Promoting Asthma Guidelines and Management Through Technology-Based Intervention and Care Coordination
Phase: NA
Conditions: Asthma Childhood
Sponsor: Montefiore Medical Center

Title:  Promoting Asthma Guidelines and Management Through Technology-
Based Intervention and Care Coordination (PRAGMATIC)
NCT03066596
IRB#:  2016-6258
IRB Approval Date:  11/06/2020
IRB NUMBER: 2016-6258
IRB APPROVAL DATE: 11/06/2020
CONFIDENTIALITY STATEMENT 
This document is confidential communication. Acceptance of this document constitutes 
agreement by the recipient that no unpublished information contained herein will be published or 
disclosed without prior approval of the Principal Investigator or other participating study 
leadership and as consistent with the NIH terms of award.  

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Promoting Asthma Guidelines and Management through Technology-Based Intervention and 
Care Coordination (PRAGMATIC)
Investigators:
Marina Reznik, MD, MS – PI
Jill S. Halterman, MD, MPH
Michael Rinke, MD, PhD
Suzette Oyeku, MD
Deepa Rastogi, MBBS
Bruce Rapkin, PhD
Sande Okelo, MD, PhD
Cheng-Shiun Leu, PhD
Background
     Asthma disproportionately affects low-income and minority children residing in inner cities such as the 
Bronx, NY.1, 2 Use of national guidelines reduces asthma morbidity by 70%3; yet, these guidelines are not 
consistently implemented.4-11 For example, providers’ failure to document symptom severity and control in the 
medical record can lead to inadequate prescription of controller medications.42 Providers also often fail to 
assess patients’ inhaler technique,10 identify in-home exposures,43 and evaluate asthma co-morbidities.44-46 
Asthma education and action plans are not consistently provided.42, 47-49 System-level barriers found in our 
research include limited access to resources (e.g. sample MDI-spacers) necessary to follow the recommended 
care.10 Provider-level barriers include lack of awareness, disagreement with the guideline recommendations, 
lack of self-efficacy for being able to carry out the best practice, low expectation that outcomes will improve, 
and external barriers such as time constraints during a visit.6, 7, 10 Patient factors may affect adherence to 
preventive medications. Many parents have uncertainty about the effectiveness of medications, lack 
understanding about proper use of preventive medicines and administration devices, and have concerns about 
potential side effects.37, 49, 50 Other factors, such as financial barriers and problems with access to care have 
also been reported.51, 52 There are missed opportunities to improve asthma care within the context of the child’s 
medical home, particularly during clinic visits that are not asthma-related.26, 42, 53  A recent AHRQ review of 
interventions to improve provider adherence to national asthma guidelines concluded that systems-level 
interventions that address barriers and all the elements of the asthma care process (i.e., prescription of 
controller medication, environmental control practices, self-management education, documentation of severity 
and control) are needed.9 Although interventions to improve provider adherence to asthma guidelines have 
been described,12-24 few studies address translation of guidelines into routine care.25, 26  
     The proposed translational study builds on our experience evaluating a Multifaceted Prompting Intervention 
(MPI) in 12 urban clinics.27 MPI uses guideline-based prompts at the time of an office visit to support providers’ 
decision-making, increasing the likelihood that they will recommend corrective actions (i.e., preventive 
medication prescription) to improve asthma management. We found that MPI delivered at one visit led to 
improved preventive care and short-term clinical outcomes (defined as number of symptom-free days 
(SFDs)).28  Although effective, this intervention must be modified in several ways to translate into practice. 
     Our earlier study found that one-time prompting did not improve long-term clinical outcomes, so support at 
multiple visits is warranted. Further, MPI was implemented by the research team to a sample of children with 
persistent asthma. Successful translation means that guideline-based care is delivered by providers and staff 
to all children with asthma, rather than just a research sample. The prompt was printed on paper, rather than 
delivered through the electronic health records (EHR), limiting wide-scale adoption. Further, the original study 
did not offer support for caregivers to follow through on providers’ recommendations (e.g., filling prescriptions, 
ongoing self-management, medication adherence). Although providers are directly responsible for making 
healthcare recommendations to patients, delivery of guideline-based care requires all clinic staff to facilitate 
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communication, make changes to clinic work flow, and ensure patients and caregivers are able to follow 
recommended corrective actions. In order to translate MPI to pediatric practices, we will enhance it in several 
ways: (1) use clinic rather than research staff to facilitate assessment for prompts at every visit; (2) ensure 
prompting for guideline-based care for all children ages 2-12 with persistent or uncontrolled asthma, rather 
than just a research sample; (3) routinely deliver prompts to the provider via EHR; (4) offer telephone-based 
care coordination, education and support to children with the highest morbidity via a dedicated Outreach 
Worker (OW) to ensure recommendations are followed; and (5) provide practice-level supports (e.g. clinic 
champions, on-going performance feedback and participatory problem solving) to promote full adoption of  
guidelines. The enhanced MPI program (eMPI) consists of innovative multi-level and team-based strategies to 
enable providers to effectively and efficiently adopt asthma care guidelines. 
     We will conduct a cluster randomized trial comparing eMPI to enhanced usual care (eUC) in 22 Bronx 
practices serving over 5,000 children ages 2-12 years with persistent or uncontrolled asthma. Eleven eUC 
practices will receive guideline information and assess children’s asthma severity and control, but active 
intervention components will not be provided. Practices will join the study in 4 waves over 4 years (4-6 
practices per year). Including attendings and residents we anticipate enrolling an estimated 200 providers into 
the study.  
Study Objectives
This study has the following objectives: 
1. To test the impact of eMPI on provider adoption of asthma management guidelines. The primary 
outcome is a clinic-level variable measured by the proportion of visits with >1 guideline-based corrective 
actions, as indicated in the EHR (i.e., controller medication prescription or adjustment, trigger evaluation). In 
this analysis we will include all patients ages 2-12 years with persistent or uncontrolled asthma (~5,000). 
Hypothesis 1 (primary): eMPI will improve provider adoption of asthma guidelines compared to eUC.
