Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial - Phase II (Part 2 - a Pilot Randomized Trial Phase)
Phase: NA
Conditions: Asthma
Sponsor: Columbia University

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Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial - Phase II (Part 
2 - a Pilot Randomized Trial Phase) 
NCT03300752 
 
March 8th, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Self-care decision-making: Feasibility of the BREATHE asthma intervention trial 
Principal Investigator: Maureen George 
Phase II: The BREATHE intervention 
 
 
 
STUDY PURPOSE AND RATIONALE 
Study Purpose 
The overall goal of this study is to develop and to preliminarily validate a novel intervention delivered by 
primary care providers (PCPs) to their Black adult patients with uncontrolled asthma in federally qualified 
health centers (FQHCs). We recently developed and rigorously tested a brief questionnaire, the Conventional 
and Alternative Management for Asthma (CAM-A) tool1,2, that screens patients for beliefs about asthma self- 
care and inhaled corticosteroid (ICS) treatment and prompts PCPs to discuss ICS adherence at office visits 
based on patient CAM-A responses3. In over 300 adults (80% Black; 67% uninsured or government-insured) 
with high rates of uncontrolled asthma (69%), the validated CAM-A identified that erroneous personal health 
beliefs and negative ICS beliefs were commonly endorsed (93% and 68%, respectively)1. Importantly, 
erroneous personal health beliefs were significantly associated with uncontrolled asthma, likely driven by ICS 
non-adherence. In the first phase of this trial we held six focus groups (AAR0605) with adult asthma patients 
and their loved ones to inform the intervention by adapting an evidence-based brief shared decision-making 
strategy with proven efficacy4-6, delivered by PCPs, for use with our validated CAM-A tool. As such, this 
project has three specific aims: 
 
Specific Aims: 
1. To develop an intervention to improve asthma control in Black adults receiving care in FQHCs 
(completed); 
2. To evaluate the feasibility and acceptability of the intervention procedures; and 
3. To assess the preliminary evidence of intervention effects on asthma control (primary outcome), 
ICS adherence, forced expiratory volume in one second (FEV1) – an objective lung function 
measure – and asthma quality of life (secondary outcomes) over a 3-month follow-up period. 
 
Please note, we already have IRB approval for Phase I (focus group and PCP review only). Focus groups 
are completed and independent PCP review is about to begin (AAR0605). 
 
In this application we are seeking approval of Aims #2 and #3 (Phase II-pilot intervention). 
 
 
Background / Rationale 
 
Uncontrolled asthma due to ICS non-adherence is common among Black adults. Nearly every asthma- 
related hospitalization and death could be prevented with appropriate self-management that achieves and 
maintains disease control7-10. However, as many as 64% of adults have uncontrolled asthma11; minorities are 
disproportionately represented within that population12. While inhaled corticosteroids (ICS) are a safe and 
effective treatment for uncontrolled asthma, relative to Whites, Blacks have lower rates of ICS adherence (74% 
vs. 29%)13-17. 
 
Health beliefs are associated with ICS non-adherence. Erroneous personal beliefs about asthma and its 
pharmacologic treatment are among the most significant factors contributing to ICS non-adherence18-21. ICS 
non-adherence, a primary cause of uncontrolled and/or fatal asthma7, is more common in Blacks relative to 
Whites13-17 due, in part, to higher rates of endorsement of non-pharmacologic approaches to asthma self-care1 
(e.g., coffee is a safe, effective asthma treatment) and negative ICS beliefs13-15,22-29 (e.g., ICS is addicting)

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These beliefs have been shown to be associated with ICS non-adherence22,23,27, more asthma attacks22,30 and 
delays in seeking care23. 
 
There are unique challenges to achieving asthma control in FQHCs. PCPs deliver up to 80% of asthma care. 
However, compared to specialists, uncontrolled asthma is more common in their patients31. There are unique 
challenges to achieving asthma control in FQHCs, a particular type of primary care setting designated to receive 
enhanced Medicaid reimbursement because their clientele are underserved, underinsured, and uninsured 
Americans who receive more episodic primary care32. In these settings PCPs have limited time to evaluate 
asthma control, to assess ICS non-adherence, and to identify beliefs associated with ICS non-adherence33. This 
speaks to the pressing need for novel brief interventions that facilitate evidence-based guideline-directed asthma 
self-management. 
 
Shared decision-making interventions to promote asthma control in this vulnerable population are 
lacking. The study is guided by the theoretical model of Shared Decision-Making in evidence-based practice34, 
which posits that the best treatment decisions are informed by patient’s preferences, the best available evidence, 
and practitioner expertise. The PCPs role is to facilitate discussion of the risks and merits associated with 
specific options in the context of patients’ goals and preferences, and in a manner that activates patients to 
engage in self-management. PCPs offer options to consider jointly35 with the goal of reconciling differences and 
reaching mutually agreed upon higher quality decisions that align patients’ needs with evidence-based 
guideline-directed care36,37. Prior research has demonstrated that with repeated lengthy engagement (1+ hour), 
highly-trained interventionists in settings other than primary care can increase medication adherence38-40; this 
intervention model improves disease control39,41-43, identifies health beliefs that conflict with evidence-based 
care44 and reduces risky behaviors4-6. The framework’s  application to asthma has been limited to children39,47 
and to White privately insured adults40. Sustained implementation of effective shared decision-making 
interventions has been restricted, in part, by burdensome protocols requiring multiple visits, lengthy 
engagement, highly-trained interventionists, and by protocols inappropriate for populations like those served in 
FQHCs. 
 
Implementation research is underutilized in asthma intervention research. Evidence-based interventions 
may be difficult to sustain8-10, in part, because factors associated with implementation are overlooked. To close 
this gap between research and practice, researchers should conduct formative assessments with the target 
audience and program providers during development, and evaluate the program features that enhance a 
program’s reach. Further, FQHCs are overlooked in asthma intervention research. 
 
Impact. Black adults with uncontrolled asthma experience profound health disparities. Despite data that point 
to the critical need for enhanced asthma self-management, we continue to see rates of controlled asthma well 
below Healthy People 2020 targets48, particularly among vulnerable populations49. Our Brief Evaluation of 
Asthma Therapy (BREATHE) intervention has the potential to offer a new avenue to asthma control via 
shared decision-making that supports ICS adherence. 
 
STUDY DESIGN AND PROCEDURES 
 
This R21 proposal will proceed in two major phases: (1) a development phase (Year 1) where BREATHE was 
developed using iterative community-based participatory research (CBPR) approaches with feedback from 
PCPs (focus groups completed; independent PCP review about to commence); and (2) a pilot randomized trial 
phase that will allow estimation of parameters crucial for a larger randomized control trial (RCT) including final 
content specification, participant recruitment rates, and potential intervention effect sizes (the focus of this 
application). 

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PHASE II ONLY 
Study Procedures 
Pilot Randomized Clinical Trial Phase 
 
Study Procedures: PCP Recruitment, Consent and Randomization. Randomization will be at the level of 
the PCP. This is a two-group randomized trial with outcomes analyzed at the patient level. We will randomize 8 
PCPs (4 / FQHC site) into BREATHE and attention control conditions stratified for provider type (physician 
vs. nurse practitioners [NPs]/physician assistant [PAs]) to insure equal numbers of PCPs within each PCP type 
are assigned to each condition. Randomization lists will be computer generated in advance by our data manager 
(allowing the biostatistician to remain blinded during analysis). We do not anticipate difficulty in recruiting 4 
PCPs/FQHC since one FQHC has ~15 PCPs (10 physicians and 5 NPs/PAs) and the other has 35 (20 physicians 
and 10 NPs/PAs). 
 
Provider Consent. After reading the informed consent and having questions addressed, PCPs will be asked to 
sign informed consent indicating they are entering the study voluntarily. Declinations to enroll, if any occur, 
will be a metric that we will track. Consent will be obtained by either the PI or the Project Manager as these 
individuals are unblended. 
 
Inclusion Criteria: PCPs (MDs and NPs/PAs) working in family, primary or internal medicine care services 
who have at least 40 adult patients with persistent asthma (defined as having been prescribed ICS) on their 
patient panel will be considered eligible for enrollment. 
 
Exclusion Criteria: PCPs whose primary focus is outside of adult health services (family, primary or internal 
medicine), such as behavioral health, pediatrics and OB-GYN. 
 
Patient Recruitment. We will recruit patients using methods we have used successfully in prior 
studies7,16,18,32,33,55. The FQHC administrator will create a potential list of subjects using a combination of ICD- 
10 (Asthma 493)-specific queries of electronic membership records and searching of scheduled patient visits for 
the FQHC PCPs to review. The research team will receive only the names and contact information of those the 
FQHC clinicians have contacted and who agree to receive a call from the research team. We will also accept 
subjects who respond to posted recruitment flyers. 
 
Patient Participants & Consent. We will enroll 80 Black adults with uncontrolled asthma (10 / PCP). The 
study team will read the informed consent and when subjects have had all questions addressed, they will be 
asked to sign indicating they are entering the study voluntarily.  Consent will be obtained the RA who is 
blinded. 
 
