A Randomized Clinical Trial A Randomized Clinical Trial Comparing Asthma Self-Comparing Asthma Self-Management Training to Management Training to

Standard Asthma Education Standard Asthma Education Among Adults With Asthma Among Adults With Asthma

PresentingPresenting to an Urban Emergency to an Urban Emergency

DepartmentDepartment____________________________________________________

The The BEATBEAT Study: Study:

BBreathe reathe EEasy asy AAsthma sthma TTrialrial

BREATHEEASY

ASTHMATRIAL(BEAT)

Principal Investigator: Felicia Hill-Briggs, PhD, ABPP

Co-Investigators: Guadalupe X. “Suchi” Ayala, PhD, MPH

Ahna Hoff, PhDYunsheng Ma, PhDCheryl 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)

BACKGROUND: ASTHMABACKGROUND: ASTHMAMORBIDITY AND MORTALITYMORBIDITY AND MORTALITY______________________________________________________________

Can be life-threatening.Can be life-threatening. Affects 17 million adults in U.S.Affects 17 million adults in U.S. Morbidity and mortality are higher Morbidity and mortality are higher

among ethnic minorities and the among ethnic minorities and the economically disadvantagedeconomically disadvantaged 3x more likely to visit ED3x more likely to visit ED 6x more likely to die from asthma6x more likely to die from asthma

Symptoms controllable with access to Symptoms controllable with access to medication and self-management medication and self-management skills.skills.

THEORETICAL BACKGROUNDTHEORETICAL BACKGROUNDFOR CHRONIC DISEASE SELF-FOR CHRONIC DISEASE SELF-

MANAGEMENT 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

ASTHMA SELF-MANAGEMENT ASTHMA SELF-MANAGEMENT FEEDBACK LOOPFEEDBACK LOOP

______________________________________________________________________

SelfMonitoring

Med adherence

ProblemSolving

Tool Kit:Peak flow meter

Action planMedication

HYPOTHESISHYPOTHESIS______________________________________________________________________

Among economically disadvantaged Among economically disadvantaged adults with asthma, an adults with asthma, an

individualized asthma self-individualized asthma self-management intervention (termed management intervention (termed

“Skills Training”) will “Skills Training”) will decreasedecrease the the number of emergency department number of emergency department visits due to asthma compared to visits due to asthma compared to

standard asthma education.standard asthma education.

BEAT: PRIMARY SPECIFIC AIMBEAT: PRIMARY SPECIFIC AIM______________________________________________________________________

The The primary aimprimary aim of this trial is to of this trial is to

evaluate the efficacy of a Skills evaluate the efficacy of a Skills

Training intervention in reducing the Training intervention in reducing the

number of emergency department number of emergency department

visits in a 12-month period. visits in a 12-month period.

BEAT: SECONDARY AIMSBEAT: SECONDARY AIMS______________________________________________________________________

Improve self-monitoring using peak flow meterImprove self-monitoring using peak flow meter Skills Training participants will demonstrate significantly Skills Training participants will demonstrate significantly

greater adherence to peak flow monitoring measured by greater adherence to peak flow monitoring measured by momentary data at 3-months relative to Education.momentary data at 3-months relative to Education.

Improve medication adherence using momentary data Improve medication adherence using momentary data (MEMS Cap)(MEMS Cap)

Skills Training participants will demonstrate a significantly Skills Training participants will demonstrate a significantly greater proportion of time they use medication when the peak greater proportion of time they use medication when the peak flow meter indicates it at 3-months relative to Education.flow meter indicates it at 3-months relative to Education.

Improve lung functioning assessed via SpirometryImprove lung functioning assessed via Spirometry Skills Training participants will demonstrate significant Skills Training participants will demonstrate significant

improvements in FEV at 3- and 12-months relative to improvements in FEV at 3- and 12-months relative to Education.Education.

Decrease asthma symptom daysDecrease asthma symptom days Skills Training participants will report fewer asthma symptoms Skills Training participants will report fewer asthma symptoms

days at 3- and 12-months relative to Education.days at 3- and 12-months relative to Education.

