CCCR Lupus Patient Navigator Program

Not Applicable

Completed

Conditions: Systemic Lupus Erythematosus (SLE)

Interventions: Behavioral: Patient Navigator Services

Registration Number: NCT04461158

Lead Sponsor: Medical University of South Carolina

Brief Summary: To address the health disparities in SLE outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on evidence from prior studies is the purpose of this research. The navigator services most commonly provided include facilitation and coordination of care, practical support, including scheduling transportation and referrals to financial assistance programs, appointment scheduling and reminders, education and psycho-social support. The most effective patient navigators address both health system and patient barriers.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

Inclusion Criteria

Self-identified Minority.
Patients ≥ 18 years of age as documented in the electronic medical record.
Meeting either American College of Rheumatology or SLICC Classification Criteria for SLE as documented in the electronic medical record.
Ability to speak and understand English by self-report.
In the past six months having ≥ 1 missed clinic or diagnostic study/laboratory visit as documented in the electronic medical record, or self-reported failure to adhere with prescribed medical therapy for SLE.
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.
Currently enrolled into the Core Center for Clinical Research (CCCR; Pro 00021985) with properly executed Informed Consent Document and HIPAA Authorization.
Have telephone access.

Exclusion Criteria

Unwilling or unable to give informed consent.
Being a prisoner or institutionalized individual.
Without telephone access.
Do not meet all of the inclusion criteria listed above.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Group	Patient Navigator Services	-

Primary Outcome Measures

Name	Time	Method
Improvement in Quality of Life	12 months - from baseline to 12 month visit	Qualify of life measured by the "LupusPRO" patient-reported questionnaire administered at Baseline and 12 Months in the Intervention Group, resulting in a LupusPRO score. LupusPRO (v1.8) includes 43 items with domains of Lupus Symptoms, Lupus Medication, Physical Health, Emotional Health, Pain, Sleep, Procreation, Cognition, Body Image, Desires-Goals, Coping, Social Support and Satisfaction with Care rated on a 5 point Likert scale, where 0=None of the time/not applicable, 1= A little of the time, 2= Some of the time, 3=Most of the time, 4= All of the time, 5= Not applicable. Total scores measure health (HRQOL) and non-health related quality of life (Non HRQOL). Item scores are totaled for each domain item and the mean domain score is obtained by dividing the total score by the number of items in that domain. The mean raw domain score is transformed to scores ranging from 0 (worst QOL) to 100 (best QOL) by dividing by 4 (the number of Likert responses {5 responses

Secondary Outcome Measures

Name	Time	Method
Improvement in Medication Adherence	12 months - from baseline to 12 month visit	Adherence with prescribed medical therapies will be defined as the ratio between the number of therapy-days supplied to the number of days until the prescription was refilled and compared between Lupus Patient Navigator Program (LPNP) participants and usual care patients. Medication adherence rates will be estimated by charts review and comparing these medications to pharmacy records on dates and quantities filled. Included medication classifications will include antihypertensives, immunosuppressants, Plaquenil (hydroxychloroquine), and glucocorticoids. Additionally, overall pill burden will be compared between LPNP participants and usual care patients. LPNP participants' medication diaries will be reviewed to determine self-reported adherence.
Improvement in Patient-reported Lupus-specific Disease Status	12 months - from baseline to 12 month visit	Changes in patient-reported lupus-specific disease status (measured by the LupusPRO v1.7) over time, from Baseline, 3, 6, 9, and 12 months, compared between interventional and usual care groups will be completed at the start and end of participation. The LupusPRO is a validated, comprehensive patient reported quality of life questionnaire specific for patients with lupus. Domain areas include: lupus symptoms, cognition, physical health, pain vitality, procreation, emotional health, body image, desires-goals, social support, coping, and satisfaction with care.
Improvement in Adherence With Medical Providers and Services	12 months - from baseline to 12 month visit	Adherence with medical providers and services will be the ratio of number of visits scheduled to the number of visits kept. Rates will be compared between LPNP participants and usual care patients.