Inclusion Criteria: Patients must be 1) adults (> 18 years of age) who self-report race as Black or African 
American; 2) with PCP-diagnosed persistent asthma; 3) prescribed ICS; 4) receiving asthma care at 
participating FQHCs; 5) who have uncontrolled asthma (defined below) ; and 6) have erroneous personal health 
and/or negative ICS beliefs (defined below). 
 
Interested participants who meet the first 4 criteria will be screened for uncontrolled asthma by administering 
the Asthma Control Questionnaire (ACQ) by phone (phone administration is both reliable and valid) 73-75. The 
ACQ includes 6 self-reported items about asthma symptoms and an objective measure of pulmonary function: 

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the forced expiratory volume in one second (FEV1). The ACQ has demonstrated validity and reliability with and 
without the use of the FEV1.    ACQ scores >1.5 have a positive predictive value of 88% in identifying 
uncontrolled asthma in clinical trials73. PCPs will be notified of all patients with ACQ scores >1.5 and patients 
will be scheduled for a follow-up visit with their PCP as these scores indicate that asthma is not in good control. 
At that visit, if they remain interested in enrolling in the trial, they will be screened for beliefs associated with 
ICS non-adherence using the CAM-A instrument, administered on customized tablet that allows for immediate 
scoring. patients will complete the 17-item CAM-A18 which will self-score. Any one endorsement of a non- 
prescription asthma management preference or negative ICS belief is considered a positive screen and the 
patient is eligible for enrollment in this two-step screening process (+ ACQ screen by phone and + CAM-A 
screen at visit). At this visit, trained study staff will also obtain the FEV1 using a hand held spirometer calibrated 
daily, as well as additional surveys (see Table 1). 
 
Exclusion Criteria: 1) participation in Phase 1 of the BREATHE trial (focus groups); 2) non-English 
speaking; 3) serious mental health conditions (e.g., psychosis) that preclude completion of study procedures or 
confound analyses. 
 
Enrollment feasibility. The two FQHCs provide primary care to over 100,000 unique patients a year, who are 
cared for by 50 providers. Each provider sees approximately 2,000 asthma patients. Using a conservative 
estimate of 8% asthma prevalence, 160 unique patients with asthma are served per provider. Based on our 
preliminary studies6, 55,58,599 we expect ~69% of subjects screened will have uncontrolled asthma (n=110 
patients / PCP); of these, 97% will screen positive on the CAM-A16 yielding 107 eligible patients / PCP. Thus, 
we have an adequate patient pool from which to draw 10 patient subjects / PCP. 
 
Blinding. Patient codes, tied to PCP assignment (active vs. control), will be entered into a tablet prior to the 
completion of the CAM-A by the RA. The meaning of these codes will not be known to the RA. Using these 
codes, the software will trigger the tablet to load either the BREATHE intervention steps or the attention 
control timer (described below) after the CAM-A has been completed. These screens will be hidden from the 
patient and the RA by two “hold” screens warning the RA/patient subject not to advance further. We will assess 
the adequacy of blinding of the subject and the RA as a process outcome at the end of the study. Both active and 
control PCPs will receive the tablet from the RA and the results of the lung function testing (FEV1). The RA 
will set up two digital recorders to capture the audio of the office visit and then leave the room. The RA will be 
instructed to stay close by to monitor the end of visit but not close enough to overhear the conversation. The 
statistician (Jia) will be blinded. The PI , Project Manager and database manager will not be blinded. 
 
Survey Administration. 
The PI and/or Project manager (unblinded) will administer the following surveys after the clinician has signed 
informed consent: Demographic and professional history; PCMI. 
The RA (blinded) will be responsible for all patient data collection. 

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Surveys, Diaries, Testing, 
Interviews and Fidelity 
Checks 
Type of Data; how 
collected 
Who 
will 
collect 
Data source 
Pre
-
visi
t 1 
(V1
) 
Visit 1  
Baseline 
Within 
24 
hours 
of V1 
Visit 2  
~ 4 
weeks 
after V1 
Visit 3 
 ~ 4 
weeks 
after 
V2 
Visit 4 
 ~ 4 
weeks 
after V1 
Post-
trial 
Asthma Control 
Questionnaire – 6 items 
(ACQ6) without item 7 
(FEV1) 
Survey; Collected by 
phone 
RA or 
PM 
Patient 
X 
 
 
 
 
 
 
Demographics 
Survey: Collected by 
phone 
RA or 
PM 
Patient 
X 
 
 
 
 
 
 
Conventional and Alternative 
Management for Asthma 
(CAM-A) 
Survey;  Collected on 
tablet 
RA 
Patient 
X 
 
 
 
 
X 
 
Asthma history  
Survey; Paper and 
pencil  
RA 
Patient  
 
X 
 
 
 
 
 
Forced Expiratory Volume in 
One Second (FEV1) alone – 
item & on the ACQ 
Non-invasive measure 
of airflow obstruction; 
hand-held spirometer 
RA 
Patient; hand-held 
spirometer 
 
X 
 
 
 
 
 
Newest Vita Sign (NVS) 
Survey; Paper and 
pencil survey 
RA 
Patient 
 
X 
 
 
 
 
 
Shared Decision Making 
Questionnaire- 9 items 
(SDMQ9) 
Survey; Paper and 
pencil  
RA 
Patient 
 
X 
 
 
 
 
 
Medication Adherence 
Record Scale-Asthma 
(MARS-A)  
Survey; Paper and 
pencil survey 
RA 
Patient 
 
X 
 
X 
X 
X 
 
Patient reported Outcome 
Measurement Information 
System- 29 items (PROMIS-
29) 
Survey; Paper and 
pencil survey 
RA 
Patient 
 
X 
 
X 
X 
X 
 
Asthma Quality of Life 
Questionnaire (AQLQ) 
Survey; Paper and 
pencil survey 
RA 
Patient 
 
X 
 
X 
X 
X 
 
Patient Immediate post-visit 
debriefing and blinding 
assessment  
Survey; Paper and 
pencil 
RA 
Patient 
 
X 
 
 
 
 
 
Asthma Control 
Questionnaire – 7 items 
(ACQ7) with FEV1 
Survey and non-
invasive measure of 
airflow obstruction; 
Paper and pencil and 
hand-held spirometer 
RA 
Patient; hand-held 
spirometer 
 
 
 
X 
X 
X 
 
Asthma  daily diary 
Diary; Paper and 
pencil 
Patient 
Patient 
 
DISPENS
ED 
 
X 
X 
X 
 
Doser electronic dose counter 
Electronic dose 
counter  
RA 
will 
downlo
ad by 
hand 
Patient; Doser 
electronic counter 
 
DISPENS
ED 
 
X 
X 
X 
 
Client Satisfaction 
Questionnaire 8 items (CSQ8) 
Survey; Paper and 
pencil 
RA 
Patient 
 
 
 
 
 
X 
 
Post-trial interviews 
Interviews, Audio 
recorded 
PI 
Patients, loved 
ones and 
providers 
 
 
 
 
 
 
X 
Provider Data Collection 
Form 
Survey; Paper and 
pencil 
PM or 
PI 
Providers 
X 
 
 
 
 
 
 
Provider Co-Management 
Index (PCMI) 
Survey; Paper and 
pencil 
PM or 
PI 
Providers 
X 
 
 
 
 
 
 
Readiness Ruler 
Scale; Collected on 
tablet 
Provid
er 
Patient 
 
X 
 
 
 
 
 
Provider Immediate post-visit 
debriefing 
Survey; Paper and 
pencil 
RA 
Providers 
 
X 
 
 
 
 
 
Brief Negotiated Intervention 
(BNI) Adherence Scale 
(Active condition) 
Fidelity Checklist  
Coder 
(TBD) 
Audio files of 
patient-provider 
visits 
 
 
X 
 
 
 
 
Fidelity Check Attention 
control condition 
Fidelity Check 
Coder 
(TBD) 
Audio files of 
patient-provider 
visits 
 
 
X 
 
 
 
 
 
 

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Intervention Condition. PCPs randomized to BREATHE will receive the tablet which, when the screen is 
advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to 
the patient’s specific beliefs endorsed on the CAM-A using content identified in our CBPR development phase 
(focus groups). See the Brief Negotiated Intervention (BNI) for the full intervention details. 
 
Step 1: Raise the subject (1½ minute). PCP establishes rapport using persuasive communication techniques and 
assesses the patient’s disease knowledge, perception of asthma control, quality of life (QoL), self-care 
preferences, and motivation for enhanced asthma control, exploring specific beliefs that may affect adherence. 
 
Step 2: Provide feedback (1½ minutes). PCP provides feedback to the patient based on assessments made in the 
prior step. The PCP candidly discusses the patient’s uncontrolled asthma and specific beliefs in the context of 
ICS non-adherence, drawing a connection between current symptoms and ICS non-adherence. 
 
