Does Shared Treatment Decision-Making Improve Asthma Adherence and Outcomes?

1. Does Shared Treatment Decision-Making Improve Asthma Adherence and Outcomes? Supported by grants from the National Heart, Lung and Blood Institute 1R01 HL69358 (PI: SWilson) and 1R18 HL67092 (PI: ASBuist)

2. Only ~50% of patients take asthma medications at effective doses Documented problems: • Under-use of controller medications • Over-use of relievers & OTC medications • Poor inhaled medication technique • Failure to fill/refill prescriptions • Failure to keep medications available when and where they are needed

3. Known contributors to non-adherence • Patient • Younger age • Low socioeconomic status • Lack of education • Memory problems • Lack of understanding of the disease • Regimen • Longer duration of treatment • Higher cost • Complexity, more frequent dosing • Properties (bad taste, more side effects, etc.) • Physician-patient relationship • Inadequate monitoring • Failure to explain side effects • Failure to analyze patient’s medication-taking behaviors • Failure to address the patient’s individual situation and preferences

4. Pt MD MD Pt Models of Clinician-Patient Interaction • Traditional model: • Interaction is directive; • Clinician makes the treatment decision • Evidence-based management usually follows a traditional model • Informed decision-making model: • Clinician provides information to the patient • Patient makes the decision

5. MD Pt • Shared decision-makingmodel: • Mutual exchange of information andtreatment preferences between clinician & patient • Both participate in treatment decisions • Each brings unique knowledge to the interaction Hypothesis: Involving patients in treatment decisions should result in: • Better adherence to treatment • Better asthma control • Greater patient satisfaction

6. Design of the BOAT trial • Three-arm, randomized controlled trial • SDM = shared decision making care management • MBG = guidelines-based traditional care management • UC = usual medical care • Data collection • Baseline and 12-mos. post-randomization • Questionnaire • PFT • 12-mos. pre and 24 mos. post-randomization (36 mo.) • Asthma medications dispensed • All health care utilization

7. BOAT study hypotheses regardingadherence and disease outcomes SDM > MBG SDM > UC

8. Primary Adherence to asthma medications Asthma-related quality of life Asthma-related health care utilization Secondary Asthma control Use of reliever medications Symptom-free days; Lung function Satisfaction with asthma care Preferences, values, & attitudes towards adherence Total asthma health care utilization Asthma-related health care costs Study Outcomes

9. Both the SDM & MBG Interventions: • Target patients with poorly controlled, moderate-severe asthma • Involve 2 in-person sessions, approximately 1 mo. apart, plus 3 follow-up calls at 3 mo. intervals • Conducted by asthma care managers: • Clinical pharmacists • Nurse practitioners and registered nurses • Physician assistants • Respiratory therapists • Parallel written protocols (scripts) guide both SDM and MBG clinician-patient interactions • Structured to enable tailoring to the individual patient • Instructional aides and worksheets are included in the interventionist manual

10. Wrap Up • Write Rx • Give Asthma Action & Management Plan • Teach proper inhaler use • Give asthma diary • Schedule follow-up appointment SDM and MBG Interventions* • Set the Stage • Establish rapport • Describe session schedule • Describe shared decision making approach • Negotiate (SDM)/Prescribe (MBG) • Summarize patient goals and priorities • Review PFTs with patient • Assess symptom control using objective criteria • Determine asthma severity per GINA guidelines • Define medication preferences • Discuss +/- of each treatment option per patient goals and preferences • Negotiate a treatment decision • Gather patient information • Asthma symptoms • Perceptions of control • Medication use • Use of alternative therapies • Environmental triggers • Patient goals & preferences • Provide information • Assess understanding of asthma • Review asthma and how it is treated • Confirm comprehension * White = MBG and SDM Gold = SDM only

13. Inclusion Criteria • Recent ED/hospital visit for asthma and/or evidence of over-use of rescue medication • 18-70 years of age • KFHP member ≥ 1 year • Self-reported, doctor-diagnosed asthma • Currently Rxed asthma medications • Meets obstruction reversibility criterion • One or more asthma control problems (ATAQ score ≥1)

14. Exclusion Criteria • Mild intermittent/seasonal asthma • Regular use of oral corticosteroids • Currently receiving asthma care-management • Not able to speak, read, and understand English • Planning to move out of area within two years

15. SDM(N= 204) Eligible Patients (N=613) MBG(N= 205) UC(N= 204) Randomization* * Adaptive randomization algorithm (Pocock, 1983) - ensures better than chance balance and increases likelihood of better than chance balance on correlated characteristics.

16. Demographic characteristics* 80% 38% * No significant group differences.

17. Baseline asthma status*  FEV1 % predicted Symptom Frequency Nocturnal Symptoms * No significant group differences in symptom frequency, nocturnal symptoms, or FEV1 % predicted at baseline.

18. De facto medication regimen and asthma control* Medication regimen Asthma Control *No significant group differences at baseline.

19. Did the SDM patients’ medication choices differ from the MBG care managers’ guidelines-based Rx? 1. Chi-square or Fishers exact test. 2. Includes Beclomethasone and Fluticasone at lower strengths, and Budesonide. 3. Includes ICSs, leukotriene modifiers, and theophylline; excludes LABAs and oral prednisone.