2. To determine whether consistent use of eMPI leads to both short- and long-term improvements in 
clinical outcomes. Our main clinical outcome is improvement in SFDs. Since these data are not in the EHR, 
we will randomly sample 512 children’s caregivers from eMPI and eUC practices. Caregivers will be 
interviewed every 3 months to examine short- (at 3 months) and long-term (at 6-12 months) change in SFDs. 
Hypothesis 2a (secondary): Short- and long-term improvements in SFDs will be greater in eMPI over eUC.  
Hypothesis 2b (secondary): We also will assess if these improvements are mediated by corrective actions 
taken at the visit. 
3. To evaluate the process of program implementation. We will apply the RE-AIM framework to address 
the intervention’s Reach (the provider-level proportion of visits with corrective actions), Effectiveness (provider 
corrective actions and SFDs), Adoption (the pace and level of uptake of guidelines), Implementation 
(improvements in reach and effectiveness over successive waves), and Maintenance (sustainable use of 
guidelines). We will evaluate group differences in the extent of healthcare utilization and resources used (i.e., 
adherence to clinic follow-up visits, specialty referrals, emergency and in-patient care, OW referrals). 
Study Overview
A. Study Design
Design Overview: We will conduct a 2-group cluster randomized trial comparing eMPI to enhanced usual care 
(eUC) in 22 Bronx practices serving over 10,000 children with asthma. The randomization will be at the 
practice level to avoid contamination. Each practice will be matched into 11 similar pairs based on size and 
type and then randomly assigned to either eMPI or eUC. 
Provider adoption of guidelines and utilization of care in all patients (~5,000) ages 2-12 years with 
persistent or uncontrolled asthma from eMPI and eUC practices will be evaluated using EHR data and 
practice-based screening for asthma severity and control. We will also enroll a random subset of 512 
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caregivers of children with persistent/uncontrolled asthma from both study arms to systematically evaluate 
caregiver-reported child morbidity outcomes and obtain measures not available in EHR. These children will be 
enrolled at the time of the office visit and followed prospectively for 4 time points - 3, 6, 9, and 12 months after 
the initial visit - to assess clinical and process-focused outcomes.
B. Subjects and Setting
Outpatient practices (n=22) that are part 
of Montefiore Health System will participate in 
the study (see Letter of Support). These 22 
practices are located throughout the Bronx, NY, 
represent different practice types, and have 
participated in several of our prior studies (Table 
3).  Though there were initially 22 proposed 
outpatient practices, two practices were closed, 
two practices (FCC-B and FCC-C) were 
combined as a single site given that they serve 
patients in the same facility, and one practice 
was excluded given no pairing available, 
resulting in a total n=18 participating outpatient 
practices. The number of children with asthma 
across practices (N=10,109) of whom we 
estimate ~ 50% (N=5,000) to have persistent or 
uncontrolled asthma is sufficient to meet our sample size needs. A subset of 512 children will be recuited over 
4 years (~128 participants each year) to obtain clinical outcomes data that are not in the EHR.
Randomization: Prior to participant enrollment, each practice will be matched into 11 pairs based on size of 
the practice and provider type (Table 1). Practices will then be randomly selected within each pair as an eMPI 
or a eUC site. Practices will join in 4 waves over the course of 4 years (4-6 practices/year). Each practice will 
remain in the study for 24 months and receive $500 donation to thank them for participation.
Inclusion Criteria: The criteria listed below will apply to ~5,000 children from eMPI and eUC practices. We will 
obtain a waiver of consent to be able to review EHR data by practice.
(1) Physician-diagnosed asthma (based on EHR).
(2) Persistent or uncontrolled asthma as per clinic assessment. Based on NHLBI guidelines,41 any one of the 
following: in past month, > 2 days/week with asthma symptoms, >2 days/week with rescue medication use, >2 
days/month with nighttime symptoms, or > 2 episodes in the past year that required systemic corticosteroids.
1) Mild persistent or more severe asthma severity, or poor asthma control (see definitions below).  *A different 
assessment of eligibility will be performed depending on whether or not the child has a current prescription 
for preventive asthma medication at baseline and parent reports its use.  This is consistent with the EPR 
recommendations that make a strong distinction between classifying asthma severity (for children not using 
preventive medications) and assessing control (for children using preventive medications).  If a child has 
used a preventive medication in the past, but reports no use of the medication in the prior 3 months, we will 
assess severity.  This 3-month time frame is consistent with the length of “wash-out” time for inhaled 
steroids.152 
a) Children not using a preventive medication at baseline: Mild persistent to severe persistent 
asthma.9,10 Any 1 of the following, during the prior 4 weeks (as defined by parent interview in the waiting 
room and EMR review):
i)
An average of >2 days per week with asthma symptoms
ii)
>2 days per week with rescue medication use
iii) >3 nights per month awakened with nighttime symptoms
iv) Minor limitation of activity
v)
>2 episodes of asthma during the past year that have required systemic corticosteroids
b) Children using a preventive medication at baseline:  Poor asthma control.  Any 1 of the following, 
during the prior 4 weeks (as defined by parent interview in the waiting room):
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i)
An average of >2 days per week with asthma symptoms 
ii)
>2 days per week with rescue medication use
iii) >2 nights per month awakened with nighttime symptoms
iv) Some limitation of activity
v)
>2 episodes of asthma during the past year that have required systemic corticosteroids.
 
(3) Age 2 and 12 years, inclusive. 
Additional inclusion criteria will apply to a subset of 512 of children whose caregivers will be interviewed to 
systematically evaluate experiences with the program and caregiver-reported morbidity outcomes:
(1) Caregiver is able to speak and understand either English or Spanish. Participants unable to read will be 
eligible as all surveys will be administered verbally by research personnel. 
(2) Consent from the primary caregiver, caregiver permission for the child to participate as well as assent from 
the child (>7 years). If there are eligible siblings, they will be enrolled if logistically possible.
Exclusion Criteria:
(1) The child has other significant medical conditions, such as congenital heart disease, cystic fibrosis, or other 
chronic lung disease, that could interfere with the assessment of asthma-related measures.
Additional exclusion criteria will apply to a subset of 512 children/caregivers as described above:
(1) No access to a telephone to conduct follow-up surveys.
(2) Children in foster care or other situations in which consent cannot be obtained from a guardian. 
