Web (YouTube) Based Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
Phase: NA
Conditions: Rheumatoid Arthritis, Arthritis, Rheumatoid
Sponsor: Rush University Medical Center

ORA: 14090405-IRB01 Date IRB Approved: 10/31/2016 Amendment Date: 7/6/2017 
 
 
 
 
 
A. Title: Web (YouTube) based educational intervention to improve patient-
physician awareness of cardiovascular risk in rheumatoid arthritis 
 
B. Organizational detail: Rush is a not-for-profit health care, education and research enterprise. 
Rush University Medical Center (RUMC) encompasses a 664-bed hospital. The mission of RUMC is 
to provide the best care for our patients. A unique combination of research and patient care has 
earned Rush national rankings in 9/ 16 specialty areas in U.S. News & World Report's 2013-14 
America's Best Hospitals issue. Our education and research endeavors, community service 
programs are dedicated to enhancing excellence in patient care in the Chicago area. RUMC’s core 
values — innovation, collaboration, accountability, respect and excellence —translate into highest 
quality patient care. The Department of Medicine’s leadership is dedicated to supporting research 
endeavors to improve patient care. Hence, both the organization and departmental leadership are 
committed to improving patient care and research. 
  
The Division of Rheumatology at RUMC (and its affiliated institutions) provides care to 
patients with rheumatoid arthritis (RA), and thus has access to large numbers of RA patients 
to pursue research. The division includes 15 salaried MD rheumatologists at two clinical 
locations. At RUMC, we see approximately 500 RA patients per year. John Stroger Hospital 
(JSH) is affiliated and in vicinity of RUMC. The primary investigator (PI) has clinical privileges at 
both the hospitals. The JSH’s Rheumatology division provides longitudinal care for 
rheumatology patients, mostly with poor or no medical insurance. Approximately 1000 RA 
patients per year are seen by Rheumatology at JSH. Our combined (RUMC and JSH) 
Rheumatology division’s leadership and faculty are actively engaged in investigator-initiated 
clinical trials, including quality improvement projects. 
 
The Department of Preventive Medicine at RUMC has been specializing in design and testing 
of rigorous multi-level interventions for cardiovascular risk reduction. The proposed study will 
have access to its statistical and methodological expertise, including experts in cardiovascular 
prevention, cardio-metabolic conditions and behavioral science. The resources of the 
Department of Preventive Medicine will enhance the methodological rigor and likelihood of 
success of this study. 
 
Other resources available to the PI: On site Center for Clinical Studies, a busy clinical trials 
unit located within the Division of Rheumatology, helps with study coordination and patient 
recruitment; and clinical assessments are performed on site. It has been conducting clinical 
research and clinical trials successfully for more than 15 years. Approximately 30-40 
protocols/year are performed, which include investigator-initiated research and multi site 
clinical trials in RA and other conditions. It maintains a disease-oriented database of 
potential study volunteers. Other Center resources include nurse coordinators, a regulatory 
affairs specialist, patient recruiters, phlebotomists, administrative, clerical and front-office 
staff, and physician faculty of the Division of Rheumatology. Two conference rooms with 
audio-visual equipment are available. In addition, networked computer facilities are available 
for study coordination, statistical and data analysis, and database management. 
 
Interdisciplinary Leadership of the proposed project and their specific roles are as follows: 
 
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Meenakshi Jolly, MD, MS is the lead PI and an Associate Professor in Department of Medicine 
(Division of Rheumatology). She is responsible for the concept, study design, regulatory aspects, 
patient recruitment, data procurement, data management, analysis, interpretation, educational 
intervention (EI), manuscript preparation and presentations. The PI is an experienced and 
trained clinical investigator in patient reported outcomes and efforts to optimize health 
outcomes. She has a record of accomplishment with successful completion of projects; has 
published in peer-reviewed journals and presented her research nationally and internationally. 
 
Rasa Kazlauskaite, MD is an Assistant Professor of Preventive Medicine & Internal Medicine 
(Preventive Cardiology & Endocrinology, Diabetes and Metabolism). Her expertise is in 
cardiovascular risk screening and management, and is a PI on NIH funded studies. Her role 
will be in study design, development of study surveys (CVR awareness) and intervention 
modules (expert opinion), data interpretation and manuscript preparation. 
  
Lisa Walt, PhD is Experimental Health and Social Psychologist at the Department of Preventive 
Medicine. She has considerable experience in the social cognitive, interpersonal 
communication, and persuasion arenas as related to risk behaviors and prevention. Her role will 
be in development of study surveys (methodological) and intervention modules (persuasion 
and social cognitive expertise), data interpretation and manuscript preparation. 
 
Augustine Manadan, MD is an Associate Professor and Division Head of Rheumatology at JSH. 
 
He will assist with patient recruitment, data accrual, interpretation and manuscript preparation. 
 
Joel A Block, MD, is Professor and Division Head of Rheumatology at RUMC. He will assist with 
study design, regulatory aspects, surveys modifications and development of case scenarios for 
PHCP surveys, patient recruitment, data accrual, interpretation and manuscript preparation. 
 
C. Goal: Our goal is to develop and pilot-test a multi-level web-based EI aimed to improve 
cardiovascular risk awareness (CVRA) in rheumatoid arthritis (RA). 
 
D. Objectives: We propose to conduct this study in two phases with the following aims: 
 
1. EI development phase. 
 
Aim 1. To develop a multi-level web-based EI for improving CVRA targeted to the patients with 
RA and their primary health care providers (PHCPs; see definition in section F). The intervention 
will be designed over the first 6 months in collaborative effort of patients and the trans-
disciplinary panel of experts in rheumatology, preventive cardiology/endocrinology, and 
experimental health and social psychology. 
 
