING
Four words seem to describe the present status
of the Trust development

• COMMITMENT
• COHERENCE
• CONCRETENESS
• PATIENCE

55
INNOVATION AND LEARNING
Were underpinned by the following issues

• Innovation management approach based on health
  technology assessment
• Continuos needs assessment, communication and
  information flow inside the organization linking
  clinical and administrative areas in the decision
  making process
• Strong committment of the trust to create and
  promote learning opportunities for the staff
• Project Management techniques for breakthrough
  and short term hard technology innovation
• Central guidance, committees, working groups and
  educational activites to manage long term
  organizational innovation and service delivery
• Clear and immediate work linkage with the local
  government
• Partnership with university research institutes
  and private companies to devolop hard and soft
  (organizational) technologies
• Incentive and rewarding systems in place linked
  to performance

56
INNOVATION AND LEARNING
ENABLERS
INNOVATION AND LEARNING
RESULTS
57
INNOVATION AND LEARNING
Next steps are to

• Improve the alignment fo clinical and corporate
  governance in the development of the organization
  bringing closer links with the performance
  agenda.
• Strenghten the way in which patients, staff and
  the public are involved in the planning and
  delivery of quality services
• Further spread evidence based practice and
  minimise the risks associated with the delivery
  of care
• Further develop information systems to support
  the audit and analysis of clinical outcomes and
  care

58
Demings view of the Organization as a System
(1950, 1994)
Three Perspectives of the Health Care System
Management Lens
Stage 0 Generation of ideas
Micro-system Lens (team level)
Improvement Science Lens
59
We believe all improvement must start with the
purpose
Our mission.. people and patients should get the
care they need when they need it
We are here to increase value for our inhabitants
SourceBudget 2007, The County Council of
Jönköping
60
Sweden
Europe
Jönköping
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What knowledge can healthcare integrate from
other high performing industries?
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Här ska du sedan skriva in din rubrik...
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General Competencies for all employees8 000
training programs

• Patient care
• Medical knowledge
• Practice based learning and improvement
• Professionalism
• Interpersonal communication Skills
• System based practice

Re-examination is done based on above competencies
ACGME
68

• Its essential to have a basic understanding of
  how a given system works. If you dont understand
  the way things work and you try to change them,
  it wont be sustainable changeAnd to create a
  high performing organization, you have to have
  high performing small systems within it
• Paul Batalden

69
Creating a sustainable situation for the
continual improvement of health care
Better patient (population) outcome
Better professional development
Better system performance
SourceBatalden,Henriks
70
Important concepts

• Design
• Processanalyze
• Primary and secondary drivers
• PDSA
• Benchmarking
• 5ps
• Creativity
• Communication

Appreciation of a System
Theory of Knowledge
Psychology
Understanding Variation
Source Deming
71
Execution
Raise high barrier breaking goals
Develop leaders for systemic projects
Spread and develop sustainability
Strong support To local improvement
Develop the person behind Professional role
Develop leadership For the microsystems
Ref Henriks, Nolan
Lessons from P2 G Henriks
72
System Levels
Example
Frontline Nursing Units
Nursing Divisions
Nursing Services
Source Henriks, Bojestig, Jonkoping CC Sweden
73
Ref Nilsson,Bojestig, Edvinsson,Henriks, Berger
74
Purpose
75
Ref Nilsson,Bojestig, Edvinsson,Henriks, Berger
76
Amount of 19 year old persons without any kaires
at all
Riket 23 2002
77
Jönköpings newspaper11/9, 2006
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Early warning system

• Monthly report of system measures

System Measures
Adversed Drug Events, ADE
Patient Satisfaction
Mortality at hospitals, over age 65
Cost per inhabitant
Cost per care event
Access
82

• How do we define our gaps?