BEAT: BEAT: PRELIMINARY PRELIMINARY

STUDIESSTUDIES

Epidemiologic Study of Epidemiologic Study of Emergency Department Use by Emergency Department Use by

Adults With Asthma in Chicago, ILAdults With Asthma in Chicago, IL

Prevalence of adult asthma: 419,000Prevalence of adult asthma: 419,000 70,000 ED visits/year70,000 ED visits/year More asthma deaths among More asthma deaths among

minorities than any other US cityminorities than any other US city

Cook County HospitalCook County Hospital 20,000 adult asthma ED visits/year20,000 adult asthma ED visits/year 60% of these adult patients with 60% of these adult patients with

asthma have at least 3 visits for asthma have at least 3 visits for asthma/yearasthma/year

BEAT: Pilot StudyBEAT: Pilot Study______________________________________________________________________

Feasibility of recruiting ED patients Feasibility of recruiting ED patients with asthma symptomswith asthma symptoms

Feasibility of interventionFeasibility of intervention Effect of intervention on selected Effect of intervention on selected

outcomesoutcomes Assess cultural sensitivity of Assess cultural sensitivity of

intervention and assessment protocolintervention and assessment protocol

Number of adults with asthma who presented to ED = 176

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%)

Figure 1. One Month Recruitment and Enrollment Yield from Feasibility Study of Asthma Intervention for Persons Presenting to an Urban Emergency Department

Stabilized for discharge (non-hospitalized) = 141 (80%)

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

Characteristic

Age, M ± SD 35 ±11

Female, N(%) 30 (60)

Education, M ± SD 10 ± 2.7

Race/Ethnicity, N(%) Black White Hispanic

37 (74)

8 (16)

5 (10)

Income, M ± SD $9,100 ± $2, 100

Medicaid or No Insurance, N (%)

34 (66)

Acute Asthma Severity, N(%) Mild Persistent or Inter Moderate Persistent Severe Persistent

38 (75)

6 (12)

6 (12)

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

5

39

43

47

57

59

79

86

0 10 20 30 40 50 60 70 80 90 100

Tried to Contact PCP Prior to ED Visit

Doesn't Have PCP

Difficulty Monitoring Symptoms at Home

Unsure When to Contact PCP

Symptoms Perceived as Severe, Emergent

ED Usual Site for Asthma Prescriptions

ED Usual Site for Problems with Asthma

Unsure What/How Much Meds to Take

Reas

ons

for E

D Vi

sit

Percent of Participants Endorsing Reason

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

Pre-Intervention Post-Intervention

Number of ED visits in previous

12 months, Median (range)

3 (1 – 6) 1 (0 – 4)*

Patients with at least one ED visit

in previous 12 months, N(%)

51 (100) 37 (72)*

Adherence to peak flow

monitoring22% 78%*

Percent of time individual uses

meds as indicated by peak flow 31% 69%*

*p<.001

BEAT: RESEARCH BEAT: RESEARCH DESIGN AND DESIGN AND

METHODSMETHODS

Setting:Cook County Hospital ED 500 pts/recruitment period

Obtain Informed Consent

Recruitment and ScreeningAssess for Eligibility

Baseline AssessmentRandomization

Skills Training (3 mths)N=100

4 weekly office visits4 bimonthly office visits

Education Only ( 3 mths)N=100

4 weekly office visits4 bimonthly office visits

Immediate post-intervention assessment: 3 months

Intervention maintenance phase – 9 monthly telephone calls

Follow-up: 12 months

RECRUITMENT and RECRUITMENT and SCREENINGSCREENING

Standard ED protocol (3-4 hours)Standard ED protocol (3-4 hours) Individual presents to ERIndividual presents to ER Physician assessment and diagnosisPhysician assessment and diagnosis Asthma treatment administeredAsthma treatment administered Patient stabilizedPatient stabilized

Begin research protocolBegin research protocol Physician asks patient if okay to speak Physician asks patient if okay to speak

with project staffwith project staff Screen for eligibilityScreen for eligibility

ASSESS FOR ELIGIBILITYASSESS FOR ELIGIBILITY ______________________________________________________________________ Inclusion CriteriaInclusion Criteria

Diagnosis of asthmaDiagnosis of asthma• Patient historyPatient history• Physician diagnosisPhysician diagnosis• All severity levelsAll severity levels

