Improving Care for Gout in the Southeast Enhancing Gout Minority Patients Care and Participation in Gout Clinical Research
Phase: NA
Conditions: Gout
Sponsor: University of Alabama at Birmingham

 
 
 
IMPROVING CARE FOR 
GOUT IN THE SOUTHEAST 
ENHANCING GOUT 
MINORITY PATIENTS CARE 
AND PARTICIPATION IN 
GOUT CLINICAL RESEARCH 
(GOUT ED) 
PRINCIPAL INVESTIGATOR: 
KENNETH G. SAAG, MD, MSC 
NCT04075903 
VERSION 3;-  JANUARY 17TH,2024 

Summary of Changes from Previous Version: 
Affected Section(s) 
Summary of Revisions Made 
Rationale 
B.2.2 
 
 
B.5.4 
 
 
B.5.1, B.9.1.3 & 
D,D.2, D.3 
Patient enrollment up to 48 hours within 
presentation to ED, including text 
messaging as a method of contact, and 
updated study site information to 
include MGH, MetroHealth, and 
University of Iowa. 
To enroll patients that were missed in 
the ED when research staff is not 
available to enroll. Text messaging 
will be used to contact patients that 
could not be reached via phone call. 
 
 
 
 
 
 
 
 
 
 
 
 

Gout ED Protocol Version 10 
A. 
Significance ................................................................................................................................................ 4 
 
Public Health Impact of Gout and Gout in Emergency Departments .................................................... 4 
 
Clinical informatics to Improve Healthcare ........................................................................................... 4 
 
Scientific Premise ................................................................................................................................ 4 
 
Storytelling as Method to Improve Chronic Disease Care .................................................................... 5 
 
Minority Participation in Clinical Research and Use of the STRIDE/ REDCap Informed Consent 
Module to Improve Minority Participation in Clinical Research ....................................................................... 5 
 
Use of Patient Navigators to Improve Minority Health Care and Participation in Clinical Research ...... 6 
B. 
Approach .................................................................................................................................................... 6 
 
Overview of Study Design ................................................................................................................... 6 
 
Patient Population ............................................................................................................................... 7 
B.2.1 
Key inclusion criteria .................................................................................................................... 7 
B.2.2 
Key exclusion criteria:................................................................................................................... 7 
 
Gout Alert Development and Validation (Aim 1) ................................................................................... 7 
B.3.1 
NLP Algorithm .............................................................................................................................. 8 
B.3.2 
Alert Chart Validation.................................................................................................................... 8 
 
Video Intervention Development .......................................................................................................... 9 
B.4.1 
Identification of Video Themes and Content ................................................................................. 9 
 
Pilot Study Procedures (Aim 2) ............................................................................................................ 9 
B.5.1 
Initial Gout Evaluation During Index ED visit and Confirming Eligibility ......................................... 9 
B.5.2 
Intervention Arm -ED Encounter ................................................................................................. 12 
B.5.3 
Usual Care Arm -ED Encounter. ................................................................................................. 13 
B.5.4 
Gout CORT Registry and Biorepository Sample Collection (Aim 3) ............................................ 14 
 
Informed Consent (IC) ....................................................................................................................... 14 
 
Data Management and Entry ............................................................................................................. 15 
 
Study Outcomes ................................................................................................................................ 15 
B.8.1 
Primary outcomes Aim 1 and 2. .................................................................................................. 16 
 
Study procedures and Assessments ................................................................................................. 16 
 
Statistical Analysis Plan ................................................................................................................. 18 
B.10.1 
Primary Outcome Analysis - Aim 1. ............................................................................................ 18 
B.10.2 
Primary Outcome Analysis- Aim 2. ............................................................................................. 18 
B.10.3 
Secondary Outcome Analyses- Aim 2. ....................................................................................... 19 
 
Sample Size Considerations for Aim 2 ........................................................................................... 19 
C. Adverse Events ........................................................................................................................................ 19 
D. Study Sites ............................................................................................................................................... 20 
 
Participant Recruitment and Consent ................................................................................................ 20 
 
Participant Retention/Discontinuation ................................................................................................ 20 
 
Site Monitoring .................................................................................................................................. 21 

E. 
Institutional Review Board (IRB) ............................................................................................................... 22 
F. 
Administrative Procedures ........................................................................................................................ 22 
 
Protocol Amendments ....................................................................................................................... 22 
 
Compliance with law, audit, and debarment ...................................................................................... 22 
 
Compliance with Financial Disclosure Requirements......................................................................... 23 
 
Publication of results ......................................................................................................................... 23 
 
Changes in study personnel .............................................................................................................. 23 
G. Appendices............................................................................................................................................... 23 
 
Video Questions ................................................................................................................................ 23 
 
Abbreviations..................................................................................................................................... 23 
H. References ............................................................................................................................................... 25 
 
 
 

A. Significance 
We propose to develop and test a health systems intervention aimed at improving identification of gout in the 
emergency department (ED) setting and improving evidence based treatment, health–related quality of life, 
and gout patients’ experience with medical care. Our intervention also has the potential to reduce ED 
recidivism and enhance patient outcomes through the reduction of recurrent gout flares and future ED visits. In 
conjunction with the implementation science component, we will also enhance participation in research 
projects including the NIAMS-funded P50 INvestigationS In Gout, Hyperuricemia, and comorbidiTies 
(INSIGHT) Center of Research Translation (CORT) and leverage collaborative experience in the Southeast to 
enhance minority participation in ongoing and future gout clinical research. In keeping with the theme and 
leveraging the resources of our INSIGHT CORT, the UAB Minority Health and Health Disparities Research 
Center (MHDRC) (U54; National Institute of Minority Health and Health Disparities Center of Excellence) will 
work collaboratively to address and improve the quality of gout care for minority patients, particularly African-
Americans, and enhance gout research participation for patients who receive medical care through the ED.   
 
Public Health Impact of Gout and Gout in Emergency Departments 
Gout affects over 9 million Americans, 1-3 is the most common form of inflammatory arthritis in men, and is 
associated with poor quality of life.4-6 The frequency of gout is increasing worldwide, with prevalence rates 
estimated to be as high as 7% in older men.2, 7, 8 Gout leads to work absenteeism, loss of productivity, 
increased healthcare utilization, and premature death.9-13 In addition, gout and hyperuricemia are strongly 
associated with comorbid conditions such as chronic kidney disease, hypertension, cardiovascular disease and 
metabolic syndrome; conditions endemic in the Southeast.14 The US National ED Sample (NEDS) reports over 
200,000 visits annually with gout as the primary diagnosis, accounting for 0.2% of ED visits and over $280 
million in annual billable charges.15 In addition, NEDS data demonstrate a marked increase in the number of 
ED visits in the US for gout, from 168K to 214K between 2006 and 2014, respectively, with more than 
1.7 million people being seen in an ED for acute gout.16 Gout patients are preferentially prescribed opioids in 
over 50% of ED encounters, potentially attributable to ED physicians de-prioritizing gout management for 
patients with more severe conditions.17 Of note, Alabama and Tennessee are both in the top 10 states for 
opioid use.18 The UAB  EDs see a combined average of 1150 patients/year with gout. Older age, male sex, 
lower income, and being an African American were associated with increased ED gout visits and greater gout-
related expenses.19-21 With an aging population that is living longer with more serious chronic comorbid 
conditions, the societal burden posed by gout is growing exponentially and will substantially burgeon over the 
coming decades.22, 23 Based on this epidemiology, the ED is a natural place to improve gout care.  Most 
patients seen in an ED will be discharged home; many with inadequate follow-up. At the time of initial gout 
symptoms, patients have accumulated significant deposits of urate leading most to life-long intermittent if not 
chronic symptoms without treatment; gout is also quite frequently accompanied or preceded by other chronic 
diseases. 24-29 For those with comorbid chronic conditions, continuity of care is the cornerstone for improving 
patient outcomes and reducing healthcare-related costs.30-32 Because gout is a chronic condition which 
develops in the presence of hyperuricemia, achieving low serum urate concentrations long-term is essential for 
improving outcomes with gout.1, 33-36 However, an optimal strategy for gout care relies on a complete 
understanding of gout prevention, good continuity of care, patient empowerment to actively participate in their 
medical care, and adherence to treatments, which cannot be optimally achieved in the ED setting. 
 
 
Clinical informatics to Improve Healthcare 
Over the last 20 years clinical decision support tools have been implemented through electronic medical record 
(EMR) systems as a means to improve care delivery and outcomes for a variety of conditions in busy clinical 
settings. 37-41  In this project, we will develop electronic alerts that operate in both Cerner (North Kansas City, 
MO) and Epic (Verona, WI) platforms, two of the most commonly used EMRs in the U.S. We will build EMR 
phenotypes that will trigger best practice alerts (BPAs) based on clinical and demographic data available in 
real time, and we will test the diagnostic accuracy of these phenotypes to identify ED patients with acute gout 
flares. When an acute gout flare alert is triggered, clinicians can then activate an evidence-based order set and 
an ED research assistant can be alerted to further evaluate each patient for possible participation in our 
interventional study and the Gout CORT Registry and Biorepository.     
 
Scientific Premise 
The premise for this project is the known disparities in gout care, a higher prevalence of gout in the Southeast 
due to disproportionate endemic obesity and comorbidity burden, lack of gout knowledge/educational 
resources, and a perceived lack of access/adherence to primary and specialty gout care, which leads to 

excessive care delivery in the ED. From prior work in osteoporosis management we have found that stories 
can influence readiness to behavior change and can act as very likely mediator of follow-up visits for care. 42, 43  
Moreover, UAB  has proven expertise both in using the ED as a setting for biomedical research and for 
conducting innovative research to enhance minority patient recruitment into clinical trials.44-53 The premise for 
aim 3 of this study is that minority recruitment is low in most studies throughout the US and, under a 
collaborative NCATS grant aimed at overcoming some of these barriers, we have developed culturally tailored 
methods we will disseminate in this proposal.  Importantly, the current CORT projects that focus on gout 
mechanisms, genetics, and precision medicine for improving gout outcomes will be enhanced by this proposal 
are dependent on sufficient phenotypic, genotypic and other patient data as well as having a diversity of 
participants to markedly improve their generalizability. 
 
 
Storytelling as Method to Improve Chronic Disease Care  
Narrative communication, also known as “storytelling,” is a basic mode of human interaction. Messages that 
include storytelling are viewed as more personal, realistic, believable, and memorable compared to didactic 
forms of communication.54 Storytelling builds on the construct of homophily, whereby persons relate best to 
stories where they can relate to the narrator and can most easily be “transported” into the story being told.  
Video-based educational materials employing storytelling by patients, such as those proposed in our study, are 
engaging and influential in promoting behavioral interventions.55, 56 Storytelling promotes patient engagement 
when the patient identifies with the storyteller and can lead to a patient’s recognition of the need to treat the 
condition, improve health outcomes and more effectively confront a patient’s barriers to medication adherence, 
as shown by a meaningful improvement in blood pressure, shown in a recent clinical trial in mostly African 
American men with hypertension.55, 56 For example, storytelling promoted social support, decreased 
participants’ sense of isolation, relieved stress, boosted self-confidence and motivated behavior change in 
African Americans with diabetes.57 Storytelling in African Americans was better liked, enhanced recall, reduced 
counter-arguing, increased medical discussions with family members, and was perceived as more novel than 
an informational video.56, 58 The potential success of our proposed project, combined with other published data, 
will represent a major step toward demonstrating the effectiveness of storytelling to improve adherence to care 
in chronic diseases and will address research priority areas, i.e., health care disparities and health care 
delivery.59-63 For example, we developed a behavioral intervention using multimodal video-based narrative 
communication that increased the readiness for behavior change in women at high risk for future factures.42, 43 
Our team is actively using storytelling to improve medication adherence and outcomes among African 
Americans with gout in a project supported by a VA Merit Review Grant and led by our collaborator Jasvinder 
Singh, MD, MPH. We will adapt these already developed stories to make them relevant to this proposal, 
focused not only on initiation and adherence to gout medications, but to diet, exercise, weight loss and 
importantly, the need to have adherence on follow-up visits. Due to the intermittently symptomatic nature of 
gout, patients often don’t understand the risk of long-term disease, severity and susceptibility to disease 
complications, and, therefore, may not balance the barriers and benefits to these important health behaviors.64 
Storytelling will be adapted from our many experiences and used in this project to overcome barriers to gout 
flare management and clinical research participation. 
 
Minority Participation in Clinical Research and Use of the STRIDE/ REDCap Informed Consent 
Module to Improve Minority Participation in Clinical Research  
Despite healthcare disparities in gout and other leading chronic disease causes of morbidity and disability, 
racial and ethnic minorities are under-represented in important research studies that have potential to reduce 
these disparities. Currently, African American and Latinos represent fewer than 10% of patients enrolled in 
clinical trials, according to the National Institute on Minority Health and Health Disparities.45-50 Minority 
participants often face particular barriers to enrollment in clinical research including skepticism based on 
distrust and negative connotations, miscommunication, and confusing procedures.46, 65 Participant barriers 
include lack of trust stemming from historical abuses, as well as limited research literacy, defined as “the 
capacity to obtain, process and understand basic information needed to make informed decisions about 
research participation”, each of which may work independently or in concert to preclude research 
participation.15, 16  
 
Recent revisions to the Common Rule highlight the importance of transparency and simplification of informed 
consent documentation and description of research projects.66 In an effort to address these issues and improve 
the engagement of minority population in clinical research, UAB, in collaboration with VUMC and the University 
of Massachusetts Medical School, have been working together through the National Center for Advancing 

Translational Sciences (NCATS)-funded STRIDE initiative to define methods aimed at improving minority 
enrollment in clinical trials. A key to addressing this issue is personalization and tailoring of consent materials 
to meet the needs of diverse prospective participants including under-represented minority groups. The 
STRIDE intervention consists of integrated components, all supporting the information exchange during the 
informed consent process: i) REDCap software electronic consent (eConsent) platform, as a way to provide a 
customized enrollment experience in a literacy and culturally-sensitive manner,  and  ii) storytelling, as a way to 
enhance understanding and relevance of the informed consent and research studies in general. These 
components were carefully designed and piloted through an iterative collaborative process with community 
stakeholders and investigators, and they will all be available to the project proposed.  
 
 
Use of Patient Navigators to Improve Minority Health Care and Participation in Clinical Research 
To help address barriers to optimal minority health care and participation in clinical research, Mona Fouad MD, 
Director, UAB Minority Health and Health Disparities Research Center (MHDRC) and Senior Associate Dean, 
Diversity and Inclusion, and her team have catalyzed the development of implementation strategies for the 
inclusion of underrepresented populations in clinical research. As part of this effort, we will leverage this team’s 
successful strategies including the use of patient navigators (a trained, lay individual of similar age, cultural 
background, and region, who provides personal guidance to patients) in clinical research and health care, 
using the Community Health Advisors Model Strategy.67 Work at UAB has shown that lay navigator assistance 
in oncology results in striking increases in patient referrals, a doubling in enrollment and significant increases in 
patient retention.45-48 This model is based on the notion that individuals who are trusted and respected by 
community members are “natural helpers” and have interest in improving the health status of individuals in 
their communities. These advisors engage “hard to reach” populations, reduce barriers to health access and 
encourage healthy behaviors. Through the efforts of the MHDRC UAB U54 and Center for Clinical and 
Translational Sciences (CCTS) Partner Network, we have successfully implemented and disseminated patient 
navigation strategies to advance recruitment and retention of minorities in health care programs as well as 
clinical and translational research initiatives.67-71 As part of the proposed project, patient navigators will provide 
continuity of care during transition from the UAB ED and facilitate access to post-gout flare healthcare services 
needed for preventing recurrent flares.   
While there have been numerous ED-based referral focused initiatives implemented in the last 20 years to 
help redirect patients seeking care in the ED to more appropriate care that provides for continuing disease 
management in the areas of mental health/substance abuse, palliative care, cancer, and osteoporosis, to our 
knowledge, our study is the first proposing such an intervention for gout.72-76 Other innovations are the multi-
modal methods we will test to improve care using a point of care EMR alert, culturally tailored educational 
material including stories delivered on a tablet computer in the ED, lay-navigators, and tailored material to 
promote minority participation in research.  
B. Approach 
 
