Targeting Effective Analgesia in Clinics for HIV - Intervention (TEACH)
Collaborative Care Intervention to Improve Providers' Opioid Prescribing for HIV-infected Patients - Intervention Component
調査の概要
状態
詳細な説明
The "Targeting Effective Analgesia in Clinics for HIV" (TEACH) Study will test the effectiveness of a collaborative care intervention directed toward HIV physicians to improve the management of chronic opioid therapy (COT) and reduce the misuse of prescription opioids among HIV-infected persons.
The intervention is composed of the following elements: 1) collaboration with an IT enabled nurse care manager; 2) physician education and academic detailing; and 3) facilitated access to a specialist in addictions to help manage the most challenging HIV-infected patients on COT. The nurse care manager will utilize an electronic registry to assist physicians in implementing guideline-driven care including opioid treatment agreements, urine drug testing (UDT), random pill counts and checking of online Prescription Monitoring Programs (PMPs). Physicians in the control group will receive information summarizing guidelines for COT but will not have access to the support of the TEACH intervention. This study is multi-site and will be conducted at Boston Medical Center and Grady Hospital (teaching hospital of Emory University). The 2-site study will use a cluster randomized trial design, randomized at the level of the physician, and compare primary outcomes over one year. The Specific Aims are to test the effectiveness of the TEACH collaborative care program to achieve the following: Aim 1 - to test whether the TEACH collaborative care program improves HIV physicians' adherence to guidelines for prescribing COT compared to standard practice; Aim 2 - to assess whether patient level outcomes improve as a result of the TEACH intervention; Aim 3 - to test whether the intervention increases HIV physicians' satisfaction with prescribing COT; and Aim 4 - to assess whether the intervention improves virologic control among HIV-infected patients who are on COT. If effective, implementation of the intervention in HIV clinics will enable physicians in clinical teams to deliver chronic opioid therapy according to established guidelines with more confidence, potentially resulting in less prescription drug abuse and improved HIV outcomes.
There are two distinct components to the study. The intervention, outlined in this Clinical Trials Protocol Registration and Results System (PRS) summary, involves consenting physicians as participants in a randomized controlled trial of an intervention and, via a waiver of informed consent, extracting patient level data on the physicians' patients from the electronic medical record. The patient cohort component, which is outlined in a separate Clinical Trials PRS summary, will involve recruiting and consenting patients in the HIV clinic on COT to be participants in an observational study, which will involve interviewing them to collect self-reported data and conducting medical chart reviews.
If effective, implementation of the TEACH intervention in clinics will enable physicians who provide primary care to HIV-infected patients in clinical teams to deliver chronic opioid therapy according to established guidelines with more confidence, potentially resulting in less prescription drug abuse and improved HIV outcomes.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
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Massachusetts
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Boston、Massachusetts、アメリカ、02118
- Boston Medical Center
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参加基準
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
説明
Physician Inclusion Criteria:
- Physician (i.e. MD, DO) or Advanced Practice Provider (i.e., Nurse Practitioner or Physicians Assistant) at enrollment sites.
- Main provider for ≥ 1 HIV-infected patient on COT (defined as having received ≥ 3 opioid prescriptions at least 21 days apart within a 6 month period).
Physician Exclusion Criteria:
- Investigator on this study.
- Planning to leave clinic < 9 months from enrollment.
Patient Inclusion Criteria:
- COT patient ages ≥ 18 who are patients of physicians enrolled in the TEACH study.
Patient Exclusion Criteria:
- None
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: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:TEACH Collaborative Care Intervention
Physicians randomized to the intervention will receive: 1) collaboration with an IT enabled nurse care manager; 2) physician education and academic detailing; and 3) facilitated access to a specialist in addictions to help manage the most challenging HIV-infected patients on COT.
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The nurse care manager at each site will collaborate with intervention physicians to implement key essential elements of guideline driven care, namely opioid treatment agreements, urine drug testing, random pill counts and periodic checking of on-line Prescription Monitoring Programs.
