Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)
- Conditions
- Systemic Lupus Erythematosus
- Interventions
- Behavioral: SLE@Duke
- Registration Number
- NCT05426902
- Lead Sponsor
- Duke University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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.
- New patients will be excluded
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SLE@Duke SLE@Duke Clinic providers in Duke Rheumatology outside of the Duke Lupus Clinic are eligible to participate in the SLE@Duke intervention. Participants complete a baseline survey and training in the Type 1 \& 2 SLE Model. They are asked to perform the intervention for all eligible patients over 4 weeks. Patients complete a survey at the end of their clinic visit, and providers complete a survey at the end of the 4 week intervention period. All participating providers were invited to an in-depth interview at the end of the intervention period.
- Primary Outcome Measures
Name Time Method Change in Feasibility of SLE@Duke, as Measured by Provider Survey Baseline (month 1), intervention period (month 2) Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note Intervention period (month 2), month 5 Collected from EMR (electronic medical record).
Number of Patients' Rheumatologists Using SLE@Duke Baseline (month 1), intervention period (month 2) Collected from EMR (electronic medical record). This is a composite measure that includes documentation in the clinic note of any component of SLE@Duke: (1) Type 1 \& 2 SLE Model mentioned, (2) dotphrase used, (3) Type 1 \& Type 2 PGAs (Physician Global Assessments) scored in note, (4) handout mentioned, (5) Type 2 symptoms discussed, or (6) purple sheet documented.
Length of Clinic Visits Baseline (month 1), intervention period (month 2) Collected from EMR (electronic medical record).
Perceived Benefits of SLE@Duke, as Measured by Provider Interviews 4 weeks In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews 4 weeks In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey Baseline (month 1), intervention period (month 2) Satisfaction was measured on a scale of 1-5, where 1 = never and 5 = always in response to the statement: "After seeing a patient with lupus, I leave the exam room feeling satisfied with the encounter."
Perceived Barriers of SLE@Duke, as Measured by Provider Interviews 4 weeks In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.
Change in Acceptability of SLE@Duke, as Measured by Provider Survey Baseline (month 1), intervention period (month 2) Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Change in Appropriateness of SLE@Duke, as Measured by Provider Survey Baseline (month 1), intervention period (month 2) Questions pertaining to the appropriateness of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree.
Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note Baseline (month 1), intervention period (month 2) Collected from EMR (electronic medical record).
Number of Lupus Patients With Type 2 SLE Treatment in Note Baseline (month 1), intervention period (month 2) Collected from EMR (electronic medical record).
Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey Baseline (month 1), intervention period (month 2) Questions pertaining to understanding were measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.
Difference in Perceived Quality of Visit, as Measured by Patient Survey Baseline (month 1), intervention period (month 2) Each question pertaining to quality of visit was measured on a scale of 1-5, where 1 = strongly disagree and 5 = strongly agree. Different patients completed the survey at month 1 and month 2. The scores at month 1 were averaged, then subtracted from the average score at month 2.
Discussion of the Type 1 and 2 Model, as Measured by Patient Survey Intervention period (month 2) The patient survey asked patients to respond "Yes" or "No" in response to the statement: "My rheumatologist discussed Type 1 \& Type 2 lupus with me today."
Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey Baseline (month 1), intervention period (month 2) Discussion of the Type 1 \& 2 SLE Model was measured on a scale of 1-5, where 1 = "never" and 5 = "always" in response to the statement: "I discuss the Type 1 \& 2 SLE Model with the patient."
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States