Overview of Study Design 
The study will be conducted within 4 geographically diverse medical centers and will harness the existing 
collaborative efforts of multi-disciplinary investigative teams with expertise in gout clinical investigation, health 
services research, emergency medicine, minority health, and clinical informatics. We bring together expertise 
from two Southeast Clinical and Translational Science Awards (CTSAs) and expert consultation from 
colleagues at another CTSA (UMass), already collaborating with us on improving minority recruitment in 
clinical trials.  We will first identify gout patients in EDs using complementary innovative clinical informatics 
methods. We will create simple, “light-touch,” generalizable strategies in an integrated gout education program 
with previously proven successful components in other diseases, aimed to streamline evidence-based care for 
gout flares in the EDs and will test its effectiveness on adherence to follow-up care, satisfaction, health-related 
quality of life and appropriate therapeutic utilization. Our overarching goal is to improve patient experience with 
gout medical care, appropriate continuity in follow-up, health related quality of life, lower health service 
utilization, decrease opioid use, and enhance other standard gout outcomes (use of urate lowering therapy, 
weight reduction, and flare frequency) in our regional medically underserved population enriched for minority 
patients. Concurrently, we will improve the generalizability of findings resulting from our ongoing CORT 
projects by supporting engagement and enrollment of these patients into our Gout Registry and Biorepository 
though a novel culturally-sensitive informed eConsent process adapted from our existing collaborations. 
As part of our ongoing CORT we have developed methods of patient identification and recruitment for 

participation in the CORT Gout Registry and Biorepository.  These efforts have focused on UAB EMR 
searches utilizing i2b2 interface to identify gout patients not currently receiving medical care in UAB 
Rheumatology clinics (i.e. diagnosed through ED, primary care clinics) and have systematically approached 
them to offer participation in our Gout Registry and Biorepository. We oversampled for African American 
populations through screening phone calls and medical record review.  A recent pilot of this recruitment 
workflow identified 3,032 African Americans patients seen in UAB clinics with an ICD 9/10 gout diagnosis 
between September 2017 and August 2018.  We generated a random sample of 400 patients for initial contact. 
From this randomly selected sample of African Americans with gout who had been seen at least once at UAB, 
15% expressed interest in a research visit and slightly over a 1/3 of those patients (6% overall) successfully 
enrolled in the CORT Gout Registry and Biorepository.  Our strategy has had a 96% success rate in identifying 
patients from administrative data who later satisfied the 2015 American College of Rheumatology (ACR) and 
European League Against Rheumatism (EULAR) gout classification criteria that utilizes a easy to use scoring 
system (≥8 points indicates gout).77, 78 These patients joined an existing, well-characterized Gout Registry and 
Biorepository bringing our total number of patients enrolled to 257 with samples collected from 154. These 
samples are being used in current CORT projects to investigate the metabolomics and genetics associated 
with gout, as well as to optimize lab methodologies (e.g. oxidative stress testing). This experience helped 
refine our recruitment strategies and through the incorporation of STRIDE to enhance participation, which we 
will deploy in this revision project, we are confident that we will be able to successfully engage minority patients 
with gout.  
 
Aims 1 and 2 
We propose an integrated and coordinated pathway from the ED to gout continuity of care through primary 
care and specialty providers. We will leverage innovative recruitment and retention strategies that utilize lay 
patient navigators at our UAB site, a 
strategy that was successfully 
pioneered at UAB by our MHDRC 
team led by Dr. Fouad for medical 
care and research in other 
disciplines including oncology.48, 69-71  
Patients classified as having gout 
based on the 2015 ACR/EULAR 
criteria77, 78 who meet the 
inclusion/exclusion criteria (noted 
below) will be randomized 2:1 
stratified by race/ethnicity, to the 
intervention or control arm of this 
demonstration study.  Figure 1 
provides an overview of the study 
design.  
 
 
Patient Population 
B.2.1 Key inclusion criteria 
• 
Meets Gaffo criteria for current gout flare or ED physician diagnosis of acute gout flare 
• 
Adult > 18 years of age,  
• 
Able to communicate and understand English language (a future objective, with additional resources, 
will include Spanish translation of all study materials).  
• 
 
B.2.2 Key exclusion criteria:  
• 
joint complaint related to significant trauma or recent surgery (< 1 month) 
• 
life expectancy of < 6 months,  
• 
current critical illness leading to admission to high acuity medical care unit (ICU, stepdown unit) or 
requiring surgical intervention (general anesthesia); confirmed septic arthritis or joint infectious arthritis. 
 
Gout Alert Development and Validation (Aim 1)  
Figure 1. Improving ED Gout Care- Study Design 
 

Prior to the start of the study, clinical staff working in the UAB  ED will participate in sessions where they will be 
trained and coached to appropriately use the novel gout alert for acute gout (flare) identification. Training will 
occur during monthly face-to-face meetings and via electronic communication (email, list-serves, social media 
and study website, short training videos). Since busy ED physicians and staff may fail to recall the details of 
the study or its purpose in real time, we will build electronic reminders (gout alerts) to notify staff to potential 
eligibility of patients during the ED visit. We will also generate monthly reports that document the number of 
patients with potential acute gout flares and compare to the number of patients approached by the on-call 
research coordinator located in each ED.  De-identified reports will be shared with practicing clinicians to 
provide feedback on performance. UAB  deploy over 200 different types of alerts, including drug interaction 
alerts from the Cerner and Epic systems, including both standard alerts and custom alerts that may be 
overridden by the clinician users. For this study, we will implement a custom alert than can be overridden at the 
point of care for the Epic and Cerner systems to identify emergency patients who may be having a gout flare. 
Administrative billing codes (ICD 10), medications (e.g. urate lowering therapy (ULT) such as allopurinol) and 
healthcare resource utilization of participants will be captured using structured data in conjunction with 
keywords in unstructured fields. Using this approach, we will identify patients with an existing gout diagnosis 
and those newly diagnosed during the index ED visit with gout when the alert is activated.  
B.3.1 NLP Algorithm  
The NLP algorithm to create the gout alert in the EMR will be structured and refined with serial pilot testing and 
chart validation (see B.3.2) initially in the Cerner environment at UAB. We will annotate a set of ED triage chief 
complaint notes and problem lists for the presence of gout flares and implement a simple algorithm for gout 
flare ED alerts. The keywords will be used to identify gout patients in the ED possibly experiencing a flare. 
Patients with a potential acute gout flare will be identified using structured data elements (e.g. prior ICD code 
for gout) and keywords such as: “gout,” “podagra,” “monoarthritis,” “toe pain” from all data fields in the EMR.  
These terms shown in Table 1 will be developed as part of the alert development and NLP algorithm. The alert 
algorithm will be developed iteratively using a gout enriched data cohort until acceptable performance is 
achieved. Keywords will be normalized using NLP to identify gout patients in the ED possibly experiencing a 
flare. The algorithm will work on simple Boolean logic and regular expressions and will identify a gout flare 
based on the presence of a gout keyword to the left of any of the PMH-GAZETEER words OR if there is both a 
location from the LOCATION-GAZETEER and the gout keyword in the past medical history. 
Table 1. Example Description Terms and Gazeteer  
GOUT-GAZETEER 
Case Insensitive 
LOCATION-GAZETEER 
Case Insensitive 
LOCATION-GAZETEER 
Case Sensitive 
PMH-GAZETEER 
Case Insensitive 
Gout 
toe 
knee 
LLE 
pmh 
Pain 
ankle 
wrist 
RLE 
hx 
Tender 
foot 
feet 
LUE 
pmxh 
Swelling 
thumb 
finger 
RUE 
pmx 
Swollen 
arm 
elbow 
UE 
Stiff 
shoulder 
hip 
LE 
. 
The alert algorithm will be developed iteratively in the Cerner environment until acceptable performance 
achieved. Once acceptable performance is achieved the keywords used and any rules will be provided to other 
sites as they are identified and approved by the UAB IRB for deployment in the their EHR environments.  
 
B.3.2 Alert Chart Validation 
An alert development dataset will be created by identifying patients at UAB with an ED visit starting in January 
2020 and working back until sample size is met. A random sample of 100 charts with an ICD10 code for gout 
and 50 charts with no ICD10 code for gout (but for whom the alert was triggered) will be identified and 
reviewed by two trained abstractionists.  Data abstraction will look to confirm:  1) a prior history of gout and 2) a 
gout flare during the time of the ED visit diagnosis; or 3) other potential diagnosis. The review will include past 
clinic notes for documentation of a diagnosis and clinical features of gout (based on 2015 ACR/EULAR 
classification criteria for gout), medication lists for drugs used for treatment of gout, review of laboratory and 

other diagnostic tests (serum urate and joint fluid urate results), imaging studies consistent with gout diagnosis 
and management (joint radiographs, ultrasound and CT/MRI) and detailed review of the ED visit to confirm 
acute gout flare at that time.  The abstraction form will be piloted before implementation, and necessary 
changes will be made. Following abstraction of chart data elements and compilation of the 150 patient dataset 
by the physician trained research coordinators, two expert rheumatologists will complete a diagnosis 
confirmation review. In the event there is discordance a third rheumatology clinician will serve as an 
adjudicator.  
 
Video Intervention Development 
In order to develop the video intervention, a group of patients who are currently successfully managing their 
gout will be interviewed and asked to tell their stories about the importance of gout care.  The overall goal of 
the gout interviews is to improve patient gout knowledge and encourage actions that will prevent flares, 
destigmatize gout, and enhance readiness to adopt available long-term treatments including medications, diet, 
and exercise. Interviews will be conducted to cover a variety of race/ethnicities that might be seen in the ED 
with gout.  Videos will be compiled from these patient interviews as anecdotes taken from these gout patients 
and presented to people in the ED who are being seen for a potential gout flare. These videos will seek to 
motivate participants to seek further gout care from their primary physician and the importance of taking ULT 
medications post-ED discharge. 
Gout patients will be identified through UAB rheumatology/gout clinics and previous UAB led gout clinical trials, 
and invited to participate based on their previous successes in controlling their gout (lowering of uric acid, 
resolution of tophi, or reduction in frequency of gout flares). Willing participants will be sent the interview 
questions ahead of time to familiarize themselves with the interview prompts, and to allow for time so they think 
about their responses. Upon arrival, the participants will be given an overview of the filming process, 
incorporating a detailed walkthrough of the entire filming protocol including review of the question prompts. 
This will be done so the interviewees may get comfortable with interview format and filming procedures. The 
interviews will be conducted by a research staff member in a conversation-style format allowing the interviewer 
to expand and deviate from the interview guide to expand further on any topics expressed by the interviewee. 
Participants will be asked to repeat the question before answering each question, and will be allowed to 
rephrase or repeat any information presented if unclear. Upon completion, all participants will be debriefed and 
thanked for their participation. 
B.4.1 Identification of Video Themes and Content  
After completion of video recordings all videos will be reviewed by project investigators/staff and edited for 
relevant themes/content based on a group process completed by study rheumatologists.  This group of 
rheumatologists will be asked to refine the overall message through a group process exercise.  Each 
participant will be asked to generate a list of 5-10 messages that they think will motivate patients to 1) follow up 
for their gout once discharged from the ED and 2) take medications for gout. Once these lists are generated 
they will be compiled and sent out to each participating rheumatologist to be ranked from most to least 
important. This will be followed by a conference call to discuss why they voted in a particular way, and lastly, a 
second round of voting to determine the most useful ideas that will be communicated to the ED patients.  We 
will then use the messages that are identified by these expert rheumatologists as the most important to relay to 
their gout patients as a roadmap to compiling the storytelling videos, and to identify any missing themes from 
or anecdotes in our videos that need further elaboration by patients. 
 
Pilot Study Procedures (Aim 2) 
B.5.1 Initial Gout Evaluation During Index ED visit and Confirming Eligibility 
Following the gout alert activation in the ED, research assistants housed in the UAB ED  will interview patients 
in person to further determine possible eligibility, and if potentially eligible, to consider randomization. 
Randomization, if approved by the ED physician, will be conducted by the research assistant in the ED using a 
random number generated programmed on the tablet computer that will serve as the primary interface for the 
study. If the patient was not enrolled in the study at the index ED visit and the treating physician’s diagnosis 
was acute gout flare; the patient may return to the ED for enrollment in the study no later than 48 hours after 
presentation to the ED. For the purposes of this study, this is considered part of the index ED visit if the patient 

is enrolled within 48 hours of initial presentation to ED. This will also include patients admitted to observation 
status or in-patient status (excluding ICU and surgical admissions, see exclusion criteria above). 
Workflow: 
Patients present to ED
Patient identified with 
possible gout flare
Identified by Alert
Identified by RA
Identified by ED Physician
After triage, wait until patient is roomed 
and undergoes initial evaluation
Answer basic exclusion/inclusion 
criteria questions
Is CC related to a 
joint complaint?
STOP, patient 
ineligible
No
Is CC related to 
significant trauma?
Yes
STOP, patient 
ineligible
Yes
Is CC related to 
recent surgery?
STOP, patient 
ineligible
Yes
RA to Calculate Gaffo Gout Flare 
Probability:
- Is there presence of at 
least 1 warm joint? +1
- Is there presence of at 
least 1 swollen joint? +1
- Is there pain at rest score >3 on 0-10 
point numerical scale? +1
- Did the patient
define this as gout flare? +1
RA discusses with ED 
physician
Not 
available
Is ED 
physician agreeable to 
enrollment?
STOP, patient 
ineligible
No
Yes
RA approaches patient
Open GOUT-ED REDCap project on iPad, 
add new record and fill out initial 
screening information
No Not sure
RA approaches patient
No
Not sure
Open GOUT-ED REDCap project on iPad, 
add new record, follow prompts
 

Is total score <2?
STOP, patient 
ineligible
No
Introduce 
patient to study, are they 
interested?
Yes
Complete screening phase
STOP, patient 
ineligible
No
Yes
Complete Consent phase: 
Go to Consent screen in REDCap and 
open as a survey. Patient reviews and 
signs consent form via the iPad.
Give Consent/HIPAA form information 
sheet to patient
Complete ED Survey:
Give patient the iPad again and open 
'ED Survey'. (Follow procedure to Open 
as a Survey)
Patient fills out social security form 
and payment verification form
As the patient is finishing the consent & 
survey, fill out label for tube of study 
blood.
Ask nurse to draw the study blood.
Store study blood following procedure
Give iPad to patient, they will be 
prompted to watch video, then retrieve 
iPad from patient.
Give patient Navigator information card
Thank patient for their time, and depart
RANDOMIZATION
RA clicks “randomize” button, than 
gives iPad to patient for intervention 
component
RA notifies ED physician that 
patient meets screen criteria
Is ED 
physician agreeable to 
enrollment?
STOP, patient 
ineligible
No
Yes
Is ED physician 
aware of possible 
enrollment?
Yes
No
Does 
patient currently have 
septic arthritis (per documentation 
or per ED physician)?
STOP, patient 
ineligible
No
Yes
Will patient 
likely be admitted to a high acuity 
medical care unit (ICU)?
STOP, patient 
ineligible
No
Yes
Not sure
Was ED 
physician diagnosis ‘acute 
gout flare’?
Yes
No
Randomized to INTERVENTION
Randomized to CONTROL
Give iPad to patient, they will be 
prompted to watch video, then retrieve 
iPad from patient.
 
 

B.5.2 Intervention Arm -ED Encounter 
During the index ED visit, patients will be offered video-based patient education employing storytelling aimed at 
promoting evidence-based gout management. These stories will be shown on a tablet computer used in the 
ED and also available to patients on the web. This health literacy-appropriate and culturally-sensitive 
educational “storytelling” intervention will aim to improve patient- knowledge of gout, readiness to adopt 
available treatments, understanding of potential therapeutic complications of therapies and lifestyle 
approaches to preventing future flares (e.g. weight loss, increased exercise, improved nutrition, and decreased 
alcohol use).55, 56 The educational materials will include stories about the appropriate need to start and 
continue on urate lowering therapy (ULT), which is generally recommended by groups such as the ACR when 
gout flares occur more than 2 times per year; for flares occurring in the setting of gout comorbidities such as 
significant chronic kidney disease (grade 2 or greater) or urolithiasis; or if there is evidence of gouty tophi on 
examination or by imaging studies.80 Stories will emphasize the key importance of seeking appropriate follow-
up care for gout management; the primary outcome of this study. This intervention component will be provided 
on a tablet computer delivered by ED research assistants to the patient and/or their family, if present. Content 
of the videos will be adapted to include information on the link between flares and uncontrolled hyperuricemia 
and used to promote shared decision-making,53, 81 self-efficacy for gout management,55, 56 and to improve 
adherence to ULT, and reduce reliance on opioid analgesics.42, 43   
The ED team will provide care referral to relevant medical services that might benefit their gout under their 
existing health plan, such as primary care services (if they do not already have a primary care physician) or to 
the Cahaba Medical Group (UAB Site) for those under insured or without insurance. 
A lay patient navigator working with and trained by the UAB MHRC and the gout research team will contact 
patients seen in the UAB ED via phone within 72 hours following the ED visit. During this initial phone 
conversation the navigators will: 1) conduct a baseline assessment to identify barriers to attending an 
outpatient visit for gout care (e.g. transportation) and to adhering to gout treatment recommendations 
(medications, diet, exercise) and, 2) determine the level of support and assistance (e.g. transportation support) 
needed by patient. The patient navigator will help facilitate the follow-up visit with a primary care/gout 
specialist, identify any barriers (e.g. lack of trust in primary care physician or/and healthcare system),82 and 
provide institutional/community resources that can be mobilized for the patient. The navigator will conduct two 
additional follow-up calls at approximately one month and at one week (anticipated) prior to the visit to confirm 
the appointment time, the level of support needed (as needs may have changed), and encourage him/her to 
keep their appointment. In the unlikely event that the appointment with the PCP/gout specialist is sooner than 
one month, this one-month pre-appointment call will be eliminated and the navigator will have only two calls 
with the patient (Figure 2). Navigators will be trained using didactic materials, including case simulations and 
role-play, that will be prepared as part of this study. Participants at all sites will be provided a card with a group 
picture of the patient navigator team that will contact them. 
 
 
 

Figure 2. Study Workflow – Patient Navigation 
First contact:
(within 72 hours of ED visit)
Call patient on phone
Patient enrolls in study and 
randomized to intervention 
arm
Facilitate scheduling of follow-up appointment 
with current or new physician
Identify any other barriers to follow up care and level 
of support required
Record date of scheduled appointment if known
Facilitate scheduling 
appointment and record in 
REDCap
No
Does 
patient have a PCP or 
rheumatologist?
Assist with 
scheduling follow up
Assist with scheduling 
new patient visit
Yes
No
Is there an
appointment 
scheduled?
Navigators notified by email 
with patient’s contact 
information
Second contact:
Call patient aprx 1 week 
prior to appointment
Second contact:
Call patient 1 month after 
ED discharge
Assess change in barriers (i.e. 
transportation, social support)
Notification sent to team that 
patient was contacted.
Is it 
scheduled within 1 
month?
Second contact:
Call patient 1 month after 
ED discharge
Yes
Yes
No
Encourage patient to keep 
their scheduled appointment
Assess change in barriers (i.e. 
transportation, social support)
Encourage patient to keep 
their scheduled appointment
Third contact:
Call aprx 1 week prior to 
appointment
Encourage patient to keep 
their scheduled appointment
 
B.5.3 Usual Care Arm -ED Encounter.  

Similar to the intervention arm patients randomized to the control arm at both institutions will be provided with a 
follow usual care referral to relevant medical services that might benefit their gout under their existing health 
plan, such as primary care services (if they do not already have a primary care physician) or to the Cahaba 
Medical Group at the UAB Site. Timing for this planned follow-up will be consistent with typical wait times to 
see a specialist or general practitioner for their gout. In most US metropolitan areas, given the limited national 
supply of rheumatologists, the average wait time is 9 to 10 weeks to see a new patient.83  To address the issue 
of an “attention control,” all persons randomized to the control arm will receive existing educational e-material 
on the tablet computer on routine preventive health measures including vaccinations and age-appropriate 
preventive care measures unrelated to gout or the study outcomes. These materials will also be emailed to 
them.  
B.5.4 Gout CORT Registry and Biorepository Sample Collection (Aim 3) 
Blood specimens and synovial fluid (if drawn) will be collected for the Gout CORT Registry and Biorepository at 
the time of the enrollment visit in the ED. Blood specimens and synovial fluid (if collected as part of ED visit)  
will be collected by ED study coordinators/RAs in PAXGene RNA/DNA tubes and stored in -80º freezer until 
transport to the UAB Division of Clinical Immunology and Rheumatology for processing and long-term storage 
(see Shipping Manual). All samples will be labeled with a patient identification (PID) number and date of visit. 
Documentation of specimens will be stored in the lab computer database, secured and password protected, 
and distributed to only to authorized personnel. Banked specimens will be available for future research in gout, 
hyperuricemia, and gout-comorbid conditions (e.g. hypertension, diabetes) and will include samples for 
genomic DNA, RNA expression, and epigenetic analysis.  
 
 
Informed Consent (IC)  
 
Our e-Consent platform includes components designed through the STRIDE project to enhance the informed 
consent process in a health literacy and culturally sensitive manner, utilizing a simplistic layout with essential 
features of the consent process described at launch, socio-demographically diverse avatars (selected by 
patients) that walk through elements of the consent process, definitions for complex terms, and videos to 
demonstrate procedures. Storytellers share their experiences in research in a way that touches upon key 
elements, e.g. why research is important, societal gains from research participation and what to expect 
throughout study participation. The process of IC will be carried out by one of the study investigators in 
conjunction with the ED study coordinator/research assistants (RA) involved in the screening visit after the 
participant appears to meet the inclusion criteria above. ED RAs will invite patients in both study arms to enroll 
in the Gout Registry and Biorepository and will utilize enhanced informed consent material. During the initial 
ED visit, the RA will provide the study participant the electronic consent tool and launch the REDCap 
application. In keeping with the guidelines established by the revision of the Common Rule (Federal Register 
Volume 82, No. 12), the informed consent form (ICF) will begin with and include a summary with key 
information on the “5 factors” about the study that will be provided to facilitate the subjects' understanding of 
the proposed research and also ensure that they understand how their data and bio-specimens may be used. 
This includes a statement that 1) the project is research and participation is voluntary; 2) a summary of the 
research that will outline duration, purpose, and responsibilities of all parties involved; 3) potential risk or 
discomforts with participating; 4) potential benefits; and 5) alternatives to participation. In addition, the consent 
will outline the collection and the use of any private information and how specimens collected for laboratory 
analysis will be used.  Patients will provide electronic informed consent before any study procedures are 
performed. In addition, we will utilize enhanced consent materials developed for STRIDE to enhance minority 
participation. To enhance participation in our gout registry we will modify the STRIDE REDCap-based e-
Consent platform specifically for the GOUT registry and deploy culturally-sensitive stories with actual patients 
who have previously participated in registry-based research, which will describe the experience of participating 
in clinical registries. 
 
Participants will be given as much time as they need to read and ask questions about the ICF. The individual 
or patient’s legally authorized representative will be informed that he/she is not obligated to participate in the 
study and that it is strictly voluntary and that he/she may withdraw from the study at any time and that 
withdrawal of consent will not affect his/her subsequent medical treatment or relationship with the treating 
physician. The IC process will ensure that there is no penalty for not participating in a clinical trial and that 
treatment will not be compromised if individuals do not participate, or if they cease participation at any time. 

By signing the electronic consent form, the participant authorizes the use of their personal health information 
(PHI), that they understand the study and its benefits and risks, and agree to all other aspects of the study 
outlined in the form. It allows the participant the opportunity to decide whether they want to participate in a 
study. During this process, individuals will be informed of all aspects of the study so that they can make an 
informed decision. Participants will then confirm their willingness to participate in the research study by signing 
the ICF. A signed version of the consent form will be kept by the study staff in REDCap database and emailed 
to the participant following consent.  
The ICF contains the following: 
• 
Disclosure of relevant information to prospective participants about the research 
• 
The participant’s comprehension of the information 
• 
The participant’s voluntary agreement to participate in a research study without coercion or undue 
influence 
• 
Complete disclosure of any appropriate alternative procedures and their risks and benefits 
• 
Disclosure of the extent of confidentiality that will be maintained 
• 
Statement of compensation and/or medical treatment available if injury occurs 
• 
Name, address, and telephone number of the PIs 
If there is a change in any of the study procedures that may affect the participant, the ICF will be revised and 
approved by the Institutional Review Board (IRB). Any participants enrolled in the study prior to a change in 
procedures will sign the amended consent form. Signed consent forms will be kept as part of the study record 
for at least 7 years after completion of the study. Participants can withdraw their consent at any time by 
informing the study coordinator. 
 
Data Management and Entry 
 Patients and study coordinators will enter baseline demographic, gout history, patient reported outcomes 
(PROs) directly into electronic case report forms into a 21CFR and HIPAA compliant REDCap (Nashville, 
Tennessee) system. We will host REDCap on one of several access-controlled, encrypted servers housed at 
UAB. Subsequent PROs and other outcome data will be captured by phone in the same REDCap database by 
the study teams. Baseline laboratory data and medication data will be obtained from our respective EMRs and 
will be reviewed during the phone calls and by the research assistant during the ED visit. 
 