Step 3. Enhance motivation (2 minutes).   The PCP attempts to enhance the patient’s motivation to increase ICS 
adherence using motivational interviewing techniques such as collaboration, empathy, concern, and acceptance 
of ambivalence about self-management. In this step, the PCP may elicit the patient’s beliefs regarding the 
benefits, and negative sequelae, of their current self-management approach (pro/con). 
 
Step 4: Shared decision-making (2 minutes). The PCP and patient jointly consider treatment options. The PCP 
will actively attempt to build consensus around ICS adherence, reconciling conflicts to better align beliefs with 
evidence-based guideline-directed ICS treatment. For example, if the patient uses ICS intermittently (rather than 
the required twice-daily dosing) because of an erroneous belief that tolerance to ICS develops with daily dosing, 
then the PCP will attempt to counter that belief using responses gleaned from the CBPR development phase 
(focus groups) and information from national guidelines. This will likely include encouraging the patient to use 
ICS once a day (50% adherence) as an initial short-term plan to be followed by a return visit and re-evaluation 
of asthma control. If the patient declines to engage in shared decision-making or declines attempts at 
negotiating ICS use, then the PCP and the patient agree to disagree. This is a one-time intervention. 
 
Usual care with an attention control condition. Patient codes associated with PCPs randomized to the 
attention control condition will trigger the tablet to load a 7-minute timer for the PCP to use to track the length 
of the attention control condition (discussion of healthy lifestyles). Control PCPs will have access to all the data 
that the active intervention PCPs have: the ACQ score, CAM-A results, and lung function results. To control for 
contact, they will be instructed to engage in a 7-minute diet and exercise discussion as this will not confound 
results and it was a common topic in our prior study; ICS adherence was not discussed18. 
 
Intervention Training for BREATHE PCPs.  We will train PCPs randomized to the BREATHE condition 
using procedures we have used before26-28,60-62 with content gleaned from our CBPR development phase (focus 
groups and PCP review) as described previously. The core training for PCPs delivering the BREATHE 
intervention will be conducted by our consultant, Dr. Pantalon, and will consist of one, 2-hour instructional 
session: 30 minutes of didactic instruction addressing the delivery of the 4 steps of the brief intervention; 10 
minutes of role-playing of commonly encountered scenarios and; a 50 minute skills workshop in which PCPs 
role play creating a trusting environment, relinquishing sole decision-making, motivating and empowering 
patients to engage in self-management decisions. A question and answer period will conclude the training. PCPs 
will receive a laminated action card that fits in a lab coat pocket summarizing the intervention steps as a 
resource although the steps of the intervention will be available to the PCP on a tablet during the visit. 
 
Immediately after training, PCPs will be tested using a standardized patient scenario to demonstrate that he/she 
can deliver the intervention in 7 minutes or less. All testing will be audiotaped and a trained rater will determine 

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whether the critical elements of the brief intervention were completed in 7 minutes using the validated Brief 
Negotiation Interventions Adherence Scale (BAS)76 adapted to asthma (see draft BNI protocol and BAS). If the 
PCP fails testing, she/he will receive additional instruction and retested. Prior studies have shown that such 
remediation re-training results in 100% proficiency76. PCPs will be encouraged to informally try out some of 
these techniques before the study goes live. The Consultant will follow-up with each PCP to answer questions 
from this “dry run” before the first subject is enrolled. 
 
Intervention Fidelity. To evaluate adherence to the treatment protocol, all BREATHE visits will be 
audiotaped. The Project Manager (who is not blinded) will review all audio files within 24 hours of the visits at 
which time she will complete the Brief Negotiated Intervention Adherence Scale (BAS) to evaluate drift, when 
in the visit (beginning, middle, end) the intervention is delivered, as well as the length of the BREATHE 
sessions. The Consultant Pantalon will conduct additional training to enhance intervention fidelity and brevity if 
problems are identified. PCPs will not be excluded from the study if they fail to deliver all elements or require 
more than 7 minutes to deliver BREATHE; this feasibility metric will be tracked. 
 
Fidelity to the attention control condition. PCPs randomized to the control intervention will not receive any 
specific training but audio files will be reviewed by the Project Manager (who is not blinded) within 24 hours of 
the visit to ascertain the content and length of the healthy lifestyles discussion (the attention control condition), 
as well as to listen for any evidence of contamination (use of the 4-step shared decision making intervention 
using motivation interviewing techniques). Feedback to improve fidelity to the attention control condition, if 
needed, will be made promptly after reviewing the audio files. 
 
Anticipated Problems and Strategies. If time does not allow for rapid review of all audio files, 20% will be 
randomly selected to be rated by the Project Manager: all 1st visits will be rated, and at least one additional file 
per PCP will be reviewed prior to enrollment of their 5th patient subject. We will minimize contamination 
within FQHCs by (1) training only BREATHE PCPs to deliver the active intervention and (2) encouraging 
PCP confidentiality regarding training and intervention content. We will also review audio files of the attention 
control condition to assess for contamination. 
 
Final assessment and refinement of the intervention. We will conduct nested cohort interviews with five 
patient subjects and five family/support person of enrolled subjects post-trial to ascertain their reactions to the 
intervention. An additional five patients will be interviewed who were lost to follow-up to better understand 
what it was that prevented their continued participation. A purposive sample of ~ 6 PCPs (2-4 who participated 
in the BREATHE intervention and two who declined participation, should we have any) will also be 
interviewed to better understand their perspectives about the intervention or their clinical settings that facilitated 
or prevented study participation. The PI will conduct the interviews and data will be analyzed as described in 
the methods section. 
 
STATISTICAL PROCEDURES 
Patient data collection. While we recognize the need for longer follow-up in a full-scale RCT, trained RAs, 
blind to treatment status, will collect data four times: baseline and 1-month, 2-month, and 3-month follow-up. 
To address the risk of assessment reactivity, both groups will receive an equal number of assessments. 
Patient subject measures (see Table 1). The primary outcome measure is patient-reported asthma control 
over 3 months as measured with the ACQ73-75. We will collect the ACQ and secondary outcomes including 
objective measures of airflow obstruction (FEV1), asthma QoL using the Asthma Quality of Life Questionnaire 
- AQLQ77,78 and ICS adherence using the Medication Adherence Record Scale-Asthma (MARS-A) 79-89. The 
MARS-A correlates with objective ICS adherence as measured by electronic monitoring and ICS fill/refill 
claims data79-89. Other surveys that will be used to characterize the subjects include the asthma history, Newest 
Vital Sign, the PROMIS-29 and the Shared Decision Making Questionnaire- 9 items. All patient subjects will 

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ε 
1i 
2ij, 
 ijt 
also be asked to complete the Patient Debriefing and Blinding Assessment survey immediately after V1. The 
blinded RA will dispense a 30-day asthma diary (4th grade reading level) to all subjects after each data 
collection visit. The Doser™, an electronic monitor capable of recording 30-days ICS use, will be attached to 
compatible ICS. Due to unique delivery systems for ICS, there is no single electronic device to monitor all ICS 
types. No change in ICS is required to participate in the Doser tracking log. Finally, we will collect patient 
satisfaction using the Client Satisfaction Questionnaire-8 (CSQ-8)90 at 3-months.. 
 
 
 
CP measures.  PCPs will be asked to complete a demographic and professional history form and one survey at 
the time they sign informed consent: the Provider Co-Management Index (PCMI). The PCMI is a measure of 
PCP shared management. All PCPs will also be asked to complete the Provider Debriefing survey immediately 
after V1. 
Data Management & Statistical Analysis. Double data entry will be made into a secure database with regular 
integrity checks. Data analysis in the context of an R21 must balance two primary agendas: (1) effect size 
estimation and (2) statistical significance testing. Our primary goal is to examine intervention feasibility, which 
will guide modifications of design elements for a future RCT, if warranted. Descriptive data analysis will 
proceed with formal hypothesis testing and model building in order to understand the data distribution and to 
check for outliers. Linear mixed models will be used to adjust for the heterogeneity of the sites and subjects by 
including PCP- and patient-specific random effects. The linear mixed model is used to adjust for clustering of 
data due to the repeated measurement of the same patient and due to association within a PCP with both PCP- 
level and patient-level random effects. We will examine the patterns of missing data; linear mixed models 
provide unbiased estimates for data with missing values. Intention-to-treat analyses will be conducted. 
 
Hypotheses 1: Intervention Feasibility. We will document BREATHE’s penetration using PCP recruitment 
data. The process evaluation  will include descriptive statistics on PCPs intervention proficiency and fidelity 
(e.g., session length) and will assess proficiency and fidelity differences by sites. If we find variability, we will 
explore potential causes (e.g., FQHC size). 
 
