- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01328431
Treating Low-Income Smokers in the Hospital Emergency Department
This study will test the effectiveness of an Emergency Department (ED) initiated tobacco intervention which includes counseling and medication. Our proposed intervention combines a Brief Negotiated Interview (BNI) with initiation of nicotine patch and gum in the ED, as well as a faxed referral to the state's Smokers' Quitline. A 6 week supply of nicotine patches and nicotine gum are provided to subjects in the intervention arm. Subjects randomized to the control arm will receive a brochure from the state's Smokers' Quitline only.
The primary hypothesis is that the intervention will be superior to the control condition in reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months.
연구 개요
상세 설명
Of the nation's 45 million adult smokers, nearly 20 million visit hospital emergency departments (EDs) each year. ED patients, particularly smokers, are disproportionately low-income, with limited access to traditional primary care settings. Patients presenting to the ED with a tobacco-related trigger event, like an asthma attack, may be experiencing a "teachable moment." Thus, the ED may be an ideal location in which to identify smokers and initiate treatment for tobacco dependence. Initial pilot research by our group has demonstrated the feasibility of ED-based brief interventions for smokers. Based on our feasibility studies, the Institute of Medicine 2006 report on tobacco and the 2008 US Public Health Service guidelines now list EDs as appropriate loci for tobacco control efforts. This study aims to test the efficacy of an ED-initiated tobacco intervention which includes counseling and medication. The intervention-Screening, Brief Intervention, and Referral to Treatment (SBIRT)-uses a form of motivational interviewing known as the Brief Negotiation Interview (BNI). Our proposed intervention combines a BNI with initiation of nicotine replacement therapy (NRT) and a fax referral to the state Smokers' Quitline during the ED visit. A 6-week starter kit of NRT (patch and/or gum, tailored to level of addiction and patient preference) will be provided with written materials. The initial dose of NRT will be given in the ED. A trained nurse will administer the booster intervention via telephone 3 days post-visit. The SBIRT+NRT arm will be compared to standard care (SC), which consists of written materials only, in a controlled trial of 778 smokers age 18 years or older randomized in a 1:1 fashion.
The primary hypothesis is that SBIRT+NRT will be superior to SC in reducing self-reported and biochemically verified 7-day tobacco abstinence at 3 months. Secondary hypotheses include: (1) Patients with a tobacco related diagnosis for the ED visit will have a higher cessation rate than patients without a tobacco related diagnosis, and (2) Patients who believe their ED visit is smoking-related will have a higher quit rate than others. The investigators will conduct a cost benefit analysis of the interventions. Follow-up assessments at 1, 3 and 12 months will combine self-report with in-person carbon monoxide testing at 3 months for smokers who assert abstinence via phone. Expansions of the proposed project as compared to earlier studies include: 1) initiation of NRT during the ED visit; 2) provision of multiple forms of NRT; 3) a proactive referral made to the Quitline; 4)a credible control condition with minimal baseline assessment, to avoid the assessment reactivity seen in similar ED studies; and 5) an economic analysis of the tested interventions.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06510
- Yale University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age > 18 years
- Speaks English
- Willing and able to give informed consent
- >100 cigarettes lifetime
- Current daily or some day smoker
- Smokes > 5 cigarettes/day
- Medicaid or self-pay insurance
Exclusion Criteria:
- Too ill or unable to consent
- Not interested in study participation
- Not interested in quitting
- Pregnant, nursing, or trying to conceive
- Current use of tobacco cessation products (patch, gum, inhaler, nasal spray, lozenge, e-cigarette)
- Actively psychotic or mentally ill
- Leaving ED against medical advice
- Investigator discretion
- Lives outside of New Haven County
- Does not have phone with CT area code
- In police custody
- History of allergic reaction to nicotine replacement products
- Currently receiving formal tobacco dependence tx
- Currently taking Zyban, Wellbutrin (bupropion) or Chantix(varenicline)
- Resides in an extended care facility
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: Standard Care
Subjects receive a brochure for the state's Smokers' Quitline only.
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실험적: SBIRT+NRT
Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.
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Brief Negotiated Interview is a manual-guided therapy designed for the ED setting.
The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED.
It combines techniques from motivational interviewing and stages of change.
a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently.
Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking.
All subjects receive 400 pieces of 2 mg nicotine gum.
All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Biochemical Verification of Tobacco Abstinence
기간: 3 months after enrollment
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Biochemical verification means a breathalyzer reading for carbon monoxide.
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3 months after enrollment
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Self-report of Tobacco Abstinence or Reduction
기간: 3 months
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Questionnaires to assess self reported tobacco abstinence
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Self-reported Tobacco Reduction or Abstinence
기간: 1 month post enrollment
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self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.
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1 month post enrollment
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Health Care Service Utilization
기간: 1 month post enrollment
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A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups.
The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care.
The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.
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1 month post enrollment
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Self-reported Tobacco Reduction or Abstinence
기간: 12 months post enrollment
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self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use.
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12 months post enrollment
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Health Care Service Utilization
기간: 3 months post enrollment
|
A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups.
The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care.
The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.
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3 months post enrollment
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Health Care Service Utilization
기간: 12 months post enrollment
|
A version of the Treatment Services Review (TSR) will be used to assess health care utilization during follow-ups.
The TSR is a self-report instrument that asks about hospitalizations, emergency room visits, and outpatient medical and psychiatric care.
The version used in this study also asks about how often the subject called the CT Smoker's Quitline, use of NRT or other medications for smoking cessation, and participation in other smoking cessation treatments.
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12 months post enrollment
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Steven L. Bernstein, MD, Yale University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
Brief Intervention with NRT Initiation에 대한 임상 시험
-
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-
University of MichiganNational Institute on Drug Abuse (NIDA)완전한
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)완전한