Trial Outcomes & Findings for Addressing Disparities in Lupus Care Through an Integrated Care Management Program (NCT NCT03915652)
NCT ID: NCT03915652
Last Updated: 2025-09-25
Results Overview
Mean change in the number of lupus-related ambulatory care visit no-shows and same-day cancellations
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
35 participants
Primary outcome timeframe
Mean change from 12 months prior to intervention and the 12 months during the intervention
Results posted on
2025-09-25
Participant Flow
The goal enrollment in this trial was 40 individuals, and of this total, the starting N was 35. We experienced difficulties recruiting our target number of 40 individuals and exceeded the time and funding allocated to this study and thus ended enrollment after 35.
Participant milestones
| Measure |
Rheum iCMP Wave 1
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
17
|
|
Overall Study
COMPLETED
|
17
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants withdrew prior to assessment of baseline outcome data.
Baseline characteristics by cohort
| Measure |
Rheum iCMP Wave 1
n=18 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=17 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Total
n=35 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
45 years
STANDARD_DEVIATION 17.5 • n=18 Participants
|
47.6 years
STANDARD_DEVIATION 19.3 • n=17 Participants
|
46.2 years
STANDARD_DEVIATION 18.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=18 Participants
|
15 Participants
n=17 Participants
|
30 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=18 Participants
|
2 Participants
n=17 Participants
|
5 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=18 Participants
|
7 Participants
n=17 Participants
|
9 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=18 Participants
|
10 Participants
n=17 Participants
|
26 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=18 Participants
|
1 Participants
n=17 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
13 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=18 Participants
|
4 Participants
n=17 Participants
|
9 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=18 Participants
|
7 Participants
n=17 Participants
|
10 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
17 participants
n=17 Participants
|
35 participants
n=35 Participants
|
|
Baseline Period Appointment No Shows
|
6 Appointment No Shows
STANDARD_DEVIATION 9 • n=17 Participants • Participants withdrew prior to assessment of baseline outcome data.
|
8 Appointment No Shows
STANDARD_DEVIATION 7 • n=12 Participants • Participants withdrew prior to assessment of baseline outcome data.
|
7 Appointment No Shows
STANDARD_DEVIATION 8 • n=29 Participants • Participants withdrew prior to assessment of baseline outcome data.
|
|
Baseline Period Acute Care Use
|
1.53 Acute Care Visits
STANDARD_DEVIATION 1.66 • n=17 Participants • Participants withdrew prior to assessment of baseline outcome data.
|
1.67 Acute Care Visits
STANDARD_DEVIATION 2.10 • n=12 Participants • Participants withdrew prior to assessment of baseline outcome data.
|
1.59 Acute Care Visits
STANDARD_DEVIATION 1.82 • n=29 Participants • Participants withdrew prior to assessment of baseline outcome data.
|
|
Quality of Lupus Care: SLE Quality Metric Scoring System for Adults
|
5.1 units on a scale
STANDARD_DEVIATION 1.89 • n=16 Participants • Participants withdrew prior to assessment of baseline checklist
|
5.75 units on a scale
STANDARD_DEVIATION 2.67 • n=12 Participants • Participants withdrew prior to assessment of baseline checklist
|
5.39 units on a scale
STANDARD_DEVIATION 2.23 • n=28 Participants • Participants withdrew prior to assessment of baseline checklist
|
|
Medication Adherence Self-Report Inventory (MASRI)
|
90 units on a scale
STANDARD_DEVIATION 0 • n=2 Participants • Subset of the population returned completed baseline and follow-up surveys.
|
97.5 units on a scale
STANDARD_DEVIATION 5 • n=4 Participants • Subset of the population returned completed baseline and follow-up surveys.
|
95 units on a scale
STANDARD_DEVIATION 5.5 • n=6 Participants • Subset of the population returned completed baseline and follow-up surveys.