The nurse care manager will use an electronic registry to retrieve pain medication information from the electronic medical record (EMR).
Registry data will be collected on the patients of the intervention group providers.
The nurse care manager will be able to use the registry to generate reports that will allow him/her to monitor those patients who are receiving opioids for chronic pain.
All intervention participants will receive a 60 minute group didactic session by a national expert on opioid prescribing for pain.
Physicians will receive two academic detailing sessions, and will be given the option of having a third, booster academic detailing session if desired.
The nurse care manager will encourage and arrange referral of challenging patients with potential abuse or dependence to prescription opioids to an addiction specialist.
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介入なし:Standard of Care Control
Physicians in the control group will receive information summarizing guidelines for COT but will not have access to the support of the TEACH intervention.
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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 |
時間枠 |
|---|---|
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Patient receipt of ≥2 UDT (Electronic Medical Record (EMR) extraction)
時間枠:12 Months
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12 Months
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% of patients who have ≥1 early refill (i.e., any early refills) (EMR extraction)
時間枠:12 Months
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12 Months
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Physician satisfaction managing HIV-infected patients on COT for pain (Physician self-report)
時間枠:12 Months
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12 Months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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≥3 primary care visits in infectious disease clinic (EMR extraction)
時間枠:12 Months
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12 Months
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% of patients who had a discontinuation of their narcotic prescriptions (EMR extraction)
時間枠:12 Months
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12 Months
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Opioid treatment agreement (EMR extraction)
時間枠:12 Months
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12 Months
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% of physicians who self-report consulting the state Prescription Monitoring Program (Physician self-report)
時間枠:12 Months
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12 Months
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Number (continuous measure) of early refills at 12 months (EMR extraction)
時間枠:12 Months
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12 Months
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Patient aberrant use (Patient self-report)
時間枠:12 Months
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12 Months
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Number of patients who have visited the emergency department to seek opioids (EMR extraction and patient self-report)
時間枠:12 Months
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12 Months
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Patient pain severity and interference (Patient self-report)
時間枠:12 Months
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12 Months
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Patient addiction severity (Patient self-report)
時間枠:12 Months
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12 Months
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Physician confidence in prescribing COT (Physician self-report)
時間枠:12 Months
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12 Months
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Patient satisfaction with COT (Patient self-report)
時間枠:12 Months
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12 Months
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Patient trust in physician (Patient self-report)
時間枠:12 Months
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12 Months
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Undetectable HIV viral load (EMR extraction)
時間枠:12 Months
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12 Months
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Cluster of differentiation 4 (CD4) cell count (EMR extraction)
時間枠:12 Months
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12 Months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Jeffrey Samet, MD, MA, MPH、Boston Medical Center
- 主任研究者:Carlos del Rio, MD、Emory University
出版物と役立つリンク
一般刊行物
- Ngo B, Liebschutz JM, Cheng DM, Colasanti JA, Merlin JS, Armstrong WS, Forman LS, Lira MC, Samet JH, Del Rio C, Tsui JI. Hazardous alcohol use is associated with greater pain interference and prescription opioid misuse among persons living with HIV and chronic pain. BMC Public Health. 2021 Mar 22;21(1):564. doi: 10.1186/s12889-021-10566-6.
- Lira MC, Tsui JI, Liebschutz JM, Colasanti J, Root C, Cheng DM, Walley AY, Sullivan M, Shanahan C, O'Connor K, Abrams C, Forman LS, Chaisson C, Bridden C, Podolsky MC, Outlaw K, Harris CE, Armstrong WS, Del Rio C, Samet JH. Study protocol for the targeting effective analgesia in clinics for HIV (TEACH) study - a cluster randomized controlled trial and parallel cohort to increase guideline concordant care for long-term opioid therapy among people living with HIV. HIV Res Clin Pract. 2019 Apr;20(2):48-63. doi: 10.1080/15284336.2019.1627509.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- H-33269
- R01DA037768 (米国 NIH グラント/契約)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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