- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01489579
Telephone Counseling for Tobacco Cessation
Evaluation of Brief, Structured, Telephone Counseling for Tobacco Cessation as Part of a Cardiovascular Risk Reduction Service
The purpose of this study is to determine whether giving more structured information to patients over the phone about quitting tobacco helps to increase the chance that they will try to quit. The results of this study will help provide direction in developing a more standard way of helping patients to quit.
Study Hypothesis:
Brief, structured, telephone tobacco cessation counseling delivered by clinical pharmacy specialists will significantly increase the percentage of self-reported tobacco cessation attempts compared to usual care among patients enrolled in a cardiovascular risk reduction program.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Colorado
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Aurora, Colorado, 미국, 80011
- Clinical Pharmacy Specialist, Clinical Pharmacy Cardiac Risk Service - Kaiser Permanente of Colorado
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
Patients who meet the following criteria will be eligible for the study:
- Enrolled in CPCRS at the time of counseling (12/11-02/12),
- Current tobacco user as noted in KP HealthConnect as of the date of the routine CPCRS evaluation and counseling. For study purposes, tobacco use includes any use of cigarettes, pipe, cigars, snuff, and chew.
- Continuous KPCO Denver/Boulder membership during study time period
Exclusion Criteria:
- Patients who meet any of the following criteria will not be enrolled in the study:
- <18 years of age,
- Non-English speakers,
- Deceased at time of survey, and/or
- Unable to provide consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: BST counseling group
The patients in the Brief, structured, telephone tobacco cessation, BST, counseling group, will receive tobacco cessation counseling, intervention, by a trained CPCRS pharmacist as part of their routine CPCRS care.
The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C).
These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting.
A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources.
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The patients in the Brief, Structured, Telephone (BST) counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care.
The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C).
These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting.
A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources ("Ready to quit" patient handout)
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위약 비교기: Usual care group
Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices.
These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications.
Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
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Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices.
These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications.
Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Percentage of Self-reported Tobacco Cessation Attempts Between Groups
기간: 3 months
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The proportion of patients in each group who report a tobacco cessation attempt during the follow-up telephone survey conducted three months following pharmacist contact
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3 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The Proportion of Patients in Each Group Who Participate in the Colorado Quitline (COQL) Within Three Months of Pharmacist Contact
기간: 3 months
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Information on COQL participation was obtained from a prevention department within KPCO that tracks these data.
Report was provided to capture who from study had participated in the COQL within 3 months of pharmacist contact.
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3 months
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The Proportion of Patients Who Attend Any KPCO Tobacco Cessation Program(s)or Webinar(s) Within Three Months Following Contact.
기간: 3 months
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The proportion of patients who attend any KPCO tobacco cessation program(s)or webinar(s) within three months following contact.
Classes include Stop Smoking the Basics and Freedom from Cigarettes.
Webinars include Break Free and Freedom from Tobacco
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3 months
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The Proportion of Patients in Each Group Who Purchase Tobacco Cessation Medication Aids From KPCO Pharmacies Within Three Months Following Pharmacist Contact.
기간: 3 months
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The proportion of patients in each group who purchase tobacco cessation medication aids from KPCO pharmacies within three months following pharmacist contact.
Medications include nicotine replacement therapy, bupropion, and varenicline
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3 months
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The Proportion of Patients in Each Group Who Report Tobacco Abstinence During at the Three Months Follow-up Telephone Survey
기간: 3 months
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The proportion of patients in each group who report tobacco abstinence during the follow-up telephone survey conducted three months following pharmacist contact
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3 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Alicia Cymbala, PharmD, BCPS, Kaiser Permanente
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CO-11-1660
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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