2. Pilot-testing phase. 
 
Aim 2A. To compare changes in CVRA in RA patients (a) after web-based EI. We hypothesize a 
20% increase in CVRA (measured using standardized survey) at 2-3 months post intervention; 
 
(b) among patients with and without web-based EI. We hypothesize significantly greater 
improvement in CVRA (using standardized survey) among RA patients with EI as compared 
to RA patients without EI, at 2-3 months. 
 
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Aim 2B. To explore changes in cardiovascular risk screening (CVRS) at the primary health care 
visits among RA patients with and without EI, at one year. 
 
E. Assessment of Need: Health care and disease burden of cardiovascular disease among men 
and women is substantial. Cardiovascular disease (CVD) is the leading cause of death and a 
major cause of disability worldwide. Coronary artery disease (CAD) is the leading cause of death 
worldwide. In the United States, CVD accounted for 34.4 % of the 2.4 million deaths in 2003, 
and remains a major cause of health disparities and rising health care costs. In 2006, health care 
spending and lost productivity from CVD exceeded $400 billion. Traditional risk factors for CVD 
are male gender, dyslipidemia, hypertension, diabetes, smoking and family history of CVD. 
Women have unique risk factors for CAD (2), and CAD’s impact on women traditionally has 
been under appreciated due to higher rates at younger ages in men. The death rates from CAD 
in US women 35-54 yrs of age are increasing. Heart disease is the leading cause of death in 
women in every major developed country and most emerging economies. First women-specific 
recommendations for CVD prevention were published in 1999. In 2007, CVD still caused 
approximately 1 death/minute among women in the US. Major gaps among patients and 
physicians remain regarding CVRA in women. 
  
The American Heart Association now recognizes systemic autoimmune diseases (e.g. RA) as an 
independent CVD risk in women (1). RA, the most common autoimmune arthritis, affects at 
least 1.3 million US adults. 1-3% of women may get RA in their lifetime. Usually, 75% of RA 
patients are women, and between 40-50 yrs. Major cause of mortality in RA is CVD. As 
compared to general population, CVD morbidity in RA is 1.5-2.0 folds (3). The mortality gap 
between RA and the general population has widened (2). Ischemic heart disease in RA is often 
silent, and precedes myocardial infarction in RA. Identification and addressal of modifiable 
traditional CVR factors in patients with RA is important, besides simultaneously targeting RA-
specific risks. The increased CVD risk in RA cannot be explained by traditional risk factors. 
Immune dysregulation, systemic inflammation, plaque instability, impaired coronary reserve, 
elevated thrombotic markers, medications (corticosteroids and non-steroidal anti-
inflammatory medications) and extra-articular manifestations contribute to increased CVD risk 
in RA (2-4). The absolute risk of CVD is highest for elderly, male patients with RA, whereas 
relative risk is highest among young female patients with RA (5). Innala et al reported 
traditional CVD risks to explain new CVD events in very early RA, and it being potentiated by 
high disease activity (6). Hence, attention to both traditional and RA-specific factors to decrease 
CVD morbidity and mortality in RA is required. 
 
Primary preventive screening before the onset of CVD is key to identifying modifiable 
traditional CVD risk factors (7). European League against rheumatism (EULAR) guidelines 
recommends CVRS using national guidelines for all RA patients (5). It has been suggested that in 
patients with low CVD risk and inactive RA, a lower frequency of assessment (e.g. every 2-3 
years), could be adopted. Currently there are no guidelines on this from the American College 
of Rheumatology. National Cholesterol Education Program guidelines recommend checking for 
dyslipidemia in adults ≥ 20 yrs every 5 years for the general population; to have this tested 
more often if either there is dyslipidemia on screening, male gender >45 yrs, or a woman > 50 
years, HDL <40 mg/dl, or if there are other risk factors for CVD. Current US preventive services 
 
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task force guidelines strongly recommends dyslipidemia screening for men aged ≥ 35 yrs, and 
for men between 20-35 yrs only if they are at increased risk of CVD. For women, dyslipidemia 
screening is only recommended if they are at risk for CVD by them. Using these guidelines, RA 
patients of any gender and age would be eligible for CVD and dyslipidemia screening. 
 
Patient-Physician based EIs to target CVD risks are successful and can improve health outcomes. 
Several studies show that EI targeting CVD risks can improve outcomes and health behaviors. In 
a study aimed at improving CVRA, a tailored EI and CV risk screening were offered in two 
communities. Greater knowledge was noted on post screening; 44% had consulted their 
internist, while 69% made at least one healthy behavior change (8). Diabetes EI is associated 
with self-management behavior (9-10), thus improving care outcomes, without having a major 
impact on health care costs (10).In another study aimed at improving diabetes care, an EI that 
targeted both the patient and physician, demonstrated the largest and most consistent drop in 
hemoglobin A1C, as well as the lowest treatment cost (11), suggesting that the patient-
physician dyad based EI, may be a better target than either person alone, as is being proposed 
in this project. 
  
Web-based EI (including video) have been found to be effective in improving practice patterns 
and health outcomes in several studies (12-17). Web-based EI have several advantages over 
conventional class room based EI as they provide flexibility, privacy and time efficient utility to 
users. For health services providers web-based EI can provide easy and quick access, globally 
to vast number of patients, efficiently and effectively, quick implementation, with least 
administrative and financial burden. 
 
