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The BEAT Study: B reathe E asy A sthma T rial

A Randomized Clinical Trial Comparing Asthma Self-Management Training to Standard Asthma Education Among Adults With Asthma Presenting to an Urban Emergency Department __________________________. The BEAT Study: B reathe E asy A sthma T rial. BREATHE EASY ASTHMA TRIAL (BEAT).

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The BEAT Study: B reathe E asy A sthma T rial

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  1. A Randomized Clinical Trial Comparing Asthma Self-Management Training to Standard Asthma Education Among Adults With Asthma Presenting to an Urban Emergency Department__________________________ The BEAT Study: Breathe Easy Asthma Trial

  2. BREATHE EASY ASTHMA TRIAL (BEAT) Principal Investigator: Felicia Hill-Briggs, PhD, ABPP Co-Investigators: Guadalupe X. “Suchi” Ayala, PhD, MPH Ahna Hoff, PhD Yunsheng Ma, PhD Cheryl Rucker-Whitaker, MD, MPH Project Director: Robert Nicholson, PhD Consultants: Edwin Boudreaux, PhD (Specialist, Emergency Department use, Asthma) Mary L. Smith, RN, CAE (Certified Asthma Educator)

  3. BACKGROUND: ASTHMAMORBIDITY AND MORTALITY_______________________________ • Can be life-threatening. • Affects 17 million adults in U.S. • Morbidity and mortality are higher among ethnic minorities and the economically disadvantaged • 3x more likely to visit ED • 6x more likely to die from asthma • Symptoms controllable with access to medication and self-management skills.

  4. THEORETICAL BACKGROUNDFOR CHRONIC DISEASE SELF-MANAGEMENT ___________________________________ • Disease knowledge/education necessary for self-management • Weak association between knowledge and • disease self-management behaviors • disease control • Self-Management involves: • Skills for self-monitoring, use of treatments • Skills for problem solving (D’Zurilla & Nezu) • translate knowledge and skills into active, ongoing care • overcome barriers care

  5. Tool Kit: Peak flow meter Action plan Medication Med adherence Self Monitoring Problem Solving ASTHMA SELF-MANAGEMENT FEEDBACK LOOP___________________________________

  6. HYPOTHESIS___________________________________ Among economically disadvantaged adults with asthma, an individualized asthma self-management intervention (termed “Skills Training”) will decrease the number of emergency department visits due to asthma compared to standard asthma education.

  7. BEAT: PRIMARY SPECIFIC AIM___________________________________ The primary aim of this trial is to evaluate the efficacy of a Skills Training intervention in reducing the number of emergency department visits in a 12-month period.

  8. BEAT: SECONDARY AIMS___________________________________ • Improve self-monitoring using peak flow meter • Skills Training participants will demonstrate significantly greater adherence to peak flow monitoring measured by momentary data at 3-months relative to Education. • Improve medication adherence using momentary data (MEMS Cap) • Skills Training participants will demonstrate a significantly greater proportion of time they use medication when the peak flow meter indicates it at 3-months relative to Education. • Improve lung functioning assessed via Spirometry • Skills Training participants will demonstrate significant improvements in FEV at 3- and 12-months relative to Education. • Decrease asthma symptom days • Skills Training participants will report fewer asthma symptoms days at 3- and 12-months relative to Education.

  9. BEAT: PRELIMINARY STUDIES

  10. Epidemiologic Study of Emergency Department Use by Adults With Asthma in Chicago, IL • Prevalence of adult asthma: 419,000 • 70,000 ED visits/year • More asthma deaths among minorities than any other US city Cook County Hospital • 20,000 adult asthma ED visits/year • 60% of these adult patients with asthma have at least 3 visits for asthma/year

  11. BEAT: Pilot Study___________________________________ • Feasibility of recruiting ED patients with asthma symptoms • Feasibility of intervention • Effect of intervention on selected outcomes • Assess cultural sensitivity of intervention and assessment protocol

