Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management
Phase: NA
Conditions: Rheumatoid Arthritis
Sponsor: University of North Carolina, Chapel Hill

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Complete Title:  Enhancing patient ability to understand and utilize complex information 
concerning medication self-management 
Short Title:  
Patient ability to understand medication self-management information 
NCT Number: 
02820038 
Drug or Device Name(s): Not applicable 
FDA IND/IDE (if applicable): Not applicable 
Sponsor:  
The University of North Carolina at Chapel Hill 
Protocol Date:     September 24, 2019 
 
 
 
 
 
Study Principal Investigator: 
 Susan J. Blalock, PhD 
2213 Kerr Hall 
Campus Box 7573 
UNC Eshelman School of Pharmacy 
University of North Carolina at Chapel Hill 
Chapel Hill, NC 27599-7573 
Phone : 919-962-0080 
email: s_blalock@unc.edu 
 
 
 

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PROTOCOL TITLE:  
Enhancing patient ability to understand and utilize complex information 
concerning medication self-management 
Short Title:  
Patient ability to understand medication self-management information 
NCT Number:  
02820038 
 
Lead Investigator: 
Susan J. Blalock, PhD 
 University of North Carolina at Chapel Hill 
Protocol Version: 1.0  
Version Date: September 24, 2019 
 
 
 
 
I confirm that I have read this protocol and understand it.    
 
Principal Investigator Name:   
Susan J. Blalock, PhD  
 
 
 
Principal Investigator Signature:  
 
 
 
 
 
 
 
Date:   
 
 
 
September 24, 2019  
 
 
 
 
 

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TABLE OF CONTENTS 
 
 
Table of Contents ...................................................................................................................... 3 
Abbreviations and Definitions of Terms .................................................................................... 4 
Protocol Synopsis ...................................................................................................................... 5 
1 BACKGROUND  AND RATIONALE ............................................................................................ 8 
2 STUDY OBJECTIVES ................................................................................................................ 12 
3 INVESTIGATIONAL PLAN ....................................................................................................... 12 
4 STUDY PROCEDURES ............................................................................................................. 14 
5 STUDY EVALUATIONS AND MEASUREMENTS ...................................................................... 16 
6 STATISTICAL CONSIDERATIONS ............................................................................................ 22 
7 STUDY INTERVENTION (DEVICE OR OTHER INTERVENTION) .............................................. 25 
8 STUDY INTERVENTION ADMINISTRATION ........................................................................... 27 
9 SAFETY MANAGEMENT ......................................................................................................... 28 
10  DATA COLLECTION AND MANAGEMENT ............................................................................. 28 
11 RECRUITMENT STRATEGY ..................................................................................................... 29 
12 CONSENT PROCESS ............................................................................................................... 29 
13 PUBLICATION ......................................................................................................................... 30 
14 REFERENCES .......................................................................................................................... 30 
Appendix ................................................................................................................................. 35 
 
 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
Abbreviation 
Definition 
API 
Application Programming Interface 
PPRN 
Patient-powered research network 
CDWH 
Carolina Data Warehouse for Health 
CMI 
Consumer medication information 
DMARDS 
Disease modifying antirheumatic drugs 
FTT 
Fuzzy Trace Theory 
GHLF 
Global Healthy Living Foundation 
Neuro-QOL 
Quality of Life in Neurological Disorders 
NVS 
Newest Vital Sign 
PC-SAS 
Statistical Analysis Software for personal computer 
RA 
Rheumatoid arthritis 
RAPID3 
Routine Assessment of Patient Index Data Version 3 
REDCap 
Research Electronic Data Capture 
SMART 
Strategic Memory Advanced Reasoning Training 
TOSL 
Test of Strategic Learning 
TSQM 
Treatment Satisfaction Questionnaire for Medication 
VSL 
Visual Selective Learning 
 
 
 

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PROTOCOL SYNOPSIS 
Study Title 
Enhancing patient ability to understand and utilize complex 
information concerning medication self-management 
Funder 
Patient-Centered Outcomes Research Institute 
Clinical Phase 
Not Applicable 
Study Rationale 
Rheumatoid arthritis is a systemic, autoimmune disorder. Current 
guidelines underscore the importance of aggressive treatment with 
disease modifying antirheumatic drugs (DMARDS) to control 
inflammation. A major issue in implementing aggressive therapy in 
practice, however, involves patient reluctance to escalate therapy 
when they believe that their symptoms are tolerable, despite the 
presence of active disease, due to concerns about medications 
risks. Moreover, patients often find it difficult to obtain accurate 
and personally-relevant information about medication risks and 
benefits that is written in language they can understand. There is a 
clear gap between the information patients want about medication 
risks and benefits and the information they currently receive as 
part of routine care. 
Study Objective(s) 
The aim of the proposed project is to compare the effectiveness of 
two strategies designed to enhance patient understanding of 
medication risks/benefits: (1) Medication Guides, mandated for 
many medications by the Food and Drug Administration and (2) 
DrugFactsBoxes®, developed by Woloshin and Schwartz to 
enhance the usability of consumer medication information. The 
investigators will also assess whether the effectiveness of these 
communication strategies can be increased by Gist Reasoning 
Training, which is designed to enhance patients’ ability to extract 
meaningful gist from complex information. 
Test Article(s) 
(If Applicable) 
Two interventions will be evaluated.  
DrugFactBoxes® are written summaries of information concerning 
medication risks/benefits that follow plain language guidelines and 
best practices to enhance comprehension among individuals with 
limited literacy or numeracy skills. 
Gist Reasoning Training delivered via the SMART Program is a 
patient education program designed to help people develop the 
cognitive skills needed to abstract meaning from complex written 
material. The cognitive skills trained include: selective attention to 
important information, integrating information, and evaluating the 
information from different perspectives. 

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Study Design 
 
The study will use a randomized controlled trial design, with four 
study arms. Data will be collected primarily via telephone 
interviews, and self-administered, Internet-based surveys using 
REDCap and Qualtrics. All participants will be followed for 6 
months after the completion of baseline data collection. 
Subject Population 
key criteria for Inclusion 
and Exclusion: 
Inclusion Criteria 
1. Subjects age 18 years and older 
2. Subjects with physician-confirmed rheumatoid arthritis or 
similar type of inflammatory arthritis  
Exclusion Criteria 
1. Subjects who do not speak English 
2. Subjects who do not have access to the internet and a 
working email address 
3. Subjects who are not eligible for DMARD therapy 
4. Subjects who have health problems (e.g., active cancer, 
planned surgery) that prevent changes in their medication 
regimen 
Number Of Subjects  
The targeted sample size is 300.  
Study Duration 
Each subject’s participation will last 6 months. 
The entire study is expected to last 3 years. 
Study Phases 
Screening 
Study Treatment 
Follow-Up   
(1) Screening: screening for eligibility and obtaining consent  
(2) Baseline data collection: Telephone interview and internet-
based self-administered questionnaire 
(3)  Intervention delivery: Given access to written medication 
information immediately following baseline. Completion of 
SMART training usually requires one to three months 
(4) Follow-Up data collection: Three follow-ups, conducted 6 
weeks, 3 months, and 6 months following completion of 
baseline data collection  
Efficacy Evaluations 
The primary outcome variable is informed decision making 
regarding use of DMARDs. Participants will be classified as 
meeting the criteria for informed decision making if they: (1) have 
adequate knowledge, have values that favor use of medications  
to control disease activity, and are using a DMARD OR (2)  Have 
adequate knowledge, have values indicating reluctance to use 
medications to control disease activity, and are not using a 
DMARD. All other individuals will be classified as not meeting the 
criteria for informed decision-making. 

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Pharmacokinetic 
Evaluations 
Not applicable 
Safety Evaluations 
Not applicable 
Statistical And Analytic 
Plan 
Using an intention-to-treat approach, the investigators will use 
logistic regression to test three hypotheses in primary analyses, 
with alpha (2-tailed) set at 0.05.  
1. Participants will be more likely to meet the criteria for 
Informed Decision-Making at the 6-month follow-up if they 
were assigned to receive written medication information via 
the DrugFactsBox® format compared to the Other CMI format. 
2.  Participants will be more likely to meet the criteria for 
Informed Decision-Making at the 6-month follow-up if they 
were assigned to receive gist reasoning training, delivered via 
the SMART Program, compared to those who were not 
assigned to receive this training. 
3.  Participants will be more likely to meet the criteria for 
Informed Decision-Making at the 6-month follow-up if they 
were assigned to receive medication information via the 
DrugFactsBox® format combined with gist reasoning training, 
delivered via the SMART Program, compared to individuals in 
the other three groups. 
DATA AND SAFETY 
MONITORING PLAN 
The principal investigator will have primary responsibility for data 
quality management and ongoing assessment of safety. The 
principal investigator will work closely with clinical co-investigators 
to assess safety concerns.  Because this project is associated with 
minimal risk, the investigators have not incorporated a formal Data 
and Safety Monitoring Board.  
 
 
 
 
 
 
 
 

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1 
BACKGROUND AND RATIONALE 
1.1 
Introduction 
Rheumatoid arthritis (RA) is a systemic, autoimmune disorder affecting 0.5% to 1% of 
the adult population in developed countries worldwide. Current guidelines underscore 
the importance of aggressive treatment of RA with disease modifying antirheumatic 
drugs (DMARDS) to control inflammation. Aggressive treatment has been shown to 
improve patient-centered outcomes, including better symptom control, functional 
status, and health-related quality of life and reduce the risk of premature death. A major 
issue in implementing aggressive therapy in practice, however, involves patient 
reluctance to escalate therapy when they believe that their symptoms are tolerable, 
despite the presence of active disease, due to concerns about medications risks. 
Moreover, patients often find it difficult to obtain accurate and personally-relevant 
information about medication risks and benefits that is written in language they can 
understand. There is a clear gap between the information patients want about 
medication risks and benefits and the information they currently receive as part of 
routine care. 
 
1.2 
Name and Description of Investigational Product or Intervention  
DrugFactBoxes® are written summaries of information concerning medication 
risks/benefits that follow plain language guidelines and best practices to enhance 
comprehension among individuals with limited literacy or numeracy skills. 
Gist Reasoning Training delivered via the SMART Program is a patient education 
program designed to help people develop the cognitive skills needed to abstract 
meaning from complex written material. The cognitive skills trained include: selective 
attention to important information, integrating information, and evaluating the 
information from different perspectives. 
  
1.3 
Non-Clinical and Clinical Study Findings  
The main potential risk associated with the study involves breach of confidentiality. 
Because the investigators are collecting information concerning patient health status 
and medication use, it is possible that a breach of confidentiality could affect 
participants' ability to obtain health insurance.  
 
The investigators anticipate that all study participants have the potential to benefit from 
study participation by receiving information concerning the risks and benefits associated 
with different RA treatment options. Patients report having difficulty obtaining this type 
of information. The investigators expect participants assigned to the DrugFactsBox® 
group combined with Gist Reasoning Training to derive the greatest benefit. In addition, 

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the investigators will offer all participants an opportunity to take part in the on-line 
BetterChoices/BetterHealth® Program free of charge. Thus, participants have the 
potential to benefit from participation in this chronic illness self-management program 
as well. 
 
1.4 
Relevant Literature and Data 
Rheumatoid arthritis (RA) is a systemic, autoimmune disorder affecting nearly 1% of the 
adult population.1 The prevalence of RA is about two times higher in females than 
males.2 As part of the disease process, chronic synovial inflammation and hyperplasia 
cause joint destruction and bone erosion,3 manifesting itself to patients through pain, 
fatigue, and functional impairment.4 Despite advances in therapy, RA often leads to 
progressive joint destruction, affecting patients’ ability to work and perform social 
roles.5 The systemic inflammation associated with RA can also damage internal organs, 
including the heart and lungs, leading to premature death.6,7 Depression is common 
among patients with RA, affecting between 13-20% of patients.8 It has recently been 
recognized that cognitive impairment is also more common among individuals with RA.9 
Thus, although the word “arthritis” may bring to mind the image of a disease that 
affects only the joints, the impact of RA on patients and their families extends much 
further, potentially affecting every aspect of life. 
Current therapeutic guidelines underscore the importance of aggressive treatment of 
RA with disease modifying antirheumatic drugs (DMARDS) to control inflammation.10 
Aggressive treatment has been shown to improve patient-centered outcomes, including 
better symptom control, functional status, and health-related quality of life and reduced 
risk of premature death.11-13 For example, a prospective cohort study involving over 
1,200 RA patients found a 70% reduction in the risk of cardiovascular death among 
patients using methotrexate (a DMARD) compared to those not using a DMARD.13 
Current guidelines endorse a treat-to-target strategy, with achieving a clinical remission 
as the primary target and emphasize the role of patients in shared decision making.10 A 
major issue in implementing treat-to-target principles in practice, however, involves 
patient reluctance to escalate therapy when they believe that their symptoms are 
tolerable, despite the presence of active disease.14-16 Across seven studies, the median 
adherence rate to DMARDs assessed using objective measures (e.g., electronic devices 
in medication caps to track usage, records from prescription claims databases) was 67% 
(range 22%-107%).17 Another review of 11 studies conducted in the US found that 
among those who initiated biologic therapy, only 38% to 56% were still using a biologic 
12 months following initiation.18 Thus, adherence and persistence with DMARD therapy 
is often suboptimal and uncontrolled inflammation places patients at increased risk for 
the types of health problems described previously (e.g., cardiovascular disease). 

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Patient reluctance to use DMARDS when they believe their symptoms are tolerable is 
understandable because the potential benefits associated with these medications are 
accompanied by concerns about serious risks.19-22 Moreover, obtaining accurate and 
personally-relevant information about medication risks is challenging. Previous research 
suggests that, although most RA patients want information about medication risks, 
many have a poor understanding of these risks.23-25 In some ways, this is not surprising. 
A study conducted by our research team found that rheumatologists provide relatively 
little information about medication risks during routine patient office visits.26 In that 
study, the investigators analyzed over 1,000 transcripts of patient office visits and 
observed relatively little discussion of medication risks. For example, in visits where the 
rheumatologist proposed adding a biologic DMARD to the patient’s medication regimen, 
risks associated with immune system suppression were discussed only 48.5% of the 
time. In visits where the rheumatologist suggested adding methotrexate, the risk of liver 
toxicity was discussed only 15.1% of the time. Other risks were discussed even less 
often. The investigators used the same transcripts to examine the clarity of the risk-
benefit communication that occurred during the visit.27 Four patients with RA coded the 
transcripts with respect to the gist that rheumatologists conveyed concerning 
medication safety, effectiveness, and need.27 In 29% of the transcripts coded, the 
patient-coders indicated that it was not clear if the rheumatologist was concerned about 
medication safety. In 14% of the transcripts, the patient-coders could not tell whether 
the rheumatologist thought a medication was helping and/or was needed. In another 
study conducted by our research team, over 80% of arthritis patients reported receiving 
conflicting information about their medications and the most commonly reported area 
of conflict involved medication risks.28  
Although the FDA requires that patients receive a Medication Guide with most DMARDs, 
research in other patient populations suggests that many patients have difficulty 
understanding the information contained in Medication Guides.29-35 These findings 
highlight the gap between the information patients want about medication risks and 
benefits and the information they currently receive as part of routine care. Together, 
the findings reported above support a simple and straight-forward conclusion: The 
strategies currently used to inform RA patients about treatment risks and benefits are 
not working.  
As described above, many patients struggle to find the right balance between wanting 
to keep their illness under control and wanting to avoid unnecessary risks. It is also 
important to recognize that medication safety is not just a function of medication 
properties alone. It is also a function of how medications are used. For example, 
medications are “safer” when patients understand and follow recommended safety 
precautions (e.g., avoiding alcohol when taking methotrexate, obtaining routine blood 
tests to monitor liver and kidney function). Because most patients self-manage their 
medications, safe medication use requires that patients understand: the nature of 

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potential adverse effects, how to monitor therapy to detect potential problems early, 
safety precautions to follow to reduce risk, and what to do if adverse effects occur.36,37 
The complexity of this information, in addition to information about alternative 
treatment options with different risk/benefit profiles, can easily overwhelm patients’ 
coping ability and interfere with optimal decision making. Health literacy/numeracy 
deficits can compound this problem. It is widely recognized that millions of Americans 
lack the health literacy and numeracy skills needed to be able to understand health-
related information and that lack of these skills can lead to poor health outcomes.38 
Emphasizing the severity of this problem, one objective within the area of Health 
Communication and Health Information Technology in Healthy People 2020 is to 
increase patient health literacy skills.39 Although many studies have been conducted to 
determine how design features (e.g., use of headers) affect patient ability to understand 
and use written health information, few studies have examined interventions designed 
to increase patient health literacy/numeracy skills.38  
This study was based on the premise that interventions designed to educate patients 
about the risks/benefits associated with different therapeutic options and medication 
self-management require a 2-pronged approach: simplifying material to convey the 
essential gist of information and helping patients develop the health literacy/numeracy 
skills needed to process information concerning complex issues (e.g., scientific 
uncertainty). The DrugFactsBox® format for presenting medication information was 
designed to address the first issue. The SMART Program was designed to address the 
second issue.  
The study was informed by fuzzy-trace theory (FTT) a dual-process model of memory, 
reasoning, judgment, and decision making that has been used to study how people 
across the life span make decisions that involve risk.40,41 Briefly, FTT posits that, when an 
individual is exposed to any meaningful stimulus (e.g., written prescription drug 
information), two types of representations of the stimulus are encoded in memory, a 
verbatim representation and one or more gist representations. Verbatim 
representations capture the exact words, numbers, or images included in the stimulus, 
whereas gist representations capture the essential, bottom-line meaning of the stimulus 
to the person, including its emotional meaning. Basic research has demonstrated that 
gist representations are retained longer in memory and are more easily retrieved from 
memory than verbatim representations, making them more accessible when individuals 
are making judgments and decisions.42,43  
A central tenet of FTT is that the ability to extract meaningful gist from complex 
information is essential for informed decision making. Gist reasoning requires one to 
“connect the dots” between separate pieces of information, rather than processing 
individual facts in isolation.44 Substantial empirical research has confirmed the FTT 
prediction that the ability to extract meaningful gist from information increases with 

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development (i.e., as children grow to adulthood) and the acquisition of expertise in a 
specific domain.45-49  
Using FTT as our theoretical framework, the aim of this study was to evaluate the 
effectiveness of two interventions designed to enhance patient understanding of 
medication risks/benefits: the DrugFactsBox® format for presenting written medication 
information and the SMART Program to enhance gist reasoning ability. As shown in 
Figure 1, the investigators hypothesized that both interventions would increase: (1) 
patient knowledge concerning medication risks/benefits and (2) interest in obtaining 
additional information about illness self-management. Moreover, by improving gist 
reasoning ability, the investigators hypothesized that the SMART Program would work 
synergistically with the Drug Facts Boxes to improve patient health outcomes. Our 
primary outcome variable was informed decision-making, defined as making a value-
consistent decision concerning DMARD use in the presence of adequate knowledge. 
Other intermediate and distal outcome variables are shown in Figure 1. 
2 
STUDY OBJECTIVE  
2.1 
Primary Objective 
The aim of the proposed project is to compare the effectiveness of two strategies 
designed to enhance patient understanding of medication risks/benefits: (1) Medication 
Guides, mandated for many medications by the Food and Drug Administration and (2) 
DrugFactsBoxes®, developed by Woloshin and Schwartz to enhance the usability of 
consumer medication information. The investigators will also assess whether the 
effectiveness of these communication strategies can be increased by Gist Reasoning 
Training, which is designed to enhance patients’ ability to extract meaningful gist from 
complex information. 
3 
INVESTIGATIONAL PLAN (brief overview) 
3.1 
Study Design 
The study will use a randomized controlled trial design, with four study arms. Data will 
be collected primarily via telephone interviews, and self-administered, Internet-based 
surveys using REDCap and Qualtrics. All participants will be followed for 6 months after 
the completion of baseline data collection.  
 
3.2 
Allocation to Treatment Groups and Blinding (if applicable) 
Participants will be randomized to study arm on a 1:1:1:1 basis. Prior to the start of 
participant recruitment, the principal investigator will generate a random allocation 
sequence using PC-SAS® (version 9.4). Random numbers will be generated in blocks of 
20 to ensure balance across the four study groups over the entire course of data 
collection. The random number sequence will be imported into the REDCap tracking 

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database used by the project director, working out of the UNC-Chapel Hill office, to 
record the name and contact information for study participants as they are enrolled in 
the study. To ensure allocation concealment, the REDCap database will be programed so 
that the group assignment variable: (1) cannot be viewed until after the patient contact 
information has been entered and (2) cannot be changed after the patient contact 
information has been entered. All personnel involved in data collection and delivery of 
the SMART program were blinded to participant group assignment. 
 
3.3 
Study Duration, Enrollment and Number of Subjects 
The study has a targeted sample size of 300. There are four data collection points, 
baseline and 6 weeks, 3 months and 6 months following baseline.  
The investigators will recruit 300 adults (age 18+) with physician-confirmed RA to 
participate in the study using a multi-pronged recruitment strategy. First, patients will 
be recruited from rheumatology clinics at four large academic medical centers: the 
University of North Carolina at Chapel Hill; the University of Alabama at Birmingham; 
the University of Texas Southwestern Medical Center located in Dallas, Texas; and the 
University of Pittsburgh Medical Center. A clinical coordinator who is a regular clinic 
staff member or a member of the research staff (working under the supervision of a 
clinic staff member) will review the clinic schedule to identify potential participants prior 
to their visit. The clinical coordinator or research staff member will then approach the 
potential participant when they arrive for their visit. 
Second, because the investigators do not want to restrict study participation to patients 
cared for by a rheumatologist, they are partnering with the Global Healthy Living 
Foundation (GHLF) to recruit participants through Creaky Joints and the Patient-
Powered Research Network (PPRN) they have established, AR-PoWER. Creaky Joints is 
an online arthritis patient support community with over 5,000 members. The AR-PoWER 
Network has over 4,000 members with most members reporting having RA. GHLF will 
post a notice pertaining to the study on the “Opportunities Central” portion of the AR-
Power Network website and will email members of both Creaky Joints and the AR-
Power Network to inform them about the study. They will also use social media such as 
Twitter to raise awareness of the study. Individuals with interest in participating in the 
study will be instructed to contact the project director at UNC-CH by phone or email. 
In efforts to expand recruitment, the investigators have created a study Twitter 
(@medigiststudy) and Facebook page (What's the Gist? About Rheumatoid Arthritis), 
and updated the Study Website (medigist@web.unc.edu). The investigators plan to 
raise awareness about the study via these social media and website outlets. Individuals 
with interest in participating in the study will be instructed to contact study personnel at 
UNC-CH by phone or email.  

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The investigators will use the Carolina Data Warehouse for Health (CDWH) to identify 
minority RA patients in the UNC Healthcare System. The investigators will mail 
recruitment letters to patients identified via the CDWH describing the study, and 
providing contact information of study personnel to those that are interested in 
participating. 
 
3.4 
Study Population 
The investigators will recruit adults (age 18+) with physician-confirmed RA to participate 
in the study. Individuals who do not speak English will also be excluded because it would 
be difficult, due to budgetary considerations, to deliver the SMART Program in 
languages other than English. Individuals will be excluded if they do not have access to 
the Internet and a working email address because the SMART Program can only be 
administered online, and many of the secondary outcome measures will be 
administered online, it is important that participants have Internet access. Participants 
will also be excluded if they are not eligible for DMARD therapy. In addition, individuals 
will be excluded if they have any health problems that prevent changes in their 
medication regimen. 
4 
STUDY PROCEDURES (what will be done) 
 
4.1 
Screening/Baseline Visit procedures 
At clinic sites, recruitment procedures will be implemented either by a clinical 
coordinator who is a regular member of the clinic staff or a research staff member 
working under the supervision of a clinic staff member. For participants recruited via the 
AR-POWER network or Creaky Joints, a research staff member will implement 
recruitment procedures. 
 
Potential participants will be interviewed to assess eligibility. Eligible participants will 
complete a telephone interview and a baseline questionnaire delivered via the Internet 
using Qualtrics and REDCap. The telephone interview will ask the participant knowledge 
questions about RA and will assess their health literacy via the standardized Newest 
Vital Signs instrument. The baseline questionnaire will include a list of DMARDS 
currently available in the US for the treatment of RA. Participants will be asked to 
indicate the ones that they are currently using.  
 