Current Clinical Gaps Identified: Status of CVRS, lipid screening or treatment of dyslipidemia in 
RA is far from optimal, even in Medicare age group patients. Traditional CVD risks and RA-
specific risk/s are well noted be to be associated with greater CVD in RA. However, the 
presence of RA does not always trigger CVRS or treatment. In RA patients (≥ 65 years), primary 
lipid screening was performed in 45% (7), an age group where all patients should receive 
dyslipidemia screening, regardless of their RA status. Adjusted predicted probabilities of lipid 
screening were 26% for RA patients seeing rheumatologist alone, to 44-48% for patients with 
some primary care physician visits (7). In another study, one third of RA patients did not have 
any lipid testing (18- 19). Furthermore, upto 26% of RA patients without CVD have sufficiently 
high risk for CVD to require statin therapy, yet and most of them remain untreated (20). 
 
Potential reasons for poor CVRS in RA, despite the indication may include lack/limited 
knowledge among RA patients and their PHCP’s about the CVD risk. Lack of knowledge in 
general about CVD risks in women and their PHCPs has been previously reported. Women do 
not always perceive themselves to be at risk for CVD (21). Furthermore, existent medical 
literature is lacking in published studies in the United States in RA that (i) ascertain patient or 
physician awareness of CVD risks, or (ii) compare the rates of CVRS pre and post EI against RA 
patients receiving usual care from PHCP. These are lost opportunities to make PHCP’s aware of 
the existent gap in knowledge and thus the need for changing behaviors. In a study done in 
United Kingdom, only 32% of general practitioners identified RA as a risk for CVD (22). They 
reported lack of educational resources on this matter. 
 
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Secondly, lack of clarity on primary responsibility for CVRS in RA, in a patient seeing two or 
more physicians, may contribute to low CVRS and treatment. RA patients who saw their 
primary care physician in the past year, in addition to their rheumatologist, were more likely to 
get CVRS by their PHCP (23). Time constraints during each visit may also burden the PHCP. 
Performance of CVRS to Physician Quality Reporting Initiative (PQRI) in RA may be helpful. 
 
Currently, there are no published, effective, EI targeting patient-PHCP CVRA in RA. 
Furthermore, there are barriers to use of currently available EI resources (classroom style 
educational events) to improve CVRA among RA patients and their PCHP. These include access, 
need for dedicated substantial time and/or financial commitment to attend continuous medical 
education or other educational events, lack of flexibility, which may impose on patient care or 
personal time. Similar access, lack of flexibility, lack of awareness of resources available, 
complexity in the content delivery, need for dedicated time and financial time commitments 
may be encountered by RA patients. A brief, focused, simple web-based EI, if found to be 
effective, can overcome the above mentioned obstacles, and be made available globally , 
rapidly, and in a cost effective use of available resources. 
  
F. Target Learner Audience: Primary audiences are RA patients and their PHCPs. Direct 
benefits from the project to RA patients are targeted in the form of improved awareness of 
primary and secondary prevention of CVD in RA. PHCP refers to any health care provider 
identified by the RA patient as their primary health care provider. This may be their 
rheumatologist, family practitioner, internist, other specialists or mid-level health providers. 
 
G. Project Design and Methods: G.1. Study design, number of participants, sites and duration: 
 
As mentioned previously, the study will consist of two phases: 
 
(i) EI development phase consisting of EI development by interdisciplinary, collaborative 
team (including RA patients), and qualitative assessments used to refine the intervention, (ii) 
Pilot-testing phase. 
 
We propose a longitudinal of 300 RA (150 with and 150 without EI), to test for (primary 
outcome) change in CVRA at 2-3 months following web-based EI, and compare that with CVRA 
changes among RA patients without IE. The proposed secondary outcomes will explore the 
rates of CVRS via medical chart review among RA patients with and without IE. Consenting 
participants (RA patients (n=300) and PCHPs) will have (a) baseline survey on CVRA, followed 
by a short EI delivered via YouTube video (n=150), followed by immediate and 2-3-month 
follow up surveys, to quantitate changes in CVRA, (b) a medical record review of participating 
RA patients (n=300) will be undertaken (records from preceding one year duration) and at 12 
months (after baseline visit) to determine the changes in CVRS in RA (Figure 1). Only PHCPs 
providing care to the EI arm RA patients will receive the CVRA evaluations and the EI. Care will 
be taken to avoid enrollment of PCHPs providing care to RA patients not in the EI arm, to not 
confound the results. 
 
Educational approach is discussed in the section I. We expect to reach out to 600 RA patients 
at RUMC and JSH, with the goal of recruiting 300 RA patients over 12 months. This screening-
to-enrolment ratio is consistent with previously observed 10:9 ratio for survey-based one-visit 
 
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studies at RUPC and JSH. We expect to reach our expected goal of 300 RA patients even if 
screening-to-enrollment ratio erodes to 10:5. Sample size calculation: To show an 
improvement of 20% in overall CVRA, with 90% power and 0.05% alpha error, we need 127 RA 
patients in each group. 
 
H. Innovation: We did not find on our review of current medical literature (PubMed and Ovid 
Medline) using the search terms “Rheumatoid arthritis” and “educational intervention” and 
“web” for any existent EI studies that study patient-PHCP CVRA or utilize a YouTube based EI to 
improve CVRA. Furthermore, use of patient-PHCP dyad for CVR EI has not been reported. We 
feel confident that our study idea is original and has significant advantages over existent 
methods as it is easier, quicker and has significant potential applications. The you tube video EI 
if successful can be offered through National organizations e.g. American College of 
Rheumatology or Arthritis Foundation; and can be made available to large numbers of RA 
patients worldwide with less resources utilization and advantages of privacy, flexibility and 
access to users. 
 
