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临床试验/NCT05426902
NCT05426902已完成不适用

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

Duke University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年1月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
Number of Patients' Rheumatologists Using SLE@Duke

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • New patients will be excluded

结局指标

主要结局

Number of Patients' Rheumatologists Using SLE@Duke

时间窗: 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.

Length of Clinic Visits

时间窗: Baseline (month 1), intervention period (month 2)

Collected from EMR (electronic medical record).

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

时间窗: 4 weeks

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

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

时间窗: 4 weeks

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

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

时间窗: 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."

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

时间窗: 4 weeks

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

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: Baseline (month 1), intervention period (month 2)

Collected from EMR (electronic medical record).

Number of Lupus Patients With Type 2 SLE Treatment in Note

时间窗: Baseline (month 1), intervention period (month 2)

Collected from EMR (electronic medical record).

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

时间窗: Intervention period (month 2), month 5

Collected from EMR (electronic medical record).

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

时间窗: 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.

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

时间窗: 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.

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

时间窗: 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."

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

时间窗: 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."

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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