 

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4.2 
Intervention/Treatment procedures (by visits) 
After participants complete the baseline questionnaire, they will be randomly assigned 
to one of four study groups: Other CMI without Gist Reasoning Training, Other CMI with 
Gist Reasoning Training, DrugFactsBox® without Gist Reasoning Training, and 
DrugFactsBox® with Gist Reasoning Training. Note that in most cases the “Other CMI” 
provided will be FDA approved Medication Guides. However, not all DMARDS are 
required to have a Medication Guide.  In these cases, the investigators will provide CMI 
developed by the American Society of Health-System Pharmacists®. These materials are 
similar to the CMI that is given to patients in the United States when prescriptions are 
dispensed.  
 
Participants will then be directed to a website that provides written prescription drug 
information (either Other CMI or DrugFactsBoxes®, depending on group assignment) for 
the medications they are currently using. The website will allow participants to print a 
hard copy of the materials, if desired. The website will also allow them to access 
information about other DMARDs. For participants randomized to the gist training group 
(SMART Program), staff at the Center for BrainHealth at the University of Texas-Dallas 
will contact participants, either by email or by phone, to enroll them in the next SMART 
Program. The training program will be delivered in small groups of 5-6 individuals over a 
1-month period. Each program will include 4 60-minute sessions delivered by research 
personnel certified to provide the program. Training will be presented via an online 
video conferencing platform, such a BlueJeans®, that permits synchronous, audio and 
visual communication between trainers and participants. Participants only need a 
computer (desk, laptop, tablet) or mobile phone with internet access to participate.  
4.3 
Follow- up procedures (by visits) 
Follow-up data will be collected 6-weeks, 3-months and 6-months after baseline. After 
the 6-week follow-up interview, all participants will be sent a letter that gives them the 
opportunity to participate in the online Better Choices, Better Health® program free of 
charge. This program is adapted from the Arthritis Self-Management Course developed 
by Lorig and colleagues. In the proposed study, the investigators will use participant 
acceptance of the offer to participate in the Better Choices, Better Health® program as a 
behavioral measure of patient interest in obtaining additional information about RA self-
management and alternative treatment options. 
4.4 
Unscheduled visits 
Not applicable 
 

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4.5 
Concomitant Medication documentation 
Not applicable 
 
4.6 
Rescue medication administration ( if applicable) 
Not applicable 
 
4.7 
Subject Completion/ Withdrawal procedures 
The interventions tested involve minimal risk. Therefore, the investigators do not plan 
to withdraw individual participants for any reason. However, if a participant becomes 
upset concerning any study procedures, the investigators will ensure that they 
understand that they have the right to withdraw from the study at any time, without 
penalty. When participants express a desire to withdraw from the study, the 
investigators will solicit their reasons for withdrawing and document the reasons given. 
4.8 
Screen failure procedures 
Individuals who were screened for study eligibility, but who did not meet the eligibility 
criteria, will be thanked for their interest in the study.  
5 
STUDY EVALUATIONS AND MEASUREMENTS (how measurements will be 
made)   
5.1 
Efficacy Evaluation (if applicable) 
Efficacy data will be collected via a combination of telephone interviews and self-
administered questionnaires, completed via REDCap. Measures included in the 
interviews and questionnaires are described below and summarized in Table 1. 
Primary Outcome: The primary outcome variable for this study is Informed Decision-
Making. Informed Decision-Making is typically conceptualized as making a decision, 
based on adequate knowledge, that is consistent with one’s values.50-53 To 
operationalize this definition, the investigators will assess three variables: knowledge of 
RA and RA treatment options, values pertaining to the management of RA, and current 
DMARD use.  
Knowledge will be assessed by three separate instruments administered via telephone 
interview: an 8-item measure developed by Fayet and colleagues54 that assesses 
knowledge concerning methotrexate, which is often first-line therapy for RA; a 20-item 
measure developed by Fraenkel and colleagues55 to assess knowledge concerning 
biologic treatment options; and an 8-item measure developed by Barton and 
colleagues56 that assesses knowledge of RA and RA treatment options more generally. 
Values. Questions included in the self-administered questionnaires will ask participants 
to indicate the extent to which they agree or disagree with 10 simple values statements 
(e.g., It is OK to ignore the risk of a serious side effect if it is extremely rare; It is better to 

17 
 
continue with the pain I know than to change my medications) developed by Fraenkel 
and colleagues.57,58 Responses will be recorded on a 4-point scale ranging from 
1=Strongly Agree to 4=Strongly Disagree. Responses will be summed and rescored to 
yield a composite scale that ranges from -15 to +15, where positive numbers reflect 
values favoring the use of medications to control RA disease activity. 
DMARD Usage will be assessed via the online questionnaires. Participants will be shown 
a checklist of 19 medications used to treat RA (abatacept, adalimumab, azathioprine, 
certolizumab pegol, cyclosporine, etanercept, golimumab, gold, hydroxycholoroquine, 
infliximab, leflunomide, methotrexate pill, methotrexate shot, minocycline, rituximab, 
sulfasalazine, tocilizumab infusion, tocilizumab shot, and tofacitinib) and asked to check 
all of those that they are currently using. Participants will also be to check an option 
labeled None of the above. DMARD Usage will be scored as “0” if the participant reports 
using no DMARDS and “1” if the participant reports using one or more DMARDS. 
Informed Decision-Making. Participants will be classified as meeting the criteria for 
informed decision making if they:  
(1) Answer at least 85% of the knowledge items correctly, score greater than 0 on the 
values scale indicating favorable attitudes concerning the use of medications to control 
disease activity, and are using a DMARD OR  
(2) Answer at least 85% of the knowledge items correctly, score 0 or less on the values 
scale indicating reluctance to use medications to control disease activity, and are not 
currently using a DMARD. 
 Individuals who fail to meet either set of criteria will be classified as not meeting the 
criteria for informed decision-making. 
Proximal Secondary Outcomes: The investigators will assess five proximal secondary 
outcomes: Gist Reasoning Ability; Selective Learning; Information Seeking; and two 
specific types of knowledge, Verbatim Recall and Medication Self-Management 
Knowledge. These variables, which are described below, are considered proximal 
because the investigators conceptualize them as direct effects of the intervention. 
Gist Reasoning Ability, also referred to as integrated reasoning, will be assessed 
by the Test of Strategic Learning (TOSL). The TOSL was developed by Chapman and 
colleagues to systematically quantify participants’ capacity to synthesize and interpret 
high-level meaning from lengthy multi-faceted textual information.59,60 The TOSL 
consists of four text passages of similar length and complexity. At each data collection 
point, participants will read one of the text passages presented via an online learning 
platform. (The texts, as well as their order of presentation, will be randomized at each 
assessment so that participants will not see the same text twice.) Participants will not be 
allowed to return to the passage once they finished reading. After reading the passage, 

18 
 
participants will be asked to provide a synthesized, condensed version of the text in 
their own words, conveying primarily high-level ideas of substance rather than specific 
details. They will be given five minutes to complete this task. Participants will then be 
asked to generate as many interpretations (i.e., lessons learned) as possible that could 
be derived from the passage. They will be given three minutes to complete this task. 
Responses will be scored using a manualized, objective scoring system by a trained and 
experienced rater, based at the Center for BrainHealth, who is blinded to participants’ 
group assignment and time point of testing. Two separate scores will be derived from 
participant responses: number of abstracted ideas (Complex Abstraction) and a 
weighted index reflecting the quantity and quality of high-level interpretations (Lesson 
Quality). High-level interpretations will be judged against a rubric based on the specific 
content of each passage.  
Selective Learning is defined as the ability to optimize processing of incoming 
information by controlling working memory to try to remember high value information 
while inhibiting low value information.61 To assess this ability, the Visual Selective 
Learning (VSL) task will be administered as part of each telephone interview by showing 
participants 3 lists of 16 words via a PowerPoint presentation imbedded in a YouTube 
video. Each word will appear on a separate screen for 1 second. Half of the words will be 
in uppercase and half will be in lowercase. In some trials, participants will be instructed 
that uppercase words are valued at 10 points and lowercase words at 1 point; in other 
trials, the point value was the opposite. Participants will be told to remember as many 
words as they could, but that their goal is to earn as many points as possible. Different 
word lists will be used at each time point and the lists will be balanced across 
participants over the course of the study using procedures parallel to those for the 
TOSL. At each time point, scores will be summed across the three lists, yielding a 
composite score with a possible range from 0 to 264.  
Information Seeking will be assessed using two behavioral measures 
incorporated into the design of the study. First, the investigators will create a website 
that provides easy access to information about RA, treatment options, and self-
management strategies. The investigators will refer to this website at the RA Self-
Management Website. Participants will be emailed a link to this website immediately 
after completion of 6-week follow-up data collection. The investigators will use Google 
analytics to track whether participants accessed the website and the specific website 
pages viewed. Second, immediately after completion of 6-week follow-up data 
collection, the investigators will email all participants an invitation to take part in 
BetterChoices, BetterHealth®, an online chronic illness self-management program, free 
of charge. The investigators will track whether or not participants enroll in the class, the 
number of class sessions attended, and whether or not participants complete the class.  

