Utilizing a Lupus Patient Navigator Program (LPNP) to Address Barriers to Care Related to Access to Preventive and Specialty Healthcare, Medication Adherence and Health Literacy in Systemic Lupus Erythematosus (SLE) for Minority Patients
Phase: NA
Conditions: Systemic Lupus Erythematosus (SLE)
Sponsor: Medical University of South Carolina

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PROTOCOL TITLE: 
 
Utilizing a Lupus Patient Navigator Program (LPNP) to Address Barriers to Care Related to Access to 
Preventive and Specialty Healthcare, Medication Adherence and Health Literacy in Systemic Lupus 
Erythematosus (SLE) for Minority Patients 
 
PRINCIPAL INVESTIGATOR: 
James C. Oates, MD 
 
 
 
1.0 
Objectives / Specific Aims 
To improve health care delivery to minority patients with SLE at highest risk for poor 
outcomes, utilizing patient navigators to address barriers to care related to access to 
preventive and specialty healthcare, medication adherence, and health literacy. 
 
2.0 
Background 
 
Despite recent progress in the diagnosis and treatment of SLE, minorities continue to bear the greater 
burden of disease with disproportionately higher morbidity and mortality compared to white patients 
with SLE (1). Longitudinal studies of patients with SLE demonstrate a strong genetic component 
impacting the development of SLE and the risk of severe disease (2); however the development of 
irreversible SLE-related and medication-related organ damage is undeniably complicated by patient 
socioeconomic factors (2, 3). Patients frequently are sent home from clinic or the hospital with 
powerful immune suppressants and an incomplete understanding of risks and benefits.  In the lupus 
Medicaid population, a large fraction of patients have medication non-adherence leading to 
increased risk of hospitalization (4). Every year 25% of SLE patients are hospitalized and 16% of 
those are readmitted within 30 days (5). Other factors associated with poor outcomes include 
transportation (6) and family caregiving obligations among others.  Patients return with either 
complications of inappropriate treatment or organ failure (nephritis, pulmonary hemorrhage) from 
their disease. 
 
Although we cannot change the patient’s genetic risk factors or socioeconomic status, we can 
identify and modify the barriers to SLE care that lead to poor health outcomes (such as difficulty 
accessing primary and specialty healthcare, low health literacy, harmful attitudes and beliefs 
regarding SLE and its treatment). 
 
3.0 
Intervention to be studied 
 
Patient navigator programs have been utilized successfully to improve health outcomes by reducing 
barriers to care for patients with several chronic diseases, including cancer, diabetes, HIV/AIDS, 
cardiovascular disease, and chronic kidney disease. A recent systematic review of patient navigator 
interventions found that 45 of the 67 randomized controlled trials reported statistically significant 
improvements in the primary outcomes (7). Since the first patient navigation program in the 1980s 
focused on breast cancer outcomes, there has been over a decade of successful use of patient 

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navigators in oncology. Consequently, for accreditation, cancer centers are required by the 
American College of Surgeons Commission on Cancer to provide patient navigation services as of 
2015 (https://www.facs.org/quality-programs/cancer). 
 
The navigator services most commonly provided include facilitation/coordination of care, practical 
support, including transportation and financial assistance, appointment scheduling and reminders, 
education and psychosocial support (7). The most effective patient navigators address both health 
system barriers and patient barriers (examples shown in Table 1). 
    
Targeted interventions have been proposed to address the common barriers to care among patients 
with SLE (8-10), but a comprehensive patient navigator approach utilizing novel interventions based 
on evidence from prior studies, such as the one proposed, has yet to be described in the literature.  
 
