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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05426902
• Other study ID #: Pro00102300
• Secondary ID: KL2TR002554
• Status: Completed
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: September 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• SLE@Duke
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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Length of Clinic Visits	Collected from EMR (electronic medical record).	Baseline (month 1), intervention period (month 2)
Primary	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)
Primary	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)
Primary	Number of Lupus Patients With Type 2 SLE Treatment in Note	Collected from EMR (electronic medical record).	Baseline (month 1), intervention period (month 2)
Primary	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
Primary	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
Primary	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
Primary	Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note	Collected from EMR (electronic medical record).	Intervention period (month 2), month 5
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)