Clinical trial NCT05426902: Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)
Official title: Utilizing Qualitative and Quantitative Methods to Understand a New Model of Type 1 and 2 Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-06-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients' Rheumatologists Using SLE@Duke
timeFrame: Baseline (month 1), intervention period (month 2)
measure: Length of Clinic Visits
timeFrame: Baseline (month 1), intervention period (month 2)
measure: Change in Physician Satisfaction With Visits With Lupus Patients, as Measured by Provider Survey
timeFrame: Baseline (month 1), intervention period (month 2)
measure: Number of Lupus Patients With Assessment of Type 1 and 2 SLE in Note
timeFrame: Baseline (month 1), intervention period (month 2)
measure: Number of Lupus Patients With Type 2 SLE Treatment in Note
timeFrame: Baseline (month 1), intervention period (month 2)
measure: Perceived Benefits of SLE@Duke, as Measured by Provider Interviews
timeFrame: 4 weeks
measure: Perceived Barriers of SLE@Duke, as Measured by Provider Interviews
timeFrame: 4 weeks
measure: How SLE@Duke Fit Into Work Flow, as Measured by Provider Interviews
timeFrame: 4 weeks
measure: Number of Lupus Patients With PRO (Patient-reported Outcomes) in Note
timeFrame: Intervention period (month 2), month 5
measure: Difference in Perceived Quality of Visit, as Measured by Patient Survey
timeFrame: Baseline (month 1), intervention period (month 2)
measure: Discussion of the Type 1 and 2 Model, as Measured by Patient Survey
timeFrame: Intervention period (month 2)
measure: Difference in Understanding of Lupus Activity & Treatment Plan, as Measured by Patient Survey
timeFrame: Baseline (month 1), intervention period (month 2)
measure: Change in Discussion of the Type 1 and 2 Model, as Measured by Provider Survey
timeFrame: Baseline (month 1), intervention period (month 2)
measure: Change in Acceptability of SLE@Duke, as Measured by Provider Survey
timeFrame: Baseline (month 1), intervention period (month 2)
measure: Change in Appropriateness of SLE@Duke, as Measured by Provider Survey
timeFrame: Baseline (month 1), intervention period (month 2)
measure: Change in Feasibility of SLE@Duke, as Measured by Provider Survey
timeFrame: Baseline (month 1), intervention period (month 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Amanda Eudy, PhD
role: PRINCIPAL_INVESTIGATOR
References: