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.
調査の概要
詳細な説明
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
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Edna Scarlett
- 電話番号：919-684-6150
- メール：edna.scarlett@duke.edu
研究連絡先のバックアップ
- 名前：Dana Burshell, MPH
- メール：dana.burshell@duke.edu
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of Eligible Patients Who Consent to and Enroll in the Study
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Kai Sun, MD, MS、Duke University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- Pro00120423
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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