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Sifting Through theTranslational Toolbox
Ralph Gonzales, MD, MSPHProfessor of Medicine; Epidemiology & Biostatistics
13 May 2008
Where Do “Tools” Fit In T2?--Taxonomy
• Conceptual Framework– Understanding behaviors
• Theoretical Approach– Determining intervention targets
• Intervention Implementation Strategy– Determining intervention components (tools)
• Program Evaluation
• Analytical Design
Where Do “Tools” Fit In T2?--NIH T2 Grant
A. Specific AimsB. Background; Rationale; Significance
– Needs Assessment– Conceptual Framework
C. Preliminary Studies– Formative Research
D. Research Methods– Theoretical Approach– Implementation Strategy & Tools– Program Evaluation– Analytical Design
E. Human Subjects
The Translational Toolbox-individual behavior change targetsCommunity
• Health fairs• Mass media• Educational
outreach• Health
Coaches• Insurance
Category Key Knowledge Enablement Prof. Service Incentives
The Translational Toolbox-individual behavior change targetsCommunity
• Health fairs• Mass media• Educational
outreach• Health
Coaches• Insurance
Patient• Education
– Printed– Computer– Internet– Video/multi-media
• Decision Aids• Disease
management– Coaches– Action plans
• Motivational interviewing
• Copayments• P4P
KeyKnowledgeEnablementProf ServiceIncentives
The Translational Toolbox-individual behavior change targetsCommunity
• Health fairs• Mass media• Educational
outreach• Health
Coaches• Insurance
Patient• Education
– Printed– Computer– Internet– Video/multi-media
• Decision Aids• Disease
management– Coaches– Action plans
• Motivational interviewing
• Copayments• P4P
Physician• Education
– CME– Outreach– Detailing
• Guidelines• Decision
support– Reminders
• Registries• Performance
feedback• P4P• Prior Auth’n
KeyKnowledgeEnablementProf ServiceIncentives
Tools
Provider-Focused• Practice Guidelines• Clinical Decision Support Systems• Audit and Feedback
Patient-Focused• Patient Education• Patient Decision Aids• Reminders
Tool Specs
• What is it?– Cost– Feasibility– Complexity
• Summary of evidence
• Ideal uses– Target behaviors– Target barriers
Practice Guidelines
– The Beginning: AHCPR Guidelines– Currently: Produced by professional societies,
governmental agencies, expert panels– Evidence-based frameworks– Recommended behaviors implicit or explicit
– Conclusion: necessary, but not sufficient• Relate back to transtheoretical model, or cognitive theory
(knowledge/awareness must be present before action)
Practice Guideline Specs• What is it?
– Cost: person-hours– Feasibility: buy-in; participation– Complexity: varies
• Summary of evidence ineffective in isolation
• Ideal uses– Target behaviors single, simple actions– Target barriers knowledge/attitudes
• Conclusion: it’s all about ‘implementation’
• Assemble a multi-disciplinary Panel (1-2 mos)– IM, FP, EM, ID
• Use evidence-based principles to assess evidence (2-3 mos)– AHRQ; ACP-CEAS
• Obtain professional society input and/or endorsement (2-3 mos)– ACP; AAFP; ACEP; IDSA
• Write (and re-write) manuscript/documents (4 months)
5 for the price of 1?• Gonzales R, Bartlett JG, Besser RE, Cooper RJ, Hickner JH, Hoffman JR,
Sande MA. Principles of appropriate antibiotic use for treatment of acute respiratory tract infections in adults: Background, Specific Aims and Methods. Annals of Internal Medicine, 2001;134:479-486.
• Gonzales R, Bartlett JG, Besser RE, Cooper RJ, Hickner JH, Hoffman JR, Sande MA. Principles of appropriate antibiotic use for treatment of uncomplicated acute bronchitis: background. Clinical Practice Guideline, Part 2. Annals of Internal Medicine, 2001;134:521-529.
• Gonzales R, Bartlett JG, Besser RE, Hickner JH, Hoffman JR, Sande MA. Principles of appropriate antibiotic use for treatment of nonspecific upper respiratory tract infections in adults: background. Clinical Practice Guideline, Part 2. Annals of Internal Medicine, 2001;134:490-494.
• Cooper RJ, Hoffman JR, Bartlett JG, Besser RE, Gonzales R, Hickner JH, Sande MA. Principles of appropriate antibiotic use for acute pharyngitis in adults: background. Clinical Practice Guideline, Part 2. Annals of Internal Medicine, 2001;134:509-517.
• Hickner JH, Bartlett JG, Besser RE, Gonzales R, Hoffman JR, Sande MA. Principles of appropriate antibiotic use for acute rhinosinusitis in adults: background. Clinical Practice Guideline, Part 2. Annals of Internal Medicine, 2001;134:498-505.
SUMMARY OF PRINCIPLES
• Don’t prescribe antibiotics for colds & URIs
• Don’t prescribe antibiotics for acute bronchitis when comorbidity is absent
• Limit antibiotics to adults with sinusitis symptoms lasting at least 1 week
• Limit antibiotics to adults with sore throat who have a positive test or clinical screen for strep
Practice Guidelines seem to be most effective…
• for acute care conditions
• when quality of evidence is superior
• when compatible with existing values
• when decision making complexity is low
• when desired performance/behavior is clearly understood
• when new skills or organizational support is not necessary for behavior change
The influence of intervention strategy and organisational factors on practice guideline effectiveness.
Adapted from BMC Health Services Research 2006;6:53
INTERVENTION
Educational Meeting
Educational Material
Consensus Meeting
Reminders
Feedback
Patient-Mediated
Outreach
Opinion Leader
Revision of Prof Roles
Financial
Organisational
SETTING
Inpatient
Outpatient
ORGANISATIONAL EFFECT MODIFIERS
Leadership (Management Support)
Learning Environment (Academic)
Physician Type and Specialty
Local Consensus (Development)
OUTCOMES
-behavioral
-clinical
Effectiveness of Specific Intervention Components
BMC Health Services Research 2006;6:53
Effect Modifiers of CPG Implementation Strategies
• Readiness to change– time in practice; age
– perception of a gap between current and optimal practices
– motivation
• The “Messenger”– opinion leader; colleagues
• “Practice enabling” strategies– information systems
– team building/support staff
– standing orders
– computerized medical records
• Reinforcements– reminders; profiling
– financial incentives
– liability
SUMMARYCPG Interventions
• Development– identify clinician knowledge and behavior gaps– identify barriers to change– evidence-based “best practice”– quantify benefit of CPG compliance on system, practice and
patient– local input & endorsement
• Implementation– opinion leader; clinical champion– point-of-service reminders– feedback/profiling
Clinical Decision Support
Clinical Decision Support SpecsKawamoto K et al. BMJ 2005
• What is it? – “…any electronic or non-electronic system designed
to aid directly in clinical decision making, in which characteristics of individual patients are used to generate patient-specific assessments or recommendations that are presented to clinicians for consideration”.
– Manual or computer-assisted preventive care– CPOE
• Cost: low-medium if infrastructure in place• Feasibility: depends heavily on IT officer buy-in• Complexity: potential for high complexity
Implementation Options for Clinical Decision Support Systems
Implementation Options for Clinical Decision Support Systems
Results of Meta-Regression of 71 studies. Kawamoto et al. BMJ 2005.
Clinical Decision Support SpecsKawamoto K et al. BMJ 2005
• Summary of evidence:– Automatic provision of support in clinical work-
flow strongly predicts success– Real-time decision support; recommendations
(not just assessments); and use of computers also predict success
– Simple prompts better than advanced systems• Ideal uses
– Target behaviors: management > diagnosis, especially drug-dosing and prevention
– Target barriers: doctors too busy; low priority problem
• Conclusion: key features of CDSS need to make system easy for doctors to use
Audit and Feedback
Audit and Feedback Specs-Jamtvedt G et al. Qual Saf Health Care 2006;15:433-6.
• What is it? – “any summary of clinical performance of
healthcare over a specified period of time”– Profile at individual, group or regional
level• Cost: fairly low depending on data source• Feasibility: not feasible for complex tasks;
ideal for testing, prescribing, referrals, procedures
• Complexity: low; acknowledge limitations of administrative data and inclusion criteria
Colorado Medical Society Joint Data Project
Truman Medical Center
URI Bronchitis Pharyngitis
Pneumonia AECB Other
0
20
40
60
80
All ARIs
EMNet Average Year 1 Truman Year 1
Truman Year 2 EBM Target
0
20
40
60
80
100
URI Bronchitis Pharyngitis AECB
Ant
ibio
tic
Pre
scri
ptio
n R
ate
EMNet Average year 1 Truman year 1Truman year 2 EBM Target
Truman Medical Center
*
URI, Bronchitis, Pharyngitis: excludes COPD, and antibiotic-responsive secondary diagnosesAECB: as 1st diagnosis, or URI/bronchitis 1st diagnosis in patient with PMHx COPD* < 5 visits
*
Audit and Feedback Specs-Jamtvedt G et al. Qual Saf Health Care 2006;15:433-6.