 
Table 1 - Features of the proposed Lupus Patient Navigator Program. 
Barriers to Optimal Care 
Lupus Patient Navigator 
Program Features 
Examples of Patient 
Navigator (PN) 
Interventions 
Missed / Forgotten / 
Cancelled Appointments 
Facilitate care 
(referrals, 
communication, 
coordination) / 
Appointment 
scheduling / 
Appointment reminder 
calls 
Patient unable to navigate 
scheduling system to make 
specialist appointments; 
PN facilitates by contacting 
specialty offices and 
coordinating appointments 
based on patient's location 
needs. 
Lack of Reliable 
Transportation 
Practical support with 
transportation options 
Pt is unfamiliar with 
transportation option in 
their area; PN provided 
public transportation 
schedules, instruction on 
how to schedule Medicaid 
van. 
Lack of Information / 
Misinformation 
Health literacy 
promotion, delivery of 
culturally tailored 
health information 
addressing patient and 
caregiver attitudes and 
beliefs 
PN discovers patient and 
caregiver misperceptions 
about Lupus; PN provides 
publicly available 
resources from the Lupus 
Foundation of America 
website. 

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Poor Adherence to 
Treatment 
Encouragement of 
treatment adherence 
through the use of 
medication diary / 
Assistance with 
enrolling into 
medication assistance 
programs 
Patient unable to obtain 
medications due to lack of 
insurance; Assist patient 
with completing 
pharmaceutical patient 
assistance applications. 
Financial Concerns 
Practical support in 
finding community 
financial resources and 
public insurance 
options 
Patient reports difficulty 
with utility bills; PN helps 
contact appropriate 
agencies for assistance. 
 
 
4.0 
Study Endpoints 
 
Improvement in Medication Adherence, Improvement in patient-reported lupus-specific 
disease status (measured by the LupusPRO), Improvement in Adherence with Primary Care 
/ Specialty Care Visits, Lab and other Study Appointments. 
Racial Discrimination will be measured using the validated 9-item Experiences of Discrimination 
(EOD) measure, which includes an index of racial discrimination experiences ever 
experienced.  The EOD is a widely used and validated measure of racial discrimination. This short, 
self-report instrument is based on a prior instrument used in the Coronary Artery Risk Development 
in Young Adults (CARDIA) study validated in AA and Latino participants and has been previously 
used for measuring experiences of racial discrimination in AA women with SLE. (11). 
 
 
5.0 
Inclusion and Exclusion Criteria / Study Population 
 
Criteria for Inclusion:  
 
INTERVENTIONAL GROUP (n=25): 1) Self-identified Minority. 2) Patients ≥ 18 years of age as 
documented in the electronic medical record. 3) Meeting either American College of Rheumatology 
or SLICC Classification Criteria for SLE as documented in the electronic medical record (12, 13). 
4) Ability to speak and understand English by self-report. 5) In the past six months having ≥ 1 
missed clinic or diagnostic study/laboratory visit as documented in the electronic medical record,  
self-reported failure to adhere with prescribed medical therapy for SLE, or the participant is newly 
diagnosed with SLE. 6) In the past six months having been prescribed at least one 
immunosuppressive medication for SLE activity as documented in the electronic medical record 
regardless of whether taking the medication. 7) Have telephone access. 
 
USUAL CARE GROUP (n=25): Meet criteria 1, 2, 3, 5, 6, 7 above for interventional group. All 
data from healthcare utilization and medication compliance will be collected via the CCCR 
biorepository request process. See data collection guidelines for this group below (Sections 12 & 
13). 
 

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Criteria for Exclusion (Interventional Group only): 1) Unwilling or unable to give informed 
consent. 2) Being a prisoner or institutionalized individual. 3) Without telephone access. 4) Do not 
meet all of the inclusion criteria listed above. 
 
Criteria for Exclusion (Usual Care Group only) 1) Do not meet usual care inclusion criteria 
above. 
 
Recruitment will be enhanced by MUSC having specialized lupus clinics already in place dedicated 
to the care of patients with SLE. 
 
 
6.0 
Number of Subjects 
 
 
Sample size of n=25 patients in the Patient Navigation Group and n=25 patients in the Usual Care  
Group. 
 