This project builds upon ongoing work in quality in RA in the Divisions of Rheumatology, and 
CVR management through Department of Preventive Cardiology. Rush has a history of 
cardiovascular prevention research studies through the Preventive Medicine Department. Dr. 
Kazlauskaite is a co-investigator in the Study of Women's Health Across the Nation and NIH – 
funded project on development of intervention for primary prevention of cardiovascular 
disease in mid-life women. She is also the PI on NIH-funded pilot study of a Lifestyle 
Intervention on the Metabolic Syndrome through changes in dietary intake, stress management 
and physical activity, working in close collaboration with Dr. Walt, who has extensive 
theoretical and practical expertise in health behavior modification from her work in NIH and 
industry-funded grants. The PI has experience in offering educational talks through you tube 
videos and social media for autoimmune diseases for patients and support groups, and is 
building on this experience to develop an active intervention in collaboration with an expert in 
preventive cardiology. The PI is actively involved in several projects aimed at quality 
improvement projects, and others relating to improving health outcomes in lupus. Dr. Jain and 
Dr. Manadan are involved in quality improvement projects, specifically pertaining to RA 
patients. 
 
I. Outcomes Evaluation:I.1 CVRA refers to cardiovascular risk awareness, whereas CVRS 
refers to cardiovascular risk screening. 
 
1. EI development phase: The primary outcome of the EI development phase will be patient-
centered EI video and PHCP-centered EI video aimed at increasing CVRA in RA patients and 
their PHCPs. 2. Pilot-testing phase: Primary outcomes of interest are (a) changes in CVRA after 
an EI among RA patients, and (b) changes in CVRA rates among RA patients with and without IE 
at 2-3 months. Our secondary outcome of interest is the change in rate of CVRS among RA 
patients with and without IE at one year. Other exploratory outcomes may include correlation 
between PHCPs CVRA and baseline CVRS; patient and PHCPs predictors of change in CVRS. 
Outcomes evaluations in terms of metrics used for the needs assessment, and addressal of 
gaps for each target group, and amount of changes expected are shown in Table 1 below. 
 
 
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Table 1: Outcomes evaluations, expected change and addressal of gaps. 
 
Aim 
Outcomes Evaluation 
Expectation 
Gap addressed 
Phase 1/Aim1: Development 
Pre testing and 
We expect the 
No educational interventions targeting patient- 
and implementation of a 30- 
Credibility surveys to 
intervention module to 
PHCP CVR awareness are yet available for RA 
minute web based (You 
evaluate the feedback 
be feasible and credible 
patients. 
Tube) educational 
provided by the patients- 
(user friendly, content, 
intervention to improve 
PHCP on the need for the 
understandibility and 
patient-physician awareness 
study, and on the ease, 
relevant) in improving 
for CVR in RA. 
content and 
knowledge of CVR in RA 
understandability, 
relevance of the 
educational module. 
Aim 2A: 
(a) Overall CVRA 
We expect a 20% 
Patients have poor knowledge in general about 
To compare changes in CVRA 
increase in CVRA at 2-3 
overall CVR, in women and in RA. No studies exist 
in RA patients 
months post EI 
yet in the United States in RA ascertaining patient 
(a) after web-based EI 
and PHCP awareness of CVR, despite the 
(b) with and without web- 
documented increased risk of CVD in RA. 
based EI 
(b) Overall CVRA 
Change in overall CVRA 
There is a lack of knowledge among PHCP about 
will be significantly 
CVD risks among women and RA. No studies exist 
greater among RA with 
yet in the United States in RA ascertaining patient- 
EI than non EI 
PHCP awareness of CVR, despite the documented 
increased CVR in RA. 
Aim 2B: 
Prevalence rates of 
Prevalence rates of CVRS 
RA patients PHCP may not be clear on whose 
To explore changes in 
relevant CVR assessment 
at 1 year follow up will 
responsibility is it for CVR assessment, when RA 
cardiovascular risk screening 
performed by PHCP 
be significantly higher 
patient sees ≥ 2 physicians. Status of CVRS, lipid 
(CVRS) at the primary health 
among RA patients (with 
among RA patients post 
screening or treatment of dyslipidemia in RA is far 
care visits among RA patients 
and without EI) 
EI as compared to 
from optimal, even in Medicare age group 
with and without EI. 
baseline. 
patients. There is a lack of knowledge in general 
Change in prevalence 
about CVD risks in women and their physicians. 
rates of CVRS at 1 yr 
No studies exist yet in the United States in RA 
follow up will be 
ascertaining patient-PHCP awareness of CVR, 
Exploratory Analysis: Patient 
CVRS and changes in 
Modifiable patient and 
Predictors of CVRS or change in CVRS will allow 
and PHCP correlates of CVRS 
CVRS, Change in CVRA 
PHCP correlates of CVRS 
evidence based development of targeted 
and changes in CVRS in RA; 
for PHCPs 
and changes in CVRS 
strategies for patient and PHCP to improve CVRS 
Change in PHCPs CVRA 
would be identified. 
in RA for future. Improvement in CVRA in PHCP 
PHCP CVRA is 
will help facilitate further studies, interventions, 
modifiable. 
and PQRI incentives 
 
CVRA: Eighteen modifiable and non-modifiable traditional CVR being assessed are (a) Fifteen 
Non-modifiable and modifiable CVR: Age, Male gender, Postmenopausal status, Ethnicity, 
Family history of premature CVD (in father at age <55 yrs, or mother at age <65 years), 
smoking, dyslipidemia, hypertension, physical inactivity, obesity (>20% over ideal body weight), 
diabetes, stress, excessive alcohol, autoimmune diseases (e.g. RA), steroids, and (b) three RA-
specific (Disease activity, duration, use of steroids). 
 