  12. Figure 1. One Month Recruitment and Enrollment Yield from Feasibility Study of Asthma Intervention for Persons Presenting to an Urban Emergency Department Number of adults with asthma who presented to ED = 176 Stabilized for discharge (non-hospitalized) = 141 (80%) Referred to study by physician = 120 (86%) Of those referred, eligible for study = 95 (79%) Of those eligible, gave informed consent = 74 (78%) Completed baseline visit and were enrolled = 51 (69%) Of enrolled, completed 3 month intervention = 50 (98%) Of enrolled, had ED data available at 12 months = 48 (94%)

  13. Table 1. Selected Baseline Characteristics of 51 Asthma Self-Management Intervention Enrollees

  14. Figure 2. Reasons for Emergency Department Visits Among Presenters with Non-Urgent Needs

  15. Table 2. Change in Primary and Secondary Outcomes Following Asthma Self-Management Intervention in 51 Presenters to an Urban Emergency Department *p<.001

  16. BEAT: RESEARCH DESIGN AND METHODS

  17. Setting: Cook County Hospital ED 500 pts/recruitment period Recruitment and Screening Assess for Eligibility Obtain Informed Consent Baseline Assessment Randomization Skills Training (3 mths) N=100 4 weekly office visits 4 bimonthly office visits Education Only ( 3 mths) N=100 4 weekly office visits 4 bimonthly office visits Immediatepost-intervention assessment: 3 months Intervention maintenance phase – 9 monthly telephone calls Follow-up: 12 months

  18. RECRUITMENT and SCREENING • Standard ED protocol (3-4 hours) • Individual presents to ER • Physician assessment and diagnosis • Asthma treatment administered • Patient stabilized • Begin research protocol • Physician asks patient if okay to speak with project staff • Screen for eligibility

  19. Inclusion Criteria Diagnosis of asthma Patient history Physician diagnosis All severity levels 18-50 years of age English language dominant Working phone At least P.O. Box Able to give informed consent Exclusion Criteria Not currently participating in asthma education COPD Medication contraindicated Refer to asthma resource if not eligible ASSESS FOR ELIGIBILITY___________________________________

  20. OBTAIN INFORMED CONSENT________________________________ • Informed Consent Procedure • Approved by university and hospital IRB • Verbal and written presentation of study • Confirm understanding of study requirements • Sign consent/HIPAA/medical records release form • Give copy of form • Obtain contact information • Obtain at least one collateral information • Schedule Baseline Visit within one week • Re-consent at every visit

  21. BASELINE VISIT(both conditions) • Baseline assessment via face-to-face interview • Who: Research nurse evaluator (blinded) • Where: Clinic • Length: 90 minutes • What: Patient interview and Spirometry • Incentive: $25.00 per assessment • Randomly assigned to condition • Meet with assigned health educator • Receipt of diary, peak flow, medication(s) • Determine needs for instrumental support: child care, transportation

  22. RANDOMIZATION ________________________________ • Research Works, Inc., an independent consultant, will conduct randomization procedure. • Blocked in multiples of 6 and 8. • Stratified on asthma severity • Phone randomization: Research Nurse Evaluator informs Project Manager of completion of baseline assessment who calls for assignment

  23. SKILLS TRAINING INTERVENTION • Intervention agent: Health Educator • Session Length: 45-60 minutes • Duration: • Acquisition phase: 4 weekly visits + 4 semi-monthly visits • Maintenance phase: monthly telephone calls • Skills Training Manual

  24. Med adherence Self Monitoring Problem Solving SKILLS TRAINING INTERVENTION: SESSION 1 • Asthma knowledge • Content: Self-Management Problem solving Brainstorm strategies Evaluate strategies Choose a strategy Implement a strategy Evaluate effectiveness

  25. SKILLS TRAINING INTERVENTION SESSIONS 2-7 • Review homework (not Session 2) • Review feedback from MEMS, peak flow, diary • Problem solve from feedback loop • Problem solve barrier from BEAT intervention guide sheet • Medication • Environmental Control • Assignment of homework SESSION 8 – End of Acquisition Phase

  26. SKILLS TRAINING MAINTENANCE PHASE: SESSIONS 9-18 • Intervention agent: Health Educator • Format: Telephone contact • Length: 10-15 minutes • Duration: Monthly for 9 months • Content: • Provide support and positive regard • Continue development of problem solving skills • Generalization of successful behavior change

