Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)

Study Overview
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Brief Summary
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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.

Official Title
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Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Behavioral: SLE@Duke


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLE@Duke<br>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. | Behavioral: SLE@Duke<br>* SLE@Duke is a set of tools to implement the Type 1 & 2 SLE Model in a clinical setting. The model includes an Electronic Medical Record (EMR) note template, patient-reported outcome measure, and training on how to discuss Type 1 & 2 SLE.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients' Rheumatologists Using SLE@Duke | 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. | Baseline (month 1), intervention period (month 2) | 
| Length of Clinic Visits | Collected from EMR (electronic medical record). | Baseline (month 1), intervention period (month 2) | 
| Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey | 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. | Baseline (month 1), intervention period (month 2) | 
| Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note | Collected from EMR (electronic medical record). | Baseline (month 1), intervention period (month 2) | 
| Number of Lupus Patients With Type 2 SLE Treatment in Note | Collected from EMR (electronic medical record). | Baseline (month 1), intervention period (month 2) | 
| Perceived Benefits of SLE@Duke, as Measured by Provider Interviews | In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke. | 4 weeks | 
| Perceived Barriers of SLE@Duke, as Measured by Provider Interviews | In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke. | 4 weeks | 
| How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews | In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke. | 4 weeks | 
| Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note | Collected from EMR (electronic medical record). | Intervention period (month 2), month 5 | 
| Difference in Perceived Quality of Visit, as Measured by Patient Survey | 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. | Baseline (month 1), intervention period (month 2) | 
| Discussion of the Type 1 and 2 Model, as Measured by Patient Survey | 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. | Intervention period (month 2) | 
| Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey | 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. | Baseline (month 1), intervention period (month 2) | 
| Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey | 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. | Baseline (month 1), intervention period (month 2) | 
| Change in Acceptability of SLE@Duke, as Measured by Provider Survey | Questions pertaining to acceptability of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree. | Baseline (month 1), intervention period (month 2) | 
| Change in Appropriateness of SLE@Duke, as Measured by Provider Survey | Questions pertaining to the appropriateness of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree. | Baseline (month 1), intervention period (month 2) | 
| Change in Feasibility of SLE@Duke, as Measured by Provider Survey | Questions concerning feasibility of SLE@Duke were measured on a scale of 1-5, where 1 = completely disagree and 5 = completely agree. | Baseline (month 1), intervention period (month 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Lupus Erythematosus