Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352781
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2006-07-13
Brief Title:
Stop Smoking Therapy for Ontario Patients
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
The STOP Stop Smoking Therapy for Ontario Patients Study The Effectiveness of Nicotine Replacement Therapy in Ontario Smokers PHASE II
Status:
COMPLETED
Status Verified Date:
2017-12
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:
STOP
Brief Summary:
Approximately 2 million Ontarians are current smokers While smoking rates have declined over the past 25 years these rates have remained constant since 2002 The rate of smoking cessation in Ontario has not kept up with the rest of Canada A new strategy is necessary to increase the number of smokers making quit attempts and to increase the odds of quitting over the long term
The overall goal of the Stop Smoking Therapy for Ontario Patients STOP Study is to evaluate the methods and effectiveness of providing nicotine replacement therapy NRT to Ontario smokers The study will develop an evidence-based protocol for providing NRT provide faculty development on combining pharmacotherapy with behavioural interventions and will provide an evaluation framework to inform future coverage models
The goal for this phase of the STOP study is to provide faculty development on combining pharmacotherapy with behavioural interventions This will be achieved by partnering with Public Health Units across Ontario who have established smoking cessation clinics but do not have the finances in place to offer NRT to their clients at a subsidized rate or free of charge Cost has been shown to be a significant barrier to the access and use of NRT in individuals trying to quit smoking However combining pharmacotherapy with behavioural interventions may be more effective than either alone Therefore we hypothesize that providing NRT free of charge to clients enrolled in a smoking cessation clinic will be more effective for smoking cessation than behavioural interventions alone
The overall goal of the Stop Smoking Therapy for Ontario Patients STOP Study is to evaluate the methods and effectiveness of providing nicotine replacement therapy NRT to Ontario smokers The study will develop an evidence-based protocol for providing NRT provide faculty development on combining pharmacotherapy with behavioural interventions and will provide an evaluation framework to inform future coverage models
The goal for this phase of the STOP study is to provide faculty development on combining pharmacotherapy with behavioural interventions This will be achieved by partnering with Public Health Units across Ontario who have established smoking cessation clinics but do not have the finances in place to offer NRT to their clients at a subsidized rate or free of charge Cost has been shown to be a significant barrier to the access and use of NRT in individuals trying to quit smoking However combining pharmacotherapy with behavioural interventions may be more effective than either alone Therefore we hypothesize that providing NRT free of charge to clients enrolled in a smoking cessation clinic will be more effective for smoking cessation than behavioural interventions alone
Detailed Description:
According to the US Surgeon Generals Report 1988 there are immediate intermediate and long-term benefits to health from quitting smoking For example there is a 50 reduction in coronary heart disease risk in 12 months and the risk of a stroke is reduced to that of a nonsmoker 5-15 years after quitting US Surgeon Generals Report 1990 pvi
In a systematic assessment of the value of clinical preventive services recommended by the US Preventive Services Task Force smoking cessation treatment for adults was one of the highest-ranked services in terms of its cost effectiveness and its potential to reduce the burden of disease Most smoking cessation interventions cost less per year of life saved than most widely accepted medical practices For example cost-effectiveness analysis of the implementation of the Agency for Healthcare Research and Quality AHRQ guidelines show costs of 4113 per life-year saved in 2001 prices compared to annual mammography for women aged 40 to 49 years which costs 71751 in 2001 prices and hypertension screening for men aged 40 years which costs 27117 in 2001 prices Therefore smoking cessation services have been referred to as the gold standard for comparing the cost effectiveness of other healthcare interventions Although some studies have shown high costs from increased healthcare utilization in the first year after quitting smoking due to illness Martinson 2003 most studies demonstrate that smokers who quit eventually have significantly lower healthcare utilization than continuing smokers Fishman 2003 Warner 2003 Thus for healthcare organizations such as the Ontario Health Insurance Plan implementing smoking cessation services will likely result in a relatively quick return on investment
Both the intensity and duration of behavioural interventions are associated with sustained remission in smoking The addition of pharmacotherapy doubles the odds of quitting successfully However many smokers face barriers in accessing pharmacotherapy The provision of free pharmacotherapy has the potential to help a substantial number of smokers to quit A study by Curry et al 1998 evaluated smokers who were willing to sign up for a cessation-support program under various degrees of coverage for either the program or nicotine replacement therapy NRT 10 of Smokers with full coverage were likely to attempt to quit as opposed to 25 with partial coverage Therefore the United States Health Human Services guidelines call for the coverage of these medications