Hypotheses 2: Intervention Effects. Intervention effects will be assessed using mixed effects regression 
models90. All hypothesis tests will be two-sided at level α=0.05. The key outcome will be asthma control; ICS 
adherence, FEV1 and QoL will be examined to inform the future RCT. Separate models will be fitted for 
different outcome measures. If yijt  is the outcome for patient j of provider i at time t, without loss generality then 
the following linear mixed model will be used: yijt  = βo  + β1Group + β3Xij  + v1i + v2ij  + εijt , where Xi and Xij  
are vectors of possible PCP- and patient-level confounders, respectively. The random term 
2 
2 
v1i iid~N(0, σ1 ) is a PCP-specific random effect and v2ij  idd~N(0, σ2) is a patient-specific random effect; 
εijt  iid~N(0, σ2) is the model random error. We assume that v  , v 
and ε 
are mutually independent. To test 
for a time and group interaction, we will add the time*group term to the model. 
 
Power & Sample Size. With a sample size of 10 patients/PCP and 4 PCPs in both intervention groups (total 
n=10*4*2=80), and a conservative estimate of 10% attrition at 12 weeks, we calculated the reliability of 
estimated mean score differences between the two groups. Power calculations were based on: (1) 4 repeated 
observations / patient over the 3-month follow-up with a correlation of ρ=0.8 between repeated measures; (2) 
intra-cluster correlation among PCPs=0.2 to account for clustering of patients from the same PCP; and (3) linear 
mixed models to estimate mean score differences. For the ACQ, the half-width of 95% CI for the estimated 
mean score difference between the 2 groups is 0.32 (assuming SD=0.76). This is equivalent to having 91% 
power to detect a medium effect size (Cohen's d=0.5). We are powered to detect a clinically meaningful 
difference on ACQ74 and AQLQ78. 

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Qualitative analysis. Qualitative descriptive data analysis will focus on refining the intervention (see draft of 
sample questions for PCPs and patient/loved ones). De-identified transcripts will be entered into NVivo 11.0 for 
coding and analysis. Three coders working independently of each other will systematically read the transcripts 
to identify emerging themes; the Patient Advocate consultant will serve as one coder. Themes will be compared 
between coders and disagreements will be reconciled by consensus. As we have done in the past, we will 
employ an iterative process in which themes in earlier interviews will be presented to subsequent interviewees 
to ascertain if they resonate with them; unendorsed themes will be discarded. Typically, this iterative process 
continues until no new essential information is obtained, an endpoint known as data saturation. Data saturation 
usually occurs after in-depth interviews with 20-30 individuals per category (e.g., patient, loved one, PCP) 55. 
However, the focus of these more limited interviews are simply to assess acceptability and identify categorical 
level findings. We will use interview data to triangulate with the 8-item Client Satisfaction Questionnaire (CSQ- 
8) that is completed by all 80 subjects.  All retained responses that are similar will be grouped together by code 
words to form the final thematic categories. Transcripts, field notes and codes will serve as points of 
triangulation. 
 
DSMP 
 
The proposed study includes (1) a development phase where we will develop the intervention using focus groups with 
patients and patients’ family/support persons (N = 60) with primary care provider (PCP) review, and (2) a pilot validation 
phase where we will conduct a pilot randomized controlled trial with 8 PCPs from Philadelphia primary care clinics 
randomized to one of two study arms: (1) the BREATHE intervention, or (2) usual care. We will follow 10 Black adult 
patients with uncontrolled asthma per PCP (N = 80) for three months post-intervention. Post-study refinement will include 
additional interviews with patients, family/support persons and PCPs who did and did not participate. 
This Human Subjects Research meets the NIH definition of “Clinical Research.” Institutional review board (IRB) 
permission for the study will be obtained from the Columbia University (IRB of record) and will be reviewed annually. 
Although the NIH requires data and safety monitoring for any clinical trials, having an Safety Monitoring Committee 
(SMC) – a small group of 3 experts who are independent of the protocol who review data from a particular study 
including independent investigators and biostatisticians - may be appropriate if the study includes multiple sites and a 
vulnerable population. Because the application includes a feasibility trial in urban minority adults from different clinical 
sites, and because inclusion criteria require that participants have uncontrolled asthma, we will establish an SMC. 
a. Monitoring entity or who will monitor the study. While the behavioral intervention itself is a low risk intervention, 
participants must have uncontrolled asthma to be eligible for enrollment. Because of this, we will appoint an SMC to 
establish a threshold for asthma exacerbations (defined below) with the PI’s input. The SMC will be appropriate experts 
who are independent of the study and available in real time to review and recommend appropriate action regarding 
adverse events and other safety issues. 
 
The SMC, appointed by the PI and approved by the Program Officer include: 
Physician knowledgeable about the disease and treatment: Emily Dimango, MD is a pulmonologist and Associate 
Professor of Medicine, Columbia University Medical Center. She is the Director of the John Edsall-John Wood Asthma 
Center and the Columbia University Asthma Coalition. She has been a PI or Co I for multi-center clinical research trials 
since 2002, helping design and/or execute nearly two dozen clinical research studies in lung disease, including a $9 
million study of the role of environmental intervention in asthma. Through her work in asthma, she has interacted with the 
local inner city community, and has been successful in recruitment and retention of inner city minority subjects into 
clinical trials. Dr. Dimango will have primary responsibility for defining a plan for monitoring safety, minimizing risk to 
subjects, and adherence to protocol requirements; defining expected adverse events (AEs) and approving the definition of 
AEs, including serious adverse events (SAE). 
Statistician: Bruce Levin, Ph.D., Professor and Past Chair, Department of Biostatistics at Columbia University Mailman 
School of Public Health will serve as the statistician on the SMC. Dr. Levin has a great deal of experience with small 
SMCs, including serving as a SMC chair for an anesthesiology study. He has served as a senior design and analysis 
statistician on many projects in diverse areas of clinical trials, HIV/AIDS, reproductive epidemiology, and statistics in the 
law. He is the senior living co-author of the classic textbook, Statistical Methods for Rates and Proportions, 3rd Edition, 
which devotes entire chapters to the randomized clinical trial and methods for analyzing trial data. He specializes in 

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innovative designs for early phase clinical trials. Of additional importance to the current proposal, he is currently a co- 
investigator of a clinical trial which aims to test the effectiveness of an asthma intervention with proven efficacy in urban 
high school students with a new sample of rural adolescents and was the statistician for the R01 that tested the efficacy of 
Asthma Self-Management for Adolescents (ASMA) with urban adolescents in NYC (R01 HL67268). He (Levin) will have 
primary responsibility for statistical monitoring of AEs reported to the SMC and, through the SMC chair, notifying the 
team if such events meet the stop rules. Prior to the start of the study, and in coordination with the other SMC members 
and the study team, he will review and approve a proposed plan for monitoring completeness and quality of the 
measurements and the statistical analysis of the data. Mr. Jesse Chittams, the study’s database manager, will assume 
responsibility for statistical tabulations and reports to the SMC. 
Clinician knowledgeable about the disease and treatment: David Evans, PhD has over 30 years of research experience 
in intervention to enhance asthma control. He was one of the developers of Open Airways for Schools (OAS), a school- 
based program for children with asthma that has been shown to reduce the frequency of asthma symptoms in participating 
children; OAS is now delivered by the American Lung Association in more than 24,000 public elementary schools 
nationwide. He also participated in the development of the Physician Asthma Care Education (PACE) program, a four- 
hour program to improve pediatricians’ medical management and patient communication and teaching skills that showed 
pediatricians could be trained to deliver the program. The PACE program is now being disseminated through the NHLBI 
website. Dr. Evans was a Co-Investigator on a recent R01 testing the efficacy of PACE Plus, a version of PACE that 
included cultural competence training. Currently, he is part of a team (as is the PI) working on a Direct-to-Phase II SBIR 
grant from NHLBI to develop and to pilot test Camp Air, a dynamic, e-learning intervention for adolescents with 
uncontrolled asthma. He serves as Director of Community Outreach and Education for two environmental health research 
centers at Columbia University, the Center for Environmental Health in Northern Manhattan and the Center for Children’s 
Environmental Health. He has served on several NIH panels to improve the quality of asthma care, including the Data and 
Safety Monitoring Board of the NHLBI Children’s Asthma Management Program clinical trial (1992-2008), and the 
NHLBI Expert Panel (Report 3) on the Guidelines for the Diagnosis and Management of Asthma (2006-2007). Dr. Evans 
will have primary responsibility for reviewing the study protocol including benefit/risk ratio of procedures and participant 
burden, selection, recruitment, and retention of participants and informed consent procedures. He will also review any 
amendments to the study protocol and consent forms, including whether any new data from other sources affect the 
equipoise of the study being monitored. 
Although not members of the SMC, the research team has a responsibility to the SMC. These include the Principal 
Investigator (PI) who is responsible for ensuring participants’ safety on a daily basis for the protocol that will be 
overseen by the same SMC. The SMC will act in an advisory capacity to the PI and to NINR to monitor participant safety, 
evaluate the progress of the study, and review procedures for maintaining the confidentiality of data and the quality of 
data collection, management and analyses. The PI will be responsible for timely communication of safety data to the 
appointed SMC, appropriate response to any safety concern identified by the SMC, and compliance with any actions that 
the SMC identifies as being needed. The PI will also be responsible for all reporting requirements. Lastly, the PI will train 
all project staff to recognize and report any adverse event immediately to her. The project manager and/or the data 
manager will review all data collected by the research assistant (RA) and communicate data and/or safety concerns in real 
time to the PI. The RA will notify the project manager and/or the PI in real-time when data collection indicates a possible 
data/safety concern. Details are provided in (d) below. 
b. Procedures for 1) monitoring study safety to include monitoring schedule, auditing selected cases for compliance 
with IRB requirements, conformance with informed consent requirements, verification of source documents, and 
investigator compliance; 2) minimizing research-associated risk, and 3) protecting the confidentiality of participant 
data. For the pilot test, we will use the following strategies to monitor and deal with possible adverse impacts. Research 
participants will be told to contact research staff (who will return calls within 72 hours) at any point during the entire 
project if they have any questions or concerns about their participation. The PI and researchers will meet daily to review 
adverse or unexpected events data and weekly to review data reports generated by the data management team regarding all 
study-related activities. This will include case detection, consent, intervention activities, and surveys/interviews. The 
SMC will act in an advisory capacity to the PI and NINR to monitor participant safety, evaluate the progress of the study, 
and to review procedures for maintaining the confidentiality of data and the quality of data collection, management and 
analyses. 
 
