Transforming the Cascade Of Hepatitis C Care
Transforming the Cascade of Hepatitis C Care
Several factors are barriers to effective Hepatitis C care: 1) The majority of Hepatitis C Virus (HCV)-positive patients (45-85 percent) are unaware that they are infected; 2) Only a small minority of those in need of treatment receive it; 3) Members of minorities and older patients are even less likely to receive needed care; and 4) Until recently, even those who were treated had a low chance of clearing the virus or achieving cure; 5) It is possible that older attitudes and expectation of futility might continue to persist among patients and provider in primary care settings.
Community Health Centers are often the most culturally appropriate and accessible choices, particularly for underserved populations, with the benefit of ongoing trust and relationships with patients. Therefore, these can be ideal places to deliver complex HCV care if they possess the needed expertise. However, most community-based primary care and community health centers lack access to Hepatitis C evaluation and treatment services, leading to a major public health problem.
Thus, investigators propose to implement and evaluate a pragmatic trial to implement and evaluate a multi-disciplinary model for HCV treatment at Currently, the treatment initiation rates at each of these sites is estimated as less than 10%. The investigators hypothesize that our project will increase the rate of participation in all the steps of the HCV care cascade and ultimately lead to more than doubled rates of treatment uptake
調査の概要
状態
状態
条件
条件
詳細な説明
Primary Objective:
Determine uptake, effectiveness and safety of IFN-free, DAAs among "real world" patients, including those with multiple comorbidities, in the primary care setting.
Secondary Objective(s):
- Demonstrate the transformation of the cascade of Hepatitis C Care at 3 primary care clinics in terms of changes from baseline in rates for rates of access to HCV care including HCV screening, evaluation, treatment consideration, treatment uptake, completion, loss to follow-up, and treatment success rate.
- Advance understanding of hepatitis C related decision-making in the era of Interferon (IFN)-free Direct acting agents (DAAs) by examining the context, needs, motivators, barriers, and preferences among patients and providers to the delivery of hepatitis C treatment at primary care clinics
研究の種類
研究の種類
入学 (実際)
入学
連絡先と場所
研究場所
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、アメリカ、15232
- UPMC Shadyside Family Health Center
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- All patients with detectable HCV RNA level, currently receiving care at any of these three community health centers
Exclusion Criteria:
- Criteria for automatic specialty referral (exclusion from treatment at community health centers) Child Turcotte Pugh Class B or C Any history of decompensated liver disease or hepatocellular carcinoma Evidence of renal disease (GFR <50) or coexisting autoimmune condition HIV of hepatitis B co-infection
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
- 観測モデル:他の
- 時間の展望:見込みのある
この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of patients achieving sustained viral response 12 weeks post treatment (SVR 12) over a three year intervention period.
時間枠:three years
|
measure percentage of patients moving through the cascade of care to cure of condition (SVR 12)
|
three years
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rates of Hepatitis C Virus (HCV) screening
時間枠:three years
|
Percentage of at risk patients in the practice who have a completed HCV antibody test
|
three years
|
|
Rate of Chronic Hepatitis C evaluation
時間枠:three years
|
Percentage of patients with a positive HCV antibody test who have a HCV polymerase chain reaction (PCR) viral load completed
|
three years
|
|
Rate of treatment consideration
時間枠:three years
|
Percentage of consented patients with a positive HCV viral load who have a clinical evaluation and assessment of psychosocial readiness for treatment documented in the medical record
|
three years
|
|
Rate of treatment uptake
時間枠:three years
|
Percentage of patients recommended for treatment who begin medical treatment
|
three years
|
|
Rate of treatment completion
時間枠:three years
|
Percentage of patients that began treatment who complete the recommended course of therapy
|
three years
|
|
Rate of patients lost to follow up
時間枠:three years
|
Percent of consented patients with a positive HCV viral load who are lost to follow up
|
three years
|
|
Hepatitis C capacity building among family medicine physicians (provider practice and perceived confidence):
時間枠:three years
|
Endpoints related to HCV capacity building among family medicine physicians: Evaluate comfort and skill among family physicians to evaluate and treat HCV infection as measured on a qualitative survey of physicians
|
three years
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (実際)
一次修了
研究の完了 (実際)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
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
その他の研究ID番号
- PRO16040427
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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