18-50 years of age18-50 years of age English language English language

dominantdominant Working phoneWorking phone At least P.O. BoxAt least P.O. Box Able to give informed Able to give informed

consentconsent

Exclusion CriteriaExclusion Criteria Not currently Not currently

participating in participating in asthma educationasthma education

COPDCOPD Medication Medication

contraindicatedcontraindicated Refer to asthma Refer to asthma

resource if not eligibleresource if not eligible

OBTAIN INFORMED CONSENTOBTAIN INFORMED CONSENT________________________________________________________________

Informed Consent ProcedureInformed Consent Procedure Approved by university and hospital IRBApproved by university and hospital IRB Verbal and written presentation of studyVerbal and written presentation of study Confirm understanding of study requirementsConfirm understanding of study requirements Sign consent/HIPAA/medical records release Sign consent/HIPAA/medical records release

formform Give copy of formGive copy of form Obtain contact informationObtain contact information Obtain at least one collateral informationObtain at least one collateral information Schedule Baseline Visit within one weekSchedule Baseline Visit within one week Re-consent at every visitRe-consent at every visit

BASELINE VISITBASELINE VISIT(both conditions)(both conditions)

Baseline assessment via face-to-face Baseline assessment via face-to-face interviewinterview WhoWho: Research nurse evaluator (: Research nurse evaluator (blindedblinded)) WhereWhere: Clinic: Clinic LengthLength: 90 minutes: 90 minutes WhatWhat: Patient interview and Spirometry: Patient interview and Spirometry IncentiveIncentive: $25.00 per assessment: $25.00 per assessment

Randomly assigned to condition Randomly assigned to condition Meet with assigned health educatorMeet with assigned health educator

Receipt of diary, peak flow, medication(s)Receipt of diary, peak flow, medication(s) Determine needs for instrumental support: child Determine needs for instrumental support: child

care, transportationcare, transportation

RANDOMIZATIONRANDOMIZATION ________________________________________________________________

Research Works, Inc., an Research Works, Inc., an independent consultant, will independent consultant, will conduct randomization procedure.conduct randomization procedure.

Blocked in multiples of 6 and 8.Blocked in multiples of 6 and 8. Stratified on asthma severityStratified on asthma severity Phone randomization: Research Phone randomization: Research

Nurse Evaluator informs Project Nurse Evaluator informs Project Manager of completion of baseline Manager of completion of baseline assessment who calls for assessment who calls for assignmentassignment

SKILLS TRAINING SKILLS TRAINING INTERVENTIONINTERVENTION

Intervention agent:Intervention agent: Health Health EducatorEducator

Session LengthSession Length: 45-60 minutes: 45-60 minutes DurationDuration: :

Acquisition phase: 4 weekly visits + 4 Acquisition phase: 4 weekly visits + 4 semi-monthly visitssemi-monthly visits

Maintenance phase: monthly telephone Maintenance phase: monthly telephone callscalls

Skills Training ManualSkills Training Manual

SKILLS TRAINING SKILLS TRAINING INTERVENTION: SESSION 1INTERVENTION: SESSION 1

Asthma knowledge Asthma knowledge Content: Content:

Brainstorm strategiesEvaluate strategiesChoose a strategy

Implement a strategyEvaluate effectiveness

Self-Management Problem solving

SelfMonitoring

Med adherence

ProblemSolving

SKILLS TRAINING SKILLS TRAINING INTERVENTION INTERVENTION

SESSIONS 2-7SESSIONS 2-7 Review homework (Review homework (not Session 2not Session 2)) Review feedback from MEMS, peak flow, Review feedback from MEMS, peak flow,

diarydiary Problem solve from feedback loopProblem solve from feedback loop Problem solve barrier from BEAT Problem solve barrier from BEAT

intervention guide sheetintervention guide sheet MedicationMedication Environmental ControlEnvironmental Control

Assignment of homeworkAssignment of homeworkSESSION 8 – End of Acquisition SESSION 8 – End of Acquisition

PhasePhase

SKILLS TRAINING SKILLS TRAINING MAINTENANCE PHASE: MAINTENANCE PHASE:

SESSIONS 9-18SESSIONS 9-18 Intervention agentIntervention agent: Health Educator: Health Educator FormatFormat: Telephone contact: Telephone contact LengthLength: 10-15 minutes: 10-15 minutes DurationDuration: Monthly for 9 months: Monthly for 9 months ContentContent: :

Provide support and positive regardProvide support and positive regard Continue development of problem solving Continue development of problem solving

skillsskills Generalization of successful behavior changeGeneralization of successful behavior change

ASTHMA EDUCATION ASTHMA EDUCATION (ATTENTION CONTROL (ATTENTION CONTROL

CONDITION)CONDITION) Intervention agent:Intervention agent: Health Educator Health Educator Session LengthSession Length: 45-60 minutes: 45-60 minutes DurationDuration: :

