N/A
Completed N=180
Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)
Source: ClinicalTrials.gov NCT05426902 ↗Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Number of Patients' Rheumatologists Using SLE@Duke — 16; 30 Participants — p=<0.0001
Summary
The purpose of this study is to pilot test SLE@Duke, a set of tools to implement the Type 1 & 2 SLE Model in a clinical setting, as well as to gain an in-depth understanding of providers experiences using the intervention during clinic visits with patients with systemic lupus erythematosus.
This record represents Aim 3 of this study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients' Rheumatologists Using SLE@Duke |
16; 30 | <0.0001 sig |
| PRIMARY Length of Clinic Visits |
67.8; 70.9 | 0.6 |
| PRIMARY Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey |
0.44 | 0.2 |
| PRIMARY Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note |
0; 27 | <0.0001 sig |
| PRIMARY Number of Lupus Patients With Type 2 SLE Treatment in Note |
5; 8 | 0.4 |
| PRIMARY Perceived Benefits of SLE@Duke, as Measured by Provider Interviews |
9; 8; 7; 5 | — |
| PRIMARY Perceived Barriers of SLE@Duke, as Measured by Provider Interviews |
4; 4; 4; 3; 3 | — |
| PRIMARY How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews |
5; 4; 4; 3; 4 | — |
| PRIMARY Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note |
0; 0 | — |
| PRIMARY Difference in Perceived Quality of Visit, as Measured by Patient Survey |
0.1; 0.06; 0.01 | 0.7 |
| PRIMARY Discussion of the Type 1 and 2 Model, as Measured by Patient Survey |
17; 8 | — |
| PRIMARY Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey |
0.1; 0.1 | 0.7 |
| PRIMARY Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey |
1.0 | 0.02 sig |
| PRIMARY Change in Acceptability of SLE@Duke, as Measured by Provider Survey |
-0.1; 0.0; -0.2; -0.2 | 0.7 |
| PRIMARY Change in Appropriateness of SLE@Duke, as Measured by Provider Survey |
-0.1; -0.1; 0.0; 0.0 | 0.7 |
| PRIMARY Change in Feasibility of SLE@Duke, as Measured by Provider Survey |
0.3; 0.3; 0.2; 0.4 | 0.3 |
Eligibility Criteria
Inclusion Criteria
- All providers in Duke Rheumatology who practice outside of the Duke Lupus Clinic are eligible.
- Patients are eligible to participate if they have an established diagnosis of SLE and are followed in Duke Rheumatology.
- All patients with a SLE diagnosis will be included in the analysis. SLE diagnosis will be based on an ICD-10 code for SLE (M32.1*, M32.8, M32.9) in the EMR.
Exclusion Criteria
- New patients will be excluded
Data sourced from ClinicalTrials.gov (NCT05426902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.