Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297700
Status:
UNKNOWN
Last Update Posted:
2017-01-11
First Post:
2006-02-24
Brief Title:
Implementing Tobacco Control in Dental Practice
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Implementing Tobacco Control in Dental Practice
Status:
UNKNOWN
Status Verified Date:
2006-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 HMOs 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 examsConsented patients will receive a short phone survey shortly after the exam to assess smoking status satisfaction with delivery of support servicesand 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
Staff in half of the HMOs 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 examsConsented patients will receive a short phone survey shortly after the exam to assess smoking status satisfaction with delivery of support servicesand 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
Detailed Description:
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 3can be maintained over time and 4 will have a positive and cost-effective impact on patient smoking-cessation rates
The HMOs 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 2800 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 staffs 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 plans 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 ie 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 159 nonwhite or mixed race and 74 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 4000 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 2800 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 ikl M Cl G kl e ikl 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 ikl 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 eg asking advising and referring smokers will be assessed primarily by analysis of the patients 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
The HMOs 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 2800 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 staffs 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 plans 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 ie 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 159 nonwhite or mixed race and 74 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 4000 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 2800 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 ikl M Cl G kl e ikl 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 ikl 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 eg asking advising and referring smokers will be assessed primarily by analysis of the patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None