4 weekly visits + 4 semi-monthly visits4 weekly visits + 4 semi-monthly visits 9 monthly telephone calls9 monthly telephone calls

Asthma Education ManualAsthma Education Manual Treatment protocolTreatment protocol guided by guided by NAEPP NAEPP

guidelinesguidelines

TREATMENT FIDELITYTREATMENT FIDELITY

DeliveryDelivery: Video-tape coding of : Video-tape coding of critical elements of session; assess critical elements of session; assess fidelity to intervention manual; fidelity to intervention manual; provide feedback to intervention provide feedback to intervention agents; attendance at sessionsagents; attendance at sessions

ReceiptReceipt: Video-tape coding of : Video-tape coding of patient engagement in sessionpatient engagement in session

EnactmentEnactment: Use of problem solving : Use of problem solving skills from daily diariesskills from daily diaries

DATA COLLECTION DATA COLLECTION ________________________________________________________________

BaselinBaselinee

In In SessionSession

3-3-MonthMonth

12-12-MonthMonth

Self-Report Self-Report MeasuresMeasures

Demographic, Demographic,

Health care utilization, Health care utilization, Asthma historyAsthma history

XX

Asthma Symptom DaysAsthma Symptom Days XX XX XX

Asthma BarriersAsthma Barriers XX XX XX

Asthma KnowledgeAsthma Knowledge XX X (#1 )X (#1 ) X X

Chart Reviews/ClinicChart Reviews/Clinic

# of ED Visits# of ED Visits XX XX XX

FEV using SpirometryFEV using Spirometry XX XX XX

BaselinBaselinee

In In SessionSession

3-3-MonthMonth

12-12-MonthMonth

Home Based Home Based MonitoringMonitoring

MEMS X X

Peak Expiratory Flow X X X

Diary Problem solve Asthma symptoms

X X

DATA COLLECTION DATA COLLECTION ______________________________________________________________

SAMPLE SIZE ESTIMATES:SAMPLE SIZE ESTIMATES: based on reduction in # returns of ED based on reduction in # returns of ED

visit:visit:

a=0.05, Power using Fisher’s test

*ED visits in 12-mos*ED visits in 12-mos

# per arm Power (%) Reduction in ED visits(%)

100100 7373 2020

100100 9090 2525

100100 9898 3030

DATA ANALYSISDATA ANALYSIS

• Number of returns to ED at 1-year Number of returns to ED at 1-year between the skills training and the between the skills training and the education groupseducation groups

• Poisson regression analyses to Poisson regression analyses to compare the difference of ED visits compare the difference of ED visits in skills training versus education in skills training versus education controlling possible confounding controlling possible confounding factors: asthma severity, gender, factors: asthma severity, gender, insurance status, and years since insurance status, and years since diagnosisdiagnosis

Primary aim:Primary aim: To evaluate the efficacy of the Skills Training To evaluate the efficacy of the Skills Training

interventionintervention

in reducing the number of emergency department visits in reducing the number of emergency department visits

in a 12-month period relative to Education only.in a 12-month period relative to Education only.

DATA ANALYSIS FOR DATA ANALYSIS FOR PRIMARY OUTCOME PRIMARY OUTCOME

(Continued) (Continued) • Our primary analysis will be intent-Our primary analysis will be intent-

to-treat using patient’s originally to-treat using patient’s originally assigned group;assigned group;

• Missing data will be computed using Missing data will be computed using multiple imputationmultiple imputation;

•94% had ED at 1-year from the pilot study

•ED visits from medical records

DATA ANALYSIS FOR DATA ANALYSIS FOR SECONDARY OUTCOMESSECONDARY OUTCOMES

• Asthma symptom days and FEV: Asthma symptom days and FEV: mixed model fitted number of mixed model fitted number of days/FEV as dependent variable, days/FEV as dependent variable, intervention condition and time as intervention condition and time as fixed effects, study subject as random fixed effects, study subject as random effect, controlling for asthma severity, effect, controlling for asthma severity, gender, insurance status, and years gender, insurance status, and years since diagnosissince diagnosis

Secondary Aim 1: Skills Training participants will demonstrate Secondary Aim 1: Skills Training participants will demonstrate significant improvements in FEV at 3- and 12-months relative to significant improvements in FEV at 3- and 12-months relative to

Education.Education.

Secondary Aim 2: Skills Training participants will report fewer asthma Secondary Aim 2: Skills Training participants will report fewer asthma symptoms days at 3- and 12-months relative to Education.symptoms days at 3- and 12-months relative to Education.