Based on our previous studies, we anticipate <10% of children will be excluded based on these criteria. 
Screening: In 22 practices, clinic staff (RN/LPN) will ask caregivers of all children 2-12 years of age with 
asthma to complete a screening survey in EPIC Electronic Health Record (EHR) during the triage portion of 
their doctor visit. The screening survey questions follow national guidelines and will identify children with 
persistent or uncontrolled asthma (Appendix A). 
Procedures for enrollment of a subset (n=512): Clinic staff will inform research team on days of recruitment 
to obtain consent and baseline assessment from a subset of children with persistent or uncontrolled asthma 
and their caregivers from whom additional morbidity measures (not present in the EHR) will be collected. 
Enrollment goals for each practice will be based on the number of children with asthma seen at the pracrice. 
Since enrollment will occur over an extended time period, we will block enrollment by site pair to assure an 
equal balance of children in each group for each seasonal time period. Research staff will be present in each 
clinic 2-3 days/week for recruitment, until monthly enrollment goals are met for that practice. We will review the 
practice’s schedule the day before to determine if potentially eligible participants are scheduled for a visit. 
Research staff will call patients with asthma ages 2-12 years and ask families to come to their appointment 
with physician 30-60 minutes earlier to be screened by the nursing staff for asthma severity. If eligible, the 
caregiver/child will be informed about the study, undergo the informed consent process and complete baseline 
survey prior to seeing the physician.  Recruitment goals will be reviewed weekly for each practice and 
adjustments of staffing made as needed. Days for recruitment will vary to ensure that patients of providers who 
are in clinic on certain days of the week are not over- or under-sampled (see Recruitment Protocol, Appendix 
A). Following informed consent/assent, research staff will conduct a 10-minute survey with the primary 
caregiver in the waiting room to obtain baseline measures of enrolled participants. All survey instruments will 
be available in English/Spanish and questions will be read aloud. Caregivers will be offered a private location 
within the waiting room to complete the survey. The baseline measures include standard demographic and 
health history variables, healthcare utilization, quality of life, beliefs about medication and adherence (Appendix 
A). 
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eMPI Intervention: The eMPI components are 
described in Table 4 and closely mirror implementation 
strategies recommended by the panel of experts in 
implementation science for development of a tailored 
multilevel strategy for implementation.54 First, at every 
office visit, caregivers of children ages 2-12 years with 
persistent or uncontrolled asthma will be asked to 
complete a screening survey in EPIC Electronic Health 
Record (EHR) during the triage portion of their doctor 
visit (Appendix A). Clinic staff will review the answers 
with the caregiver and read the questions aloud as 
needed. Based on these responses, a prompt for both 
the provider and caregiver will be generated in EPIC 
EHR using a simple algorithm (Appendix B). The 
provider prompt will be delivered to the provider at 
each visit via EHR and include information on child’s 
current level of asthma severity or control, controller 
medication use, exposure to triggers, and specific tailored recommendations for guideline-based preventive 
care (e.g. for persistent asthma without controller medication, the recommendation on the prompt will include 
starting controller medication).41 For children with poor control despite being on controller medications, 
recommendation will include evaluation of inhaler technique and medication adherence, treatment and referral 
for evaluation of co-morbidities (e.g., referral to the Asthma Center for allergy and pulmonology consultations), 
“step-up” of medications, evaluation and counseling on triggers, and outreach worker referral (See below). The 
prompt will also include a recommendation for the provider to establish treatment goals with the patient and 
inquire about any caregiver’s concerns. The prompt for the provider will be seen on the computer screen in 
EPIC EHR at the time of the visit allowing provider to check off the guideline-based recommended items 
discussed during the visit. The caregiver prompt will include immediate feedback on child’s asthma 
severity/control with personally tailored information highlighting caregiver’s goals and concerns. The prompt 
will include simplified recommendations for preventive care issues to discuss with the provider during the visit 
(e.g., to discuss triggers, medication concerns, need for asthma action plan (AAP) and medication 
administration form (MAF) for school). AAP and MAF are embedded into EPIC EHR patient chart and can be 
printed and given to patient to take home or to school. The caregiver prompt is based on the guideline 
recommendation to promote joint discussions about treatment plan and goals and will be printed for caregiver 
to bring to the visit. Outreach worker (OW)-delivered telephone-based care coordination and support will be 
provided by the bilingual (English/Spanish) OWs, lay people from the community who have asthma or a child 
with well-controlled asthma. OWs will become a practice-based resource. OWs will provide telephone-based 
care coordination, education and support to children who are already on controller medication but still have 
uncontrolled asthma and other barriers to guideline-based care (e.g., unable to fill a prescription, loss of 
medical insurance, poor medication adherence, gaps in caregiver knowledge despite provider education). The 
decision to refer family to OW service will be based on provider’s assessment at any office visit. Providers will 
be prompted to make OW referrals for children with uncontrolled asthma as part of the guideline-based care. 
We estimate that 20% of children in each intervention practice will be referred to the OW. Providers will have a 
referral mechanism embedded within EHR to refer patients to the OW with suggestions on which children 
should be referred. OW training: OWs will be trained (4-weeks) by the PI (Reznik) and Co-Is (Rastogi, 
Jariwala) using evidence-based guidelines on asthma self-management skills, proper inhaler technique, 
triggers, medication use, goal setting and problem solving. The PI will oversee OWs with bi-weekly (and more 
often if needed) meetings to discuss cases/concerns and will listen to 20% of the recorded telephone calls to 
ensure the OWs deliver the sessions as intended. OWs role: OWs will help facilitate implementation of the 
guideline-based care prescribed by provider at the office visit. If referred to the OW at the initial visit, the first 
OW telephone call with the child’s caregiver will occur within 2 weeks after the initial visit to determine any care 
coordination needs (e.g., assistance scheduling specialty appointments, inability to fill prescriptions) and then 
monthly, starting at 1-month post-initial visit for 6 months. If referred at the follow-up office visit, the same 
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schedule of OW calls will apply. OWs will use evidence-based educational materials that were previously 
adapted to the needs of our community, and focus on helping parents develop 6 key asthma management 
behaviors as per NHLBI guidelines41 and our prior research using OWs: (1) Asthma control monitoring, (2) 
Identifying and minimizing exposure to triggers, (3) Effectively using controller medications, (4) Using quick-
relief medications, (5) Using an asthma action plan, and (6) Effectively working with the child’s physician and 
schools on optimizing asthma care. The decision to work on specific behaviors will be tailored to caregiver 
needs expressed at the provider visit and based on caregiver’s concerns and goals identified by the caregiver 
prompt. During the telephone calls, OWs will also assist with patient care activities (e.g., scheduling 
appointments, refer to community services for Integrated Pest Management provided by the NYC Department 
of Health, smoking cessation programs (NYS Smokers’ Quitline), free legal services and existing on-line 
resources) and share information with the provider and other members of the clinical team via EHR if any 
concerns about patient or caregiver arise during the telephone encounters (e.g., caregiver does not have 
prescription for medication, child seen in ED or hospitalized). The OWs will use a Microsoft Access database to 
record call frequency, length, and notes taken. These calls will last ~30 minutes. OWs will also send text 
messages, if preferred by the caregivers, to remind about clinic appointments or schedule follow-up telephone 
calls. 
