Self-care Decision-making: Feasibility of the BREATHE Asthma Intervention Trial
Phase: NA
Conditions: Asthma Chronic, Health Behavior
Sponsor: Columbia University

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Self-care decision-making: Feasibility of the BREATHE asthma intervention trial  
 
 
NCT03036267 
 
Document date: 9/21/2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Self-care decision-making: Feasibility of the BREATHE asthma intervention trial  
Principal Investigator: Maureen George 
Version #1; Version Date: 09/21/16 
 
 
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 personalized 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 this feasibility trial we will develop the intervention by adapting 
an evidence-based brief shared decision-making strategy with proven efficacy4-6, for use with our validated 
CAM-A tool using community-based participatory research and delivered by PCPs. 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;   
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, at this time we are submitting for IRB approval for Aim #1 (Phase I - focus group and PCP 
review only), which will be carried out in Study Year #1. Aims #2 and #3 (Phase II-pilot intervention) will 
be conducted later; as we develop/refine the pilot study we will submit for approval for Aims #2 and #3. 
 
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 lower in Blacks relative to Whites13-17 
due, in part, to higher rates of erroneous personal health beliefs regarding asthma self-care1 (e.g., coffee is a 
safe, effective asthma treatment) and negative ICS beliefs13-15,22-29 (e.g., ICS is addicting). These beliefs have 
been shown to be associated with ICS non-adherence22,23,27, more asthma attacks22,30 and delays in seeking 
care23. 

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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 PCP’s role is to facilitate discussion of the risks and merits associated with 
specific options in the context of patient’s 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 is 
developed using iterative community-based participatory research (CBPR) approaches with feedback from 
PCPs; and (2) a pilot randomized trial phase (end of Year 1 and Year 2) 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. 
PHASE I ONLY  
Development Phase. While the final intervention content will be determined by results of an iterative process 
with asthma patients, their family/support person, PCPs and our Patient Advocate, based on our collective 
clinical and research experiences1-3,5,6,13,23,24,50-54, we anticipate the new manualized intervention will consist of 
one-time, brief (7-minute), tailored shared decision-making intervention session using motivation interviewing 

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to address personal health beliefs and negative ICS beliefs associated with ICS non-adherence (see manual 
attached-Brief intervention adapted for asthma ). To adapt BREATHE, the PI will use a 2-step process. 
Study Procedures 
PHASE I ONLY Step 1. CBPR with Adults with Persistent Asthma and their Family/Support Person to 
Adapt Intervention Content. We will conduct up to 6 focus groups composed of ~10 participants each: (a) 
two groups of only adults with persistent asthma; (b) two groups of only family/support persons of adults with 
persistent asthma unique from group a; and (c) two combined groups of adults with persistent asthma and/or 
their family/support persons who did not participate in group a or b.  
Participants will be recruited from the partner FQHCs. These are Spectrum Health Services (SHS) and Greater 
Philadelphia Health Alliance (GPHA). Letters of support for this project are attached to this application.  
PI George will conduct the focus groups using grounded theory approaches, collecting qualitative data using an 
open-ended interview guide adapted from our preliminary studies1-6,13,23,24,50-54  to obtain suggestions for 
responses PCPs will use with patients who endorse CAM-A beliefs associated with uncontrolled asthma. 
Responses will be used to design the brief intervention. Focus groups will be audiotaped and transcribed 
verbatim. A member of the research team will take field noted. 
Step 2. PCP Review. We will further refine the intervention prior to piloting by presenting the focus group 
results to four PCPs who are working in settings similar to our partner FQHCs; we chose not to use PCPs from 
our partnering FQHCs in order to avoid contamination. PCPs will provide input into the application of the 
intervention to their practice, which we will use to revise the intervention.  
 
STATISTICAL PROCEDURES     
 
Qualitative analysis. Qualitative data analysis will focus on developing the intervention. 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 from the initial 
focus groups will be presented to subsequent focus groups to ascertain if they resonate with that group; 
unendorsed themes will be discarded. This iterative process will continue until no new essential information is 
obtained, an endpoint known as data saturation. Typically data saturation occurs when between two and five 
focus groups per category (e.g., patient, family/support person) are held55; we have over-estimated by planning 
for 6 focus groups. If we find that we have reached data saturation with fewer focus groups we will end this 
phase of data collection. 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.  
 
