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Sifting Through the Translational Toolbox

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

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  1. Sifting Through theTranslational Toolbox Ralph Gonzales, MD, MSPH Professor of Medicine; Epidemiology & Biostatistics 13 May 2008

  2. 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

  3. 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

  4. Community Health fairs Mass media Educational outreach Health Coaches Insurance The Translational Toolbox-individual behavior change targets Category Key Knowledge Enablement Prof. Service Incentives

  5. 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

  6. 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

  7. Tools Provider-Focused • Practice Guidelines • Clinical Decision Support Systems • Audit and Feedback Patient-Focused • Patient Education • Patient Decision Aids • Reminders

  8. Tool Specs • What is it? • Cost • Feasibility • Complexity • Summary of evidence • Ideal uses • Target behaviors • Target barriers

  9. 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)

  10. 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’

  11. 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)

  12. 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.

  13. 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

  14. 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

  15. 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)

  16. Effectiveness of Specific Intervention Components BMC Health Services Research 2006;6:53

  17. 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

  18. 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

  19. Clinical Decision Support

  20. 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

  21. Implementation Options for Clinical Decision Support Systems

  22. Implementation Options for Clinical Decision Support Systems

  23. Results of Meta-Regression of 71 studies. Kawamoto et al. BMJ 2005.

  24. 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

  25. Audit and Feedback

  26. 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

  27. Colorado Medical Society Joint Data Project

  28. Truman Medical Center

  29. 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

  30. 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

  31. Public and Patient Education

  32. 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

  33. Patient Education-Bottom Line Search Strategy: <insert disease here> and “patient education” and “randomized clinical trial”

  34. Patient Decision Aids

  35. 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

  36. Effect of a Decision Aid on Knowledge and Treatment Decision Making for Breast Cancer SurgeryWhelan et al. JAMA 2004

  37. 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%

  38. 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:

  39. CASE STUDY 1:Colorado Joint Data Project on Careful Use of Antibiotics Clinical Practice Guidelines (local) + Performance Feedback (individual) +/- Patient Education

  40. 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

  41. 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

  42. 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)

  43. Colorado Medical Society Joint Data Project

  44. 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%)

  45. 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

  46. 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.

  47. 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

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