Recruitment. We will recruit patients using methods we have used successfully in prior studies. The federally-qualified 
health center (FQHC) administrator will create a potential list of subjects using a combination of ICD-10 (Asthma 493)- 

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specific queries of the electronic membership records and searching of scheduled patient visits for the FQHC PCPs to 
review. The research team will receive only the names and contact information of those the PCP permits the team to 
contact. We will also accept subjects who respond to posted recruitment flyers. 
Informed Consent. The study team will read the informed consent and HIPAA to the subject and will discuss it section by 
section. When subjects have had all questions and concerns addressed, they will be asked to sign the consent indicating 
they are entering into the study voluntarily. Participants will be given a copy of the HIPAA and the signed informed 
consent document; a copy of the informed consent and HIPAA will be maintained with the study team. 
Auditing Selected Cases. Fidelity to consenting, data collection and the intervention will be evaluated in the following 
manner. Twenty percent of all visits will be randomly selected for auditing of the informed consent and data collection 
protocols. In addition, intervention fidelity will be assessed by reviewing audiotapes of 20% of randomly selected visits 
(with the exception of the first visit; all first visits be reviewed) to be rated by three independent blinded raters. At least 
one additional file per PCP will be reviewed prior to enrollment of their 5th patient subject, to evaluate drift and the length 
of BREATHE sessions, and length, content and contamination, if any, of control sessions. Consultant Pantalon will 
conduct additional training to enhance intervention fidelity and brevity if problems are identified. 
Minimizing research –associated risk. While the behavioral intervention itself is a low risk intervention, participants must 
have uncontrolled asthma to be eligible for enrollment. Because of this, we will ask the SMC to use the established 
threshold for asthma exacerbations (defined below) with the team’s input (see details below). 
The risk associated with the focus group procedures and intervention may include psychological distress due to sharing of 
personal information and the loss of confidentiality (see below). To minimize the risk of loss of confidentiality, 
participants will be told that whatever they say in these group settings or report in the study surveys is confidential. 
 
We will not be collecting any sensitive patient data, such as experiences with asthma death or asthma-related depression. 
However, we will be asking about previous asthma attacks that may have been life-threatening which may be a traumatic 
memory. Subjects will be allowed to skip any questions that they find troubling and should there be any indication of 
imminent medical or psychological risk associated with any aspect of the study, participants will be referred to previously 
identified resources in the study catchment areas. In concert with our partners, we will establish specific medical and 
counseling protocols prior to study onset. To that end we have established the following procedure: all study visits will 
take place at the FQHCs which have urgent medical and psychological services available on-site for evaluation and have 
set procedures for the timely and safe transfers of acute medical and psychological conditions to appropriate services. 
 
To the best of our knowledge, the risks of obtaining spirometry (a measure of obstructive airflow) is minimal as this 
procedure is typically performed in community-based health screenings. 
Study participants will be informed that they have a right to withdraw from the study at any stage. 
Patient confidentiality. 
Paper and electronic case report forms and transcripts. Patients’ confidentiality will be protected in multiple ways. First, 
all study subjects will be assigned a code that cannot be tied to personal identifiers and this code will appear on all study- 
related materials. The personal identifiers tied to these codes will be known only to study personnel and will be stored in a 
password-protected program. All other deidentified materials will remain in a locked office in a locked cabinet. All 
electronic documents will be password-protected. 
As part of the consent process, the procedures for obtaining outcome data as well as the safeguards for maintaining 
confidentiality and minimizing invasion of privacy will be fully described to potential participants. Participants will not 
have to answer any question they do not want to answer. Participants will be given the contact information for the 
research staff to answer any questions they might have about the study and consent process. To further minimize risk, the 
PI will train the RA on potential breach of confidentiality specific to this study and study environment and will assure that 
all study personnel complete and maintain Human Subjects Protection certificates. The PI will periodically monitor 
adherence of these principles during a random sample of visits. 
Audio files. Digital audio files (focus groups, audio recorded office visits and interviews) will be downloaded as 
a media file and stored on the PIs password-protected personal computer. Digital audio files will be assigned a 
code tied to personal identifiers. The personal identifiers tied to these codes will be known only to study 
personnel and will be stored in a separate password-protected program. We will transcribe all focus groups and 
individual interviews and some/all office visits. The transcriptionist is an approved Columbia vendor and has 
provided services in support of Phase I of this trial. The same standards will apply this this second phase: Audio 
files of the interviews and office visits will be deposited to the Columbia-approved transcription vendor’s 

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dropbox. The vendor has a confidentiality agreement that all employees sign stating that they may not share 
anything about any of the work that they transcribe with anyone. The vendor will then deposit the transcript in a 
word document in the drop box for the PIs retrieval. When it has been ascertained that the transcript is a 
verbatim representation of the interview/office visit the PI will notify the vendor to destroy all files. A copy of 
the transcript will be maintained by the PI as described in the protocol. 
 
Equipment. After downloading digital audio files, the digital recorder’s memory will be cleared. The memory of 
the spirometer will be cleared of lung function results after a copy has been printed and entered into the electronic 
data base. Subjects who have the Doser™ electronic ICS monitor will have the dose counter cleared monthly after a 
record of its use has been transcribed to spread sheets that will be stored in a password-protected program. 
Data management, data entry and integrity. An electronic study database (REDCap) will be created and maintained on the 
password-protected research server at Columbia University. Data entry personnel will receive standardized training on 
data entry. The Project Manager and RA will be trained and monitored by the PI with periodic checks for drift in 
standardized practices. If drift is observed they will be re-trained. The study’s statistician (Jia) will receive deidentified 
data transferred via secured communication. 
Data entry into desktop computers will be equipped with password lockout and screen savers which activate if the 
computer is on but not in use for 15 minutes. All study personnel will have their own unique usernames and passwords. 
All servers are located in a secure datacenter, with necessary redundancies. The server is behind a firewall and is 
registered as a “Critical Host” by the University. This means Columbia follows all University polices regarding critical 
hosts: firewalls, access controls, timely patch management and anti viral scans and software updates, and an enterprise 
system monitoring solution (allowing us to detect and address intrusion attempts). All servers have HIPAA compliant 

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security. School of Nursing computers operate under a managed desktop solution which is locked down, including hard 
drive and thumb drive encryption. The base image includes, but is not limited to, Windows 7 with current patches and 
Antivirus software (which is updated every 4 hours). 
Publication or presentation of study findings. Aggregate group data will be used, free of identifiable features, in any 
publication or presentations that arise from this research. 
c. Procedures for identifying, reviewing, and reporting adverse events and unanticipated problems to the IRB and 
NINR, the type and number of events that would halt accrual and would generate a review of eligibility, 
monitoring, assessments, intervention, and how the resumption of accrual would occur. 
 