Patients who meet eligibility criteria and provide informed consent to participate in the LPNP will 
be enrolled up to the sample size goal of 25 patients. Upon completion of all study visits for the 
Patient Navigation Group, 25 additional patients who meet the inclusion criteria will be identified 
through the CCCR biorepository study to be included in the Usual Care group. Healthcare utilization 
and medication compliance data will be provided via a formal request (see Sections 12 & 13 below) 
to the CCCR and provided to study staff.  
 
 
7.0 
Setting 
 
 
MUSC Rheumatology clinics, MUSC inpatient setting 
 
8.0 
Recruitment Methods 
 
The patient's primary rheumatologist can refer the patient to the PI/study staff for eligibility review 
after discussing with the patient. If needed, Epic (EMR) rheumatology-specific clinic schedules and 
charts of those patients seeing those rheumatologists (PI/Co-I) will be reviewed weekly for patients 
with lupus and self-identified as a minority. These patients will be contacted by PI/Study Staff only 
if they not opted out for research contact. Additionally, outreach and advertising materials will be 
used to promote and introduce the study to potential candidates.  Material will be made available to 
PI/Co-I's for discussions with pts,  within MUSC Rheumatology Clinic waiting rooms for pt initiated 
access/interest, as well as hardcopy and electronic versions (email) to potential pts as appropriate 
following preferred communication method of the pt as noted in Epic.  Outside of any direct in-
person exchange/presentation, there will be an accompanying notification that explains the contact 
(i.e. brochure). Eligibility will be confirmed by the PI. Subjects will be contacted via telephone 
and/or at their clinic visit.   
 
We do not anticipate difficulty enrolling 25 patients into the LPNP intervention group within the 
initial eight months of the 24-month funding period, given the large number of high-risk patients 
followed at MUSC.  For example, based on recent experience and EMR administrative data review, 
at least 35% of the 1320 patients with SLE followed at MUSC in the last two years meet the 
demographic (age, race, disease duration) and medication criteria. 
 

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9.0 
Consent Process 
 
IRB approved personnel are authorized and qualified to obtain consent. The informed consent 
document may be sent to potential subjects prior to scheduling a screening visit, either by mail or 
email, for their review.  
 
Informed consent will be obtained in a private clinic room. The consent will be explained to the 
subjects and they may take time to read the document; subjects will be given ample time to review 
the ICF and ask questions; subject's questions will be answered by the investigator and/or study 
staff. After signing, subjects will be given a signed/dated copy of the ICF. There is no wait period. 
No study procedures will be performed prior to obtaining written informed consent. 
 
To reduce barriers to enroll in the study during times of unexpected campus and/or clinic shutdowns 
(pandemics, weather occurrences, etc.), remote consent option will be available. Participants will 
have the option to complete consent 1) via MUSC’s doxy.me system (tele consent) or 2) via 
REDCap electronic consent (e-consent) combined with a phone discussion. These procedures for 
consenting remote study participants are in line with the IRB approved procedures and are supported 
through MUSC SCTR Services.  All doxy.me signed consent forms will be saved as PDF files within 
our study records. Signatures on the consent form may be obtained electronically via 
REDCap/doxy.me.  To minimize concerns of errors/compliance with execution, Doxy.me will be 
the primary mode of eConsent with REDCap serving as a backup method in case there are system 
compatibility or end user concerns experienced.   Participants will be encouraged to print and/or 
save a copy for their resource.  If they do not have the ability to do so, a copy of the executed ICF 
will be provided to them at their next in-person visit or mailed per their preference. 
 
No undue coercion or influence will be utilized for recruitment. The amount of compensation 
subjects may receive is nominal. All possible subjects will be treated the same. All patients that may 
screen fail or choose not to participate in the study will not have their standard of care altered or 
lose access to care. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10.0 Study Design / Methods 
 
 
Schedule of Events 
 
Screening 
Call 
 
In-Person 
Baseline 
Visit α 
Monthly Call 
(Months 
1,2,4,5,7,8,10,1 
1) After 
Baseline* 
Appointment 
Reminders (15 
Days & 2 Days 
Before 3, 6, 9 
Month Visit)** 
 
Post 3, 6, 9 
Month Visitα 
Appointment 
Reminders (15 
Days & 2 Days 
Before Post 12 
Month Visit) 
 
Post 12 
Month Visitα 
Participation Assessment 
X 
 
 
 
 
 
 
Informed Consent & HIPAA 
 
X 
 
 
 
 
 
Steps To Care Intake 
Assessment Form 
 
X 
 
 
 
 
 
Steps To Care Reassessment 
Form  
 
 
 
X 
 
X 
 
X 
Participant Completed 
Assessments: 
Healthcare Resource Use 
Survey, Test of Functional 
Health Literacy 
 
X 
 
 
 
 
 
MacArthur Ladder, 
Experiences of 
Discrimination (EOD) 
measure 
 
X 
 
 
 
 
X 
LupusPRO 
 
X 
 
 
X 
 
X 
 
Medication Adherence Diary 
Review 
 
 
X 
 
 
 
X 
 
 
X 
Participant Completed 
Assessments: 
Perceived Stress Survey, 
Social Support Survey & 
Modified Picker Survey, 
Patient-Centered Care 
Questionnaire 
 
 
X 
 
 
 
 
 
X 
Appointment Reminder Calls  
 
 
 
X 
 
 
X 
 
 
Patient Satisfaction with 
Interpersonal Relationship 
with Navigator (PSN-I) survey 
 
 
 
 
 
 
 
X 
 
As Needed 
 
 
1 Week F/U Call After 
Medication Change 
 
Medication changes can occur at any time during the study. Medications to be included are those prescribed for your 
SLE. 
 
*Monthly Call window = +/- 7 calendar days. 

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**Appointment Reminder window = +/- 2 business days. 
α All in person visits can be done in clinic or remotely via doxy.me  
 
 
 
 
 
 
Screening: 
PN will assess patient willingness to participate in the study as well as eligibility via a phone call, 
remote visit, in person at their clinic appointment, or once stable during an inpatient hospital stay. 
 
Baseline  In Person or Remote Visit: 
Upon enrollment (Baseline visit) and signing of informed consent and HIPAA authorization, the 
PN will provide the following questionnaires, surveys and diaries: 
1) Steps to Care Intake Assessment Form,  
2) Healthcare Resource Use Survey,  
3) LupusPRO survey,  
4) Test of Functional Health Literacy,  
5) Medication Adherence Diary,  
6) Perceived Stress Survey,  
7) Social Support Survey & Modified Picker Survey Patient-Centered Care Questionnaire, 
8) Experiences of Discrimination (EOD) measure, 
9) MacArthur Scale of Subjective Social Status (MacArthur Ladder). 
 
Post 3, 6, & 9 Month In Person or Remote Visits: 
1) Medication Adherence Diary review, 
2) Steps to Care Reassessment Form,  
3) LupusPRO survey. 
 
Post 12-Month In Person or Remote  Visit: 
1) Medication adherence diary review, 
2) Steps to Care Reassessment Form,  
3) LupusPRO Survey, 
4) Perceived Stress Survey,  
5) Social Support Survey, 
6) Modified Picker Survey Patient-Centered Care Questionnaire, 
7) Experiences of Discrimination (EOD) measure,  
8) MacArthur Scale of Subjective Social Status (MacArthur Ladder). 
 
Monthly Phone Calls post signing of informed consent: 
1) Steps to Care Reassessment Form 
 
The PN will  contact enrolled patients to provide appointment reminders. Contacts can be via phone, 
text, email, or MyChart as preferred by participant.  These appointments are not only standard of 
care rheumatology visits but also associated to the research study in question. These contacts will 
be completed 15 days and 2 days prior to rheumatology clinic visit. 
 