83
Ref Nilsson,Bojestig, Edvinsson,Henriks, Berger
84

• A Gap between optimal treatment of cardiac
  infarction according to guidelines and what is
  really performed in the clinical activity

• Big variation between hospitals

• Big variation within hospitals

• The hospitals treatment traditions have a
  tendency to be stable over time

• Evidence based methods for quality development is
  needed

85
Ref Nilsson,Bojestig, Edvinsson,Henriks, Berger
86
Searching for Improvement ideas
- Brainstorming - Litterateur searching - Site
visits
- Learning from other teams
87
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A Generic Clinical Microsystem Model
Satisfaction of need, monitoring, assessment of
outputs
Initial Work-up, Plan for care
Entry, Assignment
Orientation
Disenrollment
RefGene Nelson
Beneficiary knowledge, including knowledge of
life while not in direct contact with the health
care system
89
Ref Nilsson,Bojestig, Edvinsson,Henriks, Berger
90
Variation

• .

Ref Strindhall, Henriks Murray
Outnyttjad kapacitet kan inte sparas
91

• How do we identify waste and links
• that do not work?

92
Ref Nilsson,Bojestig, Edvinsson,Henriks, Berger
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Business Case Fall prevention
Number of Falls reported at Kristinedal nursery
home (ward 3 and 4)
Changes done

• Education for assistant nurses and nurses
• Risk analysis of falling for all patients in the
  unit
• Meetings in the Team planning individual steps
  for each risk patient
• Systematic drug survey for all risk patients to
  prevent falling
• Information to patients/ relatives around risks
  for falling
• Clear of indoors environment
• Continuous measuring
• Notice board
• Purchase of technical facilities

One broken hip Cost for health care 10 12
000 dollars Cost in all for the society 35 000
dollars
96
Business Case Pressure Ulcer
Now
Total cost7.6 million dollars
New
Assessment acc. to Norton
Preventive treatment
Yes
Pat enrolled
Treatment of pr. ulcer
Patient discharged
Pr. Ulcer develops?
Risk?
Yes
No
No
Total cost5 million dollars
Value assessment 53 000 episodes of care/year
Assume that half of the pressure ulcers can be
prevented
4 million dollars
ALL patients are assessed 572 000 dollars
8 of patients has a risk acc. to assess-ment
572 000dollars
97
Get every one on the bus
Systems View of County Council of Jonkoping
County Council
Learning how to better
Participate in
Conduct
serve our Patients
Design and
Conduct
Participate in
Governance for
Attending
Jonkoping
Council
redesign the
Business
County Council
Spread of
professional
Business
Executive
system
Planning
Assembly
Change
meeting
Meeting
Meeting
Obtain
Feedback
Conduct
Provide
Conduct
Provide
Research
nursing
Home
Palliativ

Telephone
Conduct
Care
care visits
care
triage
evaluation
Conduct
Neuromus
Ophtal-
Provide
Surgical
Support Self
cular
mology
E-learning
care
Primary Care
Management
Manage drop in
Drop in visits
Planning for
Manage
Conduct
visits
Customers
Derma-
Provide
follow up
Infection
Ambulance
tology
care in ER
controll
care
Patients
Diagnosis, treatment and
Define Ongoing
Access
Delivery system design
Decision Support
Relationship
Nursing Homes
Provide
Ear, nose,
Provide
care for
throat
Women
care for In
Out
Speciality Care
diseases
patients
Support IT
patients
Scheduling
Conduct Social
information
Provide
appointments
planning
Surgical
systems
Pediatric
Provide
Provide
diseases
care
Intensiv
Group
care
visits
Provide
Provide
Psychiatric
care for
care
Medical
diseases
Provide Diagnoses support
Maintain
Public
Information
HR
IT
Transportation
Economy
Buildings
Clinical
Provide
Provide
Relations
system
Security
Physiology
radiology
labratory
98
Ref Nilsson,Bojestig, Edvinsson,Henriks, Berger
99
Dashboard
Dep. of medicine, Värnamo hospital
Forest and Garden, Huskvarna AB
100

• How do we integrate improvement work as an
  everyday work?