Translational Process within eMPI Clinics: At each intervention clinic, there will be three phases of eMPI 
translation into routine practice: 1) initiation (3 months, intense support provided), 2) consolidation (3 months, 
support available), and 3) sustainability (18 months, 
support as needed). During the initiation phase, the goal 
will be to introduce eMPI to the practice. First, we will 
partner with a clinic champion, a practice physician who 
will also serve on our Practice Advisory Board. The Board will consist of > 2 physicians, 1-2 nurses, 1-2 front 
desk and administrative staff. The Board will meet monthly during the initiation and consolidation phases to 
review the study protocol as it relates to the practices, discuss any provider-reported barriers to implementation 
and identify solutions to address these barriers using a collaborative problem solving approach. These Boards 
will capitalize on already existing and engaged groups created by the Bronx Ongoing Pediatric Screening in 
the Medical Home (BOPS) program described in the Preliminary Studies section. To initiate the planning 
process, we will ask Board members to complete the RE-AIM planning tool96 to highlight any concerns or 
barriers to implementation. We will engage providers in a practice improvement process by having the clinic 
champion discuss feedback received from individual providers and solutions at the regular clinic meetings. We 
will provide the champion with a tool, updated monthly, to record identified barriers to guideline implementation 
and ways to address them. We will also collect baseline information on provider corrective actions in EHR; 
assess provider self-efficacy, provider-caregiver communication, and provider competencies in guideline-
based care using a validated survey (Appendix A). During month 1 of the initiation phase, we will provide 
practice-level support (e.g., pocket cards with guidelines, brief interactive seminars, local asthma resources; 
Appendix C) to the practices to assist providers in implementing the asthma management outlined in the 
NHLBI guidelines41 and to help remove practice and provider-level barriers to guideline implementation.7, 10 
The interactive seminars, developed using principles of physician behavior change97 and led by the PI (Reznik) 
and co-Is (Rastogi, pulmonologist and Jariwala, allergist), will generate enthusiasm around prompting and 
empower providers to implement desired changes. The seminars will include an overview of guideline-based 
asthma care and orientation to the prompts, resource guides and the feedback charts. At the end of the 
seminar, a brief needs assessment survey will be done, and additional resources will be provided based on the 
needs of the individual practices. Providers will receive continuing education credit for their participation. These 
sessions will be coordinated by each practice’s champion. We will also provide practice-level feedback. eMPI 
practices will receive monthly feedback during the initiation phase on the proportion of visits with appropriate 
guideline-based preventive actions, and the proportion of patients meeting goals of therapy (limited symptoms, 
no ED visits/hospitalizations). The feedback will be delivered to the champion who will then share it with the 
rest of the providers. The information will be presented graphically with other intervention practices displayed 
by a code for comparison. A Quality Control Tool will be used to measure and assess nurse adoption of the 
asthma severity/control screening. Research staff will observe nursing staff at least once during the 
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implementation period as they conduct the severity/control asthma screening, make note of their screening 
practices and provide feedback to the nursing staff and the clinic champion. During the consolidation phase, 
we will continue to work with site champions and practices to ensure eMPI is implemented as intended and 
provide support on addressing barriers or concerns. Major activities during this time will include on-going 
monitoring of all aspects of eMPI, feedback to sites about their performance, identification of barriers and 
needed resources, and Board meetings to address these impediments. Given the COVID-19 pandemic, as of 
March 2020, Board meetings have been restricted to telephonic or video conference call only. We will finalize a 
sustainability plan with each practice to ensure on-going use of guidelines. During sustainability phase, we will 
observe practices’ continued use of guideline-based care. During this time, we will not provide regular 
consultations or support, but will be available to address questions and concerns that arise. This will allow us 
to monitor how much outside help sites require to sustain eMPI. We will provide feedback at the practices’ 
request. We expect that eMPI practices undergoing our translational program will increase guideline-based 
care during a 3-month initiation period and subsequent 3-month consolidation period, and will maintain these 
gains over an 18-month sustainability period. 
Enhanced Usual Care (eUC) Practices will receive a review packet of the NAEPP guidelines41 and 
educational resources for families. Children will be assessed for asthma severity and level of control at each 
visit as best-practice care, but active intervention components will not be provided. 
Outcomes Assessment. Follow-up assessments for 512 participants will be conducted by interviewers 
blinded to the treatment allocation at 3, 6, 9, and 12 months. Outcome measures will be assessed by 
telephone interview, and EHR data will be reviewed for all patients with asthma in both study arms. Given the 
minimal risk of survey questions and the importance of having full datasets for study analyses, in the case that 
study personnel are unable to reach the caregiver who signed consent at enrollment (after multiple phone 
attempts, letters, home visits, and scheduled appointment outreach), we will proceed to obtain verbal consent 
and survey data from another caregiver who is aware of the enrolled child's history with asthma. These 
caregivers include the other parent, guardian, grandparent, aunt, or uncle. Name and contact information of the 
alternate caregiver will have been provided at enrollment by the caregiver who initially signed consent.
Measures: The following measures are organized by clinic-, provider- and patient-level variables.
Clinic-Level Variables
The primary outcome is a clinic-level variable measured by the proportion of visits with >1 guideline-based 
corrective actions. To calculate this proportion, the denominator will include only the visits by patients aged 2-
12 years with persistent or uncontrolled asthma at the time of visit. We will obtain these data from the EHR at 
baseline, monthly during the initiation phase (to provide feedback to eMPI practices) and every 3 months 
thereafter for 24 months. Corrective actions include: (1) prescription of a new preventive asthma medication; 
(2) increase in dose of a preventive medication (for children already on preventive medication); (3) evaluation 
and counseling regarding triggers; (4) treatment of co-morbid conditions (e.g., sinusitis, allergic rhinitis, 
obesity); (5) referral to an allergy or pulmonary specialist. We will consider children receiving any of these 
guideline-based preventive care measures during the visit as having a corrective action (as not all actions may 
be necessary for each patient), and also will consider each component of preventive care separately. We 
collected prospective data on most items included in the corrective action definition in our prior work.28, 98 
Additional corrective actions include recommendations for a follow-up visit specifically to discuss asthma, 
referrals made to OW, and provision of an asthma action plan or school medication administration form. 
Covariate: Practice characteristics will include practice size (small, medium, large), practice type (hospital-
based practice, Federally Qualified Health Center, neighborhood health center), and patient mix (pediatrics, 
adult/pediatrics), involvement of support staff in the delivery of preventive asthma care, practice-level changes 
(e.g., new asthma-related initiatives in the practice). We will obtain this information from the existing database 
of practices and from interviews with the physician champion and office administrator at each practice.
Provider-Level Variables
Potential Mediators: 1) Provider Competencies: We will assess a) provider’s asthma practices (frequency of 
assessing patient symptom severity, treatment adherence, and use of guideline-consistent care),99, 100 and b) 
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frequency of use of communication and education strategies contained in the Physician Asthma Care 
Education (PACE) physician survey.101 2) Provider/Caregiver Communication: We will ask providers in all 
practices to complete a brief survey at the beginning (during initiation) and end of the study (during 
sustainability phase). The survey is adapted from the PACE102 assessment and includes questions about 
asthma care practices and communication with families. The providers will also be asked if they have been 
involved in other quality improvement or educational efforts on asthma care. Survey link will be sent to 
providers electronically.
Covariate: We will collect data on provider type (MD, PNP, PA), the level of training (resident or attending), 
specialty (family medicine or pediatrics), and if the visit’s provider was the child’s primary care provider. We will 
obtain this information from the chart review, caregiver interview for a subset of patients and provider survey. 
Patient-Level Variables
Clinical/Functional Outcomes will be 
collected from caregivers of 512 
children (Table 5).
1. Asthma Symptoms: We will assess 
number of symptom-free days (SFDs) 
(secondary outcome measure) at 
baseline, 3 months to determine short-
term effectiveness of the intervention, 
and at 6, 9, and 12 month follow-up 
evaluations to assess long-term 
intervention effects. This outcome 
measure is consistent with the symptom monitoring recommended by the national guidelines and has been 
suggested as a useful endpoint for pediatric asthma studies.103, 104 Caregivers will be asked to report the 
number of days their child experiences no symptoms of asthma (defined as 24 hours with no coughing, 
wheezing, chest tightness, or shortness of breath) in the past 2 weeks. We will also assess asthma control with 
the Asthma Control Test.105 
2. Healthcare Utilization: Caregivers will report child’s healthcare utilization at baseline and each follow-up. In 
addition, EHR data will be reviewed at each follow-up to assess for office visits (acute and routine), emergency 
department visits and hospitalizations. We will also evaluate healthcare utilization outcomes from the EHR data 
review for all patients with persistent or uncontrolled asthma (~5,000) across practices.
3. Quality of Life: Quality of life will be measured at baseline and each follow-up using Juniper’s Pediatric 
Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ).106 The PACQLQ is a standard instrument used to 
assess the quality of life of caretakers of children with asthma, and provides a quantitative score that reflects 
answers to questions about the burden of caring for a child with asthma.106
4. Functional Severity: Functional limitations of the child will be assessed at baseline and each follow-up 
evaluation using a subscale from the Children’s Health Survey for Asthma.107 The child activity subscale 
includes 5 items on limitations to the child’s activities due to asthma (Cronbach’s alpha .87-.89).
5. Beliefs about Medications and Adherence: We will use the 10-item Horne’s Beliefs about Medications 
Questionnaire (BMQ).108 Five questions assess parent’s views about the necessity (alpha=.80) and five 
measure parental concern about their child’s medications (alpha=.75). The 4-item Adherence Scale108 
measures parent-reported medication adherence using a 5-point Likert scale (alpha=.60-.83).
Covariates: 
1. Demographic Variables will include child’s age, gender, race, ethnicity, medical insurance, and caregiver’s 
education level. We will use standardized questions from the national child health surveys to obtain these data.
2. Medical Variables will include birth history (prematurity), duration of asthma diagnosis and history of 
allergies (e.g., allergic rhinitis, seasonal allergies) or eczema.
3. Caregiver Depression: Caregiver depression has been shown to affect adherence to care plans, 
communication and child’s asthma outcomes.109, 110 We will assess maternal depression using a validated 
Patient Health Questionnaire 9 (PHQ-9).111 
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Potential Mediators:
1. Caregiver/Provider Communication: We will use 5 communication items from the PACE Parent/Caregiver 
Questionnaire102, 112 to assess caregiver’s perception of their communication with the provider. Items are 
scored on a 6-point Likert scale (Don’t know, Strongly Agree-Strongly Disagree).