CVRS: Checklist used to assess CVRS will include only primary CVR factors, and these will include 
elicitation of history of diabetes (if present, glycosylated hemoglobin annually in diabetics), 
dyslipidemia (if present, lipid panel in past one year), hypertension (if present, control of blood 
pressure in past one year), rheumatoid arthritis (Steroids, lipid panel in past one year), smoking 
(if present, education for cessation in past one year), poor activity level (if present, education 
on exercise in past one year), obesity (if present, BMI and/or weight loss education 
documentation in past one year), family history of CVD. 
 
Data Collection: All consecutive patients with a diagnosis of RA seen in the Rheumatology clinics 
 
will be sought for participation. Inclusion criteria: A. RA patients: Adult men and women 
 
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meeting the following criteria (i) Diagnosed with RA with following criteria: Inflammatory 
symmetric polyarthritis of ≥6 weeks, with physician documented synovitis in medical records 
(past or current) consistent with RA, with or without rheumatoid factor, anti cyclic citrullinated 
peptide or radiologic evidence of RA. Exclusion of another etiology for above. (ii) Receipt of care 
by rheumatologist at either RUMC or JSH. This will allow us access to full medical records to 
correctly gauge the prevalence of CVRS. (iii) Informed consent. B. PHCP: (i) Physicians providing 
primary care to the RA patients recruited for this study for the EI group. Definition of PHCP has 
been previously provided (section F), (ii) Informed consent (iii) Not providing PHCP to RA 
patients in the non-EI group. 
 
I.2. Methods: 1. Education intervention development phase: The primary outcome of the 
intervention development phase will be patient-centered EI video and PHCP-centered 
education EI to increase CVRA in RA. The interdisciplinary study team will develop a multi-level 
web-based EI for CVRA targeted to RA patients and their PHCPs. This team will consist of 3-6 
RA patients and the panel of experts in rheumatology, preventive cardiology/endocrinology, 
and experimental health and social psychology. To improve overall RA patient outcomes, our 
educational approach for the web-based EI is specifically aimed at changing the knowledge, 
and thus health behaviors of RA patients and their PHCP. 
  
Educational Approach: In the development of the web-based EI (Table 1, Figure 1), we will 
utilize credible, useful, innovative educational platform and input from opinion leaders in the 
therapeutic areas. All educational content will be learner centric in approach, language and 
content (Table 2). Content appropriateness of the tailored intervention will be verified by 
the health experts. Processes of change will be focused on increasing RA patients or their 
PHCP CVRA in general and in RA, and increasing their awareness of the need for change. This 
20-30 minute You Tube EI video will be developed using scientifically researched content 
(Table 2). 
 
Table 2: Development of Content for Educational web-based Intervention 
Audience 
Major Areas in Content Develo Key Features 
Patients 
1) What is CVD and CVD in USA Definition of CVD, Leading cause of death 
2) CVD in Women 
Leading cause of death in women 
3) Traditional CVR factors 
Modifiable and Non Modifiable 
4) Autoimmune diseases and CV American Heart Association Guidelines (AHA) for CVR in women. 
5) RA and CVD 
Major cause of mortality in RA 
6) RA specific CVR factors 
Disease activity, duration, medications 
US preventive services task force guidelines, National Cholesterol Education Program 
7) Suggested CVRS applicable to guidelines, EULAR guidelines 
8) Patients role in CVRS 
For traditional CVR factors, contact PHCP; For RA factors contact Rheumatologist 
PHCP 
1) CVD in USA 
Burden of CVD in US 
2) CVD in Women 
Morbidity and mortality with CVD among women, Under recognized 
3) Traditional CVR factors 
Framingham Risk factors and calculations 
American Heart Association Guidelines (AHA) for CVR in women, especially RA, Lupus and 
4) Autoimmune diseases and CV psoriatic arthritis. Suggested adjustment for RA 
5) RA and CVD 
Review of evidence based literature for RA and CVD 
6) RA specific CVR factors 
Review of literature on RA associated factors associated with CVD eg inflammation 
Gaps in CVRS in RA, US preventive services task force guidelines, National Cholesterol 
7) Suggested CVRS in RA 
Education Program guidelines, EULAR guidelines 
8) PHCP role in CVRS 
For traditional CVR factors, contact PHCP; For RA factors contact Rheumatologist, PQRI 
 
 
 
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The finalized EI will be pretested among 5-10 RA patients and Physicians. Table 3 summarizes 
the way the planned methods address the established needs or identified gaps. 
 
 
Table 3: Approach to the needs and identified gaps in cardiovascular risk awareness. 
 
