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

NCT05426902 | Completed Results

• 2 other identifiers: Pro00102300KL2TR002554
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (16)

• 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)

Study Arms (1)

SLE@Duke

EXPERIMENTAL

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

Interventions

SLE@Duke BEHAVIORAL

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.

SLE@Duke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• New patients will be excluded

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Amanda Eudy, MSPH, Ph.D.
• Organization: Duke University

amanda.eudy@duke.edu

919-681-1811

Study Officials

• Amanda Eudy, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: January 3, 2022
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 14, 2023
• Results First Posted: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)