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

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Behavioral: SLE@Duke

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institutes of Health (NIH); National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Amanda Eudy, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Systemic Lupus Erythematosus
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: Pro00102300; KL2TR002554 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No