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临床试验/NCT00297700
NCT00297700Unknown3 期

Implementing Tobacco Control in Dental Practice

National Institute on Drug Abuse (NIDA)2 个研究点 分布在 1 个国家目标入组 2,800 人开始时间: 2004年5月最近更新:
适应症

试验速览

阶段
3 期
入组人数
2,800
试验地点
2
主要终点
Tobacco-cessation rates (30-day point prevalence) at one year.

研究概览

简要总结

Our goal is to test a dentist-hygienist team intervention to help dental patients quit smoking and determine if it can be effectively and cost-effectively implemented and sustained.

Staff in half of the HMO's 14 large dental facilities will be trained to provide brief cessation advice and assistance and to encourage smokers to talk by phone with a tobacco counselor before they leave the dental office. Phone counselors will provide brief counseling, assess stage, and offer a full list of cessation services. The Active Referral intervention strategy is both practical and innovative, as it takes advantage of available resources; efficiently distributes intervention activities between dentists, hygienists, and counseling specialists; and could be delivered in individual, small, or large dental practices. This intervention is provided as part of routine care to all patients seen for annual dental and periodontal exams.Consented patients will receive a short phone survey shortly after the exam to assess smoking status, satisfaction with delivery of support services,and satisfaction with intervention. Consented patients in treatment and control facilities will be surveyed by phone at one year to re-assess smoking status and satisfaction with services.

详细描述

The purpose of this behavioral effectiveness trial is to test the feasibility, effectiveness, cost-effectiveness, and sustainability of a team approach for delivering smoking cessation assistance to interested smokers seen within a single well-integrated group-model dental HMO. We and others have already demonstrated the efficacy of the 5-A model in medical and hospital clinical settings. The need now is to show that a practical and innovative team approach with a centralized tobacco quitline component 1) can be disseminated throughout dental care offices; 2) can be effectively and consistently delivered by dentists and hygienists; 3)can be maintained over time, and 4) will have a positive and cost-effective impact on patient smoking-cessation rates.

The HMO's 14 dental care offices will be randomly assigned to usual care or a Assisted Referral condition. In the Referral condition, dentists and hygienists will be trained to, as part of routine annual dental exams, assess, advise, and connect interested tobacco users by phone to a professionally staffed centralized tobacco quitline. If patients prefer, dental staff will have quitline staff call the patients back at a more convenient time. Quitline staff will offer brief counseling and assessment and a full menu of cessation services, including multi-session telephone and face-to-face programs and medications. The intervention will be provided as a part of routine care to all adult patients receiving annual general dental or periodontal exams.

Primary and secondary outcome measure. The primary hypothesis is that treatment will increase the probability of 30-day sustained cessation from all forms of tobacco, as reported by randomly selected patients one year after the initial clinic visit. Other secondary follow-up measures will include one-week and 6-month point prevalence at one year, stage of change, quit attempts during the year, and smoking rate among continuing smokers.

CHR research staff will survey a random sample of 2,800 consenting adult cigarette smokers in both Referral and Usual Care facilities shortly after their visits to assess rates of advice and referral, satisfaction, and other process measures. Patients will be sampled throughout a 15-month period to assess sustainability of the staff's efforts. Consenting patients will be resurveyed after one year to assess smoking cessation outcomes. Patients seen by dentists or hygienists who routinely practice in multiple facilities will be excluded to minimize contamination.

The Kaiser Permanente Dental Care Program (KPDCP) is a well-integrated single-group dental HMO with a unified administrative structure. KPDCP and the Kaiser Permanente Center for Health Research (CHR) are both divisions within a single institution- Kaiser Permanente Northwest. The dental program has 14 clinical facilities in the Vancouver, Washington; Portland, Oregon; and Salem, Oregon service areas. The dental plan's aim is to implement the tobacco control program as a permanent change in the routine care that is delivered to all patients throughout all facilities. In order to evaluate the change process and the impact of the program, however, they will stagger the rollout of the quality improvement effort with half of the facilities randomly assigned to begin during phase I and the remainder to start later once follow-up is complete.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Kaiser Permanente (KP)member
  • 18 years of age or older
  • Receiving routine primary care in KP dental offices
  • Tobacco user at time of routine dental visit

排除标准

  • Non-KP member
  • Less than 18 years or age
  • Non-tobacco user

结局指标

主要结局

Tobacco-cessation rates (30-day point prevalence) at one year.

次要结局

  • Process measures (e.g., 5As, and referrals)
  • Stage of change progression
  • Program costs

研究者

申办方类型
Nih

研究点 (2)

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