||5R01CA071377-04 Interpret this number
||University Of Wisconsin Madison
||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
Integrating smoking cessation treatment into primary care: an effectiveness study.
, McCarthy D.E.
, Jackson T.C.
, Zehner M.E.
, Jorenby D.E.
, Mielke M.
, Smith S.S.
, Guiliani T.A.
, Baker T.B.
Preventive Medicine, 2004 Apr; 38(4), p. 412-20.