Established Need/Gap 
Type of need/ Gap 
Adressal of need/Gap through this study 
Women have unique CVD risk Factors 
Knowledge 
Autoimmunity eg RA is a risk factor for CVD in 
women. We would foster education about this 
among women with RA and their PHCP. 
The death rates from CAD in US women 
Knowledge, Performance 
By educating RA patients and PHCP about RA 
35-54 yrs of age are increasing 
and CVD risk, especially in women, we expect 
PHCP and patients to partner CVRS in RA 
women, and decrease mortality. 
Major cause of mortality in RA is CVD 
Knowledge, Performance 
By educating RA patients-PHCP about RA and 
CVR, we expect thenm to partner to screen 
for CVR in RA , and decrease mortality. Also by 
documenting poor CVRA among RA Patients 
and physicians, guidelines could be developed 
to ascribe responsibility and develop quality 
improvement initiatitives through physician 
reimbursements. 
Status of CVRS in RA is far from optimal, 
Knowledge, Performance, 
By educating RA patients-PHCP about RA and 
even in Medicare age group patients 
Competence, Attitudes 
CVR, we expect physicians-PHCP would 
partner to screen for CVR in RA , and decrease 
mortality. Also by documenting poor 
awareness about CVD risks among RA Patients 
and physicians, guidelines could be developed 
to ascribe responsibility and develop quality 
improvement initiatitives through physician 
reimbursements. 
There is a lack of knowledge in general 
Knowledge, Performance, 
By educating RA patients-PHCP about CVR in 
about CVD risks in women and their 
Competence, 
general, we expect physicians-PHCP would 
physicians 
partner to screen for CVD risks , and decrease 
mortality. 
Physicians providing care to RA 
Knowledge, Performance, 
Clear designation of rheumatologist to address 
patients may not be clear on whose 
Competence, processes 
RA specific CVD risk factors, while working 
responsibility it is to screen for CVD risk 
collaboratively with the PHCP on adressal of 
and/or treatment. 
traditional risk factors will be presented to the 
patient-PHCP dyad in the intervention. By 
documenting lack of understanding on 
percieved responsibility about CVRS among 
various physicians, guidelines could be 
developed to ascribe responsibility and 
develop quality improvement initiatitives 
through physician linked reimbursements. 
Processes 
The study will fill in the gap by providing this 
No studies exist yet in the United States 
data for USA, and hence help locate 
in RA ascertaining patient or physician 
opportunities for improvement. 
CVRA, despite the documented 
increased risk of CVD in RA. 
No educational interventions targeting 
Knowledge, Performance, 
The study will help us understand if using the 
patient-physician CVRA are yet available 
Competence, processes 
latest technology of you tube to deliver the 
for RA patients. 
active educational intervention can result in 
improvement in knowledge. 
 
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EI fidelity monitoring will be undertaken through following (a) Delivery of intervention and 
process: web system will track how long each participant (Patient or PHCP) stayed on to the 
web-based YouTube EI video, before moving on to the follow up 1 survey, (b) Receipt fidelity: 
performance of CVRA at follow up 1 for patients and PHCPs, and (c) Enactment fidelity: use of 
credibility survey (described later). 
 
I. Pilot-testing phase procedures are summarized in Table 4 and figure 1. 
 
 
Table 4: Study Procedures 
 
Participant 
Procedure 
Baseline (Day 0) 
FU 1 (Day 0) 
FU 2 (2-3 month) 
FU (1 Year) 
Focus Group (RA) n=5 
Informed Consent 
√ 
Demographics 
√ 
Interviews 
√ 
CVR Survey 
√ 
Honorarium ($25) 
√ 
Pretest (RA) n=10 
Informed Consent 
√ 
Demographics 
√ 
You Tube Video 
√ 
Interviews 
√ 
CVR Survey 
√ 
Honorarium ($25) 
√ 
RA patients n=150 (EI) 
Informed Consent 
√ 
Demographics 
√ 
CVR Survey 
√ (In person) 
√ (In person) 
√ (In person) 
You Tube Video 
√ 
Honorarium ($25) 
√ 
√ 
Medical Chart 
√ 
√ 
RA Patients 
Informed Consent 
√ 
n=150 (non EI) 
Demographics 
√ 
CVR Survey 
√ (In person) 
√ (In person) 
You Tube Video 
Honorarium ($25) 
√ 
√ 
Medical Chart 
√ 
√ 
Review 
PHCP 
Informed Consent 
√ 
n=50 
Demographics 
√ 
CVR Survey 
√ (Email) 
√ (Email) 
You Tube Video 
√ 
 
Assessment of CVRA in Patients: After informed consent, each participant will be assigned a 
unique study number, which will be used to pair data from the pre- and post-intervention visits. 
Participants will be given an online survey to fill to assess their CVRA (Baseline Patient survey). 
A You Tube video will be shown to the patient on a tablet or a computer screen. The video 
recording will be of 20-30 minutes duration to avoid attention fatigue. Immediately after 
viewing the video, each patient will be given the CVRA online survey (Follow up Patient survey 
1). An exit online credibility survey will be used to gather feedback on credibility (user-
friendliness, content, understandability, and relevance), barriers experienced in using the web-
based intervention and any suggestions (open-ended). To assess retention of knowledge, 
between 2-3 months after the baseline visit the second post-intervention assessment (Follow 
up Patient survey 2) using the same CVRA survey will be administered online. Follow up survey 
 
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2 will be paired data. Medical charts records will be reviewed to quantify prevalence of CVRS 
by PHCP (within one-year period preceding baseline visit) at baseline and one-year follow up 
visit. For patients whose PHCP is not within Rush University Medical Center or John H Stroger 
Hospital, we will contact their local PHCP to obtain their pertinent medical records to quantify 
prevalence of CVRS by PHCP (within one-year period preceding baseline visit) at baseline and 
one-year follow up visit. Study participants will be asked to provide informed consent to 
communicate with their PHCP and access to their medical records to allow for assessment of 
CVRS. 
 
Assessment of CVRA in PHCPs: PHCPs will be contacted by email. Acceptance to proceed with 
the study online will be taken as informed consent. Online survey on their CVRA (Baseline PHCP 
survey) will be evaluated using case scenarios developed specifically for this purpose, followed 
by a You-Tube video developed using evidence based literature review, specially including 
autoimmune diseases and risk of CVD in women and RA. This will be developed at the level of 
the targeted audience and of 20-30 minutes duration. They will then be prompted to take the 
same case scenario based survey immediately to assess their CVRA (Follow up PHCP survey 1). 
An exit online credibility survey will be used to gather feedback on credibility (user-
friendliness, content, understandability, and relevance), barriers experienced in using the web-
based intervention and any suggestions (open-ended). 
  