19 
 
Verbatim Recall of information concerning potential medication benefits and 
harms will be assessed by medication-specific items developed specifically for this study. 
For each medication, the investigators will identify one potential benefit and one 
potential harm listed in the Drug Facts Box. Each question will ask participants about the 
probability of benefit/harm using a multiple-choice response format. To minimize 
response burden, participants will be asked these questions in relation to only one of 
their current RA medications. For participants taking more than one RA medication, the 
investigators will ask the items in relation to methotrexate, if methotrexate is being 
used. Otherwise, the investigators will ask the items in relation to the most commonly 
used biologic medication the participant is using or, in cases where the participant is not 
using any biologic medications, the investigators will ask the items in relation to a non-
biologic medication. Correct responses will be summed across the benefit and harm 
items to yield a score ranging from 0 to 2. This measure will be administered, by 
telephone interview, only at the 6-week follow-up.  
Medication Self-Management Knowledge will be assessed using a 45-item 
medication-specific measure tailored to the medications each participant reports using 
and developed specifically for this study. For participants using methotrexate, the items 
will focus on this medication. For participants not using methotrexate but using a 
biologic, the items will focus on the most commonly used biologic. Otherwise, the items 
will focus on a non-biologic. The first 42 items will involve a list of possible medication 
side-effects, some that are known risks for the targeted medication and some that are 
not. For each side-effect, participants will be asked whether or not they would call the 
doctor immediately if they experienced the side-effect. (Consumer medication 
information (CMI) typically includes information concerning those side-effects that 
require immediate medical attention.) The final three questions will be scenario-based 
and designed to assess knowledge of other aspects of medication use (e.g., whether 
medication should be stored in the refrigerator, what to do if medication is accidentally 
frozen, whether it is OK to get a flu shot when taking the medication). These questions 
will draw on information found in the medication information provided to participants. 
Correct answers will be summed across the 45 items and then transformed to a 100 
point scale, reflecting the percentage of questions answered correctly.  
Intermediate Secondary Outcomes: The investigators will assess three intermediate 
secondary outcomes: Treatment Satisfaction, Satisfaction with Medication Information, 
and Arthritis Self-Efficacy 
 
Treatment Satisfaction will be assessed by the 9-item abbreviated Treatment 
Satisfaction Questionnaire for Medication (TSQM-9).62-64 Items ask participants to rate 
their satisfaction with different aspects of their treatment regimen on a 7-point scale 
with endpoints labeled as “extremely satisfied” and “extremely dissatisfied”. The TSQM-
9 has three subscales: Effectiveness, Convenience, and Overall Satisfaction. Internal 

20 
 
consistency has been demonstrated in past research with Cronbach’s alpha exceeding 
0.80 for each subscale.62 The Overall Satisfaction subscale has demonstrated the 
greatest sensitivity to change following changes in therapy.65  
 
Satisfaction with Medication Information will be assessed using the 17-item 
Satisfaction with Information about Medicines Scale (SIMS).66 Items ask participants to 
rate the amount of information they have received about different aspects of their 
medications (e.g., what the medicine is for, how it works, whether it has side-effects). 
Responses range from “too much information” to “no information needed”. Responses 
are summed to yield a total sore with higher scores reflecting greater satisfaction with 
amount of information received. In developmental studies, Cronbach’s alpha for the 
total score ranged from 0.81 to 0.91 across eight different chronic illness subgroups.66 
The SIMS has also been shown to be sensitive to change following participation in a 
patient-centered counseling intervention.67 
 
Arthritis Self-Efficacy will be assessed using the 8-item Arthritis Self-Efficacy 
Scale.68,69 Items assess confidence in one’s ability to manage arthritis pain in different 
situations (e.g., keep pain from interfering with things you want to do). Responses will 
be recorded on a 10-point scale with endpoints labeled “very uncertain” and “very 
certain”. This measure has been widely used in arthritis patient populations and has 
been shown to have excellent psychometric properties, including high internal 
consistency (Cronbach’s alpha generally exceeds 0.90) and sensitivity to change 
following participation in illness self-management programs.70,71  
Distal Secondary Outcomes: The investigators will assess six distal outcome variables 
reflecting different aspects of health-related quality of life: Illness Intrusiveness, Health 
Distress, Depression, Fatigue, Disease Activity, and Global Health Status. Our remaining 
distal outcome variables were Objective Health Literacy, Subjective Health Literacy, and 
Medication Adherence.  
 
Illness Intrusiveness will be assessed using the 13-item Illness Intrusiveness 
Ratings Scale. Participants will be asked to rate the degree to which their “illness and/or 
its treatment” interferes with activities that are essential for quality of life (e.g., work, 
recreation, finances, social relationships).72 Responses will be recorded on a 7-point 
response scale with endpoints labeled, “not very much” and “very much.” The 
instrument can be scored by either summing across all items to obtain a total score or 
computing separate scores for three subscales: relationships and personal development 
(family relationships, social relationships, community and civic involvement), intimacy 
(relationship with partner and sex life), and instrumental (work, finances). Cronbach’s 
alpha for the total score, which The investigators used in this study, has been found to 
range from 0.78 to 0.97 across 36 different health conditions.73 

21 
 
 
Health Distress will be assessed by the 4-item measure developed by Lorig and 
colleagues.74 This measure was adapted from the Medical Outcomes Study health 
distress scale for use in arthritis populations.75 The adapted measure has demonstrated 
high internal consistency and responsiveness to change following completion of an 
arthritis self-management course.74  
 
Depression and Fatigue will be assessed using the computer adaptive testing 
version of the Neuro-QOL (Quality of Life in Neurological Disorders) version 1.0 item 
bank.76-78 These measures will be administered using the Assessment CenterSM 
Application Programming Interface (API) which is available through REDCap. The 
measures will be automatically scored by the API. Neuro-QOL measures have undergone 
substantial testing in previous research and have demonstrated both reliability and 
validity across diverse patient populations.78 
Disease Activity will be assessed using the RAPID3 (Routine Assessment of 
Patient Index Data).79,80 This patient-reported outcome measure has three components: 
physical function, pain, and global illness impact (i.e., “Considering all the ways in which 
illness and health conditions may affect you, please indicate how you are doing?”). 
Scores for each component are equally weighted and summed to calculate a total score. 
This measure has been shown to distinguish between active and control treatments in 
two clinical trials evaluating the efficacy of a biologic RA medication. In addition, the 
RAPID3 is one of the disease activity measures identified in the 2012 American College 
of Rheumatology Guidelines for the treatment of RA, which recommend using a treat-
to-target strategy based on current disease activity.10 
 
Global Health Status will be assessed by a single item asking participants to rate 
their current health on a 5-point scale from “1=Excellent” to “5=Poor”. This item has 
been shown to predict mortality and health care utilization as well as multi-item health 
status measures.81  
Health Literacy. The investigators will assess health literacy using both subjective 
and objective measures. The subjective measure, developed by Chew and 
colleagues82,83, includes three items: “How confident are you filling out medical forms by 
yourself?”, “How often do you have someone (like a family member, friend, 
hospital/clinic worker or caregiver) help you read hospital materials?”, and “How often 
do you have problems learning about your medical condition because of difficulty 
reading written material?” Each item will be answered on a 5-point scale ranging from 0 
to 4, with higher values reflecting lower health literacy. In past research these items 
have demonstrated construct validity by correctly classifying individuals determined to 
have inadequate health literacy using either the REALM or the S-TOFHLA.83 In the 
current study, the investigators will sum participant responses across the three items 
and reverse score the sum to yield a summary score with higher values reflecting higher 
health literacy.  

