Implementing Tobacco Control in Dental Practice
Recruitment status was Active, not recruiting
|First Received Date ICMJE||February 24, 2006|
|Last Updated Date||July 13, 2006|
|Start Date ICMJE||May 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Tobacco-cessation rates (30-day point prevalence) at one year.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00297700 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Implementing Tobacco Control in Dental Practice|
|Official Title ICMJE||Implementing Tobacco Control in Dental Practice|
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.
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.
While multiple clinics will offer advice and referral options to smokers, research staff at only one data collection site (i.e., CHR) will carry out all study recruitment, consent, and data collection activities as part of the post-visit and annual follow-up surveys. Because CHR is the only data collection site for study subjects, and the fact that we are all part of a single well-integrated organization operating under a single IRB, we view this as a single-site study.
Projected timeline. The first nine months of the project will be devoted to planning, development and testing the web intervention and final telephone counseling protocol, and piloting all aspects of the identification, recruitment, assessment, and intervention components of the study. Recruitment will begin shortly before year 2.
Target population distribution. The target population is 52% women, 15.9% nonwhite or mixed race, and 7.4% Hispanic.
Data acquisition and entry. Random samples of smoking patients seen for annual general dental or periodontal exams will be called to complete a short “Current Visit Survey” shortly after their visits. We will randomly select up to 4,000 smoking patients (approximately 285 per facility) to contact. We expect to achieve a minimum response rate of 70%, based on a 76% response rate achieved using this same procedure with patients seen for routine medical visits (Hollis, 2000b). A 70% response rate will yield an estimated 2,800 respondents (200 per facility).
Data analysis. Because clinics rather than patients are the unit of randomization, adjustments for the intra clinic correlation will be necessary for all treatment comparisons. The primary outcome analysis is based on the mixed effects logit model: logitY i:k:l = M +Cl +G k:l +e i:k:l (1)
The adjusted mixed effects logit model will also test for differences between the early and sustained effects of program implementation on tobacco quit rates by including a member-level time covariate (T i:k:l) and an interaction term between time and intervention effect (Cl). A significant interaction term indicates that the early and late intervention effects differ.
Delivery of the intervention components (e.g., asking, advising, and referring smokers) will be assessed primarily by analysis of the patient’s reports on the post-visit phone survey they will receive shortly after the visit and the one-year follow-up phone survey. Fields in the computerized dental record will provide another somewhat limited source of information on rates of asking, advising, and referring smokers.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Active referral|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Completion Date||April 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00297700|
|Other Study ID Numbers ICMJE||5 RO1 DA017974|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute on Drug Abuse (NIDA)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institute on Drug Abuse (NIDA)|
|Verification Date||July 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP