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

2019년 8월 28일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

관찰

등록 (실제)

390

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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

설명

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)

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
개입 / 치료
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.
행동: 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.
행동: 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.
행동: 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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Receipt of ED-initiated BUP (binary) and will be abstracted from the health record.
기간: 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

2차 결과 측정

결과 측정
기간
Proportion of patients who received ED-initiated BUP who are engaged in formal addiction treatment 30 days after the index ED visit.
기간: 12 Months
12 Months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

NYU Langone Health

협력자

National Institute on Drug Abuse (NIDA)

수사관

  • 수석 연구원: Ryan McCormack, MD, NYU Langone Health

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 6월 11일

기본 완료 (실제)

2019년 5월 29일

연구 완료 (실제)

2019년 5월 29일

연구 등록 날짜

최초 제출

2018년 5월 21일

QC 기준을 충족하는 최초 제출

2018년 5월 21일

처음 게시됨 (실제)

2018년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 8월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 8월 28일

마지막으로 확인됨

2019년 8월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 17-01513

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다