22 
 
 The investigators will assess objective health literacy using the Newest Vital Sign 
(NVS).84 This measure asks participants to look at the nutrition label from a pint 
container of ice cream. While looking at the label, participants are asked six questions 
(e.g., “If you ate the entire container, how many calories would you eat?”). Correct 
answers will be summed and then transformed to a 100 point scale, reflecting the 
percentage of questions answered correctly. In previous research, this measure has 
demonstrated internal consistency (i.e., Cronbach alpha =0.76) and construct validity 
(strong correlations with TOFHLA). Because the investigators will administer this 
measure twice in the current study, the investigators were concerned that memory 
effects would artificially inflate scores at the second assessment. Therefore, the 
investigators created a second version of the NVS based on the same ice cream 
container label, but with slightly modified questions. Participants will complete one 
version at baseline, determined randomly and balanced across participants, and the 
other version at the 6-month follow-up. 
 
Medication Adherence will be assessed by a single question that asks: “All things 
considered, how much of the time do you use your RA medications EXACTLY as 
directed?” Responses will be recorded on a 100-point visual analog scale with endpoints 
labeled “None of the Time” and “All of the time”. 
Other Participant Characteristics: For descriptive purposes, The investigators will also 
collect the following socio-demographic information from study participants: age; 
gender (male, female); race (African-American, American Indian or Alaskan Native, 
Asian, Native Hawaiian, or Other Pacific Islander, White, Other); ethnicity (Hispanic, 
non-Hispanic); education (less than high school, high school diploma only, some college 
or technical school, college degree); marital status (never married, married, widowed, 
divorced, separated); and ability to afford medications (no trouble, a little trouble, a lot 
of trouble).  
5.2 
Pharmacokinetic Evaluation ( if applicable) 
Not applicable 
 
5.3 
Safety Evaluations 
Not applicable 
 
6 
STATISTICAL CONSIDERATION    
6.1 
Primary Endpoint 
Informed Decision-Making   
6.2 
Secondary Endpoint 
See Table 1 appended  
 

23 
 
6.3 
Statistical Methods 
Preliminary Analyses: Characteristics of study participants will be presented, stratified 
by study group, using means and percentages, depending on the measurement 
properties of the variables involved. Statistical comparisons will be made using linear 
regression models for continuous variables and chi-square tests for categorical 
variables. All data analyses will be performed using SAS PC, version 9.4 (SAS Institute, 
Cary, NC). 
Primary Analyses: The primary outcome variable is Informed Decision-Making assessed 
at the 6-month follow-up. The investigators will test the following hypotheses using 
logistic regression methods. 
1.  Participants will be more likely to meet the criteria for Informed Decision-Making at 
the 6-month follow-up if they were assigned to receive written medication 
information via the DrugFactsBox® format compared to the Other CMI format. 
2.  Participants will be more likely to meet the criteria for Informed Decision-Making at 
the 6-month follow-up if they were assigned to receive gist reasoning training, 
delivered via the SMART Program, compared to those who were not assigned to 
receive this training. 
3.  Participants will be more likely to meet the criteria for Informed Decision-Making at 
the 6-month follow-up if they were assigned to receive medication information via 
the DrugFactsBox® format combined with gist reasoning training, delivered via the 
SMART Program, compared to individuals in the other three groups. 
The regression model will control for Informed Decision-Making at baseline (0=Did not 
meet criteria for Informed Decision-Making, 1=Met criteria for Informed Decision-
Making) and indicator variables for each intervention indexing whether the participant 
was assigned to SMART Training (0=No, 1=Yes) and the DrugFactsBox® group (0=No, 
1=Yes). In separate regression models, the investigators will also test three 2-way 
interactions. The first interaction will assess whether the effects of the two 
interventions are dependent of one another (Hypothesis 3). The other interaction terms 
will assess whether the effects of each intervention varies as a function of whether 
participants met the criteria for Informed Decision-Making at baseline. Statistical 
significance will be evaluated with alpha (2-tailed) set at 0.05. When significant 
interaction terms are observed, the investigators will use stratified analyses to examine 
the nature of the interaction.  
In the main analysis, the investigators will use an intention-to-treat strategy, with 
individuals included in the analysis based on random group assignment, without regard 
to whether they were actually exposed to the intervention. However, the investigators 
will only include participants with nonmissing data at the 6-month follow-up. In addition 
to the main analyses, the investigators will perform three sets of sensitivity analyses to 

24 
 
assess the robustness of the findings. The first set of sensitivity analyses will use an as-
treated approach and include only people with nonmissing data at the 6-month follow-
up. Individuals will be included in this analysis only if they actively participated in the 
interventions. For the DrugFactsBox®/Other CMI groups, the investigators defined active 
participation as viewing at least one page on the DrugFactsBox®/Other CMI website. For 
the SMART group, the investigators will define active participation as attending at least 
3 of the 4 training sessions. Note that all individuals in the No SMART group will be 
included in the as-treated analyses because they will not have an opportunity to 
participate in any training. In the second set of sensitivity analyses, the investigators will 
use an intention-to-treat approach and impute missing data using the last-observation-
carried forward method for individuals who do not complete the 6-month follow-up. In 
the final set of sensitivity analyses, the investigators will use as as-treated approach and 
impute missing data using the last-observation-carried forward method.  
Secondary Analyses: The investigators will use the same analytic strategy to examine 
the effect of the intervention on 18 secondary outcomes assessed at the 6-month 
follow-up: Medication Self-Management Knowledge, Selective Learning, Complex 
Abstraction, Lesson Quality, Use of the RA Self-Management Website, Participation in 
the BetterChoices,BetterHealth program, Self-Efficacy, Overall Medication Satisfaction, 
Global Treatment Satisfaction, Medication Adherence, Objective Health Literacy, 
Subjective Health Literacy, Disease Activity, Illness Intrusion, Illness Distress, Global 
Health, Depression, and Fatigue. In these analyses, the investigators will use either 
logistic or linear regression, depending on the measurement properties of the outcome 
variable. Due to the number of endpoints examined in these secondary analyses, the 
investigators will use the Hochberg method to adjust for the potential inflation of Type I 
error.85 
Exploratory Analyses: The investigators will use the same analytic strategy to evaluate 
intervention effects at the 6-week and 3-month follow-ups. However, these analyses 
will be considered exploratory and are designed to capture any transient intervention 
effects that may occur. 
 
6.4 
Sample Size and Power 
The primary outcome variable will be Informed Decision-Making, assessed at the 6-
month follow-up. Our targeted sample size will be 300 (75 in each of the four study 
arms). Power analyses performed a priori indicated that a sample of this sample size 
would provide 80% power to detect a between-group difference of 25% in the 
percentage of participants classified as meeting the criteria for informed decision-
making (e.g., 60% versus 35% among individuals assigned to the DrugFactsBox® versus 
Other CMI groups, respectively). This anticipated effect size was based on that observed 
in previous studies55 and corresponds to a slightly smaller than moderate sized effect 
using the criteria developed by Cohen.86 These power calculations were performed with 

25 
 
alpha (2-tailed) set at 0.05 and allowed for 15% attrition from baseline to final follow-
up. 
6.5 
Interim Analysis 
Not applicable 
7 
STUDY INTERVENTION (drug, device or other intervention details) 
The investigators will evaluate the effectiveness of two separate interventions: the 
DrugFactsBox® format (compared to Other CMI, primarily Medication Guides) and gist 
reasoning training delivered via the SMART Program (compared to standard care). Each 
intervention is described below. 
DrugFactsBox® Format. The original DrugFactsBox® format consisted of a standardized 
2-page summary that followed plain language guidelines and best practices to enhance 
comprehension among individuals with limited literacy or numeracy skills.87,88 Research 
involving nationally representative samples has demonstrated that the DrugFactsBox® 
format improves (1) patient comprehension of medication risks and benefits and (2) 
patient judgment and decision-making.88-90 To produce Drug Facts Boxes, information 
from FDA drug approval documents and systematic reviews published in the scientific 
literature are examined to extract information concerning drug benefits and harms, as 
well as areas of scientific uncertainty that are not always conveyed clearly to the general 
public. The information extracted is used by medical experts to create a Drug Facts Box. 
Each section in a Drug Facts Box is clearly labeled and provides quantitative information 
concerning the drug’s potential benefits and harms in comparison to treatment 
alternatives or no treatment (if data are from a placebo-controlled trial). This type of 
quantitative information concerning potential benefits and harms is missing from FDA-
approved medication guides and other types of CMI commonly given to patients in the 
United States when prescriptions are dispensed.  
 