I.3.Tools: 
 
Survey to assess CVRA: The survey will include the following components: 
 
1. The content of Patient surveys: Brief survey to collect demographic and self reported past 
medical history, family history, Social history and current medications, current weight and 
height. This will be administered to RA. 
 
Perception of risk of heart disease scale (PRHDS) (8), Heart Disease Fact Questionnaire 
(HDFQ)(24) will be modified to include some items on autoimmune diseases (including 
RA).Relevant components of the Behavioral Risk Factor Surveillance System (BRFSS) 2013 
survey from US Centers for Disease Control 2013 (22). This will include sections and modules 
on hypertension awareness (2 items), cholesterol awareness (3 items), chronic health 
conditions (12 items), tobacco use (5 items), pre diabetes and diabetes (10 items), 
cardiovascular health (7 items), Mental Illness and Stigma (10 items) and Emotional Support 
and life satisfaction (2 items). 
 
2. The content of PHCP surveys: A survey to assess CVRA in PHCPs will be developed. This 
survey development will be guided by the co-investigators and a questionnaire adapted from 
BRFSS and National Health and Nutrition Examination Survey (21) that was used previously in a 
similar study (8). The survey will be modified to include questions about CVRA in women and in 
autoimmune diseases. In addition, five hypothetical case scenarios will be created with various 
combinations of CVR in patients with and without autoimmune disease, and PHCP will be 
asked to select the CVRS indicated and strategies to optimize the patient’s individual CVD risks. 
 
The finalized surveys used for CVRA will be pretested among 5-10 RA patients and Physicians. 
 
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I.4. Incentives: For the participating RA, a $50 honorarium will be provided at baseline and 
follow up visit (Table 4). 
 
I.6. Data: Patient: Demographic (age, gender, ethnicity), Socio-economic status (education) and 
RA pertinent data (duration, presence of Rheumatoid factor and/or anti cyclic citrullinated 
peptide, bony erosions, medications (including steroids and biologics)). Self reported CVRA 
(Overall, Traditional and RA) will be assessed at baseline, immediately after viewing the video 
(follow up 1), and after 2-3 months (follow up 2). 
 
PHCP: Demographic (age, gender, ethnicity), type of physicians (Internal Medicine, Family 
practice, Rheumatologist), years since completion of residency in Internal Medicine or Family 
Practice, years since board certification, currently board certification status, setting of practice 
(academic, community or private practice), rank (if any), approximate number of RA patients 
seen yearly. Self reported CVRA (Overall, Traditional and RA) will be assessed at baseline, 
immediately after viewing the video (follow up 1), and after 2-3 months (follow up 2). 
  
Rates for CVRS at baseline and one year later for all RA patients (with and without EI) will be 
determined using a checklist. 
 
I.7. Proposed Analyses: (Table 1) SPSS software will be used for data analyses. Data distribution 
will be evaluated. Standard descriptive statistics will be used to analyze (a) patient 
characteristics: demographics, socioeconomic status, RA disease pertinent information; and (b) 
PHCP characteristics: demographics, type of physician and practice, board certification status, 
and annual count of RA patients. Comparison between demographics and disease 
characteristics of RA patients with and without EI will be conducted using chi square and t test 
analysis. 
 
I. 
Intervention development phase 
 
Aim 1. Qualitative analyses will be used to gather data about the content, relevance, ease-of-
use, credibility and delivery of the educational materials. This data will be used to refine the 
intervention. Descriptive EI fidelity monitoring data analysis will be undertaken (mean duration 
(Patient or PHCP) engagement YouTube EI video, completion of CVRA at follow up 1 for 
patients and PHCPs, and credibility survey data). Latter data will evaluate the need, ease, 
content and understandability, relevance of the EI. 
 
Engagement of audience will be judged through observation of body language RA patients 
during the entire study. In addition, feedback on the credibility of the intervention is being 
sought from both the patients and PHCP to establish its user-friendliness, content, relevance 
and understandability. Moreover, special efforts have been undertaken to limit survey burden 
and limit the duration of the EI to allow for full engagement of the participants. We feel that 
the technology platform being used for the intervention, brevity, its speed and ease will allow 
for greater audience engagement. 
 
II. 
Pilot-testing phase. 
 
 
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Aim 2A. To compare changes in CVRA in RA patients (a) after web-based EI. We hypothesize 
that 20% increase in overall CVRA (measured using standardized survey) at 2-3 months post 
intervention; (b) with and without web-based EI. We hypothesize significantly greater 
improvement in overall CVRA among RA patients with EI as compared to non EI group, at 2-3 
months. 
 
For patients (a) Overall CVRA (ORA), (b) Traditional CVR awareness (TRA) (c) RA CVR awareness 
(RARA) will be calculated. Awareness of all 18 CVR being tested (listed in section 1) will denote 
100% CVR awareness. To score ORA, patient’s correct responses denoting awareness to each 
of the 18 CVR being tested will be calculated in percentage of total responses. Domain-specific 
CVR awareness for traditional CVR (TRA) and RA (RARA) will be scored separately using the 
same strategy. 
  
Paired t tests to compare pre and post (Follow up 2) patient overall CVRA for our primary 
outcome of interest will be performed. Effect size of gains in overall CVRA for RA patients after 
EI (Follow up survey 2 and baseline) will be calculated. We will then compare percent change in 
overall CVRA rates (between baseline and follow up 2) using chi square analysis, among EI and 
non-EI patients with RA. A p value of ≤ 0.05 will be considered significant on two tailed tests. 
 