All study personnel will report any study-related adverse reactions and/or unanticipated problems involving risks to the 
PIs as soon as they occur. The PI and/or study researchers will review all data collection forms on an ongoing basis for 
data completeness and accuracy as well as protocol compliance. 
During the trial, subjects will be instructed to notify the study team within 48 hours of any Emergency Department (ED) 
visit or hospitalization, regardless of its cause, and to notify the study team within 48 hours of initiating oral 
corticosteroids (OCS), each event representing the standard definition of asthma exacerbation. Because not all 
exacerbations cause individuals to seek acute care, we will track OCS use as those who manage an exacerbation outside of 
the ED or hospital will manage their exacerbation with OCS. In this manner we will not miss any exacerbations. To that 
end, we will also ask subjects to report these at monthly data collection points in an attempt to capture any exacerbations 
that might otherwise go unreported. Subjects’ answers will then be compared to the medical record and/or claims data, as 
available. 
Because there are 1.75 million ED visits annually (7%) among 24 million individuals with asthma we could anticipate a 
rate of 1.7% ED visits in a 3 month trial. However, only individuals with uncontrolled asthma will be eligible for 
enrollment so we will plan for 5% of our subjects to have an ED visit for asthma at some time during the 3 month trial. 
Therefore, data on adverse events, including serious adverse events (SAEs) that meet the standard definition of asthma 
exacerbation (ED visits, hospitalizations, and OCS initiation), will be reviewed. Exacerbation rates as meeting any of the 
three standard definitions of asthma exacerbation (ED visits, hospitalizations, and OCS initiation) in excess of the 
threshold set by the SMC will trigger an immediate study shutdown (see below). AEs and SAEs will be systematically 
assessed at all data collection points via review of the medical record and/or patient interview. Subjects will be instructed 
to report AEs and SAEs to the study team within 48 hours of their occurrence. This information will then be shared with 
the SMC in real-time, as well as additional information about the event that the study team can obtain from the PCP or 
from the medical record, as available. The SMC will then determine how an AE is to be categorized using standard 
taxonomy: Unrelated (clearly not related to the research), Unlikely (doubtfully related to the research), Possible (may be 
related to the research), Probable (likely related to the research) and Definite (clearly related to the research). 
The SMC will use the following definitions: 
Adverse events are defined as unanticipated problems involving risks to study participants or others, or as any untoward 
medical occurrence that may present itself during the study time period which may or may not have a causal relationship 
with the treatment. 
Serious adverse events result in any of the following outcomes: death, a life threatening experience, inpatient 
hospitalization, or a significant disability/incapacity. Such events also include breeches of confidentiality. 
Moderate adverse events are those discomforts severe enough to cause interference with usual activities or requiring 
treatment by a health care provider. Such events also include the loss of participants from the study for reasons related in 
any way to a deviation from procedures for ensuring confidentiality. 
Mild adverse events are those events that are easily tolerated signs or symptoms of discomfort; minor irritants that cause 
no loss of time from normal activities; symptoms that require no medication or a medical evaluation; and transient signs 
and symptoms. 
Unexpected adverse events are those events, the specificity or severity of which is not consistent with the risk information 
described in the general investigative plan or the IRB proposal. "Unexpected" refers to an adverse event that has not been 
previously observed. 
Expected adverse events are those events, the specificity or severity of which is consistent with the risk information 
described in the general investigative plan or IRB proposal. 
Any ED visit or hospitalization associated with primary ICD-10-CM Diagnosis Code 493. Asthma (493.00 asthma atopic 
unspecified; 493.01 asthma atopic asthmaticus; 493.02 asthma atopic acute exacerbation; 493.10 intrinsic asthma 
unspecified; 493.11 intrinsic asthma asthmaticus; 493.12 intrinsic asthma acute exacerbation;493.20 asthma chronic 

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obstructive pulmonary disease copd; 493.21 asthma chronic obstructive pulmonary disease copd; 493.22 asthma chronic 
obstructive pulmonary disease copd; 493.81 exercise induced bronchospasm; 493.82 cough variant asthma; 493.91 asthma 
bronchial allergic nos asthmaticus; 493.92 asthma bronchial allergic nos acute exacerbation) will be characterized as a 
Probable or Definite SAE. 
 
SAE reporting. 
 
Any SAE, whether or not related to study intervention, will be reported to the IRB and the SMC. The PI will inform the 
IRB and SMC immediately and jointly make a decision whether the reported event is a SAE that must be reported to 
NINR due to the unexpectedness and/or the severity of the event. The initial SAE report will be followed by submission 
of a completed SAE report to NINR within two days (refer to Table 1. Adverse Events Form, Table 2. Adverse Events 
Coding, and Table 3. Matrix for Adverse Events Reporting). 
In the event that a patient either withdraws from the study or the investigator decides to discontinue a patient 
due to SAE, the patient will be monitored by the investigator via ongoing status assessment until 1) a 
resolution is reached, i.e., the problem requiring hospitalization has resolved or stabilized with no further 
changes expected; 2) the SAE is determined to be clearly unrelated to the study intervention; or 3) the SAE 
results in death. Outcome of SAEs will be periodically reported to the IRB and to the funding agency. A 
summary of the SAEs that occurred during the previous year will be included in the annual progress report 
to the IRB and the SMC. The report will include the participants’ sociodemographic characteristics, 
expected versus actual recruitment rates, treatment retention rates, any quality assurance or regulatory issues 
that occurred during the past year, summary of AEs and SAEs, and any actions or changes with respect to 
the protocol. 
Stop rules. If the PI, 
IRB and/or SMC 
determines that serious 
adverse events meeting 
the standard definition 
of an asthma 
exacerbation (ED visit; 
Hospitalization and/or 
OCS initiation) have 
occurred in excess of 
the 5% threshold set for 
the study, then data 
collection and study 
enrollment will be 
stopped. The SMC and 
the IRB will be asked to 
review the study and 
suggest modifications of 
the protocol, the 
threshold limit or other 
changes. If the SMC 
and the Chairperson of the IRB believe that these modifications are adequate for resumption of the study, 
then the study will resume. NINR will receive a written report within three days of any such suspension 
and/or resumption of data collection. 
 
Content of Data and Safety Monitoring Report 
The Data and Safety Monitoring Report will include the following items: 
1. Narrative/Trial Summary including study status; minutes of SMC consultations (action items, resolution 
of action items), and summary of any protocol changes. 
2. Study Administration Recruitment and Participant Status including tables reporting overall study status, 
actual vs. expected enrollment, participant enrollment status by condition, overall reasons for eligibility 

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screen failures, overall protocol deviations, protocol deviations by condition, demographic and key baseline 
characteristics, participant attrition by condition, and study duration for all participants. 
3. Study Administration Data including tables reporting overall summary of assessment measures collected, 
assessment measures collected by condition, overall summary of missing outcome measures, missing 
outcome measures by 
condition. 
4. Safety Assessments 
for All Participants 
including tables 
reporting incidence of 
adverse events and 
severity of adverse 
events overall, as well 
as incidence of 
adverse events and 
severity of adverse 
events by condition. 
 
d. For multi-site 
studies, procedures 
to ensure compliance 
with the monitoring 
plan and reporting 
requirements across 
study sites. As 
described above we 
offer a robust plan for Auditing Selected Cases. In addition, consenting and data collection will be 
conducted by the same research assistant. 
e. An assessment of external factors or relevant information (e.g., developments in the literature, 
results of related studies) that may have an impact on the safety of participants or on the ethics for the 
research study. Since our submission no new literature has been published that impacts the safety of 
participants. Uncontrolled asthma due to poor patient- and provider-recognition of uncontrolled disease with 
subsequent underuse of ICS therapy remains a major cause of excess asthma morbidity and mortality. Our 
study specifically seeks to improve recognition and treatment of uncontrolled asthma and therefore decrease 
risk of poor asthma outcomes. We will follow the literature during the trial and notify our participants and 
NINR if a change in the standard of care poses a safety risk or creates an ethical dilemma. If that were to 
occur the PI would consult with the SMC, the IRB and NINR to either stop the study or modify the protocol 
to address safety or ethical concerns. All participants would be notified and participants would be re- 
consented. 
 
 
 
f. The advanced plans for interim and/or futility analysis as appropriate. Not applicable; this is a 
feasibility trial and is not powered for statistical significance. 