• Summary of evidence:– Alone: mild-to-modest effect– In Combination: modest-to-strong effect
• Ideal uses– Target behaviors: test ordering; prescribing– Target barriers: doctors too busy; low
priority problem
• Conclusion: use in combination with education, outreach, reminders
Public and Patient Education
Consumer Education: Lots of Options!
• type of instructional media– verbal, written, audiotapes, audiovisual, computer-
assisted instruction
• type of learning activity– lecture, discussion, demonstration, practice,
interactive vs. non-interactive
• nature of follow-up– reminders, self-monitoring, support groups, feedback,
reinforcement, written action-plan
• degree of structure– planned instruction vs. unstructured information
• nature of content
Patient Education-Bottom Line
Search Strategy:
<insert disease here> and “patient education” and “randomized clinical trial”
Patient Decision Aids
Patient Decision Aid SpecsO’Connor AM et al. Cochrane Reviews 2003
• What is it? – An adjunct to counseling that
• explains options• clarifies personal values for the benefits vs. harms• guides patients in deliberation and communication
– Decision Quality• Decisions are informed (knowledge; risk perception)• Decisions based on personal values (congruence)’
– Most common conditions… most are web-based:• Breast, prostate and colon cancer screening & treatment• Menopause options• Cardiovascular disease management• Prenatal testing
Effect of a Decision Aid on Knowledge and Treatment Decision Making for Breast Cancer Surgery
Whelan et al. JAMA 2004
Results
t0 +6 mo +12m
Rx C Rx C Rx C
• Knowledge 67 59
• Conflict 1.4 1.6 1.4 1.5 1.5 1.5
• Satisfaction 4.5 4.3 4.5 4.3 4.4 4.4
• Anxiety no diff
• Depression no diff
• BCS 94% 76%
• “offered clear choice” 87% 69%
Patient Decision Aid SpecsO’Connor AM et al. Cochrane Review 2003
• Cost: development… low-medium—person-hours• Feasibility: very feasible• Complexity: potential for high complexity • Summary of evidence:
– Most RCTs measured process/intermediate outcomese (knowledge; realistic expectations; decisional conflict)
• Main effects are on knowledge and realistic expectations, with OR about 1.4-1.6.
• Reductions in decisional conflict appear modest• 5/9 studies showed improvement in satisfaction with decision
• Ideal uses– Target behaviors: health care decisions that depend on
patient preferences for harms/benefits of different options– Target barriers: poor patient knowledge; doctors too busy;
low priority problem• Conclusion:
CASE STUDY 1:Colorado Joint Data Project on
Careful Use of Antibiotics
Clinical Practice Guidelines (local)
+
Performance Feedback (individual)
+/-
Patient Education
CMS Joint Data Project-Community Partners & Collaborators
Key Organizations
Colorado Medical Society
Colorado Clinical Guidelines Collaborative
Colorado Dept of Public Health and Envt
University of Colorado Health Sciences Center
MCOs
Cigna Healthcare of CO
Community Health Plan of the Rockies
HMO Colorado (BCBS)
One Health Plan
PacifiCare CO
Sloans Lake Health Plan
UnitedHealthcare of CO
Intervention Design: Year 1•7 Health Plans representing 1 million covered
lives
•Target Conditions: pharyngitis & bronchitis
•All CMS Physicians (n=2500)
• practice guidelines for acute respiratory illnesses (Colorado Clinical Guidelines Collaborative)
• patient education sheet
•Physicians > 10 visits in MCO data (n=750)
• Individual physician profiles based on aggregated MCO data
Intervention Design: Year 2•All Physicians > 5 visits Winter 1999 (n=750)
• pre/post physician profiles on bronchitis and pharyngitis
• practice guidelines for acute respiratory illnesses (Colorado Clinical Guidelines Collaborative)
Colorado Medical Society Joint Data Project
Are Administrative Data Valid?-Maselli et al, J Clin Epidemiol, 2001.
