- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02721082
Changing the Default for Tobacco Treatment
연구 개요
상태
정황
상세 설명
In many health conditions, the default treatment approach is to first identify the health condition and then begin treatment. In this scenario, the physician discusses treatment options with the patient. The patient is free to decline treatment as they wish. If patients do nothing though, they will receive care.
For tobacco users, the default treatment is for them to "opt in" to receive smoking cessation assistance. The provider asks the smoker if they are ready to quit, and they offer medication and support only to those who respond back "yes". This limits the amount of smokers that receive treatment because only 1 in 3 smokers say they are ready to quit.
This study is looking at a novel approach to smoking cessation treatment. This study will compare the traditional, "standard of care" approach to opting in against a new approach where all smokers are provided with cessation medication and counseling unless they refuse it.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Speak English or Spanish
- Have access to a telephone or mobile phone
- Not be currently pregnant or breast feeding
- Have no significant co-morbidity that precludes participation
- Current daily smoker
- Not in treatment for tobacco dependence
- Reside in Kansas or Missouri
Exclusion Criteria:
- Admission greater than 3 days
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Opt Out
Participants in this arm will be first enrolled to receive cessation treatment and will only not receive it by "opting out".
Participant will receive a Opt Out treatment program.
Participants will receive counseling and nicotine replacement therapy.
|
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
다른 이름들:
Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
다른 이름들:
|
활성 비교기: Opt In
Traditional approach to tobacco treatment program.
Participants must first indicate they are ready to quit smoking by "opting in" to receive Opt In treatment program.
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Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
다른 이름들:
Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
다른 이름들:
Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking.
For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
7-day Point-prevalence Abstinence
기간: Month 1
|
7-day, self-reported and verified cigarette abstinence.
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Month 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Treatment Engagement
기간: Month 1
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Percentages of participants who use cessation medications and participate in counseling post discharge
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Month 1
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Default-theory Based Measures
기간: Month 1
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We will assess the impact of opt-out versus opt-in treatment on perceived treatment coercion using items adapted from the Admission Experience Survey (AES) short form.
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Month 1
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7-day Point-prevalence Abstinence
기간: Month 6
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7-day, self-reported and verified cigarette abstinence.
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Month 6
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Cost-effectiveness
기간: Month 6
|
Counselor time, wage estimates, pharmacotherapy costs, and abstinence rates will be combined to report the incremental cost-effective ratio (ICER).
The ICER is the ratio of the difference in costs divided by the difference in effectiveness between the two study arms.
ICER indicates the added cost per additional quitter, a metric that will allow comparisons to other smoking cessation economic studies.
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Month 6
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kimber Richter, PhD, University of Kansas Medical Center
간행물 및 유용한 링크
일반 간행물
- Faseru B, Mussulman LM, Nazir N, Ellerbeck EF, Shergina E, Scheuermann TS, Gajewski BJ, Catley D, Richter KP. Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment. Subst Abus. 2022;43(1):1035-1042. doi: 10.1080/08897077.2022.2060441.
- Faseru B, Ellerbeck EF, Catley D, Gajewski BJ, Scheuermann TS, Shireman TI, Mussulman LM, Nazir N, Bush T, Richter KP. Changing the default for tobacco-cessation treatment in an inpatient setting: study protocol of a randomized controlled trial. Trials. 2017 Aug 14;18(1):379. doi: 10.1186/s13063-017-2119-9.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00001774
- R01HL131512 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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