|Grant Number:||5R01CA071377-04 Interpret this number|
|Primary Investigator:||Baker, Timothy|
|Organization:||University Of Wisconsin Madison|
|Project Title:||Efficacy and Effectiveness of Nicotine Patch Adjuvants|
DESCRIPTION: (Applicant's Description) The ultimate goal of this research is to identify effective smoking cessation interventions appropriate in primary care settings that will reduce the morbidity and mortality caused by smoking-related disease. This study will evaluate the efficacy and effectiveness of the nicotine patch for smoking cessation when it is paired with three different intensities of psychosocial adjuvant. This research will identify the intensity of psychosocial adjuvant that maximizes the effectiveness, generalizability, cost-effectiveness, and durability of "real-world" clinical smoking cessation interventions. This study will occur in primary care clinics in two large managed care organizations serving diverse patient populations. The interventions will be implemented via a clinic-wide approach: every patient entering the clinic will be asked about smoking status during the vital signs assessment and all smokers will be offered cessation treatment. Thus, the interventions build upon existing clinic practices so that every smoker is offered a cessation intervention. Once smokers express an interest in quitting, they are randomly assigned to one of two treatment assignment strategies. In a phone call from a health educator, a patient will be offered treatment via either a Random N = 750) or Self-Selection (N = 750) strategy. In the Random strategy, the patient must accept one of three treatments to which s/he is randomly assigned. In the Self-Selection strategy, the patient receives information about the same three treatments and chooses one of them. The three cessation treatments.can be easily implemented in clinic settings: Patch Only (8 weeks of patch therapy), Patch + Low Intensity (patch therapy + personalized mailings and phone support), and Patch + High Intensity (patch therapy + personalized mailings and phone support + individual counseling). Abstinence rates will be assessed for one year post-treatment. The study assesses both the efficacy and effectiveness of psychosocial adjuvants to patch therapy. The Random strategy is that used by clinical trials (efficacy), whereas the Self-Selection strategy resembles clinic practice (effectiveness) where the patient has some choice over how s/he will stop smoking. The three cessation treatments may have very different outcomes in the two treatment assignment conditions. For instance, abstinence rates may differ greatly when smokers choose treatments vs. being assigned. Or, a treatment that produces high abstinence rates in randomly assigned subjects may have little potential public health benefit if smokers do not choose to enter it. Finally, cost-benefit profiles of the various cessation treatments will be estimated under the different assignment strategies.