Lupus Nephritis (LN)
Conditions
Keywords
lupus nephritis
Brief summary
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.
Detailed description
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
Interventions
BEHAVIORALLupus Nephritis (LN) Care Pathway
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.
Sponsors
Duke University
Rheumatology Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eligible Patients Who Consent to and Enroll in the Study | 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. |
| Proportion of Enrolled Participants Who Complete the 6-Month Lupus Nephritis Care Pathway | 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. |
| Proportion of Enrolled Participants Who Complete at Least 50% of Planned Visits | 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. |
| Feasibility of the Lupus Nephritis Care Pathway as Measured by the Feasibility of Intervention Measure | 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. |
| Acceptability of the Lupus Nephritis Care Pathway as Measured by the Acceptability of Intervention Measure | 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. |
Contacts
CONTACTEdna Scarlett
CONTACTDana Burshell, MPH
PRINCIPAL_INVESTIGATORKai Sun, MD, MS
Duke University
Outcome results
None listed