  27. ASTHMA EDUCATION (ATTENTION CONTROL CONDITION) • Intervention agent: Health Educator • Session Length: 45-60 minutes • Duration: • 4 weekly visits + 4 semi-monthly visits • 9 monthly telephone calls • Asthma Education Manual • Treatment protocol guided byNAEPP guidelines

  28. TREATMENT FIDELITY • Delivery: Video-tape coding of critical elements of session; assess fidelity to intervention manual; provide feedback to intervention agents; attendance at sessions • Receipt: Video-tape coding of patient engagement in session • Enactment: Use of problem solving skills from daily diaries

  29. DATA COLLECTION ________________________________

  30. DATA COLLECTION _______________________________

  31. SAMPLE SIZE ESTIMATES: based on reduction in # returns of ED visit: a=0.05, Power using Fisher’s test *ED visits in 12-mos

  32. DATA ANALYSIS Primary aim: To evaluate the efficacy of the Skills Training intervention in reducing the number of emergency department visits in a 12-month period relative to Education only. • Number of returns to ED at 1-year between the skills training and the education groups • Poisson regression analyses to compare the difference of ED visits in skills training versus education controlling possible confounding factors: asthma severity, gender, insurance status, and years since diagnosis

  33. DATA ANALYSIS FOR PRIMARY OUTCOME (Continued) • Our primary analysis will be intent-to-treat using patient’s originally assigned group; • Missing data will be computed using multiple imputation; • 94% had ED at 1-year from the pilot study • ED visits from medical records

  34. DATA ANALYSIS FOR SECONDARY OUTCOMES • Secondary Aim 1: Skills Training participants will demonstrate significant improvements in FEV at 3- and 12-months relative to Education. • Secondary Aim 2: Skills Training participants will report fewer asthma symptoms days at 3- and 12-months relative to Education. • Asthma symptom days and FEV: mixed model fitted number of days/FEV as dependent variable, intervention condition and time as fixed effects, study subject as random effect, controlling for asthma severity, gender, insurance status, and years since diagnosis

  35. DATA ANALYSIS FOR SECONDARY OUTCOMES • Secondary Aim 3: Skills Training participants will demonstrate significantly greater adherence to peak flow monitoring measured by momentary data at 3-months relative to Education. • Secondary Aim 4: Skills Training participants will demonstrate a significantly greater proportion of time they use medication when the peak flow meter indicates it at 3-months relative to Education. • # peak flow use and medication adherence (% use) per week: linear regression model fitted peak flow measure/medical adherence as dependent variable, intervention condition as independent variable, controlling for asthma severity, gender, and years since diagnosis

  36. HUMAN SUBJECTS • Protection of Human Subjects: verbal consent for initial screening, consent form (including HIPAA-IRB waiver) obtained before baseline assessment; assurance of confidentiality. • Inclusion of Women and Minorities. • Children not included in this study.

  37. DATA SAFETY MONITORING BOARD(DSMB) ________________________________ • DSMB Members: • Independent experts • From outside institutions • Regular, Periodic meetings q6mths and prn • Including: • Bioethicist • Behavioral Scientist • Pulmonologist • Biostatistician—interacts in closed session with DSMB • Nurse Educator • Epidemiologist

  38. BEAT: STOPPING RULES ________________________________ • Two standard deviation above or below the overall mean FEV (using Spirometry) at 3- and 12-months • Two standard deviation above or below the overall mean of ED visits (using medical chart reviews) at 3- and 12-months

  39. COST EFFECTIVENESS ___________________________________ • Estimated cost for implementation of this intervention is $ 500 per person • Direct costs saved/person/year if 1 visit to the ER are averted: $800 • Indirect costs saved/person/year in terms of days of work/cost to society: $800

  40. Time Line

  41. DISSEMINATION STRATEGIES : LOCAL AND NATIONAL • Present information at ED Grand Rounds • Investigators will present results of the BEAT trial at SBM, ALA, Internal Medicine, Family Medicine Meetings • Publications will be submitted to medical, public health, and psychology journals • Curriculum available through the Local Asthma Consortium and University website. • Investigators will attend state and regional medical, public health meetings to share the BEAT curriculum and results.

  42. Questions about “The BEAT?” “Partnering to BEAT Asthma For Life!” Ahhhhh....

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