Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder (ED-CONNECT)

28 августа 2019 г. обновлено: NYU Langone Health

NIDA CTN-0079: Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder

The purpose of this study is to learn what resources are needed to improve outcomes for patients with opioid use disorder. The study will look at how patients engage in treatment and the decisions that patients and providers make regarding treatment, specifically buprenorphine treatment, for opioid use disorder.

The aims of this study are:

  1. To evaluate using mixed methods the feasibility and acceptability of OUD screening, ED-initiated BUP, and referral.

  2. Over the course of the study and as XR-BUP is added to hospital formularies, to estimate the percentage and confidence intervals of patients assessed, treated, and engaged in treatment at Day 30. This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact. Investigators will develop, introduce and update site-specific ED clinical protocols and implementation plans for OUD screening, ED-initiated BUP, and referral for treatment. A participatory action research approach will be utilized along with mixed methods incorporating data derived from:

    • Medical record and administrative data abstraction,
    • Research assessments involving patients who are eligible for and willing to receive ED-initiated BUP (including both those who do, and do not, receive BUP); these assessments will document the index ED visit and the 30th day after the index ED visit,
    • Qualitative interviews, focus groups, and quantitative assessments involving providers and staff, patients, and other stakeholders.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Наблюдательный

Регистрация (Действительный)

390

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Соединенные Штаты
    • New Hampshire
      • Claremont, New Hampshire, Соединенные Штаты, 03743
        • Valley Regional Healthcare
      • Manchester, New Hampshire, Соединенные Штаты, 03102
        • Catholic Medical Center
    • New York
      • New York, New York, Соединенные Штаты, 10016
        • New York University School of Medicine
      • New York, New York, Соединенные Штаты, 10016
        • Bellevue Hospital Center

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact

Описание

Inclusion Criteria:

  • ED STAFF: ED/Hospital leadership and staff: Leadership and staff across multiple disciplines (e.g., nurses, social workers, physicians, NPs, PAs, pharmacist, physician and nursing directors) at each ED site will be recruited to participate in the formative evaluation and the IF.
  • PROVIDERS: Community treatment providers/OTP leadership and program staff: Providers, leadership and staff involved in the provision of office-based BUP, community treatment, and/or at opioid treatment programs (OTPs) will be recruited to participate in the formative evaluation and the Implementation Facilitation.
  • COMMUNITY: Other Stakeholders: Other community leaders and members (e.g., EMS, fire department, police, local government leadership, community advocacy groups, etc.) may be recruited to participate in qualitative interviews or focus groups.
  • PATIENTS: ED patients will be recruited to participate in interviews or focus groups.
  • PATIENT-PARTICIPANTS: ED patients who are eligible for and willing to receive ED-initiated BUP will be recruited to participate in two research visits.
  • ALL ED PATIENTS: Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc.

Stakeholder-Participant Inclusion Criteria

  • A member of one of the stakeholder groups (1-4 above)

Patient-Participant Inclusion Criteria

  • Eligible for and willing to receive ED-initiated BUP

    1. Eligibility for ED-initiated BUP is operationally defined as meeting site clinical protocol criteria determined and documented by site clinical staff. See Section 9.2 Clinical Protocol.
    2. Willing to receive ED-initiated BUP is operationally defined as providing an affirmative answer to the following question, which will be embedded in each site's clinical protocol: Would you like to receive buprenorphine today?
    3. NOTE: Patients meeting these criteria, and not meeting exclusion criteria below, may be included as study participants regardless of whether they receive or do not receive ED-initiated BUP

Exclusion Criteria:

Stakeholder-Participant Exclusion Criteria

  • Unwilling or unable to provide consent
  • Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study

Patient-Participant Exclusion Criteria

  • Not able to speak English sufficiently to understand study procedures and provide written informed consent
  • Unable or unwilling to provide written informed consent or to participate in study procedures
  • Currently receiving any medication treatment for OUD at the time of index ED visit
  • Current research participant in a substance use intervention study or previous participation in the current study
  • Are currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
  • Inadequate locator information (unable to provide 2 unique means of contact)

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
ED and OUD treatment providers and staff
  • ED patients will be recruited to participate in interviews or focus groups.
  • ED patients who are eligible for and willing to receive ED-initiated BUP will be recruited to participate in two research visits.
  • Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc.
Поведенческий: Employ a multifaceted approach to facilitate clinical protocol implementation
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Community Stakeholders
  • Community treatment providers/OTP leadership and program staff: Providers, leadership and staff involved in the provision of office-based BUP, community treatment, and/or at opioid treatment programs (OTPs) will be recruited to participate in the formative evaluation and the Implementation Facilitation.
  • Other Stakeholders: Other community leaders and members (e.g., EMS, fire department, police, local government leadership, community advocacy groups, etc.) may be recruited to participate in qualitative interviews or focus groups.
Поведенческий: Employ a multifaceted approach to facilitate clinical protocol implementation
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Patients
ED patients will be recruited to participate in interviews or focus groups.
Поведенческий: Employ a multifaceted approach to facilitate clinical protocol implementation
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Лекарство: Initiate BUP (SL-BUP or XR-BUP) in the ED
The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Receipt of ED-initiated BUP (binary) and will be abstracted from the health record.
Временное ограничение: 12 Months
Proportion receiving emergency department BUP amongst patients who have been determined to be eligible for and willing to receive ED-initiated BUP
12 Months

Вторичные показатели результатов

Мера результата
Временное ограничение
Proportion of patients who received ED-initiated BUP who are engaged in formal addiction treatment 30 days after the index ED visit.
Временное ограничение: 12 Months
12 Months

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

NYU Langone Health

Соавторы

National Institute on Drug Abuse (NIDA)

Следователи

  • Главный следователь: Ryan McCormack, MD, NYU Langone Health

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

11 июня 2018 г.

Первичное завершение (Действительный)

29 мая 2019 г.

Завершение исследования (Действительный)

29 мая 2019 г.

Даты регистрации исследования

Первый отправленный

21 мая 2018 г.

Впервые представлено, что соответствует критериям контроля качества

21 мая 2018 г.

Первый опубликованный (Действительный)

1 июня 2018 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

30 августа 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

28 августа 2019 г.

Последняя проверка

1 августа 2019 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 17-01513

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться