Improving Rhode Island's Tuberculosis Preventive Services in Primary Care: A Mixed-Methods Evaluation of an Innovative Telementoring Model
Phase: NA
Conditions: Latent Tuberculosis
Sponsor: Kent Hospital, Rhode Island

 
 
 
 
PROTOCOL  
 
 
1.) TITLE OF PROJECT: Improving Rhode Island’s tuberculosis preventive services in 
primary care: A mixed-methods evaluation of an innovative telementoring model 
Principal Investigator (PI):  Daria Szkwarko, D.O., M.P.H.  
 
 
 
 
 
 
 
 
 
 
 
 
Other Investigator(s):    
E. Jane Carter, M.D., Roberta Goldman, PhD, Dr. Charles Eaton, 
M.D., Steven Kim 
 
 
 
 
 
NCT 04188041 
Last Update: 2/10/21 
  
                            
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
2.) Description of Study 
A. Specific Aims   
This pilot study will use a mixed-methods design called an exploratory sequential translational 
research design. In this type of study design, the initial qualitative phase informs the design of an 
intervention (in this case a TB infection ECHO) and an instrument (in this case structured 
surveys) to study an intervention. The final phase implements the designed intervention and/or 
instrument to collect data and quantitatively assess the outcomes of interest (in this case 
feasibility and impact).   
Specific Aim 1: Explore the specific knowledge, attitudinal, and skills gaps to TB infection 
testing and treatment among primary care providers in RI through qualitative key informant 
interviews. 
In Aim 1, at least 40 primary care team members from our Brown Family Medicine and Care 
New England networks will be purposively sampled to undergo key informant interviews 
regarding TB infection testing and treatment knowledge, attitudinal, and skill gaps. Questions 
will be asked to ascertain gaps throughout the entire latent TB infection care cascade. The results 
from Aim 1 will be used to design the survey instrument and the curriculum for an innovative, 
telementoring program (TB infection ECHO).  
Specific Aim 2: Design and evaluate an evidence-based telementoring intervention (ECHO 
model) that addresses the identified TB infection gaps in Aim 1, and evaluate this model for 
feasibility as well as its impact on primary care team member knowledge and TB infection 
testing and treatment in RI. 
In Aim 2, at least 50 primary care team members will be recruited to participate in a virtual six-
month TB infection ECHO course. Participants will complete quantitative surveys before and 
after the course as well as post-session surveys following each session. Survey questions will 
assess feasibility measures related to process, resources, and management and impact measures 
related to learning and performance. Paired data from pre- and post-course surveys will be 
analyzed accordingly depending on the distribution of results. The nature of this pilot project 
provides budgetary limits for an effective sample size. Therefore, for analyzed question 
responses that do not demonstrate a significant change between pre- and post- we will carefully 
note any relevant trends. In addition to the quantitative survey results, we will conduct 
approximately 15 qualitative interviews with ECHO participants. Given that practice change is 
difficult to assess quantitatively, questions will be asked regarding the impact of the ECHO 
course on practice change and about improvements that can be made to future LTBI ECHO 
courses.  
 
Specific Aim 3: Pilot a retrospective electronic medical record (EMR) data review to examine RI 
PCPs’ testing and treatment before and after ECHO implementation and evaluate the model’s 
reach. 
In Aim 3, data will be retrospectively extracted from two participants’ clinics to research RI 
PCPs’ testing and treatment patterns before and after the ECHO course. Aim 3 will evaluate the 
model’s reach, or the degree to which the population that is eligible to benefit from an 
intervention actually benefits. In the case of LTBI, there is one lab test type (interferon gamma 
release assay) and two medications (rifampin and isoniazid) used. They are used sparingly for 
other ailments in primary care. Therefore, LTBI lab tests and prescriptions could be an excellent 
proxy measure of providers’ behavior change related to LTBI testing and treatment, and 
ultimately the reach of the ECHO model. 

 
 
 
 
 
B. Background  
Tuberculosis (TB) remains a significant cause of mortality globally.1 In the United States (US), 
80% of TB disease is a result of untreated, latent TB infection. This persists despite available 
treatment that can significantly decrease the rate of progression from TB infection to disease.2 
Currently, up to 13 million individuals have latent TB infection in the US, and approximately 
10% of these individuals will progress to infectious TB disease.3 In 2016, the United States 
Preventive Services Task Force (USPSTF) updated their latent TB infection recommendation to 
a Grade B based on strong evidence supporting TB infection testing and treatment as a 
preventive measure, signifying its importance.4  
Accordingly, the USPSTF recommendation encourages primary care providers (PCPs) to add TB 
testing to their routine preventive screening and initiate treatment in the primary care setting – 
tasks that were previously reserved for specialists. Unfortunately, primary care training 
incorporates only minimal training regarding TB, and therefore, PCPs in the US are not prepared 
to incorporate testing and treatment for this critically under-addressed infection. Due to this 
significant gap in training, PCPs continue to refer patients to specialists for treatment. These 
unnecessary referrals are likely to complicate care for patients, resulting in barriers to initiation 
and completion of TB infection therapy and, ultimately, increased healthcare costs.  
This proposed project has significant public health implications. To achieve TB elimination in 
our lifetime, there is a critical need to implement innovative continuing medical education 
models to expand primary care provider knowledge and capacity regarding TB infection. The 
Extension for Community Healthcare Outcomes (ECHO) ModelTM is an effective, evidence-
based telementoring intervention designed to address knowledge gaps in primary care in a 
manner that fosters convenient and high-level PCP participant to expand patient access to 
previously specialist-only care.5-10 The ECHO model incorporates didactics, mentoring, and case 
review and virtually connects topic experts with primary care teams at the frontline of 
community care. It has demonstrated improvement in healthcare provider knowledge, attitudes, 
and skills (KAS) as well as better patient outcomes in several disease areas. There are currently 
three TB ECHOs in the US, however, the model’s impact on PCP knowledge, skills, and 
attitudes regarding TB infection have not yet been studied. 
Telementoring Education Intervention for Latent TB Infection: Participation in one-time CME 
activities is not sufficient to actually develop new understandings, skills, and capabilities.24 The 
Extension for Community Healthcare Outcomes (ECHO) ModelTM is an effective, evidence-
based telementoring intervention that incorporates didactics, mentoring, and case review during a 
virtual teleECHO session. This model was developed in 2003 in rural New Mexico to help PCPs 
manage hepatitis C virus.25 It has been expanded to address other complex chronic diseases such 
as pain management, osteoporosis, cervical cancer, and substance abuse disorders in underserved 
areas.7-9, 26 For other diseases, this model has demonstrated improvement in healthcare provider 
knowledge, attitudes, and skills as well as improved patient outcomes.10 There are three TB-
related ECHO programs in the country – New Mexico, Washington, and Massachusetts. These 
three TB ECHOs have been strictly focused on care and have not incorporated formal 
methodology to explore gaps and rigorously evaluate the model. There is currently no evidence 
for the model’s impact on PCP knowledge related to TB infection testing and treatment 
practices. There are >150 ECHO hubs in 45 states,27 yet Rhode Island has to date not developed 
any ECHO hubs. The RI Department of Health  has expressed great interest in the 
implementation and evaluation of this model as it has potential to improve care beyond LTBI. 

 
 
 
 
This is a unique opportunity to pilot the ECHO model specifically for latent TB infection, and 
lay the foundation to expand this innovative model to address other high priority diseases in 
Rhode Island. 
 
C.  
 Experimental Method 
This proposal will incorporate an exploratory sequential translational research framework. In 
Aim 1, we will recruit at least 40 primary care team members throughout the RI community from 
academic practices, federally qualified health centers, and private practices to participate in 
qualitative key informant interviews to assess KAS gaps. In Aim 2, we will use the results from 
Aim 1 to design a TB infection ECHO educational intervention for primary care team members  
that specifically addresses the KAS gaps. We will also use Aim 1 results to design quantitative 
surveys to assess feasibility and participant  learning and performance. In Aim 3, we will pilot a 
retrospective EMR data extraction and examine RI PCPs’ testing and treatment behavior before 
and after LTBI ECHO implementation. 
To achieve our aims, we propose a cross-disciplinary research collaboration. The PI (Szkwarko), 
a primary care physician and junior investigator in the Brown department of family medicine has 
experience in facilitating a TB infection ECHO in Massachusetts.  She will work closely with 
three mentors with complementary expertise: Dr. Jane Carter, a Brown pulmonologist and world 
renown TB expert with over four years of ECHO experience, will support TB content expertise. 
Dr. Roberta Goldman, a qualitative researcher in the department of family medicine at Brown, 
will provide mentorship on qualitative research methods. Dr. Charles Eaton, MD at the Kent 
Hospital and  Steven Kim, a medical student at the Warren Alpert Medical school, will aid the PI 
in data collection and analysis. We will collaborate with the RI Department of Health to ensure a 
concerted educational effort and avoid any parallel processes. The results of this study will 
formally assess, for the first time, primary care team member KAS gaps regarding TB infection. 
It will also provide quantitative results regarding feasibility and impact and reach of a TB 
infection ECHO. This will lay the foundation for a larger prospective cohort study to further test 
the model for effectiveness as well as provide a framework for expansion and evaluation of the 
ECHO model in RI to other diseases. Additionally, the study will provide the PI with an 
opportunity to further develop skills in mixed-methods translational research and continue her 
desire to study TB prevention strategies to achieve TB elimination globally. 
 
D  Brief Description of Subjects 
For both, the qualitative key informant interviews and the quantitative surveys, the eligibility 
criteria will be the same. Participants must be: 
Primary team members in Rhode Island: This includes MD, DO, nurse practitioners, physician 
assistants, nurses or other team members who work in a primary care setting. We will exclude 
urgent care providers as they do not routinely perform preventive screening such as TB infection 
screening. Individuals must be able to speak English as interviews and ECHO course will be in 
English.  
There will be no age limits for recruited participants. However, given our training inclusion 
criteria, all participants will be over the age of 18 since a higher level of training after high 
school is required for all eligible primary care providers. Therefore, children will not be eligible 
to participate in this study.  
 

 
 
 
 
We will use purposive sampling for the recruitment of both qualitative interview participants and 
ECHO course participants. In our alumni and community provider network at Brown Family 
Medicine and Care New England, there are many female and male primary care team members. 
Given our small sample of at least 40 key informant interviews and at least 50  participants for 
the TB infection ECHO, we do not anticipate any challenges in recruiting an equal number of 
men and women.  
 
Regarding minorities, our primary care network has < 10% minority primary care providers. 
Using purposive sampling, we will make every effort to ensure that our sample includes 10% or 
more minorities to represent the general PCP population in RI. 
  
E  Study Design 
Exploratory Sequential Translational Research Design Overview: Primary care team member 
KAS gaps are suspected barriers that impact all steps of the LTBI care cascade yet they have not 
been formally studied in the literature. This study will utilize a four-phase exploratory sequential 
mixed methods design23, in which we will: 1) Explore these TB infection KAS gaps qualitatively 
(Aim 1), 2) Translate the qualitative findings to inform curriculum design within an innovative, 
evidence-based telementoring model, and inform quantitative surveys that measure key 
implementation outcomes (Aim 2), and 3) Implement a LTBI ECHO intervention for RI primary 
care teams and utilize the survey instrument as well as qualitative interview feedback to assess 
feasibility and impact of the LTBI ECHO intervention (Aim 2), and  4) Pilot a retrospective 
EMR review to assess the reach of the LTBI Echo on patients’ care. 
Qualitative Methods 
In the first phase of this four-phase exploratory sequential translational research study, we will 
use qualitative key informant interviews to explore, for the first time, the potential gaps listed 
above that impact latent TB infection testing and treatment. 
Key Informant Interviews (KIIs): In collaboration with the RI Department of Health, we will 
identify a purposive sample of key informants from our Brown Department of Family Medicine 
and Care New England networks of primary care provider teams practicing outpatient primary 
care and serving immigrant populations. In total, there will be at least 40 KIIs. Interviews will be 
conducted to the point of data saturation such that no new information is obtained, adding more 
KIIs if needed.  
Instrument Development and Interview Structure: With mentorship from Roberta Goldman, 
PhD, a semi-structured question guide for the KIIs will be developed based on the knowledge, 
attitudinal, and skill gaps in Table 1. The semi-structured guide will include open-ended core 
questions that will be supplemented with spontaneous probes and follow-up questions to explore 
the possible barriers impacting all latent TB infection steps.  
 
The ECHO Model 
The ECHO Model uses a virtual hub-and-spoke educational approach to successfully link 
interdisciplinary expertise to generalists to increase their ability to manage complex medical 
cases and ultimately address growing public health problems.10 Unlike “telemedicine” where 
specialists assume care of the patient, the ECHO model allow generalist clinicians to retain 
responsibility for managing patients. Participants from similar settings with similar barriers learn 
from each other through shared case management discussion and decision-making. The ECHO 
model typically consists of a fifteen-minute didactic presentation by a content expert followed by 

 
 
 
 
case-based discussions of one or two de-identified latent TB infection cases presented by 
participants. Cases are prepared and submitted prior to each ECHO session using an ECHO case 
presentation form. Cases are reviewed by ECHO leads (in our case, these will be reviewed by the 
PI and Dr. Jane Carter) to ensure adequate data are included for discussion. As part of the ECHO 
model, descriptive data for each session (date, topic, length, case presentations, participant 
demographic information) are collected through ‘iECHO’ and accessible to hub members at any 
time through a web-based, password protected platform. 
 
A TB infection ECHO educational intervention will be designed that specifically addresses the 
KAS gaps identified in Aim 1 so that the course content is specific to Rhode Island primary care 
team members .  
 
Participant Recruitment: A random and representative sample of at least 40 primary care team 
members will be purposively recruited. Gender, race, and practice setting during recruitment will 
be considered to enhance the diversity of our sample. However, given the two-year time frame, it 
may not be possible to achieve equal demographics for our participant sample. Participants who 
attend at least four out of six latent TB infection ECHO sessions will receive CME credits.  
 
Quantitative Methods  
Aim 2: Survey Design: Quantitative pre- and post- ECHO course surveys and post-session 
surveys will be designed based on qualitative results from Aim 1 (Sample surveys have been 
uploaded in IRBnet and an amendment will be submitted with modified surveys after Aim 1 
results are available). The PI will seek support from Advance-CTR faculty to build and manage 
surveys in REDcap or comparable survey program. These surveys will be used to assess the 
model’s feasibility and impact on primary care team member knowledge and TB infection testing 
and treatment practices in RI. If it appears from Aim 1 results that there are several thematic 
segments in knowledge, attitudes, and skills, we will develop several questions related to each 
thematic segment. The surveys will include single-item binary and likert-type questions 
depending on the measure of interest. For example, questions related to learning as described 
below will be likert-type to improve reliability of our survey. The PI will ask mentors and 
Advance-CTR faculty to preliminarily review the surveys to ensure the questions are clear, 
concise, and not complex. The surveys will be pretested with five primary care volunteers.  
 
To assess feasibility, we will explore process, resources, and management.36 Feasibility data will 
be attained from iECHO, post-session evaluations, and post-ECHO course surveys. Process will 
include participant attendance, participant retention, case submission, and timing of the ECHO 
sessions. Resources will relate to connectivity issues and videoconferencing equipment 
availability at all sites. Management questions will relate to content expert facilitation and ease 
of communication with ECHO coordinator and content experts. 
 
To assess impact on providers, we will use Moore’s Expanded Outcomes Framework for 
Assessing Learners and Evaluating Instructional Activities24 to study participants’ self-reported 
learning and performance. Learning questions will focus on procedural knowledge (the degree to 
which participants state how to do what the activity intended them to know how to do). 
Procedural knowledge questions will focus on participants’ self-reported confidence in latent TB 
infection testing and treatment. Performance questions will focus on the degree to which 

 
 
 
 
participants do what the ECHO activity intended them to be able to do in their practices. 
Performance questions will ask participants to provide approximate estimates for the number of 
patients they have tested and/or treated for latent TB infection. To supplement the quantitative 
survey and assess impact on providers’ practice changes, we will conduct in-depth qualitative 
interviews with approximately 15 ECHO participants. A semi-structured interview guide will be 
created following a similar process as described in Aim 1. 
 
 
Aim 3: Reach of the ECHO: To assess reach on patients, we will perform a retrospective EMR 
data extraction that will examine RI PCPs’ testing and treatment behavior before and after LTBI 
ECHO implementation. Specifically, regarding the interferon gamma assay and rifampin and 
isoniazid prescriptions. Data will be obtained from two clinics that anticipate having participants 
in Rhode Island’s LTBI ECHO course. Blackstone Valley Community Health Center (BVCHC) 
will be one of the sites. Respective IRB approval will be sought once clinics are identified and 
prior to clinics’ data personnel accessing EMR for study purposes. 
 
F  Specific Procedures or Treatments 
Specific Aim 1: In this aim, at least 40 key informant interviews with primary care team 
members in Rhode Island will be performed. The department of Family Medicine has a list of all 
primary care providers who are alumni or are community preceptors. There is also a list of 
primary care providers including other specialties like internal medicine and pediatrics 
throughout Care New England. Using these contact lists, participants will be recruited via email 
initially. Several chief medical officers at federally qualified health centers have given us 
permission to also circulate recruitment emails via health center listserves to recruit their primary 
care team members. For those who do not respond positively or negatively, a phone call to their 
primary care office during business hours will be made. If the participant agrees to be 
interviewed, a convenient time will be arranged to meet with the participant. Interviews will be 
performed in a quiet, private location either at the participant’s office or in the department of 
Family Medicine at 111 Brewster St. Pawtucket RI. We will attempt to reschedule interviews up 
to three times for participants in order to retain them in the interview process. Written consent 
will be obtained at the start of the interview. 
 
Specific Aim 2: In this aim, participants will be recruited to participate in the TB infection 
ECHO course. The same recruitment procedure will be used as in Aim 1 to recruit at least 50 
participants. Participants will be invited to complete the survey via email and will complete 
online consent prior to initiating the survey. Participants who did not complete the quantitative 
surveys, but volunteer to participate in qualitative interviews will undergo consent virtually prior 
to the start of the interview.. This study aims to assess the TB infection ECHO course in a real-
world setting. Therefore, we will not make any additional efforts to retain participants in the 
course outside of routine course email reminders.  
 
Specific Aim 3: In this aim, two health centers or clinics with participants who enrolled in the 
Rhode Island LTBI ECHO will be selected. One of these sites will be Blackstone Valley 
Community Health Center where the staff is conducting a clinical chart review for latent TB 
infection. Dr. Verma, a family medicine physician and public health student, has been added as a 
co-investigator to assist in the analysis of the de-identified patient database. Further information 

 
 
 
 
about the second site will be provided to the IRB. We will pilot the extraction of electronic 
medical record data from these two sites. The PI has significant experience with data queries in 
EPIC at the Family Care Center and has confirmed that prescription data can be queried from 
this system. The Brown Department of Family Medicine has a strong relationship with health 
centers and primary care sites throughout Rhode Island. Further, the Center for Primary Care and 
Prevention has active projects involving data query from EMRS at other clinic sites. 
Potential variables related to testing and treatment will be discussed with the health 
centers or clinic sites, and data extraction will be requested through the site’s data team. 
Data variables to be queried will include provider ECHO enrollment, HIPAA compliant 
patient demographic information, ICD-10 diagnosis code to separate TB disease from TB 
infection, TB infection laboratory testing data, and LTBI prescriptions. At Blackstone Valley 
Community Health Center, the following additional information will be included in the database: 
age, gender, primary language, country of origin, refugee status if available, ICD-10 diagnoses to 
separate TB disease from TB infection, date of IGRA test, type of IGRA test, IGRA test result, 
LTBI evaluation including chest x-ray and documentation of symptom screen, LTBI treatment 
plan including referral and/or LTBI treatment initiation(medications such as rifampin or 
isoniazid), and treatment completion or documentation from specialist of LTBI treatment 
completion.  Data will be retrospectively collected to capture the three months prior to LTBI 
ECHO implementation, six months during the LTBI ECHO, and three months after LTBI ECHO 
implementation. We will work with health center sites to determine the best way to link ECHO 
participants to health center data. This could include health centers including provider names in 
the database if acceptable or providing health centers with names of their ECHO provider 
participants and having them code the database in a way that enables the study team to 
differentiate ECHO participants from other providers and protect anonymity. Dr. Verma in her 
role as co-investigator will oversee the ECHO participant linkage with health center data.  
 
G  Data Analysis  
Qualitative Data Analysis: With direct oversight from Roberta Goldman, PhD, an expert in 
qualitative methods, as well as continued support from the Advance-CTR Clinical Research 
Design, Epidemiology, and Biostatistics Core, the PI will work closely with the research 
assistant to analyze the data using immersion/crystallization and analysis methods.30 KII 
transcripts will be analyzed in an iterative fashion as they become available. This ensures that 
ideas from early transcript analyses can be explored during KIIs, and the guide can be revised to 
effectively capture relevant information. The transcripts will first be read for familiarity with 
content. During this reading, broad themes will be isolated while notes are taken in the process. 
Next, a codebook will be created based on the KAS constructs at each cascade step, and on 
themes that emerged during the KIIs.31 The codebook will be tested, refined, and used for line-
by-line coding of transcripts with the data analysis software, NVivo.32, 33 We will maintain 
flexible coding schemes to accommodate expansion as new codes are established.34 Using the 
resulting code reports, the data will be categorized into meaningful topical and/or thematic 
segments to reach final data interpretation. Findings will be discussed with mentors to reach 
consensus and prevent under or over-interpretation.35 
 
Quantitative Data Analysis: Anonymous data from surveys will be automatically populated into 
an electronic database via REDCap or a comparable survey program. Data will be imported into 
STATA for analysis. Statistical analysis will be conducted with support from Advance-CTR 

 
 
 
 
faculty. For feasibility analysis, descriptive statistics will be performed to determine proportion 
of registered participants attending each session and to determine proportion of participants 
retained at the end of the course. For the remaining feasibility measures, the proportion of 
participants reporting adequate connectivity, adequate equipment, adequate content expertise, 
and adequate communication with ECHO hub will be computed. Guidance will be sought from 
the University of New Mexico Project ECHO team at the time of the latent TB infection ECHO 
intervention to select appropriate feasibility cutoff measures so that the cutoff is consistent with 
national data from other ECHO hubs. 
For the impact analysis, the majority of these questions will be likert-scale type. The 
distributional properties of the pre- and post- responses will be examined. The paired data will be 
analyzed using Wilcoxon-signed rank test or a paired t-test depending on whether or not the 
responses seem to be following a normal distribution. Significance will be considered if p-value 
is < 0.05. 
 
Regarding Aim 3, Blackstone Valley Community Health Center has been selected as one of our 
sites. Currently, BVCHC staff are reviewing patient charts for clinical purposes in order to 
design a latent TB infection clinic. Therefore, a de-identified database with LTBI tests ordered 
and LTBI prescriptions written by PCPs exists. For the purpose of this study and after written 
approval from BVCHC, this de-identified patient database will be provided to the study team as 
per the data sharing agreement. Once we identify another site, data variables from the two EMRs 
will be sorted, matched, and coded synchronously so that all data can be analyzed together. We 
will work with health center sites to determine the best way to link ECHO participants to health 
center data. Descriptive statistics will be performed to determine the number of LTBI tests 
ordered and LTBI treatment prescribed by PCPs in each time period (before, during, after). We 
will study potential denominators including total number of patient visits, number of wellness 
visits, number of patients diagnosed with LTBI, and number of visits with immigrant/refugee 
patients to explore the best potential measures of effectiveness in future studies. Comparison 
between the ECHO participants and non- ECHO participants will also be considered to assess 
initial trends. 
 
H. Material Inducements 
    Knowledge gained. 
 
I.  Training of Research Personnel 
Steven Kim, a medical student, will serve as our research assistant for this study. He will receive 
qualitative training from Dr. Roberta Goldman and Dr. Daria Szkwarko via online lectures and 
recordings as he will attend the ECHO immersion training and will also assist Dr. Szkwarko with 
the qualitative interviews. Our study team will provide him with any necessary research training 
to ensure that he can conduct his duties as the research assistant. Dr. Shelly Verma is a family 
medicine physician and global health fellow at the Department of Family Medicine at Brown 
University. She is currently receiving a Masters in Global Public Health at Brown University 
School of Public Health. We will ensure that her CITI training is up to date and that she receives 
training and mentorship in quantitative data analysis. 
 
3)  Human Subjects 

 
 
 
 
A. Subject Population  
For both the qualitative key informant interviews and the quantitative surveys, the eligibility 
criteria will be the same. Participants must be: 
Primary care team members in Rhode Island: This includes MD, DO, nurse practitioners,  
physician assistants, nurses or other team members who work in a primary care setting. We 
will exclude individuals who work in urgent care as they do not routinely perform preventive 
screening such as TB infection screening. Individuals must be able to speak English as 
interviews and ECHO course will be in English.  
There will be no age limits for recruited participants. However, given our training inclusion 
criteria, all participants will be over the age of 18 since a higher level of training after high 
school is required for all eligible participants. Therefore, children will not be eligible to 
participate in this study.  
We will use purposive sampling for the recruitment of both qualitative interview participants 
and ECHO course participants. In our alumni and community provider network at Brown 
Family Medicine and Care New England, there are many female and male primary care team 
members. Given our small sample of at least 40 informant interviews and 40-50 participants 
for the TB infection ECHO, we do not anticipate any challenges in recruiting an equal number 
of men and women.  
Regarding minorities, our primary care network has < 10% minority primary care providers. 
Using purposive sampling, we will make every effort to ensure that our sample includes 10% 
or more minorities to represent the general PCP population in RI. 
The retrospective chart review will involve data from ECHO participants as well as data 
from other providers who have ordered a TB test or prescribed LTBI medication at the two 
health care centers or clinics that are selected. 
  
B. Recruitment and Consent Procedures  
Specific Aim 1: In this aim, at least 40 key informant interviews with primary care team 
members in Rhode Island will be performed. The department of Family Medicine has a list of 
all primary care providers who are alumni or are community preceptors. There is also a list of 
primary care providers including other specialties like internal medicine and pediatrics 
throughout Care New England. Using these contact lists, participants will be recruited via 
email initially. Several chief medical officers at federally qualified health centers have given 
us permission to also circulate recruitment emails via health center listserves to recruit their 
primary care team members. For those who do not respond positively or negatively, a phone 
call to their primary care office during business hours will be made. If the participant agrees 
to be interviewed, a convenient time will be arranged to meet with the participant. Interviews 
will be performed in a quiet, private location either at the participant’s office or in the 
department of Family Medicine at 111 Brewster St. Pawtucket RI. Given primary care team 
members’ busy schedules, interviews may also be conducted via phone. In this case, 
informed consent documents will be sent via the participant’s preferred method, email or 
mail. The consent will be read aloud over the phone, and the verbal consent will be 
documented by the study team by signing the informed consent and writing a note that 
informed consent was obtained over the phone for the participant. We will attempt to 
reschedule interviews up to three times for participants in order to retain them in the 
interview process.  

 
 
 
 
Specific Aim 2: In this aim, participants will be recruited to participate in the TB infection 
ECHO course. The same recruitment procedure will be used in Aim 1 to recruit participants 
for the ECHO course. Since all registration for the ECHO course is being conducted 
electronically, an informed consent form will be included at the beginning of the online 
survey. Participants will confirm their understanding of the consent form and will be provided 
an email address to send any comments or concerns prior to participation. If an individual 
does not agree to participate, they will not be able to proceed to the survey. Study participants 
names will be linked to surveys to allow for possible clinical outcome tracking in Aim 3. 
Study participants will provide unique IDs so that names will only be included on a codesheet 
(see below). Only de-identified data with unique IDs will be included in the final database. 
This study aims to assess the TB infection ECHO course in a real-world setting. Therefore, 
we will not make any additional efforts to retain participants in the course outside of routine 
course email reminders. We will email ECHO participants at the end of the course to ask for 
volunteers to participate in qualitative interviews. Those who agree will undergo the same 
consent process as described in Aim 1. 
Specific Aim 3: The retrospective chart review will be requested through the data teams of 
the two selected sites and will be de-identified to not include HIPAA protected information.  
 
C.  Potential Risks   
a. This research is classified as non-exempt human subjects research. All procedures of this 
research will be conducted in accordance with 45 CFR Part 46 and will be approved by the 
Care New England affiliated Institutional Review Board. This study involves quantitative 
surveys that will be conducted electronically with at least 50 recruited and consented primary 
care team members participating in the TB infection ECHO course intervention. The pre- and 
post- ECHO course surveys and post-session surveys aim to assess feasibility of the 
intervention and impact – PCPs’ learning and performance before and after the course. The 
final survey database will be coded with a unique identifier and a codesheet linking unique 
identifiers to participants will be locked in a filing cabinet in the PI’s locked office. The 
unique identifier will be used to pair pre-, post-, and session surveys. Additionally, 
qualitative data collection via key informant interviews (KIIs) with at least 40 primary care 
team members  will inform the course and the survey design.  
b. Aim 1: Study procedures and materials - For KIIs in Aims 1 and 2, we will have participants 
share demographic information at the end of their interview which we will record on a 
tracking form. This form will collect the following demographic information: age, gender, 
provider type, specialty, and years out of training. Potential risks – There is a small risk of 
disclosure of sensitive information during KIIs during or after recorded sessions. 
Minimization: To reduce risk, participants’ responses will be treated confidentially by the 
study team. All paper documents and/or digital recordings will be stored in locked filing 
cabinets in the Center for Primary Care and Prevention or on a computer requiring at least 
two levels of security. Due to the trusting and intimate nature of interviews, participants may 
wish to retract personal stories that were shared during these sessions. This will be included 
in the consent process. If requested by the participant during or following data collection, we 
will remove the sensitive material from the transcribed record and delete from the digital 
recordings. 
Aim 2: Study procedures and materials – The TB infection ECHO course is an evidence-
based, educational intervention. The ECHO course will take place over a virtual platform 

 
 
 
 
(Zoom) every month for six months. Participants will receive continuing medical education 
credit if they attend 4/6 sessions. Clinical cases presented during ECHO sessions will be de-
identified and no identifiable information will be shared with participants. All quantitative 
surveys will be designed and administered via qualtrics. Each participant will be asked to 
complete eight surveys: one pre-course, six post-session, and one post-course. Demographic 
information (same as in Aim 1) will be collected on the pre-course survey. Potential Risks – 
There is a small risk of disclosure of sensitive information during the TB infection ECHO 
course by participants . Minimization: To reduce this risk, standard ECHO procedures will be 
followed and clinical cases will be reviewed by the ECHO coordinator, content expert, 
and/or principal investigator prior to the session to ensure no identifiable information is 
included.  
Aim 3: Study procedures and materials – For the retrospective EMR data query, two clinic 
sites will be chosen. In order to explore this EMR data query, we are acquiring a de-identified 
database from BVCHC, obtained via the terms of the data agreement plan, in order to assess 
preliminary LTBI testing and treatment. We had several BVCHC staff participate in Aim 1 so we 
are hopeful that this site will include participants from the ECHO course who attended at least 
4/6 sessions. the database will include provider names (not considered patient identifiers by 
BVCHC) which will allow linkage to ECHO provider participants. The data query will involve 
the variables listed in part 2 section F: Specific Procedures or Treatments. Additional de-
identified variables may be added in consultation with the two clinic sites if they are important 
variables to consider that may impact LTBI testing and treatment. Potential Risks – There is a 
small risk of disclosure of PHI during the data query process. We will work closely with the 
clinic sites’ data teams to ensure that no PHI is provided to our team during this process and will 
follow the procedures as stated in the data sharing agreement. The database will be kept in a 
password protected file on password protected computers, and only the study team will have 
access to it. 
 
D.  Protection of the Subject 
1. Adequacy of Protection Against Risks 
a. Informed Consent: Informed consent for study participation will be obtained prior to 
subject participation commencement adhering to Kent IRB guidelines. Written informed 
consent will be the preferred method of consenting process. Should the participant not be 
able to provide written consent, verbal consent will be obtained and documented. 
Informed consent will be read aloud to key informants and ECHO participants and 
participants will be given time to ask questions before consenting to participate. The 
participants will be offered a copy of the informed consent documents to keep. For Aim 
2, consent forms will be embedded within the electronic survey and participants will have 
the opportunity to ask questions about the study via email.  
b. Protections Against Risk: To minimize risks from potential disclosure of sensitive 
information, key informants and participants will have study procedures fully explained 
or described in writing before giving consent, with explanations about potential risks 
involved in participation. All participants will have ample time to ask questions prior to 
giving consent. No identifiable information will be collected during the interviews or 
surveys except names which will be kept in a linked codesheet and removed from the 
final database. All study materials will be stored either in a locked filing cabinet or 
electronically with two layers of security.  

 
 
 
 
c. The data safety monitoring plan will be designed by the principal investigator and mentors 
and will be submitted and reviewed in detail by the Care New England affiliated 
Institutional Review Board prior to any study procedures. Only the core study team will 
have access to survey data and transcribed interview data. The core study team includes 
the principal investigator (Daria Szkwarko), mentors (Jane Carter, Roberta Goldman and 
Charles Eaton), and the medical student research assistant (Steven Kim). No identifiable 
information will be collected during interviews or survey administration. We will code 
interviews and surveys with a unique identifier. Enrollment log linking unique IDs to 
participants (in the event that we need to contact them regarding interview or survey 
content) will be locked in a filing cabinet. Signed informed consent forms and any other 
study material will be stored in a separate locked filing cabinet.  
d. Qualitative data will be recorded using a digital voice recorder. Prior to interviews, 
demographic forms will be completed by each participant. These forms will be coded 
with a unique study ID. After each recording, the study team member will transfer all 
new recordings from the device to a password-protected computer in a locked office. The 
files will be labeled with the participants’ unique study ID. The research assistant or the 
principal investigator will listen to the recording in the digital file and we will use NVivo 
to edit out any names or identifying information that may appear in the recordings, while 
incorporating unique IDs into the recordings so that participants can later be compared by 
characteristics. The original recordings with identifiable information will be deleted from 
the computer and the recording device after transcript cleaning takes place. Transcript 
files will be encrypted and stored securely in a password-protected file, on a password-
protected computer and backed up on two password- protected external hard drives. Once 
analysis and research is completed, all recordings will be deleted from the computer and 
external hard drives.  
e. Quantitative data will be collected via REDCap or comparable survey program. Survey 
links will be shared with participants via email. At the time of informed consent, 
participants will provide their unique ID to the study team which will be stored on a 
separate page as listed above. The data from the surveys will be auto-populated into an 
electronic database. Only de-identified data will be entered into survey database. The 
database will be exported and saved on a password protected computer with at least two 
layers of protection. The database will be backed up on two password protected external 
hard drives after each of the eight survey periods. Hard drives will be stored in the locked 
filing cabinet with other study material.  
f. EMR data will be queried by the clinic sites’ data team.  We will provide them with the 
ECHO participant names and ask the team to code these names so that no provider names 
are identifiable to the study team at the time of database acquisition.  BVCHC will be one 
of the clinic sites. The research team will acquire a de-identified database from the clinic, 
via the terms of the  shared data agreement plan,  with preliminary LTBI testing and 
treatment data. . The database will include provider names (not considered patient 
identifiers by BVCHC) which will allow linkage to ECHO provider participants. The 
database will be saved as a password protected file on password protected computers. 
The database will be backed up as explained above for the survey data. 

 
 
 
 
 Potential Benefits  
Potential Benefits to Research Participants and Others: There will be no direct benefit to key 
informants. Participants who participate in the ECHO course will gain knowledge regarding TB 
infection testing and treatment that they may also pass on to colleagues and co-workers in their 
practices. If the ECHO course has a positive impact on learning and performance, this may 
ultimately increase the number of patients who are tested for TB infection and started on 
treatment. A successful ECHO course will also be an important component of an ECHO 
translational research framework at Brown and could be a model for future ECHO programs for 
other diseases in Rhode Island. 
 
C. Risk-Benefit Ratio  
Importance of the Knowledge to be Gained: This study will provide us with important 
information regarding the impact of the ECHO model on primary care team members’ 
knowledge and performance regarding TB infection testing and treatment. The study will also 
provide, for the first time, important information about the knowledge, attitudinal, and skill gaps 
related to TB infection testing and treatment in primary care. 
 
 
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