101
Simple rules

• We protect the patients and ourselves
• It is the systems result that counts
• We share the results from our development and
  improvement work with others
• Health care emanates from the patients value,
  need and whishes
• Either solve the problem or take responsibility
  for the handing over to next step
• Feedback to the step before
• Work with guidelines

Ref The County Council of Jönköping,
2002 Bojestig, Henriks
102
The system for care
Everybody are involved and improve the processes
in the system Change at all levels
Lean Consumption User friendly and oriented
Teamness
CARESYSTEM
Ref The county council of Jönköping, 2005,
Bardon, Bojestig, Henriks
103
Ref Nilsson,Bojestig, Edvinsson,Henriks, Berger
104
Demings view of the Organization as a System
(1950, 1994)
Three Perspectives of the Health Care System
Management Lens
Stage 0 Generation of ideas
Improvement Science Lens
Micro-system Lens
105
Improvement of Healthcare

• Improvement of health care systems requires
  learning
• Learning from research
• Learning from quality improvement
• Learning from daily management and practice
• Effective integration of these learning
  opportunities can accelerate the rate of
  improvement

106
Workshop

• Work in small groups
• Discuss a recent improvement in health care in
  one of your organizations.
• Where did the knowledge to make this improvement
  come from?
• Clinical research
• Quality improvement
• Clinical practice
• Discuss additional examples of improvements as
  time permits.

107
Evaluating Quality of Evidence

• I. At least one systematic review of multiple
  well-designed Randomized Control Trials (RCT).
• II. At least one properly designed RCT of
  appropriate size
• III. Well-designed trials without
  randomization (single group, time series or
  matched case-control studies)
• IV. Well-designed non-experimental, based on
  clinical evidence, descriptive studies or reports
  of expert committees
• V. Opinions of respected authorities, based on
  clinical evidence, descriptive studies or reports
  of expert committees

Source Sackett DL. Evidence-based medicine how
to practice and teach EBM. Churchill Livingstone
1997
108
The Science of Improvement

• Dr. W. Edwards Deming stressed the importance of
  studying four areas to become more effective in
  leading improvement
• Appreciation of a system
• Understanding variation
• Theory of knowledge
• Psychology
• Deming called the interplay of these
• four areas Profound Knowledge

Source Improvement Guide, Introduction, p
xxiv-xxvi
109
Clinical Research

• Study of a drug, biologic, or device in human
  subjects
• Encompasses
• translational research (study of laboratory
  findings in humans)
• clinical trials of preventive and therapeutic
  strategies
• epidemiology, behavioral research, and health
  services and outcomes research.
• Results in treatments (and drugs) that directly
  improve health care.

Harold Varmus, MD www.najbr.org/public/research_de
finitions
110
Clinical Research
Campbell et at BMJ 20003216946
111
Characteristics of Clinical Research

• Focus is new knowledge
• Emphasis on linear cause-effect relationships
• Each study is a single learning cycle
• Attention to control of bias to sharpen
  comparison
• Selection
• Confounding
• Measurement
• Chance
• Methods to ensure uniform application of study
  design across study participants
• Goal is generalizability principles or theory
  that goes beyond specific settings and patients

112
Health Care Quality Improvement (QI)A
broad range of activities of varying degrees of
complexity and methodological and statistical
rigor through which health care providers
develop, implement, and assess small-scale
interventions and identify those that work well
and implement them more broadly in order to
improve clinical practice
The Ethics of Improving Health Care Quality
Safety A Hastings Center/AHRQ Project, Mary Ann
Baily, PhD, Associate for Ethics Health
Policy, The Hastings Center, Garrison, New
York, October, 2004
113
Characteristics of Health Care QI

• Contextual factors (background variables or
  confounders in research) are a major focus
• The initial intervention (changes to the system)
  are adapted and modified as study progresses
• Measuring over time (improvement is temporal)
• Graphical analysis and presentation (SPC)
• Involvement of local expertise in conducting
  project
• Multiple experimental cycles for quick feedback
  and learning
• Multi-factor experiments to learn from complex
  systems with non-linear and dynamic cause and
  effect relationships
• Building reliability of the interventions can be
  a major part of the effort
• Sustainability is a consideration from the
  beginning of the project
• Design and execution led by the Science of
  Improvement

114
Model for Improvement
Framework, or Roadmap, for Quality Improvement
Projects
What are we trying to
accomplish?
How will we know that a
change is an improvement?
What change can we make that
will result in improvement?