Study Outcomes 
Study outcomes (Table 2) will be collected from patients at 6 weeks and 3 months following the initial ED visit 
with questionnaires deployed using computer assisted telephone interviews (CATI) programmed in REDCap.  
Validated items about gout flares and gout medications have been used in the past by our team.84 
 
 

 
B.8.1 Primary outcomes 
Aim 1 and 2.   
The primary outcome of 
aim 1 will be the ability of 
the alert to successfully 
identify gout patients.  For 
aim 2, it will be the 
proportion of patients that 
have a follow-up visit 
addressing gout in the 3-
month period after the ED 
visit. Many gout patients 
are not adherent with their 
follow-up visits due to a 
lack of awareness of the 
consequences of untreated 
gout, poor care access, and/or inadequate assistance to obtain a follow up visit. Even rapidly-scheduled 
outpatient visits (next business day) following an ED encounter are only attended by 73% of those seen in a 
recent study and rates of post-ED follow-up for many chronic disease are closer to 50%.91, 92 Moreover, most 
patients, ~80%, leave the ED with knowledge deficits that impact adherence and outcomes.93, 94 Having a 
usual source of primary care and establishing continuity of care after an ED visit is critical to optimal disease 
outcomes in all chronic diseases including gout.30-32 This data will be captured both by self-report on surveys 
(this will be the primary study outcome) and by review of EMR data within our respective healthcare systems. 
While self-report will be impacted by recall and possible social desirability bias, this should be non-differential 
(bias towards the null).95  EMR data will be more accurate for some outcomes but will miss any gout care 
delivered outside our urban Southeastern medical centers and their satellite facilities. 
 Secondary outcomes - Aim 2 
1) Gout medical care- Self-reported flare rates will be captured using the Gaffo gout flare criteria (developed 
and validated at UAB) and adapted to self-report.79, 84 Uptake of evidence-based gout care will include self-
reported prescribing rates of ULT and opioid analgesics. We also will determine medication adherence based 
on participant self-report. Since obesity is a major factor associated with gout and weight reduction will be 
addressed in the stories (as well as how to avoid foods high in purines), we will examine changes in self-
reported weight between study entry and follow-up.  
2) Healthcare resource utilization- outcomes will include repeat ED visits (ED recidivism) and re-hospitalization 
rates. Outpatient visits to primary care and/or rheumatologists will be measured as the primary outcomes.   
3) Health-related Quality of Life (HRQL), Shared Decision Making and Perception – HRQL will be recorded 
using the European Quality of Life (EQ-5D) scale86-88. We will use the CollaboRATE scale, a brief patient 
survey focused on shared decision making, to measure perception of shared decision making from a patient 
perspective.90  
 
   Key Covariates Aim 2.   To better describe the population we are studying and to adjust for any 
potential imbalances that might not be addressed by randomization, we will collect key social determinants of 
health as covariates at baseline and for dynamic measures, again at month 3. These will include:health 
literacy,103 economic factors, transportation, discrimination and other key demographics such as educational 
level, community social economic status, and personal measure of socioeconomic status will be assessed 
using measures from the Behavioral Risk Factor Surveillance System.108 We will also capture the time of 
“stories” watched as a measure of dose-response of the intervention. 
 
 
Study procedures and Assessments 
 Screening, Enrollment, and Randomization (see Step-By-Step Guide in Appendix) 
Following the gout alert activation in the ED, research assistants housed in the UAB  ED will interview patients 
in person to further determine possible eligibility, and if potentially eligible, to consider randomization. Patients 
classified as having acute gout based on the Gaffo criteria who meet the inclusion/exclusion criteria will be 
Table 2. Specific Aim 2 Outcomes and Covariates 
Time Point 
Primary Outcome 
ED 
WK 6 
Mo 3 
Outpatient primary care or specialist visits targeted for gout*  
 
X 
X 
Secondary Outcomes / Covariates 
 
 
 
Social Determinants of Health 
 
 
 
Environmental and social factors 
X 
 
 
Gout medical care 
 
 
 
Number of gout flares (Gaffo criteria)79, 84 
X 
X 
X 
Rates of urate lowering therapy (ULT)** 
X 
X 
X 
ULT adherence 
 
X 
X 
Opioid prescriptions* 
X 
X 
X 
Weight reduction 
 
X 
X 
Healthcare resource utilization (visit number) 
 
 
 
ED visits (indicative of recidivism)*  
 
X 
X 
Hospitalizations* 
 
X 
X 
Health-related quality of life 
 
 
 
European Quality of Life (EQ-5D)86-88 
X 
X 
X 
Shared decision making: CollaboRATE scale 90  
 
X 
X 
* gout follow-up within 3-months of ED visit. ** Assessed through chart or system review 

randomized 2:1 stratified by race/ethnicity, to the intervention (storytelling +/- patient navigation) or control arm 
(usual care). All intervention arm patients in the UAB ED also will be assigned lay navigators to provide 
personalized support for care transitions and access to post-gout flare medical services needed for preventing 
recurrent flares.  
 
The following procedures will be completed during the index ED visit: 
• Review inclusion/exclusion criteria for registry participation 
• Informed Consent 
• Review of current/past gout status and medication chart review 
• Pain Assessment 
• Laboratory  
o Serum uric acid (from chart review) 
o Sample banking 
• Survey assessments 
o HRQL 
o SDOH 
 
Laboratory draw will be done in conjunction with ED care blood draw when possible. At the conclusion of visit, 
participants randomized to navigator arm will be provided navigators picture, contact information, and informed 
that they will receive a call w/in 72 hours.  
 
 Patient Navigator Contact 
 
72 hours post ED visit 
During this initial phone conversation the navigators will: 1) conduct a baseline assessment to identify barriers 
to attending an outpatient visit for gout care (e.g. transportation) and to adhering to gout treatment 
recommendations (medications, diet, exercise) and, 2) determine the level of support and assistance (e.g. 
transportation support) needed by patient. The patient navigator will help facilitate the follow-up visit with a 
primary care/gout specialist, identify any barriers (e.g. lack of trust in primary care physician or/and healthcare 
system), and provide institutional/community resources that can be mobilized for the patient.  
 
4 weeks post ED visit and 24-48 hours prior to appointment (anticipated) 
The navigator will conduct two additional follow-up calls at approximately one month (4 weeks) and in the week 
(anticipated) prior to their visit to confirm the appointment time, the level of support needed (as needs may 
have changed), and encourage him/her to keep their appointment. In the unlikely event that the appointment 
with the PCP/gout specialist is sooner than one month, this one-month pre-appointment call will be eliminated 
and the navigator will have only two calls with the patient.  
 
 6 Week Follow-up Assessment 
At 6 weeks following ED visit, participants will be contacted by the Coordinating Center (CC) to to assess 
project outcomes via a telephone survey. The following information will be collected, and data collected via the 
surveys and EMR. Following completion of the follow-up surveys the study coordinator will inform and debrief 
the patient that they participated in a study evaluating methods to improve continuity of gout care. The debrief 
will be conducted after the 1st survey. If RA the coordinator is unable to reach participant on the phone, the 
survey questions used to collect the primary outcomes will be sent via email or text messaging using Mosio, 
which is an HIPAA-compliant application. 
• Survey assessments 
o Patient satisfaction 
o HRQL 
o PROs 
• Updated medical history and review of concomitant medications 
• Assessment of Adverse Events (AEs) (as meeting NIH definition of Phase III study AEs will be 
collected)  
 3 Month Follow-up Assessment  

At 3 months (anticipated) post ED visit participants will be contacted to complete a second follow-up survey 
and end of study (EOS) via telephone to assess secondary outcomes (e.g. adherence to orders, medication 
RX, and labs (if ordered)).  
• Survey assessments 
o Patient satisfaction 
o HRQL 
o PROs 
• Updated medical history and review of concomitant medications 
• Assessment of Adverse Events (AEs) (as meeting NIH definition of Phase III study AEs will be 
collected)  
 Table 1 Visit Schedule  
Visit description / Study 
procedures 
Screening 
and 
Ernollment 
(ED) 
 
V1 
(phone) 
V2 
(phone) 
 
V3 
 
V4  
EOS 
 
Day 0 
72 Hours 
4 WK 
6 WK° 
3 MO 
Review of Inclusion/exclusion 
criteria following alert notification 
X 
 
 
 
 
Informed consent for INSIGHT 
Registry 
X 
 
 
 
 
Medical history  
X 
 
 
 
 
Laboratory 
 
 
 
 
 
SUA 
X 
 
 
 
 
Sample banking 
X 
 
 
 
 
Randomization 
X 
 
 
 
 
Patient Navigator Contact# 
 
X 
X$ 
X$ 
 
Updated medical history and 
concomitant medications 
 
X 
X 
X 
X 
Outcome ascertainment  
X 
 
 
X 
X 
Study debriefing 
 
 
 
X 
 
Assess AEs 
 
 
X 
X 
X 
°Primary outcome assessment will occur at any point upto 6 weeks post ED visit dependent on routine care 
visit; # For individuals randomized to navigation arm; $Navigator will contact participant in the week prior to 
scheduled follow-up visit 
 
