Clinical trial NCT04461158: CCCR Lupus Patient Navigator Program
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus (SLE)
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: University of Alabama at Birmingham
First posted: 2020-07-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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.
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, or self-reported failure to adhere with prescribed medical therapy for 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. Currently enrolled into the Core Center for Clinical Research (CCCR; Pro 00021985) with properly executed Informed Consent Document and HIPAA Authorization.
8. Have telephone access.

Exclusion Criteria:

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.

Primary outcomes:
measure: Improvement in Quality of Life
timeFrame: 12 months - from baseline to 12 month visit
Secondary outcomes:
measure: Improvement in Medication Adherence
timeFrame: 12 months - from baseline to 12 month visit
measure: Improvement in Patient-reported Lupus-specific Disease Status
timeFrame: 12 months - from baseline to 12 month visit
measure: Improvement in Adherence With Medical Providers and Services
timeFrame: 12 months - from baseline to 12 month visit
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Jim C. Oates, MD
role: PRINCIPAL_INVESTIGATOR
References: