Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012948
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Centralized Telephone Outreach to Assist Smoking Cessation Among Veterans
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Centralized Telephone Outreach to Assist Smoking Cessation Among Veterans
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
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:
Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care rates of identification of tobacco use and provision of brief andor intensive smoking cessation services are suboptimal Telephone outreach TO may serve to increase access to counseling and medications to assist smoking cessation From the standpoint of health systems TO provides the opportunity for centralized oversight and quality assurance economy of scale and dissemination strategies that are practical to implement At the provider level TO addresses barriers to delivery of services such as limited time and skills From the standpoint of the smoker attractions of TO include accessibility convenience and privacy
Detailed Description:
Background
Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care rates of identification of tobacco use and provision of brief andor intensive smoking cessation services are suboptimal Telephone outreach TO may serve to increase access to counseling and medications to assist smoking cessation From the standpoint of health systems TO provides the opportunity for centralized oversight and quality assurance economy of scale and dissemination strategies that are practical to implement At the provider level TO addresses barriers to delivery of services such as limited time and skills From the standpoint of the smoker attractions of TO include accessibility convenience and privacy
Objectives
The objectives of the study are to 1 determine if TO increases successful quitting among veterans who smoke compared to the distribution of written self-help materials and 2 determine the cost-effectiveness of TO for smoking cessation for veterans who smoke
Methods
The study involved a population-based sample of veterans in VISN 13 who use one of the five Network VAMCs for primary care 838 smokers were recruited enrolled and randomly assigned to 1 written self-help materials TO or 2 written self-help materials alone The behavioral intervention protocol included follow-up calls scheduled in a relapse-sensitive fashion Use of nicotine replacement therapy NRT was encouraged and prescriptions facilitated Data was collected at baseline 3 months and 12 months by telephone Information on demographic characteristics medical and mental health histories smoking history intervention and use of clinical services for smoking cessation was included Cost data will be calculated from administrative databases and will include 1 written materials 2 counseling personnel time equipment space and 3 medications The primary outcome was 6 months of prolonged abstinence from smoking measured 12 months following intervention Secondary analyses evaluated 3 month and 12 month point prevalent abstinence from smoking quit attempts and a formal cost-effectiveness analysis that will include total costs total and marginal effects and cost-effectiveness ratios average costquit and average costmarginal quit for TO and SH interventions
Status
Data collection and main outcome analyses have been completed The main manuscript will be submitted to JAMA in October 2004 We are starting cost-effectiveness analyses
Smoking cessation interventions including behavioral and pharmacological components have been demonstrated to be both effective and cost-effective Although there is a high prevalence of smoking and smoking-related disorders among veterans who use VA medical centers for health care rates of identification of tobacco use and provision of brief andor intensive smoking cessation services are suboptimal Telephone outreach TO may serve to increase access to counseling and medications to assist smoking cessation From the standpoint of health systems TO provides the opportunity for centralized oversight and quality assurance economy of scale and dissemination strategies that are practical to implement At the provider level TO addresses barriers to delivery of services such as limited time and skills From the standpoint of the smoker attractions of TO include accessibility convenience and privacy
Objectives
The objectives of the study are to 1 determine if TO increases successful quitting among veterans who smoke compared to the distribution of written self-help materials and 2 determine the cost-effectiveness of TO for smoking cessation for veterans who smoke
Methods
The study involved a population-based sample of veterans in VISN 13 who use one of the five Network VAMCs for primary care 838 smokers were recruited enrolled and randomly assigned to 1 written self-help materials TO or 2 written self-help materials alone The behavioral intervention protocol included follow-up calls scheduled in a relapse-sensitive fashion Use of nicotine replacement therapy NRT was encouraged and prescriptions facilitated Data was collected at baseline 3 months and 12 months by telephone Information on demographic characteristics medical and mental health histories smoking history intervention and use of clinical services for smoking cessation was included Cost data will be calculated from administrative databases and will include 1 written materials 2 counseling personnel time equipment space and 3 medications The primary outcome was 6 months of prolonged abstinence from smoking measured 12 months following intervention Secondary analyses evaluated 3 month and 12 month point prevalent abstinence from smoking quit attempts and a formal cost-effectiveness analysis that will include total costs total and marginal effects and cost-effectiveness ratios average costquit and average costmarginal quit for TO and SH interventions
Status
Data collection and main outcome analyses have been completed The main manuscript will be submitted to JAMA in October 2004 We are starting cost-effectiveness analyses
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