For this study, the investigators will create a website that contains 16 Drug Facts Boxes 
for those medications most commonly used to treat RA in the United States (i.e., 
abatacept, adalimumab, certolizumab, etanercept, golimumab, hydroxychloroquine, 
infliximab, leflunomide, methotrexate pill, methotrexate shot, prednisone, rituximab, 
sulfasalazine, tocilizumab infusion, tocilizumab shot, and tofacitinib). A pill bottle icon 
for each of these medications will appear on the website landing page. When the icon 
for a medication is clicked, an overview of the medication will appear. The overview will 
include a section labeled Bottom Line which contains a narrative summary of potential 
medication benefits and harms, emphasizing bottom-line gist. The overview page will 
also provide links to other pages within the website that contain additional information 
about the medication. These links will be labeled: Trials, Side Effects, How to Use, 
Lifestyle Changes, and Interactions. The Trials page will provide quantitative information 

26 
 
concerning potential medication benefits and harms, mirroring the original 
DrugFactsBox® format.  
Effects of the DrugFactsBox® format will be evaluated in comparison to other types of 
written CMI. All participants assigned to receive Other CMI will be given access to a 
website that contains CMI for the same 16 medications listed above. For medications 
that have an FDA-approved Medication Guide (i.e., abatacept, adalimumab, 
certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab infusion, 
tocilizumab shot, and tofacitinib), the website will provide a link to the Medication 
Guide. For the remaining medications (i.e., hydroxychloroquine, leflunomide, 
methotrexate pill, methotrexate shot, prednisone, and sulfasalazine), the website will 
provide a link to CMI developed by the American Society of Health-System Pharmacists®. 
These materials are similar to the CMI that is given to patients in the United States when 
prescriptions are dispensed. The DrugFactsBox® website and the Other CMI website will 
both allow participants to print a hard copy of the materials, if desired. 
Because federal law mandates that Medication Guides be given to patients when certain 
medications are dispensed, the investigators view them as a component of usual care. 
Nonetheless, the investigators are aware of no research demonstrating that the Guides 
improve patient-centered health outcomes. Moreover, research suggests that many 
patients have difficulty understanding and using the information contained in the 
Guides.31-35,91 Comprehension of information contained in the Guides is particularly low 
among older patients and those with limited health literacy.32,33  
 
SMART Program. The SMART Program was designed to enhance gist reasoning ability by 
training participants on the use of three metacognitive strategies: Strategic Attention 
(e.g., ignoring or eliminating distractions to facilitate single-minded focus on 
understanding the specific topic at hand, prioritizing health issues/problems with 
greatest impact on daily function, understanding signs and symptoms of brain fatigue 
and taking mental breaks to recharge), Integrated Reasoning (e.g., strengthening 
integrative mental capacity to synthesize general as well as medical information from 
multiple sources), and Innovation (e.g., examining multiple perspectives and 
information sources to best understand the information at hand, comparing and 
contrasting information to help determine the best decision, asking insightful questions 
that involve considering information from differing perspectives).92 In randomized 
controlled trials, the SMART Program has been shown to strengthen gist reasoning 
ability especially as evidenced in efficient synthesis and comprehension of complex 
information encountered in everyday life such as news articles and medical 
information.60,92-94 Evidence has also demonstrated generalized benefits of improved 
performance on cognitive, neural and functional measures immediately post training 
and 3-6 months post-training.92 Thus, considerable evidence supports the effectiveness 
of the SMART program in enhancing gist reasoning ability. However, this will be the first 

27 
 
study to examine whether the program enhances patient ability to understand written 
prescription drug information and whether better understanding translates into 
improved decision-making and health outcomes. 
 
Effects of the SMART Program will be evaluated in comparison to standard care. 
Because participants will be recruited from multiple, geographically diverse sites, the 
investigators will not attempt to measure the content of care received. However, 
because the type of gist reasoning training provided by the SMART Program is very 
innovative, the investigators believe that it is unlikely that any participants in the 
comparison group had access to similar programs.  
8 
STUDY INTERVENTION ADMINISTRATION(if applicable)  
Participants will be randomized to study arm on a 1:1:1:1 basis. Prior to the start of 
participant recruitment, the principal investigator will generate a random allocation 
sequence using PC-SAS® (version 9.4). Random numbers will be generated in blocks of 
20 to ensure balance across the four study groups over the entire course of data 
collection. The random number sequence will be imported into the REDCap tracking 
database used by the project director, working out of the UNC-Chapel Hill office, to 
record the name and contact information for study participants as they are enrolled in 
the study. To ensure allocation concealment, the REDCap database will be programed so 
that the group assignment variable: (1) cannot be viewed until after the patient contact 
information has been entered and (2) cannot be changed after the patient contact 
information has been entered. All personnel involved in data collection and delivery of 
the SMART program were blinded to participant group assignment. Because the study 
involves minimal risk, the investigators have no plans to unblind participants or study 
personnel. However, participants will be encouraged to report any problems they 
experience to the research staff so that unanticipated problems might be identified. 
Immediately following completion of baseline data collection, participants will be 
emailed a link to either the DrugFactsBox® website or the Other CMI website, 
depending on the group to which they will be randomized. To track website utilization, 
participants will be assigned a unique username that they will be required to enter each 
time they visited the website. Participants will be free to access the site whenever they 
chose and will have access to the site from the time their username is assigned until the 
end of the study. At the conclusion of the study, tracking data will be downloaded and 
used to assess how often each participant visited the website and the specific pages 
viewed.  
Participants randomized to the SMART Program will be contacted by staff at the Center 
for BrainHealth at the University of Texas at Dallas following completion of baseline data 
collection, by email and telephone, to enroll them in the next SMART Program. The 

28 
 
program will be delivered by Center research personnel certified to provide the program 
using an online video conferencing platform that permits synchronous, audio and visual 
communication between trainers and participants. Participants will only need a 
computer or mobile phone with internet access to participate. Initially, the program will 
be delivered via four 60 to 90 minute sessions, spanning a one month period. In most 
cases, the program will be delivered in small groups with three to four participants. 
However, the program will be delivered one-on-one, if needed to accommodate 
participant schedules.  
9 
SAFETY MANAGEMENT 
This project is associated with minimal risk. Therefore, the investigators have not 
incorporated a formal Data and Safety Monitoring Board. The project will be monitored 
by Drs. Blalock, Karp, Solow, and Carpenter. Dr. Blalock will meet with the Project 
Director on a weekly basis to monitor any adverse effects reported by study 
participants. Drs. Blalock, Karp, Solow, and Carpenter will meet quarterly to monitor 
safety concerns. Study participants will be instructed to call the Project Director if they 
experience any problems that they attribute to study participation. To make it easy for 
participants to contact the Project Director if needed, the investigators will give all 
participants a magnetized card with the Project Director’s name and telephone number 
to place on their refrigerator. The Project Director will record each problem reported in 
a database created for that purpose. Dr. Blalock and the Project Director will discuss all 
problems reported on a weekly basis. Each event reported will be classified into one of 
the following categories: 
1. Mild Adverse Event – Event results in mild or transient discomfort, not requiring 
intervention or treatment; does not limit or interfere with daily activities. 
2. Moderate Adverse Event – Event is sufficiently discomforting so as to limit or 
interfere with daily activities; may require interventional treatment. 
3. Severe and Undesirable Adverse Event – Event results in significant symptoms 
that prevents normal daily 
The interventions the investigators will test involve minimal risk. Therefore, the 
investigators have no plans to withdraw individual participants for any reason. However, 
if a participant becomes upset concerning any study procedures, the investigators will 
ensure that they understand that they have the right to withdraw from the study at any 
time, without penalty. 
10 
DATA COLLECTION AND MANAGMENT  
Data will be collected primarily via telephone interviews, and self-administered, 
Internet-based surveys using REDCap and Qualtrics. All individuals involved in the study 
will be trained as to the confidential nature of all data collected. In addition, all 
personnel will complete ethics training in accordance with IRB policy before they are 

29 
 
allowed to have any contact with study participants or data obtained from study 
participants. All participants will be assigned a unique identifying number that will allow 
the investigators to track them over the course of the study. A key linking participants’ 
names and contact information to this unique identifier will be stored in an encrypted 
file stored on a password protected computer housed behind a firewall on the UNC-CH 
computer system. Only the principal investigator and project director will have access to 
this encrypted file. Participants will not be identified in any report or publication about 
this study. All sharing of research documents between research team members will 
occur via a secure online drive. All information stored in computer files will be 
password-protected and passwords will be changed on a regular basis. Information sent 
by clinical coordinators to the central project office as part of the recruitment process 
will be sent to a fax machine located in a private office, dedicated to this research 
project. The office will be locked when study personnel are not present. All information 
collected that contains the names of study participants will be kept in locked filing 
cabinets when not in use.. 
 
The names of patients identified at participating clinics and the date of their next visit 
will be entered into an on-line database using the UNC REDCap Software. Data entered 
using the REDCap system are maintained on secure, HIPAA-compliant servers. Each 
clinic site will have access only to information entered at their site. If a hard copy of 
information in this database is needed to facilitate recruitment, staff working on the 
project will be instructed to shred the hard copy at the end of each clinic day. 
  
11 
RECRUITMENT STRATEGY 
Please see Section 3.3 “Study Duration, Enrollment and Number of 
Subjects” 
 
12 
CONSENT PROCESS 
We will obtain written informed consent from participants. We will go over the consent 
form with potential participants, solicit questions they may have about the study, obtain 
the participant's signature on the consent form, and provide the participant with a copy 
of the consent form. Consent will be obtained by clinical coordinators working at clinic 
sites and research assistants and the project director working in the central project 
office at the University of North Carolina at Chapel Hill. We will emphasize to all 
potential participants that they are not obligated to take part in the study and that they 
may decline study participation for any reason, and without providing a reason, without 
any negative consequences. The investigators do not plan to enroll individuals who are 
decisionally-impaired or lack sufficient English-language proficiency to understand study 
procedures and the potential risks and benefits associated with participation. 

30 
 
 
13 
PLANS FOR PUBLICATION 
The investigators plan to publish up to three papers reporting study 
findings in the peer-reviewed literature. 
 
14 
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35 
 
 
15 
APPENDIX 
 
Figure 1. Conceptual Framework 
 
 
 
 
 
Written 
Medication 
Information  
SMART 
Program 
Proximal Outcomes  
Intermediate 
Outcomes 
Distal 
Outcomes  
Patient 
satisfaction 
Arthritis  
self-efficacy 
Informed 
decision- 
making 
Health 
related 
quality of life 
Health 
literacy 
Knowledge 
Information 
seeking 
Gist reasoning 
ability 

36 
 
Table 1. Summary of study measures  
 
Variable 
 
Time 
Assessed 
Data Collection 
Instrument 
 
Range 
Baseline 
Alpha 
Knowledge 
B, 6W, 3M, 
6M 
Telephone 
Interview 
0 to 100 
0.84 
Values 
B, 6W, 3M, 
6M 
Self-
Administered 
Questionnaire 
-15 to +15 
0.67 
DMARD Usage 
B, 6W, 3M, 
6M 
Self-
Administered 
Questionnaire 
0=Not using 
any 
DMARDS 
1=Using 1+ 
DMARDS 
NA 
Informed 
Decision-Making 
B, 6W, 3M, 
6M 
Composite 
measure based 
on Knowledge, 
Values and 
DMARD Usage  
0=Did not 
meet criteria 
1=Met 
criteria 
NA 
Gist Reasoning 
Ability: 
 
Complex 
Abstraction 
B, 6W, 3M, 
6M 
Self-
Administered 
Questionnaire† 
0 to 8 
NA 
Lesson  
Quality 
B, 6W, 3M, 
6M 
Self-
Administered 
Questionnaire† 
0 to 5 
NA 
Selective Learning B, 6W, 3M, 
6M 
Telephone 
Interview 
0 to 264 
0.67 
Verbatim Recall  
6W 
Telephone 
Interview 
0 to 2 
0.14†† 
Medication Self-
Management 
Knowledge 
6M 
Telephone 
Interview 
0 to 100 
0.36 
 
 
 
 
 
 
 
 
 
 
 
 
 

37 
 
 
Variable 
 
Time 
Assessed 
Data Collection 
Instrument 
 
Range 
Baseline 
Alpha 
Information 
Seeking: 
 
Use of RA Self-
Management 
Website 
6M 
NA 
0=Never 
accessed 
website 
1=Accessed 
website 1+ 
times 
NA 
Participation in 
BetterChoices, 
Better Health 
6M 
NA 
0=Did not 
participate 
in all 6 
sessions 
1=Participat
ed in all 6 
sessions 
NA 
Treatment 
Satisfaction: 
 
Global 
B, 6W, 6M 
Self-
Administered 
Questionnaire 
0 to 100 
0.83 
Effectiveness 
B, 6W, 6M 
Self-
Administered 
Questionnaire 
0 to 100 
0.90 
Side-Effects 
B, 6W, 6M 
Self-
Administered 
Questionnaire 
0 to 100 
0.82 
Convenience 
B, 6W, 6M 
Self-
Administered 
Questionnaire 
0 to 100 
0.86 
 
 
 
 
 

38 
 
 
Variable 
 
Time 
Assessed 
Data Collection 
Instrument 
 
Range 
Baseline 
Alpha 
Satisfaction with 
Medication 
Information: 
 
Overall 
B, 6W, 6M 
Self-
Administered 
Questionnaire 
0 to 17 
0.88 
Actions 
B, 6W, 6M 
Self-
Administered 
Questionnaire 
0 to 9 
0.78 
Problems 
B, 6W, 6M 
Self-
Administered 
Questionnaire 
0 to 8 
0.85 
Arthritis Self-
Efficacy 
B, 6W, 6M 
Self-
Administered 
Questionnaire 
0 to 100 
0.87 
Illness 
Intrusiveness: 
 
Overall 
B, 6M 
Self-
Administered 
Questionnaire 
0 to 100 
0.90 
Relationships 
B, 6M 
Self-
Administered 
Questionnaire 
0 to 100 
0.85 
Instrumental 
B, 6M 
Self-
Administered 
Questionnaire 
0 to 100 
0.71 
Intimacy 
B, 6M 
Self-
Administered 
Questionnaire 
0 to 100 
0.82 
Health Distress 
B, 6M 
Self-
Administered 
Questionnaire 
0 to 5 
0.91 
 
 
 
 
 
 
 
 
 
 

39 
 
 
Variable 
 
Time 
Assessed 
Data Collection 
Instrument 
 
Range 
Baseline 
Alpha 
Depression 
B, 6M 
Self-
Administered 
Questionnaire 
T-Score:  
Mean =50, 
SD=10  
in reference 
population 
NA 
Fatigue 
B, 6M 
Self-
Administered 
Questionnaire 
T-Score:  
Mean =50, 
SD=10  
in reference 
population 
NA 
Disease Activity 
 
B, 6W, 3M, 
6M 
Self-
Administered 
Questionnaire 
0 to 10 
0.81 
Global Health 
Status   
B, 6M 
Self-
Administered 
Questionnaire 
1 to 4 
NA 
Subjective Health 
Literacy  
B, 6M 
Self-
Administered 
Questionnaire 
0 to 4 
0.80 
Objective Health 
Literacy  
B, 6M 
Telephone 
Interview 
0 to 100 
Version 
A: 0.60 
Version 
B: 0.49 
Medication 
Adherence   
 
B, 6M 
Self-
Administered 
Questionnaire 
0 to 100 
NA 
†A separate online, self-administered questionnaire was used to assess Gist 
Reasoning Ability. It was completed before participants did the questionnaire 
assessing other study measures. 
††This variable was only assessed at the 6-week follow-up.  Therefore, the alpha 
reported is for that time point. 
NOTE: For all variables except Global Health Status, higher values reflect higher 
levels of the attribute measured. For Global Health Status, higher values reflect 
poorer health status.