• Random medical record review of CMS Data Project office visits for acute bronchitis (medical record=“gold standard”)
• Verification of diagnosis (Age 18-64 years; n=497): 79%• Verification of antibiotic prescription for acute bronchitis
Administrative DataMedical Record antibiotic prescription
+ -+ 357
96 - 9 48
sensitivity (95% CI) 79% (75-83%)specificity (95% CI) 84% (81-87%)concordance (95% CI) 79% (75-83%)positive predictive value (95% CI) 98% (97-99%)negative predictive value (95% CI) 33% (29-37%)
Sub-Intervention Design: Year 2•Randomly selected profiled physicians (n=18)
• MCO member households received educational materials (n=14,400) (distributed across participating MCO plans)
• materials production and delivery sponsored by GlaxoSKB and Abbott
Adult Office Visits for Acute Uncomplicated BronchitisCMS Joint Data Project
0
20
40
60
80
100
'98 '99 '00 '98 '99 '00 '98 '99 '00
Adj
uste
d A
ntib
ioti
c R
x R
ate
P=0.4259 P=0.0009
P=0.0037
No Profile Profile Profile + Education
Physician Group**Each year represents a 4 month winter period beginning Nov of that year. 98 is the baseline winter, 99 is the first winter in which profiles were mailed, and 00 is the second year in which profiles were mailed, as well as household patient educational materials to a subset of profiled physicians.
CASE STUDY 1:Colorado Joint Data Project on
Careful Use of AntibioticsClinical Practice Guidelines (local)
+
Performance Feedback (individual)
+/-
Patient Education
CONCLUSIONS
• Guidelines & Feedback do not appear effective without patient education
CASE STUDY 2:IMPAACT Trial
Clinical Practice Guidelines (national)
+
Performance Feedback (group)
+
Patient Education
The IMPAACT TrialR Gonzales – co-PI – AHRQJ Metlay – co-PI – VAMCC Camargo – Co-I – EMNetT MacKenzie (UCHSC)C McCulloch (UCSF)
IMPAACT Intervention Sites
UNM Health Sciences CenterAlbuquerque VAMC
Medical College of GeorgiaAugusta VAMC
Northwestern Memorial Hospital Chicago VAMC
Lincoln Medical CenterBronx VAMC
IMPAACT Multi-Dimensional Intervention Strategy
• Four regions randomized to receive:1. Provider education (practice guidelines)
delivered by local opinion leaders
2. Group audit and feedback
3. Patient education
• Sites provided individualized adaptation of components
0
20
40
60
80
100
URI Bronchitis Pharyngitis AECB
Ant
ibio
tic
Pre
scri
ptio
n R
ate
EMNet Average year 1 Truman year 1Truman year 2 EBM Target
Truman Medical Center
*
URI, Bronchitis, Pharyngitis: excludes COPD, and antibiotic-responsive secondary diagnosesAECB: as 1st diagnosis, or URI/bronchitis 1st diagnosis in patient with PMHx COPD* < 5 visits
*
Patient Education
• Waiting Room Patient Education– Pamphlets/Cards– Informational Kiosk
• Examination Room Materials– Bronchitis Posters
Exam Room Poster
KIOSK
• Waiting room signs directed patients to kiosk
• Patients were encouraged to use kiosk by ED staff
• Rotating messages on screen suggested content
• All text on screen could be heard through speakers
• Bilingual educational printout at end of program
Kiosk Care Plan printout(Spanish and English)
Adjusted Abx Rx Rates for all ARIs
-15
-10
-5
0
5
10
15
Control Sites Intervention Sites
p= .17
% V
isit
s P
res
cri
be
d A
nti
bio
tic
s:
Inte
rve
nti
on
- B
as
eli
ne
Pe
rio
ds
Adjusted Abx Rx Rates for URI/AB
-15
-10
-5
0
5
10
15
Control Sites Intervention Sites
p = .04
% V
isit
s P
resc
rib
ed A
nti
bio
tics
:In
terv
enti
on
- B
asel
ine
Per
iod
s
CASE STUDY 2:IMPAACT Trial
Clinical Practice Guidelines (national)
+
Performance Feedback (group)
+
Patient Education
CONCLUSIONS
• Multidimensional Intervention IS effective at reducing overuse of antibiotics in EDs.
ABx Treatment of URIs/Bronchitis Decreased at Intervention Sites
Metlay et al, Ann Emerg Med, 2007.
SUMMARY
• Uncommon to have any single tool prove >10% effect… thus, use multifaceted implementation strategies
• Guidelines/Knowledge necessary starting point, but rarely sufficient– Nicely augmented by performance feedback, opinion
leaders, and reminders– Consider adding patient education when appropriate
• Decision aids can be very useful, particularly when at point of service/decision making
Effects of Organisational Features on Guideline Impact
BMC Health Services Research 2006;6:53