Research has shown that coverage for tobacco dependence treatments can enhance not only the rate of quit attempts but also long-term abstinence for smokers Levy Friend 2002 Schauffler McMenamin Olson Boyce-Smith Rideout Kamil 2001 On average the odds ratio of quitting at one year was 16 for those given free NRT Therefore some insurers both public and private reimburse patients for stop smoking medications However a study by Boyle et al 2002 found that simply including the medication in an insurance plan did not increase quit rates or utilization of medications Adequate precautions must be taken to ensure that free pharmacotherapy is distributed in conjunction with behavioural interventions to be successful and to be used by those smokers most likely to benefit from pharmacotherapy
Pharmacotherapy can be very expensive if provided to all smokers However not all smokers want to quit or require medications to quit McDonald 2003 Most smokers use about 2-3 weeks of pharmacotherapy when not combined with behavioural interventions Pierce 2002 About 005 of smokers looking to quit will seek specialized care Moreover if we assume that 70 of current tobacco users Approximately 16 million in Ontario will try to quit in a given year and that 10 ie 169000 of these individuals would qualify for and seek reimbursement for 10 weeks of therapy at 30week then the total estimated cost will be about 50 million This is clearly not fundable and therefore a comprehensive strategy combined with some rational use of pharmacotherapy is necessary
Hypotheses
1 The provision of free NRT will increase quit attempts in Ontario smokers
2 The provision of free NRT will increase long-term quit rates 6 months in Ontario smokers
3 Smokers who quit smoking using NRT will have reduced health care costs after the first year of treatment
In a systematic assessment of the value of clinical preventive services recommended by the US Preventive Services Task Force smoking cessation treatment for adults was one of the highest-ranked services in terms of its cost effectiveness and its potential to reduce the burden of disease Most smoking cessation interventions cost less per year of life saved than most widely accepted medical practices For example cost-effectiveness analysis of the implementation of the Agency for Healthcare Research and Quality AHRQ guidelines show costs of 4113 per life-year saved in 2001 prices compared to annual mammography for women aged 40 to 49 years which costs 71751 in 2001 prices and hypertension screening for men aged 40 years which costs 27117 in 2001 prices Therefore smoking cessation services have been referred to as the gold standard for comparing the cost effectiveness of other healthcare interventions Although some studies have shown high costs from increased healthcare utilization in the first year after quitting smoking due to illness Martinson 2003 most studies demonstrate that smokers who quit eventually have significantly lower healthcare utilization than continuing smokers Fishman 2003 Warner 2003 Thus for healthcare organizations such as the Ontario Health Insurance Plan implementing smoking cessation services will likely result in a relatively quick return on investment
Both the intensity and duration of behavioural interventions are associated with sustained remission in smoking The addition of pharmacotherapy doubles the odds of quitting successfully However many smokers face barriers in accessing pharmacotherapy The provision of free pharmacotherapy has the potential to help a substantial number of smokers to quit A study by Curry et al 1998 evaluated smokers who were willing to sign up for a cessation-support program under various degrees of coverage for either the program or nicotine replacement therapy NRT 10 of Smokers with full coverage were likely to attempt to quit as opposed to 25 with partial coverage Therefore the United States Health Human Services guidelines call for the coverage of these medications
Research has shown that coverage for tobacco dependence treatments can enhance not only the rate of quit attempts but also long-term abstinence for smokers Levy Friend 2002 Schauffler McMenamin Olson Boyce-Smith Rideout Kamil 2001 On average the odds ratio of quitting at one year was 16 for those given free NRT Therefore some insurers both public and private reimburse patients for stop smoking medications However a study by Boyle et al 2002 found that simply including the medication in an insurance plan did not increase quit rates or utilization of medications Adequate precautions must be taken to ensure that free pharmacotherapy is distributed in conjunction with behavioural interventions to be successful and to be used by those smokers most likely to benefit from pharmacotherapy
Pharmacotherapy can be very expensive if provided to all smokers However not all smokers want to quit or require medications to quit McDonald 2003 Most smokers use about 2-3 weeks of pharmacotherapy when not combined with behavioural interventions Pierce 2002 About 005 of smokers looking to quit will seek specialized care Moreover if we assume that 70 of current tobacco users Approximately 16 million in Ontario will try to quit in a given year and that 10 ie 169000 of these individuals would qualify for and seek reimbursement for 10 weeks of therapy at 30week then the total estimated cost will be about 50 million This is clearly not fundable and therefore a comprehensive strategy combined with some rational use of pharmacotherapy is necessary
Hypotheses
1 The provision of free NRT will increase quit attempts in Ontario smokers
2 The provision of free NRT will increase long-term quit rates 6 months in Ontario smokers
3 Smokers who quit smoking using NRT will have reduced health care costs after the first year of treatment
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