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Sifting Through the Translational Toolbox. Ralph Gonzales, MD, MSPH Professor of Medicine; Epidemiology & Biostatistics 13 May 2008. Where Do “Tools” Fit In T2? --Taxonomy. Conceptual Framework Understanding behaviors Theoretical Approach Determining intervention targets

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sifting through the translational toolbox

Sifting Through theTranslational Toolbox

Ralph Gonzales, MD, MSPH

Professor of Medicine; Epidemiology & Biostatistics

13 May 2008

where do tools fit in t2 taxonomy
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
Where Do “Tools” Fit In T2?--NIH T2 Grant
  • Specific Aims
  • Background; Rationale; Significance
    • Needs Assessment
    • Conceptual Framework
  • Preliminary Studies
    • Formative Research
  • Research Methods
    • Theoretical Approach
    • Implementation Strategy & Tools
    • Program Evaluation
    • Analytical Design
  • Human Subjects
the translational toolbox individual behavior change targets
Community

Health fairs

Mass media

Educational outreach

Health Coaches

Insurance

The Translational Toolbox-individual behavior change targets

Category Key

Knowledge

Enablement

Prof. Service

Incentives

the translational toolbox individual behavior change targets1
Community

Health fairs

Mass media

Educational outreach

Health Coaches

Insurance

The Translational Toolbox-individual behavior change targets

Patient

  • Education
    • Printed
    • Computer
    • Internet
    • Video/multi-media
  • Decision Aids
  • Disease management
    • Coaches
    • Action plans
  • Motivational interviewing
  • Copayments
  • P4P

Key

Knowledge

Enablement

Prof Service

Incentives

the translational toolbox individual behavior change targets2
Community

Health fairs

Mass media

Educational outreach

Health Coaches

Insurance

The Translational Toolbox-individual behavior change targets

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

Key

Knowledge

Enablement

Prof Service

Incentives

tools
Tools

Provider-Focused

  • Practice Guidelines
  • Clinical Decision Support Systems
  • Audit and Feedback

Patient-Focused

  • Patient Education
  • Patient Decision Aids
  • Reminders
tool specs
Tool Specs
  • What is it?
    • Cost
    • Feasibility
    • Complexity
  • Summary of evidence
  • Ideal uses
    • Target behaviors
    • Target barriers
practice guidelines
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
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’
slide11
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
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
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
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
slide15

The influence of intervention strategy and organisational factors on practice guideline effectiveness. Adapted from BMC Health Services Research 2006;6:53

SETTING

Inpatient

Outpatient

INTERVENTION

Educational Meeting

Educational Material

Consensus Meeting

Reminders

Feedback

Patient-Mediated

Outreach

Opinion Leader

Revision of Prof Roles

Financial

Organisational

OUTCOMES

-behavioral

-clinical

ORGANISATIONAL EFFECT MODIFIERS

Leadership (Management Support)

Learning Environment (Academic)

Physician Type and Specialty

Local Consensus (Development)

effectiveness of specific intervention components
Effectiveness of Specific Intervention Components

BMC Health Services Research 2006;6:53

effect modifiers of cpg implementation strategies
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
summary cpg interventions
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 specs kawamoto k et al bmj 2005
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
clinical decision support specs kawamoto k et al bmj 20051
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 specs jamtvedt g et al qual saf health care 2006 15 433 6
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
slide27

Colorado Medical Society

Joint Data Project

truman medical center1
Truman Medical Center

*

*

URI, Bronchitis, Pharyngitis: excludes COPD, and antibiotic-responsive secondary diagnoses

AECB: 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 61
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
consumer education lots of options
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
Patient Education-Bottom Line

Search Strategy:

<insert disease here> and “patient education” and “randomized clinical trial”

patient decision aid specs o connor am et al cochrane reviews 2003
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
slide36
Effect of a Decision Aid on Knowledge and Treatment Decision Making for Breast Cancer SurgeryWhelan et al. JAMA 2004
results
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 specs o connor am et al cochrane review 2003
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

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

CMS Joint Data Project-Community Partners & Collaborators

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

Key Organizations

Colorado Medical Society

Colorado Clinical Guidelines Collaborative

Colorado Dept of Public Health and Envt

University of Colorado Health Sciences Center

intervention design year 1
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
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)
slide43

Colorado Medical Society

Joint Data Project

are administrative data valid maselli et al j clin epidemiol 2001
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 Data

Medical Recordantibiotic 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
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 bronchitis cms joint data project
Adult Office Visits for Acute Uncomplicated BronchitisCMS Joint Data Project

P=0.0037

P=0.4259

P=0.0009

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 antibiotics1

CASE STUDY 1:Colorado Joint Data Project on Careful Use of Antibiotics

Clinical Practice Guidelines (local)

+

Performance Feedback (individual)

+/-

Patient Education

  • CONCLUSIONS
  • Guidelines & Feedback do not appear effective without patient education
case study 2 impaact trial

CASE STUDY 2:IMPAACT Trial

Clinical Practice Guidelines (national)

+

Performance Feedback (group)

+

Patient Education

slide52
The IMPAACT Trial

R Gonzales – co-PI – AHRQ

J Metlay – co-PI – VAMC

C Camargo – Co-I – EMNet

T MacKenzie (UCHSC)

C McCulloch (UCSF)

slide53

IMPAACT Intervention Sites

Lincoln Medical Center

Bronx VAMC

Northwestern Memorial Hospital

Chicago VAMC

UNM Health Sciences Center

Albuquerque VAMC

Medical College of Georgia

Augusta VAMC

impaact multi dimensional intervention strategy
IMPAACT Multi-Dimensional Intervention Strategy
  • Four regions randomized to receive:
    • Provider education (practice guidelines) delivered by local opinion leaders
    • Group audit and feedback
    • Patient education
  • Sites provided individualized adaptation of components
truman medical center2
Truman Medical Center

*

*

URI, Bronchitis, Pharyngitis: excludes COPD, and antibiotic-responsive secondary diagnoses

AECB: as 1st diagnosis, or URI/bronchitis 1st diagnosis in patient with PMHx COPD

* < 5 visits

patient education
Patient Education
  • Waiting Room Patient Education
    • Pamphlets/Cards
    • Informational Kiosk
  • Examination Room Materials
    • Bronchitis Posters
kiosk
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
slide60

Kiosk Care Plan printout

(Spanish and English)

adjusted abx rx rates for uri ab
Adjusted Abx Rx Rates for URI/AB

% Visits Prescribed Antibiotics:

Intervention - Baseline Periods

case study 2 impaact trial1

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
ABx Treatment of URIs/Bronchitis Decreased at Intervention Sites

Metlay et al, Ann Emerg Med, 2007.

summary
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
Effects of Organisational Features on Guideline Impact

BMC Health Services Research 2006;6:53