 Blinding and Unblinding 
Participants will blinded to study assignment at enrollment, and following primary outcome ascertainment will 
be debriefed regarding the study and its purpose/goals. 
 Statistical Analysis Plan 
B.10.1 Primary Outcome Analysis - Aim 1.  
All analyses will adhere to the principles of rigor, reproducibility and transparency.109, 110  To determine the 
effectiveness of our alert system, we will examine the diagnostic properties (sensitivity/specificity) of the EMR 
alerts against a gold standard of NLP/ML detection (section C.4.2) 
B.10.2 Primary Outcome Analysis- Aim 2.  
Descriptive statistics, including measures of central tendency (means for continuous, proportions for 
categorical) and dispersion (variance, interquartile range) will summarize the distribution of baseline 
characteristics of randomized patients seen in both EDs. Descriptive statistics will be summarized by treatment 
arm as well as enrollment site. These statistics will inform the successfulness of randomization in creating 
comparable groups and ascertain our success in recruiting the populations we seek to target (particularly 
under-represented minorities). We also will compare the descriptive characteristics between those participants 
who do and don’t respond to follow-up surveys to detect and report any evidence of a selective non-response 
bias. The primary analysis approach for testing treatment effect will be a multivariable logistic regression 

model. We have chosen multivariable logistic regression over Cochran-Mantel-Haenszel approaches to allow 
for effect estimation of multiple covariates (race, gender, age) upon the primary outcome and to allow tests of 
interactions. Logistic regression models, including interaction terms, will be developed for 6 week outcomes 
and 3 month outcomes. We will examine the significance of the effects of the intervention as the outcome of 
persons receiving at least one outpatient gout follow-up visit at 3 months. We will analyze rates on an intent-to-
treat basis for the primary analysis. We will conduct all analyses using SAS 9.4 (Cary, NC) 
 
B.10.3 Secondary Outcome Analyses- Aim 2.  
Patient reported outcomes (PROs) and other process of care measures are of key interest in this study. We 
will examine secondary outcomes using either two-sample t-tests or multiple linear regression models. 
Distributional assumptions for residuals (normality, homogeneity of variance) will be examined using normal 
probability plots and residual plots. We will conduct a set of stratified analyses (contrasts) to examine how the 
between-site differences in approaches affect outcomes. First, comparing across control arms at the four sites 
we can estimate the impact of the intervention. Second, comparing across intervention arms at the foursites, 
we can estimate the difference attributable to case manager versus navigators when all individuals receive 
story telling. We will also examine sex as a biological variable as well as effects of age and race/ethnicity 
(heterogeneity of treatment effect). We will conduct sensitivity analyses using multiple imputations to account 
for missing data. While we provide an example sample size for one 
such measure, the evaluation of these endpoints will be hypothesis-
generating only. 
 
 Sample Size Considerations for Aim 2 
The funding announcement we are responding to seeks to improve 
care and reduce healthcare disparities for chronic disease in the 
Southeast. Thus, our approach to this study is to maximize the number 
of patients we can evaluate and improve gout care outcomes. We 
based our sample size considerations on experience from prior ED 
interventions, a pilot study conducted at UAB (section C.3.5) aimed at 
recruiting minority patients for our CORT Registry and Biorepository, based on a prior diagnosis of gout in the 
UAB EMR, and experience recruiting clinic patients. Annually in the ED, UAB see approximately 720 and 450, 
gout patients (with primary or secondary diagnoses), respectively. We 
anticipate identifying approximately 60% of these patients using the alert in real-time (n = 702). We also 
estimate that 80% of the ED physicians will respond to the ED alert and activate the gout order set and referral 
to the study coordinator (this rate may be improved with approaches discussed in section C.4.4) (n =560). 
Based on the results of our UAB pilot study (that contacted patients without a known recent flare/acute gout), 
we anticipate that 50% of these patients will remain eligible (based on medical record review and 
questionnaire). Thus, we conservatively estimate randomizing a combined total of approximately 280 gout 
patients annually between UAB . Despite plans to offer compensation for survey completion, we anticipate a 
30% rate of survey non-response for the primary outcome at 3 months (n = 196, in the per protocol analysis), 
which we believe will be slightly disproportionate between those receiving the intervention vs. control arm. 
Based on a sample size of 200 patients and assuming 2:1 randomization in favor of story-telling, the study will 
have 80% power to detect relative risks of 1.68 or below using a two-tailed Type I error rate of 0.05, assuming 
the proportion in the control arm scheduling an outpatient primary care or specialist visits targeted for gout 
within 3 months is above 30% (Figure 4). We picked these rates of visit follow-up visits to represent the range 
of rates of ED follow-up within 3 months for other conditions such asthma, stroke, and diabetes. 111-115    
C. Adverse Events 
As this study meets the NIH definition of a clinical trial, and as outlined in our data safety monitor plan we will 
collect information including diagnosis errors and participant anxiety from answering questions about their 
health status. All AEs will be captured on the appropriate electronic case report form.  
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant who received study 
intervention regardless of its relationship to the study intervention. This determination will be made by the study 
Figure 4. Power for Study Aim 2 
Relative Risk 

principal investigator. Preexisting conditions will not be considered adverse events; however, worsening of a 
preexisting condition may be considered an AE. AEs will be assessed as to their relationship to the research, 
severity, and duration. They will be documented appropriately, regardless of the relationship, with start dates 
occurring any time after informed consent until 7 days after the last day of study participation. AEs will be 
reported in aggregate to the Safety Officer (SO), Institutional Review Board (IRB) and NIAMS (through the 
Executive Secretary) as part of the routine safety report.  
A Serious Adverse Events (SAE) is any AE that results in death, is life-threatening, results in or prolongs 
hospitalization, or causes a permanent, persistent or significant disability. SAEs will be reported to the SO, 
IRB, and NIAMS (Executive Secretary) within 48 hours of the investigator becoming aware of the event. All 
SAEs will be followed until satisfactory resolution or until the site investigator deems the event to be chronic or 
the participant is stable.  
An Unanticipated Problem (UP) includes any incident, experience, or outcome that is unexpected and 
possibly related to participation in the research. UPs will be reported to the SO, IRB and NIAMS (Executive 
Secretary) within 48 hours of the investigator becoming aware of the event. 
A protocol deviation is defined as any substantial divergence from the IRB-approved study protocol. Any 
protocol deviation impacting patient safety will be reported to the SO, IRB and NIAMS (Executive Secretary) 
within 48 hours of the investigator becoming aware of the event; all other deviations will be reported as a part 
of the routine safety report.  
For additional details see Data Safety Monitoring Plan. 
D. Study Sites 
Investigational study sites are the University of Alabama at Birmingham and Vanderbilty University Medical 
center,  two large academic medical centers. The study site staff will ensure participants are consented and 
randomized in accordance with established good clinical research practices. Additionally, site investigators and 
their staff will be required to have prerequisite human subjects training, and will answer study related 
questions, as needed. 
• 
University of Alabama at Birmingham (UAB), Birmingham, AL, United States 
• 
Massachusetts General Hospital (MGH), Boston, MA, United States 
• 
MetroHealth Meidcal Center, Cleaveland, OH, United States 
• 
University of Iowa, Iowa City, IA, United States  
Approximately n= 168 participants will be enrolled at the UAB site and n = 112 from MGH, MetroHealth, and 
University of Iowa study sites. 
 Participant Recruitment and Consent 
The site study staff will: 
• 
Provide participants with adequate information concerning the study procedures, and scope 
• 
Provide adequate opportunity for the participant to consider all available options 
• 
Respond to the participant’s questions and concerns 
• 
Ensure that each participant understands all information provided 
• 
Obtain the participant’s written voluntary consent to participate 
• 
Sign the consent form as witnesses 
• 
Provide participants with a copy of the consent form 
 Participant Retention/Discontinuation 
Participants will have the option to withdraw from the study at any time. Study staff will make at least 3 
attempts to contact participants for study intervention visits (ie, Patient Navigation at UAB, MGH, MetroHealth, 

and University of Iowa) and outcomes assessment surveys at 6 weeks and 3 months. In order to minimize the 
chances of losing touch with patients, study staff are collecting email addresses and secondary contact names 
and phone numbers at the original emergency department visit. 
If study staff are not able to reach participants after at least 3 phone attempts, they will attempt to reach the 
secondary contact listed and/or send an email or text message to the participant. Text messages will be sent 
through the Mosio application, which is an HIPAA-compliant application.If these methods are not successful in 
contacting participant, then participant will be considered lost to follow up. 
 Site Monitoring  
Since this is a four site study, sites will be monitored by the PIs at each respective site according to established 
monitoring standard operating procedures (SOPs). Study site PIs will oversee the study to assure satisfactory 
data recording, adherence to the study protocol, Good Clinical Practice (GCP), and study medication 
accounting. UAB will monitor recruitment utilizing automated reports generated from the study database. UAB 
investigators and staff MGH, MetroHealth, and University of Iowawill have meetings monthly to monitor site 
recruitment and to determine any intervention for poor recruitment. The staff listed in the study roster will be 
responsible for all aspects of the trial. The study will be conducted in compliance with the protocol, 
International Council for Harmonization/Good Clinical Practice requirements (ICH/GCP), and applicable state, 
local and federal regulatory requirements.This includes but is not limited to the following: 
• 
Development of the study protocol 
• 
Development of the manual of procedures and its maintenance 
• 
Participant randomization  
• 
Development and implementation of the data flow and data tracking 
• 
Development of procedures for data entry, error identification, and error correction 
• 
AE monitoring and reporting 
• 
Quality control procedures  
• 
Submitting for IRB review and approval 
• 
Creating reports - enrollment, AEs, participant status (e.g., withdrawals) 
• 
Preparing and sending required reports to the Safety Officer and the IRB 
• 
Submitting all required reports to the study appointed Safety Officer. 
• 
Distribution of all changes, updates and policies of above mentioned reports and documents to the 
study appointed Safety Officer.  
• 
Maintaining the study binder (regulatory and clinical documents) 
• 
Preparation of all study materials- data tables, recruitment materials, official reports 
• 
Identifying, recruiting, screening, and enrolling participants 
• 
Obtaining IC from each participant 
• 
Protecting participants' rights 
• 
Collecting study data and following participants through study completion 
• 
Compliance and accountability of administration of study intervention 
• 
Communicating questions, concerns, and/or observations to the PIs 
All of the above activities will be carried out by the study’s project coordinators, project managers, and 
research assistants on a weekly basis (or more frequently as needed) and monitored by the principal and co-
investigators.  
In the event a problem is identified by either study site PI or staff, a teleconference/webinar will be scheduled 
to review the issue. These teleconferences/webinars will include discussions of overall recruitment status and 
identified barriers to recruitment experienced by the site with the study team. Detailed recruitment issues and 
suggestions will be discussed, as well as identified barriers.  

The study will be conducted under the auspices of the IRBs at UAB. The respective site investigators will 
ensure that an appropriately constituted IRB that complies with the requirements of the current International 
Conference on Harmonization (ICH)-GCP version or applicable regulations will be responsible for the initial 
and continuing review and approval of the clinical study. Prior to initiation of the study, the investigator will 
forward copies of the protocol, ICF, Investigator's Brochure, Investigator's curriculum vitae (if applicable), study 
advertisements (if applicable), and all other subject-related documents to be used for the study to the IRB for 
its review and approval. Before initiating a study, the site PI will have written and dated full approval from the 
responsible IRB for the protocol. The investigators will also promptly report to the IRB all changes in the study, 
all unanticipated problems involving risks to human subjects or others, and any protocol deviations, to 
eliminate immediate hazards to subjects. 
E. Institutional Review Board (IRB)  
The study site PI and/or staff will not make any changes in the study or study conduct without IRB approval, 
except where necessary to eliminate apparent immediate hazards to the subjects. For minor changes to a 
previously approved protocol during the period covered by the original approval, it may be possible for the 
study site PI to obtain an expedited review by the IRB as allowed. As part of the IRB requirements for 
continuing review of approved studies, the Investigators will be responsible for submitting periodic progress 
reports to the IRB (based on the Committee's requirements), at intervals appropriate to the degree of subject 
risk involved but no less than once per year. The study site PI should provide a final report to the IRB following 
study completion. To the maximal extent possible, these functions will be assisted by study personnel at the 
Coordinating Center (CC), the University of Alabama at Birmingham.  
F. Administrative Procedures  
 
Protocol Amendments 
Any change that affects the conduct of the study or significantly alters the protocol will be made in the form of 
an amendment. Any change or addition to this protocol requires a written protocol amendment that must be 
approved by the CC before implementation. Amendments significantly affecting the safety of participants, the 
scope of the investigation, or the scientific quality of the study require additional approval by the IRB. Examples 
of amendments requiring such approval are: 
• 
A significant change in the study design (e.g. addition of a new immunosuppressive) 
• 
An increase in the number of study visits and procedures to which participants are exposed 
 
Compliance with law, audit, and debarment 
Study site PIs will conduct the study in an efficient and diligent manner and in conformance with this protocol; 
generally accepted standards of GCP; and all applicable federal, state, and local laws, rules and regulations 
relating to the conduct of the clinical study. The study site PIs also agree to allow the IRB/Independent Ethics 
Committee, and regulatory agencies to inspect and review trial-related documents and procedures, and 
provide for direct access to all study-related source data and documents. The study site PIs will not seek 
reimbursement from patients, their insurance providers, or from government programs for procedures included 
as part of the study.  
The study site PIs will prepare and maintain complete and accurate study documentation in compliance with 
GCP standards and applicable federal, state, and local laws, rules and regulations.  
Study documentation will be promptly and fully disclosed by the study site PI upon request for inspection, 
copying, review, and audit at reasonable times by any regulatory agencies. The study site PI agrees to 
promptly take any reasonable steps that are requested by designated representatives as a result of an audit to 
cure deficiencies in the study documentation and CRFs. 

Persons debarred from conducting or working on clinical studies by any court or regulatory agency will NOT be 
allowed to conduct or work on this studies.  
 
Compliance with Financial Disclosure Requirements  
The study site PIs will provide accurate financial information to allow submission of complete and accurate 
certification and disclosure statements as required by US FDA regulations (21 CFR Part 54). This requirement 
also extends to sub-Investigators. 
 
Publication of results 
It is mandatory that the first publication will be based on data from both centers that has been analyzed as 
stipulated in the protocol. Participating PIs agree not to present data gathered from one center before the full 
publication, unless formally agreed to by all other PIs. 
 
Changes in study personnel 
If there is a change of any personnel listed on IRB personnel form, a new form reflecting the change will be 
completed and forwarded to the IRB along with the new staff member’s signed curriculum vitae, medical 
license (if relevant), and signed financial disclosure statement. 
G. Appendices 
 
 
 Video Questions 
Q1: What would be the compelling message(s) that videos should make to motivate patients to go to a clinic 
appointment for gout? 
- Gout is a chronic disease that requires ongoing treatment 
- Untreated gout affects quality of life 
- Visits to the ED can be prevented 
- Primary care physicians and specialists can prescribe effective medications for gout 
- The sooner the gout is treated the easier it would be to prevent gout flares and complications 
- Medications for flares can be prescribed by physicians outside the ED 
Q2: What would be the compelling message(s) that videos should make to motivate patients to take gout 
medications? 
- 
Effective medications for gout exist 
- 
Medications prevent gout flares 
- 
Goal of treatment is SUA < 6 mg/dL  
- 
Limiting certain foods/beverages is helpful, but by itself it is not effective 
- 
Medication regimens are relatively simple 
- 
Most people start taking 2 medications, but in about 6 months only one medication will be needed 
- 
Tophi will dissolve with medications 
 
 
 
 Abbreviations 
ACR 
American College of Rheumatology 
AE 
Adverse Event 
BPA 
Best Practice Alert 
CATI 
Computer Assisted Telephone Interview 
CC 
Coordinating Center 
CCTS 
Center for Clinical and Translational Sciences 

CFT 
Code of Federal Regulations 
CORT 
Center of Research Translation 
CT 
Computerized Tomography 
CTSA 
Clinical and Translational Science Award 
DNA 
Deoxyribonucleic Acid 
ED 
Emergency Department 
EMR 
Electronic Medical Record 
EOS 
End Of Study 
EQ-5D 
European Quality of Life Scale 
EULAR 
European League Against Rheumatism 
GCP 
Good Clinical Practice 
HRQL 
Health Related Quality of Life 
HIPAA 
Health Insurance Portability and Accountability Act 
IC 
Informed Consent 
ICD 
International Classification of Diseases 
ICF 
Informed Consent Form 
ICH 
International Council for Harmonization 
ICU 
Intensive Care Unit 
IPQ 
Illness Perception Questionnaire 
IRB 
Institutional Review Board 
INSIGHT 
INvestigationS In Gout, Hyperuricemia, and comorbidiTies 
MGH 
Massachusetts General Hospital 
MHDRC 
Minority Health and Health Disparities Research Center 
ML 
Machine Learning 
MRI 
Magnetic Resonance Imaging 
NCATS 
National Center for Advancing Translational Sciences 
NEDS 
National ED Sample 
NIAMS 
National Institute of Arthritis and Musculoskeletal and Skin 
Diseases 
NIH 
National Institutes of Health 
NLP 
Natural Language Processing 
PCP 
Primary Care Provider/Physician 
PHI 
Protected Health Information 
PHQ 
Patient Health Questionnaire 
PI 
Principal Investigator 
PID 
Patient Identification 

PRO 
Patient Reported Outcome 
RA 
Research Assistant 
REDCap 
Research Electronic Data Capture 
RNA 
Ribonucleic Acid 
SAE 
Serious Adverse Event 
SDOH 
Social Determinants Of Health 
SO 
Safety Officer 
SOP 
Standard Operating Procedure 
STRIDE 
Strengthening Translational Research in Diverse Enrollment 
SUA 
Serum Uric Acid 
UAB 
University of Alabama at Birmingham 
ULT 
Urate Lowering Therapy 
UP 
Unanticipated Problem 
 
 
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