Additionally, the PN will calls the patients one week following any changes in medications for their 
SLE (per primary Rheumatologist or patient reported) and will ensure patient has filled in proper 

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information on their Medication Adherence Diary during that contact. The PN will respond to phone 
calls from participating patients for health and general questions, notifying the appropriate medical 
provider when necessary and documenting all patient-initiated calls in the EMR. The PN will assess 
whether the patients’ basic needs are being met (i.e. are there adequate resources for food, housing, 
medications, etc.) and make referrals for support services as needed (to include referrals for dietary 
modification, smoking cessation, exercise, obesity prevention, psychiatry, and substance abuse). 
 
For each of these in-person visits with surveys, participants will be compensated $10 (for a total of 
$50.00 over 12 months of participation). Compensation will be delivered via ClinCard. The in-
person PN visits will be planned in conjunction with scheduled outpatient clinic visits. 
 
For the Usual Care Group only: As stated above, in order to properly obtain data, while minimizing 
risk to patients in this study, the study staff will only utilize data for those patients that have already 
enrolled in the Division of Rheumatology Core Center for Clinical Research (CCCR; Pro21985). 
These patients will have provided properly executed HIPAA authorization to utilize Protected 
Health Information through the CCCR for optional research portions of the CCCR study (see 
General Comments of IRB application to review CCCR HIPAA Authorization). Data on healthcare 
utilization and adherence to prescribed medications based on pharmacy records would be collected 
on the Usual Care group as part of standard quality of care monitoring, which are allowed to be 
collected through the CCCR; Pro21985. This data will be provided through a formal request process, 
reviewed by the executive committee of the CCCR, and provided to this study’s staff via this 
request. Note that this group of patients (Usual Care) will not have a formal informed consent 
process completed and executed as only analysis of data already collected for standard of care is 
necessary and falls under the HIPAA Authorization for the CCCR. 
 
 
11.0 Specimen Collection and Banking 
No specimens will be collected. 
12.0 Data Management  
 
The MUSC CCCR Patient Resource Core (Pro00021985) will act as an honest broker for the 
provision of clinical data of patients that fit criteria and are already enrolled in the CCCR study. The 
clinical data provided to the PN and PI of this study will include all data listed in sections 4.0 & 
10.0 and will be provided to study staff de-identified. The data provided will only include 25 patient 
data sets for the “Usual Care” group that has not had contact with the patient navigator and serves 
as the control group for this study.  
 
Analyses will be primarily descriptive in nature.  Means, standard deviations, medians, inter-quartile 
ranges, and proportions will be reported on each outcome of interest, as appropriate.  These statistics 
will be reported at baseline, 3 months, 6 months, and at 12 months for the primary outcome measure 
(Medication Adherence) and all secondary outcome measures. The secondary outcome measures 
are 1) Adherence with Primary Care and Specialty Care Visits, 2) Adherence with Lab and other 
Study Appointments, 3) Healthcare Utilization, 4) Disease-related Damage, 5) Corticosteroid Use 
and 6) Patient-Reported Outcomes.   
  
In addition to results reported by our site, we will report results from our collaborating site, 
University of Alabama at Birmingham (UAB), during their implementation of the LPNP protocol.  

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Analyses will include estimates of site to site variability utilizing a combined MUSC and UAB 
dataset.  All data sharing will be de-identified and maintained on MUSC’s supported REDCap 
platform.  Shared data and analyses were included in the Scope of Work executed by NIH subaward 
funding of 3P30AR072582-03S1, Improving Minority Health in Rheumatic Diseases.    
 
Although this is not a randomized trial, we will use statistical methods such as propensity score 
weighting (36) to gain an understanding of how the use of PNs improves outcomes (e.g. medication 
adherence) when compared to usual care.  Generalized linear mixed models will be used in 
conjunction with propensity score weighting to compare treatment group outcomes and estimate 
relevant effect sizes while adjusting for relevant baseline covariates (e.g. age, SLEDAI) and 
accounting for repeated measures within patients over time. 
 
Since we will have all healthcare utilization data over the 12-month time, calculations will also be 
performed to indicate how intervention and control patients compared monthly throughout the 
study.  These data will help us design a larger randomized, multi-center, clinical trial.  The pilot 
study will be extremely valuable both in demonstrating feasibility and in providing data for sample 
size estimation for our next step trial. 
 
Since this is a pilot study, our sample size of n=25 patients in the PN group and n=25 patients in the 
“Usual Care” group were selected primarily to ensure that we can assess feasibility of providing this 
intervention in this high-risk population.  Having n=25 patients in each group will also allow us to 
estimate group-specific outcomes with relatively strong precision (i.e. within ± 0.3 standard 
deviations for continuous outcomes and ±10%-20% percentage points for proportions).  All this 
information will be vital for designing a future, definitive randomized controlled trial. In obtaining 
preliminary estimates of effectiveness, our sample sizes will also provide sufficient power (>80%) 
to detect moderate differences in medication adherence rates between treatment groups, assuming 
2-sided hypothesis testing and an alpha level of 0.05.   
 
 
13.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
 
The investigator and other study personnel will keep confidential any information related to this 
study, all data and records generated during conducting the study, and will not use the information, 
data, or records for any purpose other than conducting the study. These restrictions do not apply to: 
(1) information that becomes publicly available through no fault of the investigator or site personnel; 
(2) information that is necessary to disclose in confidence to an IRB solely for the evaluation of the 
study; (3) information that is necessary to disclose in order to provide appropriate medical care to a 
patient; or (4) study results that may be published in an aggregate fashion. 
 
All data will be stored on MUSC Network Storage with survey results entered into a secure MUSC 
REDCap database, only accessible by personnel approved on this study application with MUSC 
login credentials.  The data from the two institutions (MUSC and UAB) will be maintained 
separately, with data entry and editing performed only by IRB-approved personnel specific to each 
site.   
 
Patients will be assigned an identification number. Personal identifiers will not be accessible to 
individuals beyond the investigative site. Confidentiality will be maintained by the use of codes for 
identifiers. All study related documents (physical paper documents, if needed) and materials will be 

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kept in secured locked file cabinets in a locked office space of the Division of Rheumatology with 
limited access by non-study personnel. 
 
 
14.0 Withdrawal of Subjects 
 
Subjects can withdrawal at any time during the 12-month study simply by verbally telling the PN 
either in person or over the phone they wish to withdraw. 
 
15.0 Risks to Subjects 
 
Confidentiality: There is the potential risk of loss of confidentiality. Every effort will be made to 
keep information confidential; however, this cannot be guaranteed. After the study is completed, the 
data may be placed in a central storage location or public database. This will include all the 
information learned from this study and not just information specific to an individual patient. Any 
data will not include patients’ names or other information that can identify an individual patient. 
The purpose is to make study data available to other researchers who must request permission to 
use it. 
 
Questionnaires/Surveys: The questions that will be asked may be sensitive in nature and make the 
patient feel uncomfortable. The patient may be asked personal questions that the patient finds 
distressing. The patient may refuse to answer any question(s) that they do not wish to answer. 
 
 
16.0 Potential Benefits to Subjects or Others 
 
If having a Patient Navigator improves a patient's compliance with medication adherence, clinic and 
lab appointments, the patient's overall health and quality of life may improve. It may also reduce 
the SLE related damage to vital organs which may improve overall health and quality of life. 
However, this cannot be guaranteed.  
 
 
17.0 Sharing of Results with Subjects 
Since all study subjects are patients of the MUSC Rheumatology clinics, their primary 
Rheumatologist will have access to data in the patient’s EMR. Results of survey data will 
not be shared with the participants. All other data is a part of the participant’s standard of 
care and thus is continuously shared with them via their care providers.  
 
18.0 Drugs or Devices (if applicable)  
 
 
No drugs or devices will be used in this study. 
 
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