Women's Initiative for Nonsmoking - WINS

Description:

The goal of the Women's Initiative for Nonsmoking (WINS) trial was to evaluate the efficacy of a smoking-cessation intervention in women hospitalized with a diagnosis of cardiovascular disease (CVD) or peripheral vascular disease (PVD).

Hypothesis:

Smoking-cessation intervention will be associated with a longer smoke-free time compared with usual care in women hospitalized for CVD or PVD.

Study Design

Study Design:

Patients Screened: 1,028
Patients Enrolled: 277
Mean Follow Up: 30 months
Mean Patient Age: Mean age 61 years
Female: 100

Patient Populations:

Women admitted to the hospital for medical or surgical treatment of CVD or PVD; age ≥18 years; history of smoking cigarettes within the past month; willing to make a serious attempt to quit smoking and not to smoke after their discharge from the hospital; medically stable and able to provide informed consent; and agreed to give written informed consent to participate in the trial, which required a commitment to 30 months of participation

Exclusions:

Inability to read or speak English, medically unstable, current diagnosis of alcohol or substance abuse, and having dementia or schizophrenia

Primary Endpoints:

Time smoke-free

Drug/Procedures Used:

Women hospitalized for CVD or PVD at 12 San Francisco Bay Area hospitals were randomized to a usual care group (n=135) or intervention group (n=142). Usual care included strong physician’s advice, a self-help pamphlet, and a list of community resources.

The intervention group received strong physician’s advice and a nurse-managed smoking cessation and relapse-prevention intervention at bedside. Additionally, patients in the intervention group received up to five telephone contacts at 2, 7, 21, 28, and 90 days after discharge.

Concomitant Medications:

Nicotine replacement therapy for eight weeks in the form of a nicotine patch (NicoDerm, 14 mg or rarely, 21 mg) or nicotine gum (Nicorette, 2 or 4 mg) was offered to women who relapsed to smoking.

Principal Findings:

Baseline characteristics were well balanced between the groups. Nicotine replacement therapy was used in 23% of the usual care group and 20% of the intervention group. Patients in the usual care group had smoked cigarettes for a median of 40 years versus 38 years in the intervention group, with the median age they began smoking of 16 and 17 years, respectively.

Smoke-free time for the intervention group was significantly longer than in the usual care group (p=0.038). The point prevalence for estimated percent of nonsmokers trended higher in the intervention group at six months (51.5% vs. 40.8%, p=0.15), but did not differ at 12 months (47.6% vs. 41.7%, p=0.40), 24 months (48.5% vs. 46.2%, p=0.77), or 30 months (50.0% each, p=1.0). While the overall number of women using nicotine replacement therapy was small, use of such therapy was associated with smoking at six months after adjusting for randomized therapy (odds ratio 3.7, 95% confidence interval 1.6-8.7, p=0.003).

Interpretation:

Among women hospitalized for CVD or PVD, use of a smoking-cessation intervention was associated with longer smoke-free duration through 30 months compared with usual care. Prior studies have shown beneficial effects of smoking cessation intervention in men, but such data in women have been limited. Additionally, the authors noted that research has shown that women may respond differently to behavioral intervention.

The smoking cessation rate in the usual care group was higher than in previous studies. Despite the benefit associated with the intervention group, smoking relapse rates were high in both arms.

References:

Sivarajan Froelicher ES, Miller NH, Christopherson DJ, et al. High rates of sustained smoking cessation in women hospitalized with cardiovascular disease: the Women's Initiative for Nonsmoking (WINS). Circulation 2004;109:587-93.

Clinical Topics: Vascular Medicine, Atherosclerotic Disease (CAD/PAD)

Keywords: Odds Ratio, Behavior Therapy, Nicotine, Recurrence, Telephone, Confidence Intervals, Informed Consent, Pamphlets, Nurses, Smoking Cessation, Peripheral Vascular Diseases


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