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REFERENCES 
 
1.  George, M., Topaz, M., Rand, C., Sommers, M.S., Glanz, K., Pantalon, M.V., Mao, J., & Shea, J. 
(2014). Inhaled corticosteroid beliefs, complementary and alternative medicine and uncontrolled asthma 
in urban minority adults Journal of Allergy and Clinical Immunology, 134, 1252–59. 
2.  George, M, Pinilla, R., Abboud, S., Shea, J., Rand, C., (2013). Innovative use of a standardized 
debriefing guide to assist in the development of a research questionnaire with low literacy demands. 
Applied Nursing Research, 26, 139-42. 
3.  George, M., Abboud, S., Pantalon, M.V., Sommers, M.S., Mao, J., & Rand C. (2016). Changes in 
clinical conversations when providers are informed of asthma patients' beliefs about medication use and 
integrative medical therapies. Heart & Lung, 45, 70-8. 
4.  Pantalon MV, Sledge WH, Bauer SF, et al. Important medical decisions: Using brief motivational 
interviewing to enhance patients' autonomous decision-making. J Psychiatr Pract. 2013;19(2):98-108. 
5.  D'Onofrio G, Fiellin DA, Pantalon MV, et al. A brief intervention reduces hazardous and harmful 
drinking in emergency department patients. Ann Emerg Med. 2012;60(2):181-192. 
6.  D'Onofrio G, Pantalon MV, Degutis LC, Fiellin DA, O'connor PG. Development and implementation of 
an emergency practitioner-performed brief intervention for hazardous and harmful drinkers in the 
emergency department. Acad Emerg Med. 2005;12(3):249-256. 
7. Expert Panel Report 3 (EPR-3) (2007). National Asthma Education and Prevention Program. 
Guidelines for the diagnosis and management of asthma. NIH pub no 07–4051. Bethesda, MD: National 
Heart, Lung, and Blood Institute, National Institutes of Health. 2007. Available from: 
http://www.nhlbi.nih.gov/ guidelines/asthma/. 
8.  Powell H, Gibson PG. Options for self-management education for adults with asthma. Cochrane 
Database Syst Rev. 2003(1):CD004107. 
9.  Steuten L, Lemmens K, Vrijhoef B. Health technology assessment of asthma disease management 
programs. Curr Opin Allergy Clin Immunol. 2007;7(3):242-248. 
10. Toelle BG, Ram FS. Written individualised management plans for asthma in children and adults. 
Cochrane Database Syst Rev. 2004;(2)(2):CD002171. 
11. Uncontrolled Asthma among Persons with Current Asthma. 
http://www.cdc.gov/asthma/asthma_stats/uncontrolled_asthma.htm 
12. Akinbami LJ, Moorman JE, Liu X. Asthma prevalence, health care use, and mortality: United States, 
2005-2009. Natl Health Stat Report. 2011;(32)(32):1-14. 
13. Apter AJ, Boston RC, George M, et al. Modifiable barriers to adherence to inhaled steroids among 
adults with asthma: It's not just black and white. J Allergy Clin Immunol. 2003;111(6):1219-1226. 
14. Le TT, Bilderback A, Bender B, et al. Do asthma medication beliefs mediate the relationship between 
minority status and adherence to therapy? J Asthma. 2008;45(1):33-37. 
15. Bender BG, Bender SE. Patient-identified barriers to asthma treatment adherence: Responses to 
interviews, focus groups, and questionnaires. Immunology and Allergy Clinics of North America. 
2005;25(1):107-130. 
16. Krishnan JA, Diette GB, Skinner EA, Clark BD, Steinwachs D, Wu AW. Race and sex differences in 
consistency of care with national asthma guidelines in managed care organizations. Arch Intern Med. 
2001;161(13):1660-1668. 
17. World Health Organization. Adherence to long-term therapies: Evidence for action. 2003;92 4 154599 2. 
18. Horne R. Compliance, adherence, and concordance: Implications for asthma treatment. Chest. 
2006;130(1 Suppl):65S-72S. 
19. Boulet LP, Vervloet D, Magar Y, Foster JM. Adherence: The goal to control asthma. Clin Chest Med. 
2012;33(3):405-417. 

Version #1R; 8-7-=8-17 
Page 18 of 20 
 
20. Conn KM, Halterman JS, Lynch K, Cabana MD. The impact of parents' medication beliefs on asthma 
management. Pediatrics. 2007;120(3):e521-6. 
21. Eakin MN, Rand CS. Improving patient adherence with asthma self-management practices: What 
works? Ann Allergy Asthma Immunol. 2012;109(2):90-92. 
22. Baptist AP, Deol BB, Reddy RC, Nelson B, Clark NM. Age-specific factors influencing asthma 
management by older adults. Qual Health Res. 2010;20(1):117-124. 
23. George M, Birck K, Hufford DJ, Jemmott LS, Weaver TE. Beliefs about asthma and complementary 
and alternative medicine in low-income inner-city African-American adults. J Gen Intern Med. 
2006;21(12):1317-1324. 
24. George M, Freedman TG, Norfleet AL, Feldman HI, Apter AJ. Qualitative research-enhanced 
understanding of patients' beliefs: Results of focus groups with low-income, urban, African American 
adults with asthma. J Allergy Clin Immunol. 2003;111(5):967-973. 
25. Ponieman D, Wisnivesky JP, Leventhal H, Musumeci-Szabo TJ, Halm EA. Impact of positive and 
negative beliefs about inhaled corticosteroids on adherence in inner-city asthmatic patients. Ann Allergy 
Asthma Immunol. 2009;103(1):38-42. 
26. Wells K, Pladevall M, Peterson EL, et al. Race-ethnic differences in factors associated with inhaled 
steroid adherence among adults with asthma. Am J Respir Crit Care Med. 2008;178(12):1194-1201. 
27. Roy A, Lurslurchachai L, Halm EA, Li XM, Leventhal H, Wisnivesky JP. Use of herbal remedies and 
adherence to inhaled corticosteroids among inner-city asthmatic patients. Ann Allergy Asthma 
Immunol. 2010;104(2):132-138. 
28. Institute of Medicine. Unequal treatment:Confronting racial and ethnic disparities in health care (with 
CD). The National Academies Press; 2003. http://www.nap.edu/openbook.php?record_id=12875. 
29. Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use 
among adults: United States, 2002. Adv Data. 2004;(343)(343):1-19. 
30. George M, Topaz M. A systematic review of complementary and alternative medicine for asthma self- 
management. Nurs Clin North Am. 2013;48(1):53-149. 
31. Murphy KR, Meltzer EO, Blaiss MS, Nathan RA, Stoloff SW, Doherty DE Asthma management and 
control in the United States: results of the 2009 Asthma Insight and Management survey. Allergy 
Asthma Proc. 2012 Jan-Feb;33(1):54-64. doi: 10.2500/aap.2011.32.3518. Epub 2011 Dec 15. 
32. Chang CH, Lewis VA, Meara E, Lurie JD, Bynum JP. Characteristics and Service Use of Medicare 
Beneficiaries Using Federally Qualified Health Centers. Med Care. 2016 May 23. [Epub ahead of print] 
33. The Physician Workforce. Projections and research into the current issues affecting supply and demand 
(2008). US Dept Health Human Services Health Resources and Services Administration Bureau of 
Health Professions. http://bhpr.hrsa.gov/healthworkforce/reports/physwfissues.pdf. Accessed 2/12 2014. 
34. Satterfield JM, Spring B, Brownson RC, et al. Toward a transdisciplinary model of evidence-based 
practice. Milbank Q. 2009;87(2):368-390. 
35. Wagner EH, Bennett SM, Austin BT, Greene SM, Schaefer JK, Vonkorff M. Finding common ground: 
Patient-centeredness and evidence-based chronic illness care. J Altern Complement Med. 2005;11 Suppl 
1:S7-15. 
36. Street RL,Jr, Makoul G, Arora NK, Epstein RM. How does communication heal? pathways linking 
clinician-patient communication to health outcomes. Patient Educ Couns. 2009;74(3):295-301 
37. Battersby M, Von Korff M, Schaefer J, et al. Twelve evidence-based principles for implementing self- 
management support in primary care. Jt Comm J Qual Patient Saf. 2010;36(12):561-570. 
38. Schedlbauer A, Davies P, Fahey T. Interventions to improve adherence to lipid lowering medication. 
Cochrane Database Syst Rev. 2010;(3):CD004371. doi(3):CD004371. 
39. Schneider J, Kaplan SH, Greenfield S, Li W, Wilson IB. Better physician-patient relationships are 
associated with higher reported adherence to antiretroviral therapy in patients with HIV infection. 
Journal of General Internal Medicine. 2004;19(11):1096-1103. 