2. Self-Efficacy: We will assess caregiver self-efficacy in communication with their child’s provider using the 
validated Perceived Efficacy in Patient-Physician Interaction questionnaire (PEPPI).113-115
RE-AIM Measures: We will use RE-AIM framework93 to evaluate the translational process: (1) the provider-
level proportion of visits with corrective actions (Reach); (2) the impact of the intervention on provider delivery 
of guideline-based care (corrective actions taken at the visit) and SFDs (Effectiveness); (3) the pace and level 
of uptake of guidelines and changes in service utilization (Adoption); (4) improvements in reach and 
effectiveness over successive waves (Implementation); and (5) continued use of guidelines and sustainability 
of strategies by practices in order to facilitate dissemination to other clinical settings (Maintenance). We will be 
completing post-study qualitative interviews with approximately 125 clinic stakeholders (e.g. advisory board 
members, physicians, medical directors, nurses, and administrative personnel) from both eMPI and eUC 
practices to further evaluate the process of program implementation. Individual interviews will be completed 
through Zoom audio conference call, where clinic stakeholders will answer questions related to their clinic’s 
culture, asthma management workflows, and barriers and facilitators to program implementation. The 
interviews will be audio-recorded and transcribed verbatim for further qualitative analyses. 
Analysis of qualitative data: Transcribed interviews will be imported into the NVivo qualitative data software 
to assist with data organization. Qualitative data will be analyzed according to the concepts of grounded 
theory. Codebooks will be developed in an iterative fashion. Coders will independently code the first 3 
transcripts, meet to compare codes, and then alter or add codes as necessary. After this, a codebook will be 
created to include definitions, rules, and examples for each code. The coders will then code all subsequent 
transcripts and revise the codebook as necessary to incorporate new codes or refine existing codes. The 
constant comparison method will be used to determine if there are any patterns or themes by 
provider/stakeholder characteristics.
Summary of Analytic Plan:
We will use graphical and numerical summaries to describe the outcomes at each assessment point. If 
distributional assumptions for particular statistical procedures are violated, appropriate transformations will be 
made or non-parametric tests will be used. All primary and secondary analyses will follow the intent-to-treat 
principle; all participants will be analyzed in the group to which their clinic was assigned irrespective of their 
post-randomization behavior, and all participants will be analyzed using multiple imputation techniques. 
Hypothesis-driven comparisons will be made with control of the type I error rate at 0.05 (two-sided).  
Preliminary Analysis. We will examine data for out of range values. Descriptive statistics will be generated 
regarding practice characteristics such as size (small, medium, large), practice type (hospital-based practice, 
Federally Qualified Health Center, neighborhood health center), and patient mix (pediatrics, adult/pediatrics) to 
help to understand the sample as well as the generalizability of study findings. We will determine whether there 
are differences at baseline between the eMPI and eUC providers and patients in demographics and 
background characteristics. This will include analogs of t-tests (or Wilcoxon rank sum tests) for continuous 
variables and chi-square (or Fisher's Exact) tests for categorical variables adjusted by generalized estimating 
equation (GEE) methods for the clustering induced by providers within clinics.
Aim 1. To test the impact of eMPI on provider adoption of asthma management guidelines. 
The primary outcome is a clinic-level variable measured by the ratio of number of visits with >1 guideline-
based corrective actions to the number of visits by patients aged 2-12 years with persistent or uncontrolled 
asthma at the time of visit. The primary null hypothesis is that there is no difference between eMPI and eUC 
clinics in the mean proportion of visits where the necessary corrective actions were taken. To test this null 
hypothesis, we will use a matched-pairs randomization (or permutation test) at the 0.05 two-tailed level of 
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significance. The permutation test will account for the fact that clinics (rather than providers) are randomized 
and that the randomization will be performed within clinic pairs. Each pair of clinics will produce a matched 
difference in the proportions of corrective actions, and under H0 the randomization can be viewed as attaching 
a random plus or minus sign. Thus there will be 211 = 2,048 possible signed permutations, allowing a two-tailed 
p-value as significant as 2/2,048 < 0.001 (if all 11 pairs show a greater proportion of corrective actions taken by 
the eMPI practices).  Assuming no important practice characteristics are significantly out of balance (at two-
tailed p<0.01), the permutation test will comprise the primary analysis. If any important clinic characteristics are 
significantly imbalanced at p<0.01, we will adjust for such variables in a linear regression model and report the 
adjusted intervention coefficient as the primary result. We will also examine for a clinic-size (or provider-type) 
by intervention interaction. If not significant at the 5% level, the above approach will be used to provide the 
primary results. If significant, we will attempt to identify factors that affect the primary outcomes and might differ 
between clinics (or provider types). If including such factors removes the interaction, we will quote the adjusted 
intervention effect from the model including such factors. If not, we will quote two intervention effects (for large 
and small clinics) leaving the interaction unresolved.
Power Analysis. We conservatively estimate that the mean difference between eMPI and eUC clinics in the 
proportion of visits where the necessary corrective actions were taken will be at least 25 percentage points. To 
express this as a standardized effect size, we assume the standard deviation of the paired differences in the 
proportion of corrective actions will be no more than 0.2, based on several mock data sets generated by the 
investigators reflecting their clinical experience and best estimates. We present one generated data set in 
Table 6 for illustration. This hypothetical data set has an average matched difference in proportions of 0.246 
(about 25 percentage points) with standard deviation 0.142 (14.2 percentage points).  Our assumption of a 
standard deviation of 0.2 or 20 percentage points is thus about 50% larger than in this illustrative example. 
Table 6. A Mock Data Set
Clinic Pair
1
2
3
4
5
6
7
8
9
10
11
Proportion Difference 
.25
.10
.20
.50
.00
.25
.30
.40
.10
.30
.30
The standardized effect size is therefore 0.25/0.20 = 1.25.  Approximating the power of the permutation test by 
that of a paired t-test with 10 degrees of freedom, a sample size of 11 clinics per arm will yield a non-centrality 
parameter of 1.25√11 = 4.15, providing more than 95% power to detect a standardized effect size of 1.25 or 
more. The detectable effect size at 80% power is a mean difference 17.8 percentage points between eMPI and 
eUC practices. Even if the true standard deviation of the matched differences in proportions were as large as 
0.281, we would still have 80% power to detect a 25 percentage point mean difference.
Aim 2. To determine whether consistent use of eMPI leads to both short- and long-term improvements 
in clinical outcomes. In this Aim, we will compare the change from baseline to each of the follow up (FU) time 
points (i.e., 3, 6, 9, and 12 months) in number of SFDs between eMPI and eUC patients using intent-to-treat 
principles. We will employ the generalized linear model (GLM) with identity link function for this comparison. 
