Systemic Lupus Erythematosus (SLE)
Conditions
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.
Interventions
BEHAVIORALPatient Navigator Services
The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support
Sponsors
Medical University of South Carolina
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJim C. Oates, MD
Medical University of South Carolina
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Receiving Lupus Patient Navigator Program services. | 52 |
| Usual Care Comparison Group Usual Care Comparison Group meeting eligibility criteria for intervention but not receiving Lupus Patient Navigator Program services. | 23 |
| Total | 75 |
Baseline characteristics
| Characteristic | Intervention Group | Usual Care Comparison Group | Total |
|---|---|---|---|
| Age at lupus onset | 25.6 years STANDARD_DEVIATION 10.2 | 28.4 years STANDARD_DEVIATION 10.3 | 26.5 years STANDARD_DEVIATION 10.2 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 23 Participants | 75 Participants |
| Age, Continuous | 34.0 years STANDARD_DEVIATION 11.4 | 34.8 years STANDARD_DEVIATION 10.6 | 34.2 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 21 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 50 Participants | 22 Participants | 72 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 52 participants | 23 participants | 75 participants |
| Sex: Female, Male Female | 50 Participants | 18 Participants | 68 Participants |
| Sex: Female, Male Male | 2 Participants | 5 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 23 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Improvement in Quality of Life
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
Time frame: 12 months - from baseline to 12 month visit
Population: 52 patients with SLE self identified as a minority, met inclusion / exclusion criteria, and provided informed consent to participate with the Lupus Patient Navigator Program intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Interventional Group | Improvement in Quality of Life | Baseline Health-related QOL | 59.2 score on a scale | Standard Deviation 20.6 |
| Interventional Group | Improvement in Quality of Life | 12 Month Health-related QOL | 63.6 score on a scale | Standard Deviation 22.1 |
Secondary
Improvement in Adherence With Medical Providers and Services
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.
Time frame: 12 months - from baseline to 12 month visit
Secondary
Improvement in Medication Adherence
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.
Time frame: 12 months - from baseline to 12 month visit
Secondary
Improvement in Patient-reported Lupus-specific Disease Status
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.
Time frame: 12 months - from baseline to 12 month visit