Reducing Disparities in Medication Adherence of Patients With Systemic Lupus Erythematosus (SLE)
Phase: NA
Conditions: Systemic Lupus Erythematosus
Sponsor: Duke University

Version Date: 06Sep2018 
1
Research Summary  
Version Date: 07Sep2018 
NCT03738826 
 
Protocol Title: Reducing Disparities in Medication Adherence of Patients with Systemic Lupus 
Erythematosus (SLE) 
 
Department/Division/Clinical Setting: Division of Rheumatology & Immunology, Duke 
University Medical Center. 
Key Personnel: PI: Kai Sun, MD, MS. Instructor, Division of Rheumatology & Immunology, 
Duke University Medical Center. 
CRC: Edna Scarlett 
Consultant: Amy Corneli, PhD 
 
Purpose of the Study:  
The aims of this study are to: 
1) Identify key contributors to medication nonadherence among minority SLE patients using 
mixed methods, including patient self-efficacy, patient-provider communication and racial 
discordance;  
2) Develop a multi-level intervention directed towards providers, clinic staff, and patients 
based on concepts of self-affirmation and positive affect to increase medication adherence 
among minority SLE patients by addressing specific findings from Aim 1; and 
3) Pilot test the intervention designed in Aim 2 to address barriers that originate in the clinical 
interaction in the Duke Lupus Clinics. 
 
Background & Significance:  
 
Systemic lupus erythematous (SLE) is more common, severe, and deadly in Hispanics, Asians, 
and African Americans than in Caucasians. Medication non-adherence is more prevalent in ethnic 
minorities and may be a significant contributor to known outcome disparities. A range of barriers 
to adherence have been identified including factors both extrinsic (such as cost, insurance, 
medication complexity, side effects) and intrinsic (patient level factors, patient-provider 
relationship) to the patient encounter. This study will focus on two modifiable risk factors 
intrinsic to the clinical encounter that are especially relevant in the care of minority lupus 
patients: 1. self-efficacy, or confidence in one’s own ability to take action to overcome barriers 
with regards to a specific behavior; and 2. effective patient-provider communication. Data 
suggest that both of these factors are diminished among minority populations, particularly when 
the patient and provider come from different cultural backgrounds. 
 
Treating lupus, an incurable multisystem autoimmune disease, often requires long term use of 
immunosuppressive and immunomodulatory medications to prevent disease progression and 
damage. Barriers to adherence include both unpleasant medication side effects and incomplete 
efficacy, leading to frequent medication changes. Paradoxically, while troublesome symptoms 
like fatigue have no effective treatments, severe organ manifestations such as nephritis may be 
completely asymptomatic, leading patients to question the necessity of treatment escalation. 
Additional patient-specific challenges such as self-management of physical activity, nutrition, 
medications, financial complications from medical care and disability, and stress reduction, make 
patient self-efficacy a critical management challenge. As a result of these many challenges, 

Version Date: 06Sep2018 
2
medication non-adherence is as high as 75% among patients with SLE. Such complexities make 
patient-centered lupus care and effective patient-provider communication crucial. 
 
Further complicating medication adherence, the high rate of racial discordance between lupus 
patients and providers may pose barriers; while African-Americans comprise nearly 40% of SLE 
patients, they represent only 0.8% of US adult rheumatologists. Racial discordance is associated 
with stereotypical threat, or apprehension about being negatively stereotyped. This threat impairs 
patient-provider communication and decreases patient self-efficacy. Also, racial discordance has 
been linked to implicit bias in providers – unconscious attitudes or stereotypes that affect one’s 
understanding, actions, and decisions, which can further impair communication.  
 
All these factors are important because poor communication and low patient-self efficacy can 
both undermine patient-centered care, medication adherence and clinical outcomes. Lupus 
providers also experience stress as a result of patient non-adherence, which creates feelings of 
powerlessness, helplessness, and frustration that stem from a sense of lack of control. Poor patient 
outcomes that result from non-adherence may cause providers to question their self-image as a 
competent health care professional, making them more vulnerable to burnout. Such provider 
challenges can in turn negatively impact patient adherence. Psychological interventions aimed at 
self-affirmation (the act of affirming one’s core values and sources of personal pride) and positive 
affect (feelings that reflect pleasurable engagement with the environment) enhance both patient-
physician communication and patient self-efficacy by defusing stereotypical threat, buffering 
against stress, and reducing defensive rejection of information. Directing psychological 
interventions towards both lupus providers and patients is a promising strategy to improve 
adherence and reduce outcome disparities; randomized controlled trials demonstrate that 
promoting self-affirmation and positive affect improves medication adherence and health 
behaviors among patients and improves performance among students and professionals. 
 