The analysis model is of the form EYij=α+βIi+∑γjTij+∑δjIiTij, where for subject i Yij is the number of SFDs for at 
time j, Ii denotes group indicator for eMPI group (vs. eUC), and Tij is the indicator for time at FUj evaluation (vs. 
baseline). The regression coefficient δj corresponding to the group-by-time interaction term estimates the 
difference in average change of SFDs at FUj evaluation vs. baseline, comparing eMPI to eUC groups, and thus 
represents the effect of intervention on the SFDs. We will use generalized estimating equations (GEE) 
methodology to account for within-subject correlation due to multiple assessments for the same subject as well 
as the within-provider and within-practice correlations due to cluster sampling. We will also determine whether 
or not the corrective actions taken mediates the effect of intervention on outcomes; we will use the test of joint 
significance of the 2 paths involving a potential mediator, which best balance Type I error and statistical 
power.116 A variable M will be declared a mediator only if both the test of the regression coefficient of the 
explanatory factor X on the mediator and the test of the coefficient of the mediator on the outcome variable Y 
controlling for X are significant at level alpha = 0.05, 2-tailed.  This approach allows for partial mediation which 
we fully expect to occur. In subsequent analyses we will estimate the indirect path effect with 95% confidence 
intervals using the asymmetric distribution of products method.116 Further exploration of causal mediation will 
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follow the methods of Imai et al.117, 118 We will also examine whether the effect of intervention on SFDs is 
mediated by provider competencies, provider/caregiver communication or caregiver self-efficacy.
Missing data: Every effort to retain participants in the study will be exerted in order to avoid bias due to attrition. 
For those individuals who refuse continued participation, we will document reasons for study discontinuation 
and Rubin’s multiple imputation method119 with 5 repeated imputations will be employed to impute the missing 
endpoint for conducting the intent-to-treat analysis. 
Power Analysis. With a recruitment of 512 participants at baseline, we anticipate a final sample of 460 
participants with complete data for the primary analysis assuming no more than 10% attrition at 12 month 
evaluation. This estimate of attrition rate is conservative based on our prior experience. To account for the 
intra-cluster correlation due to cluster sampling, we estimate that an intra-provider correlation coefficient is no 
greater than 0.03 from our prior studies. Although the intra-practice correlation coefficient should be smaller 
than intra-provider correlation coefficient, we conservatively used the same value (i.e., 0.03). Under the above 
assumption, with 230 participants per group, we will be able to provide 80% power to detect a standardized 
effect size of >0.29 in change of number of SFDs. Even if actual attrition is greater than we expect (e.g.,15%), 
the detectable standardized effect size will only increase slightly to 0.30. Further, as we will impute missing 
data using informative covariates for the primary analyses, the power to detect such effects will be >80%. 
Aim 3. To evaluate the process of program implementation: In order to evaluate the potential for 
dissemination of this primary care intervention, we will report specific summary measures recommended by the 
RE-AIM93 framework. We will compare the provider-level proportion of visits with corrective actions taken by 
the eMPI providers to that of eUC providers using the same analytic approach stated in Aim 2 (Reach). We will 
evaluate the impact of eMPI on guideline-based corrective actions and symptoms (Effectiveness). We will 
qualitatively describe problem solving progress that occurs in each practice as part of process of improvement, 
by coding the specific barriers that arise during implementation and are collected by clinic champions, and the 
solutions that eMPI practices identify (Adoption). We will report consistency with which participants in the 
intervention arm receive the protocol through EHR data, practice observations of the process of 
implementation and data collected from OW contacts with participants. Additional measures of implementation 
of eMPI include 1) caregivers’ completion of severity/control assessments at the visit; 2) provider and caregiver 
receipt of prompts; 3) providers’ documentation of asthma discussion (Implementation). We will use provider 
survey responses to evaluate the extent to which each intervention component was continued or modified 
post-study and sustained effects on the primary outcome (Maintenance). Using EHR records of 5,000 children 
across all four waves of translation, we will determine if eMPI practices will (a) reach successively higher levels 
of guideline-based care, (b) achieve that level more quickly, and (c) sustain use of guidelines for 18 months. 
The analytic approach to address this will involve a statistical model with the main effect of intervention 
condition, time (which represents the level of Implementation), and the indicators of waves (which will allow us 
to evaluate sustainability), plus all the two-way and three-way interactions. We expect to see specific three-way 
interaction effects involving trends in rates of guideline-based care over 24 months, with an ever steeper linear 
increases and less pronounced downturns seen from wave to wave, in eMPI practices vs. eUC. Guideline-
based care is intended to ensure that children receive needed services in a more timely fashion. We will 
examine patterns of utilization by children in both groups using the EHR, including adherence to clinic visits, 
specialty referrals, emergency and in-patient care, and OW referrals.
1.
Compensation
Caregivers will receive $20 at baseline, 3, 6, and 9 months follow-up, and $30 at 12 months follow-up. 
In cases where caregivers are unreachable after multiple call attempts, we will offer an additional $10 gift card 
incentive in an effort to obtain accurate contact information and complete pending follow up surveys. If 
caregivers are still unreachable after these efforts, we will attempt to meet at the caregiver’s home or in the 
community to complete the respective survey, obtain accurate contact information, and provide their 
compensation. Given the COVID-19 pandemic, as of March 2020, home visit and appointment outreach efforts 
have been restricted, focusing only on telephonic outreach to complete follow up surveys. In addition, each of 
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the 22 practices will be given a donation of $500.00 to thank them for their participation. This participation will 
include providing space for research assistants to speak with families. Practice staff will also assist research 
staff with printing schedules and identifying families for enrollment. Providers will also be asked to complete 
three brief surveys: baseline, 1, and 2 year follow-ups. 
There is no cost to those who participate in this study. The participants and their insurance company will be 
responsible for the cost of all standard of care office visits and medications. This intervention is meant only to 
help assure that appropriate medications are prescribed and national asthma guidelines are followed. 
2.