DATA ANALYSIS FOR DATA ANALYSIS FOR SECONDARY OUTCOMESSECONDARY OUTCOMES

• # peak flow use and medication # peak flow use and medication adherence (% use) per week: linear adherence (% use) per week: linear regression model fitted peak flow regression model fitted peak flow measure/medical adherence as measure/medical adherence as dependent variable, intervention dependent variable, intervention condition as independent variable, condition as independent variable, controlling for asthma severity, controlling for asthma severity, gender, and years since diagnosisgender, and years since diagnosis

Secondary Aim 3: Skills Training participants will demonstrate Secondary Aim 3: Skills Training participants will demonstrate significantly greater adherence to peak flow monitoring measured by significantly greater adherence to peak flow monitoring measured by

momentary data at 3-months relative to Education.momentary data at 3-months relative to Education.

Secondary Aim 4: Skills Training participants will demonstrate a Secondary Aim 4: Skills Training participants will demonstrate a significantly greater proportion of time they use medication when significantly greater proportion of time they use medication when the peak flow meter indicates it at 3-months relative to Education.the peak flow meter indicates it at 3-months relative to Education.

HUMAN SUBJECTS

• Protection of Human Subjects: verbal Protection of Human Subjects: verbal consent for initial screening, consent consent for initial screening, consent form (including HIPAA-IRB waiver) form (including HIPAA-IRB waiver) obtained before baseline assessment; obtained before baseline assessment; assurance of confidentiality.assurance of confidentiality.

• Inclusion of Women and Minorities.Inclusion of Women and Minorities.

• Children not included in this study. Children not included in this study.

DATA SAFETY MONITORING DATA SAFETY MONITORING BOARDBOARD(DSMB) (DSMB)

________________________________________________________________ DSMB Members:DSMB Members:

Independent expertsIndependent experts From outside institutionsFrom outside institutions Regular, Periodic meetings q6mths and prnRegular, Periodic meetings q6mths and prn Including:Including:

• Bioethicist Bioethicist • Behavioral ScientistBehavioral Scientist• PulmonologistPulmonologist• Biostatistician—interacts in closed session with Biostatistician—interacts in closed session with

DSMBDSMB• Nurse EducatorNurse Educator• EpidemiologistEpidemiologist

BEAT: STOPPING RULES BEAT: STOPPING RULES ________________________________________________________________

Two standard deviation above or below Two standard deviation above or below

the overall mean FEV (using the overall mean FEV (using

Spirometry) at 3- and 12-months Spirometry) at 3- and 12-months

Two standard deviation above or below Two standard deviation above or below

the overall mean of ED visits (using the overall mean of ED visits (using

medical chart reviews) at 3- and 12-medical chart reviews) at 3- and 12-

monthsmonths

COST EFFECTIVENESS COST EFFECTIVENESS ______________________________________________________________________

Estimated cost for implementation of Estimated cost for implementation of this intervention is $ 500 per person this intervention is $ 500 per person

Direct costs saved/person/year if 1 Direct costs saved/person/year if 1 visit to the ER are averted: $800 visit to the ER are averted: $800

Indirect costs saved/person/year in Indirect costs saved/person/year in terms of days of work/cost to society: terms of days of work/cost to society: $800$800

Time LineTime LineQuarterQuarter

TaskTask11 22 33 44 55 66 77 88 99

1100

1111

1122

Study Preparation X XRecruitment X X X XIntervention X X X X X X X XMaintenance X X X X X X XFollow-up X X X X X X X XData Management X X X X X X X X X XAnalysis X X X X X X X XDissemination X X X

DISSEMINATION DISSEMINATION STRATEGIES : LOCAL AND STRATEGIES : LOCAL AND

NATIONALNATIONAL Present information at ED Grand RoundsPresent information at ED Grand Rounds Investigators will present results of the Investigators will present results of the

BEAT trial at SBM, ALA, Internal BEAT trial at SBM, ALA, Internal Medicine, Family Medicine MeetingsMedicine, Family Medicine Meetings

Publications will be submitted to medical, Publications will be submitted to medical, public health, and psychology journalspublic health, and psychology journals

Curriculum available through the Local Curriculum available through the Local Asthma Consortium and University Asthma Consortium and University website.website.

Investigators will attend state and Investigators will attend state and regional medical, public health meetings regional medical, public health meetings to share the BEAT curriculum and results.to share the BEAT curriculum and results.

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