Version #1R; 8-7-=8-17 
Page 19 of 20 
 
40. Wilson SR, Strub P, Buist AS, et al. Shared treatment decision making improves adherence and 
outcomes in poorly controlled asthma. Am J Respir Crit Care Med. 2010;181(6):566-577. 
41. Cooper LA, Roter DL, Carson KA, et al. A randomized trial to improve patient-centered care and 
hypertension control in underserved primary care patients. J Gen Intern Med. 2011;26(11):1297-1304. 
42. Von Korff M, Katon W, Rutter C, et al. Effect on disability outcomes of a depression relapse prevention 
program. Psychosom Med. 2003;65(6):938-943. 
43. Ludman E, Katon W, Bush T, et al. Behavioural factors associated with symptom outcomes in a primary 
care-based depression prevention intervention trial. Psychol Med. 2003;33(6):1061-1070. 
44. Cooper LA, Roter DL, Carson KA, et al. A randomized trial to improve patient-centered care and 
hypertension control in underserved primary care patients. J Gen Intern Med. 2011;26(11):1297-1304. 
45. Von Korff M, Katon W, Rutter C, et al. Effect on disability outcomes of a depression relapse prevention 
program. Psychosom Med. 2003;65(6):938-943. 
46. Ludman E, Katon W, Bush T, et al. Behavioural factors associated with symptom outcomes in a primary 
care-based depression prevention intervention trial. Psychol Med. 2003;33(6):1061-1070. 
47. Butz A, Kub J, Donithan M, et al. Influence of caregiver and provider communication on symptom days 
and medication use for inner-city children with asthma. J Asthma. 2010;47(4):478-485. 
48. US Department of Health and Human Services. Healthy people 2020. 
http://healthypeople.gov/2020/default.aspx. 
49. Centers for Disease Control and Prevention (CDC) (2007).Asthma self-management education among 
youths and adults--United States, 2003. MMWR Morb Mortal Wkly Rep. 2007 Sep 7;56(35):912-5. 
50. Peytremann-Bridevaux I, Arditi C, Gex G, Bridevaux PO, Burnand B. Chronic disease management 
programmes for adults with asthma. Cochrane Database of Systematic Reviews 2015, Issue 5. Art. No.: 
CD007988. DOI: 10.1002/14651858.CD007988.pub2. 
51. Probst J, Barker J, Enders A, Gardiner P, Roberston A. Current state of child health in rural America: 
how context shapes children's health. J Rural Health. In revision. 
52. Stokols D. Translating social ecological theory into guidelines for community health promotion. Am J 
Health Promot. 1996;10(4):282-298. 
53. Lau M, Lin H, Flores G. Racial/ethnic disparities in health and health care among U.S. adolescents. 
Health Serv Res. 2012;47(5):2031-2059. 
54. George M, Campbell J, Rand C. Self-management of acute asthma among low-income urban adults. J 
Asthma. 2009;46(6):618-624. 
55. George, M. & Margolis, M.L. (2010). Race and lung cancer surgery-- a qualitative analysis of relevant 
beliefs and management preferences. Oncology Nursing Forum, 37, 740-748. 
56. Townsend, K., Corry, J.M., Quigley, B., George, M. (2012). A feasibility study of Q-sort to determine 
recall of skin test results and environmental remediation education. Journal of Asthma, 49, 83–89. 
57. Keddem, S. Barg, F. Glanz K. Jackson, T, Green, S. George, M. (2015). Mapping the urban asthma 
experience: using qualitative GIS to understand contextual factors influencing asthma control. Social 
Science & Medicine, 140, 9-17. 
58. George, M., Keddem, S., Barg, F., Greene, S., Cavanaugh, E., & Glanz, K. (2014). Urban adults’ 
perceptions of factors influencing asthma control. Journal of Asthma, 52, 98-104. 
59. Rhodes, K.V., Rodgers, M., Sommers, M.S., Hanlon, A., & Crits-Cristoph, P. (2014). The social health 
intervention project (SHIP): Protocol for a randomized controlled clinical trial assessing the 
effectiveness of a brief motivational intervention for problem drinking and intimate partner violence in 
an urban emergency department. BMJ Central, 14, 10. 
60. Sommers, M.S., Lyons, M.S., Bohn, C.M., Ribak, J., & Fargo, J.D. (2013). Health-compromising 
behaviors among young adults in the urban emergency department: Opportunity for a teachable moment. 
Clinical Nursing Research, 22(3), 285-309. 
61. Sommers, M.S., Lyons, M.S., Fargo, J.D., Sommers, B.D., McDonald, C.C., Shope, J.T., & Fleming, 
M.F. (2013). ED-based brief intervention to reduce risky driving and hazardous/harmful drinking in 

Version #1R; 8-7-=8-17 
Page 20 of 20 
 
young adults: A randomized  controlled trial. Alcoholism: Clinical and Experimental Research, 37(10), 
1753-1762. 
62. Kangovi S, Long JA, Emanuel E. Community health workers combat readmission. Arch Intern Med. 
2012;172(22):1756-1757. 
63. Kangovi S, Grande D, Meehan P, Mitra N, Shannon R, Long JA. Perceptions of readmitted patients on 
the transition from hospital to home. J Hosp Med. 2012;7(9):709-712. 
64. Kangovi S, Barg FK, Carter T, et al. Challenges faced by patients with low socioeconomic status during 
the post-hospital transition. J Gen Intern Med. 2013. 
65. Kangovi S, Mitra N, Grande D, White ML, McCollum S, Sellman J, Shannon RP, Long JA (2014). 
Patient-Centered Community Health Worker Intervention to Improve Posthospital OutcomesA 
Randomized Clinical Trial. JAMA Intern Med. 2014;174(4):535-543. 
66. Bruzzese J-M, Bonner S, Vincent EJ, et al. Asthma education: the adolescent experience. Patient 
Education and Counseling. 2004;55(3):396-406. 
67. Bruzzese J-M, Kingston S, Sheares BJ, Cespedes A, Sadeghi H, Evans D. Feasibility and preliminary 
outcomes of a school-based intervention to help inner-city, ethnic minority adolescents with 
undiagnosed asthma. Patient Education & Counseling. 2011;85(2):290-294. 
68. Bruzzese J-M, Sheares BJ, Vincent EJ, et al. Effects of a school-based intervention for urban 
adolescents with asthma: a controlled trial. American Journal of Respiratory and Critical Care 
Medicine. 2011;183(8):998-1006. 
69. Bruzzese J-M, Unikel LH, Gallagher R, Evans D, Colland VT. Feasibility and impact of a school-based 
intervention for families of urban adolescents with asthma: results from a randomized pilot trial. Family 
Process. 2008;47(1):95-113. 
70. Bruzzese, J.M., Kingston, S., Zhao, Y., DiMeglio, J.S., Cespedes, A. & George, M. (2016-in 
press). Psychological factors influencing the decision of urban adolescents with undiagnosed asthma to 
obtain medical care. J Adol Health. 
71. Carlsen B, Glenton C. What about N? A methodological study of sample-size reporting in focus group 
studies BMC Med Res Methodol. 2011; 11: 26. 
72. Juniper EF, Bousquet J, Abetz L, Bateman ED; GOAL Committee. Identifying 'well-controlled' and 'not 
well-controlled' asthma using the Asthma Control Questionnaire. Respir Med. 2006 Apr;100(4):616-21. 
73. Schatz, M, Kosinski, M, Yarlas, AS Hanlon, J, Watson, ME, Jhingran, P. The minimally important 
difference of the Asthma Control Test.J Allergy Clin Immunol 2009;124:719-23) 
74. Juniper EF, O'Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a 
questionnaire to measure asthma control. Eur Respir J. 1999;14(4):902-907. 
75. Pantalon MV, Martino S, Dziura J, et al. Development of a scale to measure practitioner adherence to a 
brief intervention in the emergency department. J Subst Abuse Treat. 2012;43(4):382-388. 
76. Juniper EF, Guyatt GH, Ferrie PJ, Griffith LE. Measuring quality of life in asthma. Am Rev Respir Dis. 
1993;147(4):832-838. 
77. Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. 
European Respiratory Journal 2002 19: 398-404 
78. Clatworthy J, Price D, Ryan D, Haughney J, Horne R. The value of self-report assessment of adherence, 
rhinitis and smoking in relation to asthma control. Prim Care Respir J. 2009;18(4):300-305. 
79. Cohen JL, Mann DM, Wisnivesky JP, et al. Assessing the validity of self-reported medication adherence 
among inner-city asthmatic adults: The medication adherence report scale for asthma. Annals of Allergy, 
Asthma & Immunology. 2009;103(4):325-331. 
80. Koster ES, Raaijmakers JA, Vijverberg SJ, Maitland-van der Zee AH. Inhaled corticosteroid adherence 
in pediatric patients: The PACMAN cohort study. Pharmacoepidemiol Drug Saf. 2011;20(10):1064- 
1072. 

Version #1R; 8-7-=8-17 
Page 21 of 20 
 
81. Menckeberg TT, Bouvy ML, Bracke M, Hugtenburg JG, Lammers JW, Raaijmakers JA. Patients' 
understanding of the reasons for starting and discontinuing inhaled corticosteroids. Br J Clin Pharmacol. 
2008;66(2):255-260 
82. Mora PA, Berkowitz A, Contrada RJ, et al. Factor structure and longitudinal invariance of the medical 
adherence report scale-asthma. Psychol Health. 2011;26(6):713-727. 
83. Patient-reported Outcome Measurement Group. Structured review of patient-reported outcome measures 
(PROMS) for asthma. Report to the Department of Health. 2009. 
84. Ohm R, Aaronson LS. Symptom perception and adherence to asthma controller medications. J Nurs 
Scholarsh. 2006;38(3):292-297. 
85. Roy A, Lurslurchachai L, Halm EA, Li XM, Leventhal H, Wisnivesky JP. Use of herbal remedies and 
adherence to inhaled corticosteroids among inner-city asthmatic patients. Ann Allergy Asthma Immunol. 
2010;104(2):132-138. 
86. Roy A, Battle K, Lurslurchachai L, Halm EA, Wisnivesky JP. Inhaler device, administration technique, 
and adherence to inhaled corticosteroids in patients with asthma. Prim Care Respir J. 2011;20(2):148- 
154. 
87. Sofianou A, Martynenko M, Wolf MS, et al. Asthma beliefs are associated with medication adherence in 
older asthmatics. J Gen Intern Med. 2012. 
88. Wojtczak HA, Wachter AM, Lee M, Burns L, Yusin JS. Understanding the relationship among 
pharmacoadherence measures, asthma control test scores, and office-based spirometry. Ann Allergy 
Asthma Immunol. 2012;109(2):103-107. 
89. Larson, DL, Attkinsson, CC, Hargreaves, WA, Nguyen, TD (1979). Assessment of client/patient 
satisfaction: Development of a general scale. Eval and Progr Plan, 2, 197-207.