MEASURES 
Immediately prior to the focus groups, but after obtaining HIPAA and informed consent, we will administer 
surveys. These can be found under separate attachment. 
 
Adults with asthma  will complete: 
Family/support person of adult with asthma 
will complete: 
Demographics 
Demographics 
Asthma History Patient version 
Asthma History Family Version 
Conventional and Alternative Management for Asthma 
(CAM-A) Patient version 
Conventional and Alternative Management for 
Asthma (CAM-A) Family Version 
Newest Vital Sign  
Newest Vital Sign 
Medication Adherence Record Scale – Asthma  
Medication Adherence Record Scale – Asthma 

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Asthma Control Questionnaire (without item #7-
spirometry) 
_ 
Asthma Quality of Life Questionnaire 
_ 
PERSONNEL 
 
In addition to the PI, two other Columbia personnel are investigators. They are 
1. Dr. Haomiao Jia, statistician for the project,  
2. Dr. Jean-Marie Bruzzese, in-kind effort for behavioral science expertise. 
 
Four investigators are from the University of Pennsylvania School of Nursing (SON) and/or the University of 
Pennsylvania School of Medicine (SOM) serve as key personnel: 
1. Dr. Marilyn Sommers (SON) is an expert on brief interventions targeting risk-taking behaviors in urban 
populations and will contribute health and culture expertise to tailor the intervention (phase II) in the 
target population.  As an expert in training and fidelity for behavioral interventions, she will also lead 
the evaluation of the fidelity to the interventions, which includes designing the fidelity plan and 
supervising the blinded assessors.  She will also review the planned analysis and make suggestions for 
additional statistical reports and will participate in the preparation of reports and manuscripts for this 
project. 
2. Dr. Karen Glanz (SON/SOM) is a public health expert and Director of the Center for Health Behavior 
Research at the University of Pennsylvania. Her primary role will be to provide consultation as needed 
regarding the public health aspects of the trial, trial design and implementation and the planned analysis. 
She will review and contribute to the design, results and discussion sections of all manuscripts.  
3. Dr. Shreya Kangovi (SOM) will provide in-kind effort for her expertise in health and culture. She 
works one day a week at Spectrum, one of the federally-qualified health centers that will serve as a 
performance site for this trial. Her primary role will be to provide access to patients and primary care 
colleagues, to assist George and the Consultant Pantalon with provider training and to provide expert 
consultation, as needed, on chronic disease management in primary care. She will also review the 
planned analysis and make suggestions for additional statistical reports and will participate in the 
preparation of all manuscripts. 
4. Mr. Jesse Chittams (SON) will have primary responsibility for the creation of the REDCap data 
management system and data security with the PI. He will also assist the PI on the execution of the 
SMC. In Year 01 he will review the training in all data entry and management procedures; overseeing 
the double data entry, data cleaning, and preliminary analyses. He will supervise the final analysis of 
the cleaned and validated database and assist Jia in the writing of the statistical methods section for the 
primary results and secondary results papers.  
 
There are two consultants on the project. Dr. Michael Pantalon, Yale School of Medicine, is a psychologist with 
expertise in training health care professionals to deliver brief interventions using motivational interviewing 
approaches. On this project, he will supervise the training of the health care providers in the delivery of brief 
intervention techniques (Phase II). As a Consultant, he will also be one of the blinded personnel responsible for 
reviewing the audio files to determine if fidelity to the BREATHE intervention has been maintained and 
making recommendations for additional training, if needed, until consistency and fidelity is achieved. 
5. Ms. Coleman is a 30 year old female with lifelong persistent asthma who receives asthma care at GPHA, 
one of the federally-qualified health centers that will serve as a performance site for this trial. She has 
agreed to serve as the Patient Advocate and has been involved in every aspect of this application. In 
Year 01, Ms. Coleman will be involved in coding of the focus groups, adapting the draft intervention 
and piloting of the protocol. In addition, in Year 02 she will have primary responsibility for contributing 
to the design, planned analysis and preparation of reports, presentations and manuscripts for this project. 
Ms. Coleman will assist in analyzing the qualitative data from post-trial interviews for final refinement 
of the protocol. 

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