• Other Frameworks
• Exist
• DMAIC (from 6 Sigma)
• Focus PDCA
• 7-step Problem Solving
• QI Story

PDSA The Continuous Scientific Method
Source Improvement Guide, p 10
115
Repeated Use of the PDSA Cycle
Changes That Result in Improvement
DATA
Implementation of Change
Wide-Scale Tests of Change
Follow-up Tests
Theories Ideas
Very Small Scale Test
116
Evaluating Progress in QI ProjectsAnnotated
Time Series
117
Some Challenges in Quality Improvement Projects

• Description of the system is imprecise
• The need to serve as both advocate and
  investigator
• The use of external resources can hamper the
  ability to sustain the improvement
• Building new knowledge is insufficient
• Replication is difficult
• Publishing QI studies

Nolan and Nolan Chapter 13, http//symptomresearc
h.nih.gov
118
Improvement vs. ResearchContrast of
Complementary Methods

• Improvement
• Aim Improve practice of health care
• Methods
• Test observable
• Stable bias
• Just enough data
• Adaptation of the changes
• Many sequential tests
• Assess by degree of belief

• Clinical Research
• Aim Create New clinical knowledge
• Methods
• Test blinded
• Eliminate bias (e.g. case mix)
• Just in case data
• Fixed hypotheses
• One fixed test
• Assess by statistical significance

119
Clinical Practice vs. Research and Quality
Improvement

• Clinical practice is designed to take care of a
  specific patient's medical needs
• Clinical practice includes adaptation and
  innovation.
• Clinical practice provides a daily opportunity
  for learning that can lead to improvement

The Ethics of Improving Health Care Quality
Safety A Hastings Center/AHRQ Project, Mary Ann
Baily, PhD, Associate for Ethics Health
Policy, The Hastings Center, Garrison, New
York, October, 2004
120
Improvement in Daily Practice

• Ongoing patient feedback systems
• Daily and weekly performance measurement
• Work toward standardization
• Daily huddles to optimize communication
• Use of QI tools with individual patients (control
  charts, experimental design)
• Formal learning from special causes
• Daily PDSAs
• Philosophy of stopping the line and addressing
  problems as they occur

121
Control Chart for Osteoporosis Patient
122
Patient with Insomnia Experimental Variables
Jesper Olsson, et al, Quality Management in
Health Care Volume 14, Issue 4, Oct-Dec, 2005
123
Integrating Learning from Research, Improvement,
and Practice
Local learning and improvement
Continuous, enduring improvement in care
Pragmatic Science
Improvement in Daily Work
Rigorous research and evaluation
124
Workshop

• Medication Errors are a common safety problem in
  todays health care system.
• Discuss in your group how the three learning
  approaches can be leveraged to solve this
  problem
• Clinical research
• Quality improvement
• Clinical practice

125
Special Report The Ethics of Using QI Methods to
Improve Health Care Quality and Safety,
July-August 2006/Hastings Center Report
Research
Clinical Managerial Innovation and Adaptation
Research on QI
QI / Research on QI
Quality Improvement
QI Research
Note Figures not drawn to scale
126
Superior Cancer Survival in Children Compared to
Adults A Superior System of Cancer Care?Joseph
V. Simone, M.D. and Jane Lyons, M.B.A.

• It is instructive to learn that the cure rate
  for childhood acute lymphoblastic leukemia rose
  from about 40 in the early-1970s to about 70
  in the mid-1990s without a single new frontline
  therapeutic agent.
• In leukemia and other cancers, improvements came
  largely from trial-and-error adjustments of
  therapeutic dosages and schedules made possible
  by the large pool of patients participating in
  clinical trials. This was true for other
  childhood cancers as well.

www.iom.edu 6/2003
127
Methods for learning

• Clinical research methods and quality improvement
  methods are different ways to apply the
  scientific method
• Good research involves elements of QI
• Good QI involves attention to research methods
• Ongoing improvement is also an important
  component of clinical practice
• More careful integration of these approaches will
  accelerate improvements in health care