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

NCT ID: NCT05426902

Last Updated: 2023-09-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SLE@Duke

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amanda Eudy, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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KL2TR002554

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00102300

Identifier Type: -

Identifier Source: org_study_id

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