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.
연구 개요
상세 설명
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
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Edna Scarlett
- 전화번호: 919-684-6150
- 이메일: edna.scarlett@duke.edu
연구 연락처 백업
- 이름: Dana Burshell, MPH
- 이메일: dana.burshell@duke.edu
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of Eligible Patients Who Consent to and Enroll in the Study
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Kai Sun, MD, MS, Duke University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- Pro00120423
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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