Aim 2B. To explore changes in cardiovascular risk screening (CVRS) at the primary health care 
visits among RA patients with and without EI. 
 
The medical records of RA patients with and without EI will be reviewed in electronic medical 
record, and analyzed using standardized checklist to assess the prevalence of CVRS and CVD 
risk reduction plan (meaningful use). Changes in CVRS rates among EI and non EI groups will be 
calculated, and compared using chi square analysis. A p value of ≤ 0.05 will be considered 
significant on two tailed tests. 
 
Exploratory analysis on improvement in PHCP overall CVRA using analysis similar to those 
discussed for aim 2a will be undertaken, a post hoc power analysis and effect size will be 
obtained. In addition exploratory univariate and multivariate logistic or linear regression 
analysis for patient and PHCP correlates of CVRS (baseline) and change in CVRS will be 
performed. Improvements in Traditional and RA-specific CVRA among RA and PHCPs will be 
assessed. 
 
J. Dissemination plan: The first step in disseminating outcomes will be to share the results of 
the study with the participants of the study, RA patients and their PHCP. 
 
Next, the results of the study would be submitted for presentation at a regional or National 
conference pertinent to primary care providers, rheumatology and preventive cardiology 
audience. Options include American College of Physicians, Quality improvement 
conferences, American College of Rheumatology, American Heart Association and Women’s 
health Conferences. Preparation and publication of the manuscript will be the pivotal step in 
disseminating the outcomes. Potential target journals for submission could be from Internal 
Medicine, Preventive Medicine, Cardiovascular, Outcomes or Rheumatology based. General 
Medicine Journals targeted could include Journal of American Medical Association, Lancet, 
 
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while cardiology journal circulation may be of interest. Rheumatology journals of interest would 
include Journal of Rheumatology, Arthritis Care and Research, Annals of Rheumatic Diseases or 
Arthritis Research & Therapy. Publication of data may encourage discussion or statement from 
the National organizations with strategies to increase CVD risk awareness and screening. 
Continuing medical education activities could be built based on the results dissemination. 
 
We feel that web-based EI could reach many more RA patients in a timely fashion without 
using many resources. In addition, this strategy could provide patients ease, flexibility and 
privacy with their educational module administration. National organizations such as the 
Arthritis Foundation and with support of such web-based resources through unrestricted 
educational funds could further mobilize this intervention to across the globe. 
 
 
K. Project Timeline: Major study processes and data accrual with corresponding anticipated 
timeline are shown below in figure 1. Deliverables and timelines for entire project are shown in 
Table 5 below. 
 
 
 
 
 
 
Patients & 
Figure 1: Main processes and data
Experts 
Develop Surveys: Patient and 
Develop  Educational 
Intervention 
1/2015-6/30/15 
PHCP 
videos 
 
 
 
 
Pretest 
 
 
 
 
 
Web EI 
 
PHCP of 
Web EI RA 
 
EI-RA 
Web EI 
(n=150) 
BASELINE 
FU-1 
Medical 
Surveys 
Surveys 
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Table 5: Project Timeline and Deliverables 
 
Deliverable 
Tasks 
Date 
Institutional Review Board 
Regulatory documents, HIPPA etc for RUMC 1/1/2015-3/1/2015 
and JSH 
Develop Study Documents 
Defining processes, training of research 
1/30/2015-3/1/2015 
assistant, study cordinator, 
incentives/parking organization 
CVR Surveys 
Modify the existent survey tools, Obtain 
3/1/2015 to 5/30/2015 
permission for use of surveys, Collaborative 
meetings to discuss content and format, 
Develop Case Scenarios for Physicians, 
Reviews, Refinement , Pretest surveys 
You tube Educational module-Pat Focus group, gather pertinent content, 
6/30/2015 
parse information, develop transcripts, 
assess understandibility level, schedule 
recording, recording, editing, pretesting, 
refining 
You tube Educational module-Phy Gather pertinent content, parse 
6/30/2015 
information, develop transcript, assess 
reading/understandibility level, schedule 
recording, recording, editing, pretesting, 
refining 
RA and PHCP recruitment status At RUMC and JSH 
7/1/2015 to 7/1/2016 
Medical Chart reviews for RA 
Identification of PHCP, review of records, 7/1/2015 to 7/30/2016 
patients Baseline 
data entry 
Identification of PHCP, review of Identification of PHCP, review of records, 7/1/2016 to 8/15/2017 
records, data entry-One year 
data entry 
Follow up 
Data Management 
Data entry, data cleaning, simple analysis 7/15/2015 to 10/15/2017 
Simple Results 
Statistical analysis, interpretation 
11/15/2017 
Presentation of Results 
Abstracts writing, submission and 
11/15/2017 to 1/1/2018 
presentation 
Manuscript 
Writing of manuscript, submission 
12/30/2017 to 3/31/2018 
 
L. Additional Information: Abbreviations glossary is provided below. 
 
RA (Rheumatoid Arthritis); PHCP (Primary health care provider); EI (Educational intervention); 
CVD (Cardio-vascular disease); CVR (Cardiovascular risk); CAD (Coronary artery disease); CVRA 
(Cardiovascular risk awareness); CVRS (Cardiovascular risk screening);RUMC (Rush University 
Medical Center), JSH (John H Stroger Hospital); PI (Primary investigator); Co-I (Co 
investigator); NIH (National Institute of Health). 
 
 
 
 
 
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