Safety or Risk
The study proposed should pose minimal risk to the participants, with the primary concern for loss of 
confidentiality.  To minimize this risk, all records will be kept strictly confidential as required by the policies and 
procedures of the Montefiore Medical Center where data are collected, processed, or reported.  Any significant 
concerns will be relayed promptly to the study coordinator, the principal investigator, the NHLBI, and the 
Institutional Review Board. During follow-up, all children with persistent symptoms or poor control will be 
referred to their primary care provider for care. The primary care provider or the family can discontinue the 
child’s participation at any time during the study.
3.
Data Storage and Confidentiality 
Recruitment, Informed Consent, and Confidentiality:  Human subjects’ rights will be protected as explained in 
the consent form used for the study. The Institutional Review Board (IRB) will review all protocol and informed 
consent documents and research will be carried out only after proper approval from the IRB. Written consent 
will be obtained prior to the initiation of any research evaluations from the subset of 512 participants.  Informed 
consent will be obtained from all potential subjects by a researcher trained and certified in human subjects 
protection.  The informed consent process will detail the potential benefits of participating in the research as 
well as the potential risks of the intervention.  Assent also will be obtained from children in the program who 
are 7 years of age and older.  Subjects will be informed that they may choose not to answer any of the 
questions on the surveys and that they may withdraw from the study at any time without negative 
consequences.  Strict confidentiality will be maintained throughout the study.  The data will be stored in 
password protected computers and locked file cabinets in a study office, and only the researchers or their 
associates will have access to these data.  
We will obtain a waiver of consent to be able to review de-identified EHR data by practice to identify the 
proportion of visits with > 1 guideline-based corrective actions (clinic-level variable). These data will be 
obtained on a clinic-level without identifying specific patients. 
To obtain a waiver of consent, the following criteria will be met (45 CFR 46.116(d):
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Protection against Risk:  
During recruitment, parents will be offered private areas in the waiting room to conduct informed consent and 
baseline assessments.  For confidentiality protection, the identity and personal information of each subject will 
be used only for purposes of this study and will only be accessed by appropriate study personnel.  For specific 
analyses, files consisting of pertinent data from the individual records will be formed from the base data file.  All 
data will be held confidentially and stored in locked files, accessible to authorized staff and investigators only. 
Any parent indicating high risk for depression during a follow-up interview will be referred to their primary care 
provider or mental health provider present in each clinic, and will be sent a summary of community resources 
available for care.  Additionally, parents will be informed of emergency resources at the time of the telephone 
interview, including lifeline, social work supports, and 911.  This mechanism is being used in our current 
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school-based study, is approved by our institutional review board, and has been well received by parents.
Additional Measures to Protect the Data:
We will take additional measures to minimize the risk of breaching the confidentiality of data. These include but 
are not limited to the following: 

Electronic firewalls 

Audit trails

Disaster prevention and recovery plans

Systems certification

All research personnel take yearly HIPAA training
Identity of participants will not be revealed in the presentation or publication of any results from the project. All 
personnel working on the project will be regularly educated about the importance of strictly respecting 
participants’ rights to confidentiality.
Data and Safety Monitoring Plan
Data Quality Monitoring
Baseline data forms will be completed electronically by research staff on Tablet PCs in the waiting room.  All 
survey data collected on the Tablet PCs are entered using data entry forms created by Adobe Creative Suite 3 
software, which allows for integration with secure data entry forms to an off-site server. Asthma severity and 
control assessment and data necessary for generation of the prompts will be entered into each patient’s EPIC 
Electronic Health Record (EHR).   For the safety of private subject information, no data will be stored on the 
Tablet PCs.  For the 4 follow-up telephone interviews, data will be collected using RedCap database.  Pre-
intervention training of study staff will be conducted to increase knowledge about asthma, asthma medications, 
and other important information in order to reduce the number of “real-time” data collection errors.  Through 
this training, staff will note any inconsistencies in parent reported data and will discuss them with the parent at 
the time of the interview.
A separate team of researchers will perform all follow-up interviews and follow-up data management.  This 
group will work independently from the “enrollment team” and thus will be able to perform blinded assessments 
of outcomes.  Randomization information will not be included with any follow-up materials in order to assure 
blinding of outcome assessment.
Once data have been collected, simple range checks as well as cross-form validation checks will be performed 
to ensure the accuracy and completeness of the data.  A list of all data checks performed will be maintained 
and any errors detected by this method will be noted.  In addition, data forms, valid informed consent 
documents for each enrolled patient, and supporting source documentation materials will be reviewed by the 
data analysts for accuracy.  Required regulatory documents (IRB approval, updates to the protocol, data 
monitoring documents) will be maintained by the study coordinator.  All events during the course of the trial 
including study enrollments, adverse events and study terminations will be reported to the study coordinator 
(see safety section below).  
Safety Monitoring Plan
Potential risks related to participation in this study are minimal since surveys are administered and information 
is relayed to caregivers and providers during the time that children will be receiving care at their primary care 
office.  No medications or investigational treatments are given as part of this study.  Any significant adverse 
events will be flagged by the follow-up team and relayed promptly to the study coordinator, the principal 
investigator, the child’s primary care provider, and the Institutional Review Board within 24 hours.  We plan to 
hold monthly research review meetings with the study team to provide monitoring to ensure subject safety as 
well as treatment integrity.  Any child experiencing an exacerbation or persistent symptoms at the time of an 
assessment will be referred to their primary care provider.  All records will be kept strictly confidential as 
required by the policies and procedures of the Albert Einstein College of Medicine /Montefiore Medical Center 
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where data are collected, processed, or reported.  The family can discontinue their participation at any time 
during the study.
4.
Potential Benefits
There are potential benefits of this intervention.  Children obtaining care from the eMPI practices may have 
improved care due to the use of prompts and telephone-based care coordination, education and support 
provided by the Outreach Worker to help promote discussion of the child’s asthma, provide recommendations 
for asthma care and promote full adoption of asthma guidelines.  In addition, both groups may benefit by 
having the asthma guidelines reinforced with all practices, and providing resources for physicians.  All families 
will receive multiple phone calls in order to assess the child’s symptoms.  It is possible that an increased 
awareness of symptoms and enhanced communication with the primary care provider will occur, and will result 
in reduced morbidity for these children.  
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