20. CMA = Number of days’ supply of a medication dispensed/365 days Proportion of days on which medication was available for use on Rxed regimen A commonly used indicator of adherence to the intended daily regimen Data from the HMO’s pharmacy database ~95% of patients obtain all their medications from the HMO pharmacy Adherence measure = Continuous Measure of Medication Acquisition (CMA)

21. Cumulative medication acquisition (CMA) values pre and post randomization, by experimental group CMA index – Mean (SD)

22. Conclusions: For non-adherent patients with poorly controlled asthma -- • Involving patients in a meaningful way in treatment decisions does not result treatment regimens that conflict with standard guidelines, assuming patients have a basic understanding of: • asthma • their current level of disease control • the medical rationale for asthma treatment.

23. Conclusions: • For non-adherent patients with poorly controlled asthma, care management that utilizes a shared clinician-patient approach to selection of the treatment regimen significantly improves adherence to asthma controllers over a one year period when compared with both: • usual medical care, and • traditional, prescriptive care management • Intervention effects did not differ as a function of ethnic group (Caucasian, Asian and African American)

24. Conclusions - continued • Clinical approaches of asthma care managers can be shaped such that treatment decision making is shared with the patient in a meaningful way. • This required use of a detailed intervention protocol, training, and ongoing feedback. • Patients evaluate their own vs. the clinician’s influence on treatment decisions differently when they experience a shared decision making approach than when they experience prescriptive care management

25. Questions being investigated by analyses in process • Does shared decision-making lead to: • better asthma control? • better asthma-related quality of life? • reduced asthma health care utilization? • increased patient satisfaction? • Are adherence outcomes mediated by patient perceptions of their influence on treatment decisions? • Are disease outcomes mediated by medication adherence?

26. Process outcomes • How closely did interventionists follow the protocol• Who made the treatment decisions? Rating scales: Protocol Adherence - 1 = Relevant elements not covered 3 = All elements covered, but some briefly, incompletely, or inadequately 5 = All topics covered completely, thoroughly, and accurately Decision Roles - Treatment decisions were made by: 1 = Care manager alone 2 = Care manager mostly 3 = Patient and care manager equally 4 = Patient mostly 5 = Patient alone

27. Investigators Sandra Wilson, PhD, PI (PAMFRI, SUSM) Sonia Buist, MD, PI (OHSU, CHR) William Vollmer, PhD (CHR) Tom Vogt, MD (CHR) Nancy L. Brown, PhD (PAMFRI, SU) Philip Lavori, PhD (SUSM) Margaret Strub, MD (TPMG) Stephen VanDenEeden, PhD (KRFI/DOR) Clinical Site Co-investigators Faith Bocobo, MD (TPMG) Christine Fukui, MD (TPMG) Donald German, MD (TPMG) John Hoehne, MD (TPMG) Matthew Lau, MD (TPMG) Myngoc Nguyen, MD (TPMG) Consultants Amiram Gafni, PhD Elizabeth Juniper, PhD Cynthia Rand, PhD Sean Sullivan, PhD Kevin Weiss, MD

30. (SDM only)

31. Post-randomization CMA indices for inhaled corticosteroids, by group1 Overall p<0.00012,3 Mn = 0.62 N = 204 Mn = 0.54 N = 202 Mn = 0.39 N = 203 • N=504. Excludes 4 patients with mild persistent asthma for whom no ICS was prescribed. • Overall test of group differences, Wilcoxon/Kruskal Wallis test. • Multiple comparisons: SDM vs. MBG, p=0.02; SDM vs. UC, p<0.0001; MBG vs. UC, p<0.0001.

32. Post-randomization CMA indices for all asthma controllers combined, by group1 Overall p<0.00012,3 Mn = 0.69 N = 204 Mn = 0.59 N = 205 Mn = 0.49 N = 204 • N = 504. Excludes 4 patients with mild persistent asthma, for whom no controller was prescribed. • Overall test of group differences, Wilcoxon/Kruskal Wallis test. • Multiple comparisons: SDM vs. MBG, p=0.02; SDM vs. UC, p<0.0001; MBG vs. UC, p=0.0023.

33. Pre-randomization CMA for all controllers, by ethnicity, within relevant sites Northern CA & Hawaii Northern CA & Portland Mn = 0.47 N = 205 Mn = 0.41 N = 344 Mn = 0.40 N = 94 Mn = 0.36 N = 59

34. Post-randomization CMA for all controllers, by group, separately for Whites and Asians. White Asian Mn=0.78 N = 18 Mn=0.87 N = 19 Mn=0.52 N = 22 Mn=0.66 N = 68 Mn=0.74 N = 68 Mn=0.52 N = 69 Regression model Group comparison: p-value <=0.0001. Group x Ethnicity interaction: p-value = 0.4478

35. Post-randomization CMA for all controllers, by group, separately for Whites and African Americans White African American Mn = 0.55 N = 33 Mn = 0.51 N = 32 Mn = 0.34 N = 29 Mn = 0.63 N = 113 Mn = 0.53 N = 116 Mn = 0.74 N = 115 Regression model Group comparison: p-value <=0.0001; Group X Ethnicity interaction: p-value = 0.6993.