|
|
Beliefs about Medications Survey
|
2.53 units on a scale
STANDARD_DEVIATION 0.81 • n=3 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
2.4 units on a scale
STANDARD_DEVIATION 1.01 • n=4 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
2.46 units on a scale
STANDARD_DEVIATION 0.85 • n=7 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
|
Lupus Disease Activity (SLAQ)
|
10 units on a scale
STANDARD_DEVIATION 7.07 • n=2 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
16.3 units on a scale
STANDARD_DEVIATION 13.8 • n=3 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
15.5 units on a scale
STANDARD_DEVIATION 8.23 • n=5 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
|
Depressive Symptoms Scale (MHI-5)
|
48 units on a scale
STANDARD_DEVIATION 22.6 • n=2 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
62 units on a scale
STANDARD_DEVIATION 19.8 • n=2 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
55 units on a scale
STANDARD_DEVIATION 19.1 • n=4 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
|
PROMIS Patient Reported Global Health - Physical Health
|
43.2 units on a scale
STANDARD_DEVIATION 2.94 • n=3 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
43.2 units on a scale
STANDARD_DEVIATION 1.50 • n=3 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
43.2 units on a scale
STANDARD_DEVIATION 2.09 • n=6 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
|
Social Determinants of Health (SDoH) Number of Needs
|
1.67 units on a scale
STANDARD_DEVIATION 1.15 • n=3 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
1.25 units on a scale
STANDARD_DEVIATION 0.96 • n=4 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
1.43 units on a scale
STANDARD_DEVIATION 0.98 • n=7 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
|
Everyday Discrimination Scale
|
8 units on a scale
STANDARD_DEVIATION 7.55 • n=3 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
0.5 units on a scale
STANDARD_DEVIATION 1 • n=4 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
3.71 units on a scale
STANDARD_DEVIATION 5.96 • n=7 Participants • All participants did not complete baseline and follow-up surveys for secondary outcomes.
|
PRIMARY outcome
Timeframe: Mean change from 12 months prior to intervention and the 12 months during the interventionMean change in the number of lupus-related ambulatory care visit no-shows and same-day cancellations
Outcome measures
| Measure |
Rheum iCMP Wave 1
n=17 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=12 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
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Lupus-related Appointment Nonadherence
|
6.2 Appointment No Shows
Standard Deviation 7.4
|
5.2 Appointment No Shows
Standard Deviation 5.6
|
PRIMARY outcome
Timeframe: Mean change from 12 months prior to intervention and the 12 months during the interventionMean change in the number of ED visits plus number of hospitalizations
Outcome measures
| Measure |
Rheum iCMP Wave 1
n=17 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=12 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
|
Composite Measure of Acute Care Utilization
|
1.29 Acute Care Use Visits
Standard Deviation 2.54
|
1.17 Acute Care Use Visits
Standard Deviation 1.90
|
PRIMARY outcome
Timeframe: Percent of quality metrics remaining at 12 monthsPercent of quality metrics from the SLE Quality Metric Scoring System for Adults remaining from baseline 12 months after the start of the intervention. The percent of needs remaining at 12 months was determined and the mean (SD) percent of remaining needs was calculated by arm. Percentages can range from 0-100, with 100 meaning that more quality metrics were not completed (worse outcome).
Outcome measures
| Measure |
Rheum iCMP Wave 1
n=17 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=12 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
|
Quality of Lupus Care: SLE Quality Metric Scoring System for Adults
|
64 Percent of score
Standard Deviation 32
|
53 Percent of score
Standard Deviation 41
|
SECONDARY outcome
Timeframe: Mean change from baseline to 12 months after the start of the intervention.Population: Subset of the population who returned completed baseline and follow-up surveys.
Mean change in MASRI score (for lupus medications) from baseline to 12 months. Score range is 0-100. Higher scores indicate greater adherence (on a scale from 0 to 100, 100 indicating a person's rating of perfect adherence).
Outcome measures
| Measure |
Rheum iCMP Wave 1
n=2 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=4 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
|
Medication Adherence Self-Report Inventory (MASRI)
|
65 units on a scale
Standard Deviation 49.5
|
98.8 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Mean change from baseline compared to 12 months after the start of the interventionPopulation: Participants who completed baseline and follow-up surveys.
Mean change in Beliefs About Medications score (for lupus medications) from baseline to 12 months after the start of the intervention. Score range is 5-25. Higher scores indicate a worse outcome (higher scores indicate more negative feelings about lupus medications).
Outcome measures
| Measure |
Rheum iCMP Wave 1
n=3 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=4 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
|
Beliefs About Medications Survey
|
2.13 units on a scale
Standard Deviation 1.14
|
1.4 units on a scale
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: Mean change from baseline compared to 12 months after the start of the interventionPopulation: Individuals who completed baseline and follow-up surveys
Mean change in patient-reported lupus disease activity from baseline to 12 months using the SLAQ score. Score range is 0-46. Higher scores indicate a worse outcome (higher scores indicate more lupus disease activity).
Outcome measures
| Measure |
Rheum iCMP Wave 1
n=2 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=3 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
|
Systemic Lupus Activity Questionnaire (SLAQ)
|
11 units on a scale
Standard Deviation 7.07
|
14.3 units on a scale
Standard Deviation 4.93
|
SECONDARY outcome
Timeframe: Mean change from baseline compared to 12 months after the start of the interventionPopulation: Participants who completed baseline and follow-up surveys
Mean change in depressive or anxious symptoms from baseline to 12 months using the MHI-5 survey. Score range is 0-100. Higher scores indicate a better outcome (higher scores indicate better mental health).
Outcome measures
| Measure |
Rheum iCMP Wave 1
n=2 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=2 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
|
Mental Health Inventory-5 (MHI-5)
|
48 units on a scale
Standard Deviation 17
|
58 units on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Mean change from baseline compared to 12 months after the start of the interventionPopulation: Participants who completed baseline and follow-up surveys.
Mean change in global health from baseline to 12 months using the PROMIS global health scale short form. Score range is 9-45. Higher scores indicate a better outcome (higher scores indicate improved global health and well-being).
Outcome measures
| Measure |
Rheum iCMP Wave 1
n=3 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=3 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Scale Short Form
|
39 units on a scale
Standard Deviation 2.76
|
39.8 units on a scale
Standard Deviation 4.27
|
SECONDARY outcome
Timeframe: Percent of social determinants of health-related needs remaining 12 months after the start of the interventionPopulation: Participants who completed baseline and follow-up surveys.
Percent of social determinants of health (SDoH)-related needs at 12 months from baseline using the SDoH Survey. The survey range is 0-8 and the percent of remaining needs is 0-100 with 100 meaning that all of the needs remain (worse outcome).
Outcome measures
| Measure |
Rheum iCMP Wave 1
n=3 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=4 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
|
Social Determinants of Health (SDOH) Survey
|
2.33 Percent of baseline score
Standard Deviation 1.15
|
1 Percent of baseline score
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Mean change from baseline compared to 12 months after the start of the interventionPopulation: Participants who completed baseline and follow-up surveys.
Mean change in daily discrimination encountered from baseline to 12 months using the Everyday Discrimination Scale. Score range is 0-40. Higher scores indicate a worse outcome (higher scores indicate a greater amount of discrimination encountered).
Outcome measures
| Measure |
Rheum iCMP Wave 1
n=3 Participants
20 patients enrolled immediately in Rheum iCMP
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
Rheum iCMP Wave 2
n=4 Participants
20 patients enrolled in Rheum iCMP after 4 months; will receive monthly lupus educational materials mailed to their home during the first 4 months
Rheum iCMP: Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
|
|---|---|---|
|
Everyday Discrimination Scale
|
1.33 units on a scale
Standard Deviation 1.15
|
1.75 units on a scale
Standard Deviation 2.87
|
Adverse Events
Rheum iCMP Wave 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rheum iCMP Wave 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place