Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorder With Chronic Direct Acting Antiviral Treatment
2016年5月5日 更新者：VA Office of Research and Development
Integrated Care for Patients With High Risk Substance Use and Psychiatric Disorders With Chronic Hepatitis C Receiving Direct Acting Antiviral Treatment
To determine the effect of an integrated care protocol on antiviral treatment and sustained virologic response (SVR) rates following initiation of direct acting antiviral therapies (DAA) treatments in 2011.
調査の概要
詳細な説明
Background and aims: Approval of direct acting antiviral (DAA) therapies in 2011 initiated a new era of more effective treatments for hepatitis C (HCV). The impact of more effective therapies on patient access to treatment is unknown. Integrated Care (IC) involving patient case management may overcome barriers to treatment access imposed by psychiatric and substance use disorders (SUD).
Methods: Prospective, randomized trial at a single medical center. Patients with HCV at risk for active psychiatric and SUD between Jan 2012 and Jan 2013 were recruited and randomized to IC or Usual Care (UC). A mid-level mental health practitioner was placed in the IC clinic and provided brief mental health care and case management.
研究の種類
介入
入学 (実際)
83
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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San Diego、California、アメリカ、92161
- VA San Diego Healthcare System, San Diego, CA
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～75年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients with HCV infection who were referred to the VA HCV clinic and who received the usual initial evaluation in the clinic
- All patients 18 and 75 years old with confirmed HCV infection
- Patients were required to be classified as "high risk candidates for antiviral treatment" on any one of a set of screening measure in order to participate
Screening measures and cutoffs for inclusion were depression:
- Beck Depression Inventory: (BDI) > 10
- Alcohol use: Alcohol Use Disorders Identification Test (AUDIT-C) > 4
- PTSD: VA Primary Care PTSD Screen = endorsement of three or more items or any single endorsement of item #3
- Drug use: Drug Use Questionnaire = self-reported drug/alcohol use within 6 months prior to screen
Exclusion Criteria:
- Lacked a confirmed test of HCV RNA
- Had HIV/HCV co-infection and received care at San Diego or Palo Alto sites (these patients were treated in a separate clinic)
- Had Hepatitis B (HBV) co-infection
- Had decompensated liver disease with active or recent encephalopathy, variceal bleeding, or ascites or Child-Pugh class B or C
- Had other significant near term life-threatening diseases
- Were treatment non-responders with pegylated Interferon plus ribavirin
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：Integrated Care
Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.
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The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD.
Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc).
Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians.
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介入なし：Usual Care
The usual care group received "standard of care" required for HCV patients as currently performed in each clinic.
All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist
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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 |
|---|---|---|
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Sustained Viral Response (SVR)
時間枠：up to 24 weeks
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The primary outcome for the study was the proportion of patients that achieve an SVR.
Patient adherence to completing the prescribed therapy and SVR were both tracked with medical records.
Viral load at 4, 12-and 24-weeks during treatment initiation have been shown to predict final SVR.
Final SVR data consists of viral tests conducted at 6 months after the termination of therapy.
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up to 24 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With Treatment Initiation and Completion
時間枠：up to 24 weeks
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The main secondary outcomes for the study include rates of Interferon-based treatment initiation and completion.
Treatment data from the HCV clinics were reviewed for each patient at each site.
Participants who a) filled at least one prescription for Interferon and ribavirin, and b) had at least one treatment-related physician visit with a medical record note stating they began taking the medications were deemed to have initiated antiviral treatment.
Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
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up to 24 weeks
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Percentage of Participants That Completed Planned Duration of Treatment Using a Cutoff of 80%
時間枠：up to 24 weeks
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Patients were considered to have completed treatment if they a) were prescribed and received the full course of antiviral treatment recommended by their HCV physician, and b) had at least one medical record note stating they had completed treatment.
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up to 24 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Samuel B Ho, MD、VA San Diego Healthcare System, San Diego, CA
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年1月1日
一次修了 (実際)
2013年1月1日
研究の完了 (実際)
2014年2月1日
試験登録日
最初に提出
2015年12月21日
QC基準を満たした最初の提出物
2016年1月4日
最初の投稿 (見積もり)
2016年1月6日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年5月20日
QC基準を満たした最後の更新が送信されました
2016年5月5日
最終確認日
2016年5月1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
- IIR 07-101-A
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