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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Improvement in Quality of Life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Interventional Group
干预措施: Patient Navigator Services (Behavioral)
结局指标
主要结局
Improvement in Quality of Life
时间窗: 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
次要结局
- Improvement in Patient-reported Lupus-specific Disease Status(12 months - from baseline to 12 month visit)
- Improvement in Adherence With Medical Providers and Services(12 months - from baseline to 12 month visit)
- Improvement in Medication Adherence(12 months - from baseline to 12 month visit)
研究者
Jim Oates
Professor and Director, Division of Rheumatology & Immunology
Medical University of South Carolina