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OpenTrials
Completed

NCT Number: NCT05426902

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Patients' Rheumatologists Using SLE@Duke

    Time frame: 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.

  2. Length of Clinic Visits

    Time frame: Baseline (month 1), intervention period (month 2)

    Collected from EMR (electronic medical record).

  3. Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey

    Time frame: 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."

  4. Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note

    Time frame: Baseline (month 1), intervention period (month 2)

    Collected from EMR (electronic medical record).

  5. Number of Lupus Patients With Type 2 SLE Treatment in Note

    Time frame: Baseline (month 1), intervention period (month 2)

    Collected from EMR (electronic medical record).

  6. Perceived Benefits of SLE@Duke, as Measured by Provider Interviews

    Time frame: 4 weeks

    In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.

  7. Perceived Barriers of SLE@Duke, as Measured by Provider Interviews

    Time frame: 4 weeks

    In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.

  8. How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews

    Time frame: 4 weeks

    In-depth interviews with participating rheumatologists related to the intervention, including acceptability, utility, implementation, integration and practicality of SLE@Duke.

  9. Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note

    Time frame: Intervention period (month 2), month 5

    Collected from EMR (electronic medical record).

  10. Difference in Perceived Quality of Visit, as Measured by Patient Survey

    Time frame: 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.

  11. Discussion of the Type 1 and 2 Model, as Measured by Patient Survey

    Time frame: 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."

  12. Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey

    Time frame: 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.

  13. Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey

    Time frame: 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."

  14. Change in Acceptability of SLE@Duke, as Measured by Provider Survey

    Time frame: 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.

  15. Change in Appropriateness of SLE@Duke, as Measured by Provider Survey

    Time frame: 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.

  16. Change in Feasibility of SLE@Duke, as Measured by Provider Survey

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 22, 2022
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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