Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123682
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2005-07-21
Brief Title:
TeleQuit Smoking Cessation Program
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Telephone Care Coordination to Improve Smoking Cessation Counseling
Status:
COMPLETED
Status Verified Date:
2015-02
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:
TeleQuit is a group randomized trial testing whether a telephone care coordination program increases the rate of smoking cessation treatment for VA patients at study sites We are testing whether proactive care coordination counselor initiates the call to the patient is more effective than reactive coordination coordinator waits for the patient to call and whether multi-session counseling is more effective than brief primary care-based counseling plus self-help materials We randomly assigned study sites to either quitline counseling or brief counseling only All patients receive brief smoking cessation counseling from their primary care physician smoking cessation medications once they are in contact with the VA care coordinator and a follow-up call at 6 months Care coordination will be provided by VA clinical staff Intensive counseling is provided by the California Smokers Helpline
Detailed Description:
Background
Despite 40 years of progress smoking remains the leading preventable cause of death in the United States responsible for 435000 deaths per year Smoking is a particular problem within the VA as VA users smoke substantially more than the general population across all categories of sex age and race When adjusted for age and gender the rate of smoking among VA users is 10 higher than the general US population - 33 vs 23 The prevalence of heavy tobacco users defined as 20 cigarettes per day in the VA is more than double that of the non-VA US population 74 vs 35
Current VA policy and new VADoD guidelines both mandate that patients be offered treatment medications and counseling regardless of whether they attend a smoking cessation program Thus it is essential to treat patients within primary care since most smokers interested in quitting cannot or will not attend a cessation program
Objectives
This project sought to make smoking cessation an area of excellence for two VA networks by adapting and expanding the primary care-based Telephone Care Coordination Program TCCP throughout Sierra Pacific Healthcare Network VISN 21 and Greater Los Angeles Healthcare System VISN 22
This regional expansion built on the TCCP a very successful VA Substance Use Disorder QUERI demonstration project implemented at two facilities In the demonstration project across the 10 intervention sites there were 2900 referrals for smoking cessation in 10 months VA care coordinators proactively contacted patients and connected them with the California Smokers Helpline About 45 of patients starting treatment were abstinent six months later--equal to or better than smoking cessation clinics A cost analysis showed substantial savings per quitter compared to provider-based and clinic-based programs
Methods
We developed a telephone-based smoking cessation program that was integrated as a routine clinical care option at five VISN 21 and VISN 22 facilities 38 clinic sites Referrals to the program were generated by a provider during a visit through a brief consult in CPRS Program staff then recruited patients and after obtaining consent enrolled the patients into treatment Data were collected at the site level quantity of referrals service origins etc and at the patient level demographics enrollment rates abstinence rates at six months etc
This project was a group randomized trial testing of whether telephone care coordination increases the rate of smoking cessation treatment At the patient level two questions are addressed
1 Is proactive care coordination counselor initiates the call to the patient more effective than reactive coordination coordinator waits for the patient to call
2 Is multi-session counseling more effective than brief primary care-based counseling plus self-help materials
We randomly allocated all participating sites within VISNs 21 and 22 to either self-help or intensive counseling treatment arms We randomly allocated each week of program referrals to either proactive or reactive care coordination All patients received brief smoking cessation counseling from their primary care physician smoking cessation medications after study enrollment by the VA care coordinator and a follow-up call at 6 months Care coordination was provided by VA clinical staff donated as in-kind support from the participating facilities Intensive counseling was provided by the California Smokers Helpline
Status
Complete except for ongoing data analysis
Despite 40 years of progress smoking remains the leading preventable cause of death in the United States responsible for 435000 deaths per year Smoking is a particular problem within the VA as VA users smoke substantially more than the general population across all categories of sex age and race When adjusted for age and gender the rate of smoking among VA users is 10 higher than the general US population - 33 vs 23 The prevalence of heavy tobacco users defined as 20 cigarettes per day in the VA is more than double that of the non-VA US population 74 vs 35
Current VA policy and new VADoD guidelines both mandate that patients be offered treatment medications and counseling regardless of whether they attend a smoking cessation program Thus it is essential to treat patients within primary care since most smokers interested in quitting cannot or will not attend a cessation program
Objectives
This project sought to make smoking cessation an area of excellence for two VA networks by adapting and expanding the primary care-based Telephone Care Coordination Program TCCP throughout Sierra Pacific Healthcare Network VISN 21 and Greater Los Angeles Healthcare System VISN 22
This regional expansion built on the TCCP a very successful VA Substance Use Disorder QUERI demonstration project implemented at two facilities In the demonstration project across the 10 intervention sites there were 2900 referrals for smoking cessation in 10 months VA care coordinators proactively contacted patients and connected them with the California Smokers Helpline About 45 of patients starting treatment were abstinent six months later--equal to or better than smoking cessation clinics A cost analysis showed substantial savings per quitter compared to provider-based and clinic-based programs
Methods
We developed a telephone-based smoking cessation program that was integrated as a routine clinical care option at five VISN 21 and VISN 22 facilities 38 clinic sites Referrals to the program were generated by a provider during a visit through a brief consult in CPRS Program staff then recruited patients and after obtaining consent enrolled the patients into treatment Data were collected at the site level quantity of referrals service origins etc and at the patient level demographics enrollment rates abstinence rates at six months etc
This project was a group randomized trial testing of whether telephone care coordination increases the rate of smoking cessation treatment At the patient level two questions are addressed
1 Is proactive care coordination counselor initiates the call to the patient more effective than reactive coordination coordinator waits for the patient to call
2 Is multi-session counseling more effective than brief primary care-based counseling plus self-help materials
We randomly allocated all participating sites within VISNs 21 and 22 to either self-help or intensive counseling treatment arms We randomly allocated each week of program referrals to either proactive or reactive care coordination All patients received brief smoking cessation counseling from their primary care physician smoking cessation medications after study enrollment by the VA care coordinator and a follow-up call at 6 months Care coordination was provided by VA clinical staff donated as in-kind support from the participating facilities Intensive counseling was provided by the California Smokers Helpline
Status
Complete except for ongoing data analysis
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