Despite the clear morbidity that stems from medication non-adherence, few studies have 
investigated determinants of non-adherence in SLE. This knowledge gap is even wider for 
minority populations. Our proposal will begin to fill this gap by studying the relationship between 
race, patient-provider communication, patient self-efficacy in taking lupus medicines, and 
medication adherence in SLE patients. 
 
Methods:  
Aim 1: Mixed Methods Approach to Identify Key Barriers of Medication Adherence 
a. Quantitative study: We will analyze data already collected through the Duke Lupus Registry 
(DLR) (Pro00008875) and Sub-studies of the DLR (Pro00094645). The following table shows 
cross-sectional data that are collected by self-report. We anticipate analyzing data from 124 
consecutively enrolled participants. In addition, the DLR has also collected information from 
medical records including: insurance, medication details, disease duration, missed visits, 
hospitalizations/emergency room visits in the past 12 months, comorbidities, medication refill 
data and drug levels of hydroxychloroquine, azathioprine, and mycophenolate mofetil when 
available. The Systemic Lupus Activity Questionnaire (SLAQ), a patient reported disease activity 
measure, and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), a provider 
derived lupus disease activity measure, both routinely collected at each visit in Duke Lupus 
Clinic, will also be included.  
Self-report data:  
Demographics 
Age, Gender, race/ethnicity, employment status, marital 
status, living arrangement will be ascertained by self-
report 

Version Date: 06Sep2018 
3
Medication Adherence Self-Report 
Inventory (MASRI) Part A 
A 6-item questionnaire about the amount of medication 
taken.  Provides a numerical estimate of adherence from 
0-100%. Validated in lupus.  
Patient-Reported Outcomes 
Measurement Information System 
(PROMIS) Self-Efficacy for 
Managing Medications and 
Treatments – Short Form 8a 
An 8-item on a 5-point Likert scale measuring patient 
confidence in taking medications in a variety of 
situations. 
PROMIS General Self-Efficacy – 
Short Form 4a 
A 4-item on a 5-point Likert scale measuring general 
level of confidence in managing various situations, 
problems, and events.  
Interpersonal Process of Care 
Survey (IPC) 
A multidimensional instrument measuring 
communication, patient-centered decision making, and 
interpersonal style using 29 items on a 5-point Likert 
scale. 
Positive and Negative Affect 
Schedule (PANAS) 
Two 10-item mood scales measuring positive and 
negative affect on a 5-point scale.  
 PROMIS-29 
Measures 7 domains with 29 items: physical function, 
anxiety, depression, fatigue, sleep disturbance, social 
function, and pain. Validated in SLE. 
Statistical Analysis: Adherence based on self-report will be analyzed as a continuous variable 
from 0-100%. Adherence as a binary variable based on a cutoff of ≥80% will also be explored. 
Patient self-efficacy and patient-physician communication will be analyzed as continuous 
variables. We will also explore analyzing them as binary variables dichotomized at the median to 
high vs. low. Disease activity will be categorized as remission, low, medium, and high. The 
association between medication adherence as a continuous variable and 1) patient self-efficacy 
and 2) patient-provider communication will be assessed using linear regression models. 
 
b. Qualitative study: We will conduct individual interviews with minority lupus clinic patients, 
clinical staff and providers to better understand facilitating factors and barriers to adherence with 
a focus on patient-physician communication and patient self-efficacy. We will also measure 
provider stress and implicit bias using the implicit association test 
(https://implicit.harvard.edu/implicit/). Prior to start of interviews, each participant will compete a 
brief questionnaire that include basic demographic information from the participants including 
age, gender, race/ethnicity, education, years since disease diagnosis for patients, years of being a 
rheumatologist for providers. 
Inclusion: Patients are eligible if they are non-Caucasian, have an established diagnosis of SLE, 
actively followed in the Duke Lupus Clinic for at least 6 months, and are prescribed at least 1 
scheduled oral or injectable disease modifying medication for lupus. All clinic staff and providers 
are eligible. 
Exclusion: we will exclude patients who are pregnant or nursing, seen for the first time in Duke 
Lupus Clinic, and those with significant cognitive impairment as determined by treating 
rheumatologist.  
Sampling Strategy and recruitment: Two purposeful samples of 1) lupus clinical staff and 
providers, and 2) patients with SLE will be studied. Recruitment will continue until idea 
saturation, typically by 12 subjects in a group. Eligible patients will be identified via review of 
the lupus clinic schedule and contacted the day before lupus clinic to verify willingness and 
availability to participate. 
Research Design and Subject Compensation: Semi-structured interviews will be conducted 
using an interview guide (see attached). Consenting patients will complete the interview at the 
end of the lupus clinic visit in person. Clinic staff and providers will complete their interviews 
either in-person or over the phone. Each interview will take 30-60 minutes. A $25 stipend will be 
offered to each patient as an appreciation of his/her time.  

Version Date: 06Sep2018 
4
Data Analysis & Statistical Considerations: We will use qualitative, thematic analysis. Interviews 
will be audio-recorded and transcribed verbatim. Nvivo, a qualitative research software, will be 
used to facilitate analysis. Two analysts from Duke QualCore will apply deductive, structural 
codes, followed by inductive, thematic codes to the data. We will then identify the most salient 
themes, further explore the nuances of each theme and how they relate to each other as well as 
identify sub-themes, primarily based on salience. 
 
Aim 2: Intervention Development  
Based on findings from the first aim of the study, a multi-disciplinary team will develop a multi-
level intervention. We will seek to identify new approaches physicians can use to communicate 
with minority patients more effectively. Any component of the intervention directed at the patient 
will be delivered at the beginning of the clinical encounter after obtaining informed consent. The 
intervention will most likely focus on provider-patient communication and self-efficacy, but will 
be driven by data from Aim 1. The target population will also be determined based on Aim 1 
data.  
Study Team: The intervention will be developed in collaboration with lupus clinic providers, 
staff, and patients. We will convene 3-6 monthly meetings to review results from Aim 1, identify 
targets for intervention, and develop feasible and acceptable interventions.  
Intervention Targets: We hypothesize that an intervention that involves self-affirmations and 
positive affect for physicians, staff, and patients will improve provider-patient communication 
and enhance patient self-efficacy. It is possible, however, that Aim 1 will not demonstrate these 
factors as important in the racial disparities in medication adherence. If this were to happen, we 
would work with the multi-disciplinary team to identify different targets and interventions that 
would be more effective, based on the results of Aim 1.  
 
Aim 3: Pilot Testing of Intervention  
The intervention developed from Aim 2 of the study will be implemented in clinic, focusing on a 
small cohort of providers, clinic staff, and African American SLE patients. The baseline measures 
collected in the Aim 1 surveys will be collected at the time of the intervention and again 3 months 
later. Feasibility and acceptability of the intervention will be assessed. At the completion of this 
pilot, we will have feasibility and outcomes measures to adjust or expand the intervention project. 
 
Consent Process  
 
Quantitative data analysis: The consent form for the DLR includes use of medical information.  
 
Qualitative study: Participants will provide signed informed consent prior to participation in 
individual interviews. The consent process will include an explanation of the project design and 
intent, an assurance of confidentiality and data security, and a reminder that participation is 
voluntary. When each participant is invited, it will be clear that this is a research study and their 
responses will be used for research. Consent will be conducted by Study PI and/or CRC’s 
 
Pilot intervention: Details of the intervention will be dependent on our findings from Aim 1. An 
addendum to the IRB with details of the intervention will be submitted prior to start of this phase 
of the study. If consent is applicable, it will also be submitted through process of an amendment.  
 
Subject’s Capacity to Give Legally Effective Consent: Patients who are not competent to 
provide informed consent in English will not be included. 
 
Study Interventions: To be determined based on findings from Aim 1. 
 

Version Date: 06Sep2018 
5
Risk/Benefit Assessment: Being included in this study does not pose any increased risk to 
participants involved. There is minimal potential risk for loss of confidenciality, Patients who 
participate in the intervention may experience improved patient-physician communication, self-
efficacy, and/or medication adherence. The data obtained, may improve the care for patients with 
SLE in the future.  The risk to each participant in this study is no greater than minimal, making it 
reasonable given the potential benefit to future patients. 
 
Costs to the Subject: None 
 
Data & Safety Monitoring: A data monitoring committee will not be used. 
 
Privacy, Data Storage & Confidentiality: All data including the audiotapes and transcriptions 
will be maintained on a secure server. Participants will be assigned a unique identification number 
that will not be related to their name, date of birth, social security number, or medical record 
number. For data analysis, the unique ID number will be the only patient identifier used.