Lupus Nephritis Care Pathway
Evaluation of a Lupus Nephritis Care Pathway Integrating Telemedicine and Clinical Pharmacist Practitioners
The purpose of this study is to evaluate an approach to managing patients with lupus nephritis called the Lupus Nephritis (LN) Pathway among approximately 25 patients. Activities include answering surveys and participating in an interview.
Objectives include: 1) Assess feasibility and acceptability of the LN Care Pathway, 2) evaluate user experiences to identify opportunities for improvement, and 3) explore the preliminary effect of this pathway on medication adherence and clinical outcomes.
研究概览
详细说明
The Lupus Nephritis (LN) Pathway is an innovative, scalable, team-based model that leverages clinical pharmacist practitioners (CPPs) to deliver frequent telemedicine visits and implement protocol-based adherence support, medication management, and remote monitoring, all with oversight from rheumatology and nephrology physicians.
The investigators will include 25 patients with lupus nephritis. The study primarily assesses the LN Care Pathway's feasibility and acceptability using surveys, exit interviews, and metrics of enrollment, retention, and engagement. The investigators will also evaluate user experiences and identify areas for improvement in exit interviews. Lastly, the investigators will explore preliminary effects on medication adherence and key clinical outcomes
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Edna Scarlett
- 电话号码：919-684-6150
- 邮箱：edna.scarlett@duke.edu
研究联系人备份
- 姓名：Dana Burshell, MPH
- 邮箱：dana.burshell@duke.edu
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Active patient at a Duke University Health System clinic
- Current diagnosis of Systemic Lupus Erythematosus (SLE) based on the 1997 ACR,32 2012 Systemic Lupus International Collaborating Clinics (SLICC),33 or 2019 European League Against Rheumatism (EULAR)/ACR (American College of Rheumatology)34 classification criteria
- Aged 18 years or older
- Able to provide informed consent
- Able to attend telemedicine visits
- New onset or ongoing active LN based on rheumatologist or nephrologist evaluation
Exclusion Criteria:
- Patients with severe cognitive impairment
- Do not wish to receive longitudinal care at our health system
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Lupus Nephritis (LN) Care Pathway
All participants receive the same LN Care Pathway intervention.
|
The LN Care Pathway is an innovative, scalable, team-based model that leverages clinical pharmacist practitioners (CPPs) to deliver frequent telemedicine visits and implement protocol-based adherence support, medication management, and remote monitoring, all with oversight from rheumatology and nephrology physicians.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Proportion of Eligible Patients Who Consent to and Enroll in the Study
大体时间：From study start through completion of enrollment
|
The proportion of eligible patients who provide informed consent and enroll in the study.
Feasibility of recruitment will be supported if at least 70% of eligible patients consent to and enroll.
|
From study start through completion of enrollment
|
|
Proportion of Enrolled Participants Who Complete the 6-Month Lupus Nephritis Care Pathway
大体时间：6 months
|
The proportion of enrolled participants who complete the 6-month Lupus Nephritis Care Pathway.
Feasibility of retention will be supported if at least 80% of enrolled participants complete the Care Pathway.
|
6 months
|
|
Proportion of Enrolled Participants Who Complete at Least 50% of Planned Visits
大体时间：6 months
|
The proportion of enrolled participants who complete at least 50% of planned telehealth visits during the 6-month Lupus Nephritis Care Pathway.
Feasibility of participant engagement will be supported if at least 75% meet this threshold.
|
6 months
|
|
Feasibility of the Lupus Nephritis Care Pathway as Measured by the Feasibility of Intervention Measure
大体时间：6 months
|
The Feasibility of Intervention Measure is a 4-item measure of perceived feasibility.
Each item is rated on a 5-point scale from 1 to 5, with higher scores indicating greater feasibility.
The mean score across items will be calculated.
|
6 months
|
|
Acceptability of the Lupus Nephritis Care Pathway as Measured by the Acceptability of Intervention Measure
大体时间：6 months
|
The Acceptability of Intervention Measure is a 4-item measure of perceived acceptability.
Each item is rated on a 5-point scale from 1 to 5, with higher scores indicating greater acceptability.
The mean score across items will be calculated.
|
6 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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