Before the study onset, focus group analysis of low-income smokers reported that the majority preferred counseling sessions on relapse prevention to be done by telephone rather than in person by the office nurse at the practice sites. We anticipated frequent disruptions in telephone service for the study population, so several innovative methods to maintain telephone treatment were developed, such as: (1) immediately contacting directory assistance for disruptions in service; (2) verifying site records for phone numbers changes; (3) contacting participants during subsequent clinic visits to update phone numbers; and (4) mailing a self-addressed stamped postcard requesting immediate feedback.
Independent Variables
Participants were evaluated for standard demographic characteristics of sex, age, socioeconomic status, education level, and working status. Baseline smoking activity was evaluated on the basis of the number of cigarettes smoked per day, the number of years of smoking, the mini-Fagerstrom Tolerance Questionnaire (FTQ),19 household activity, confidence in quitting, and personal reasons for quitting. Medicaid insurance status was verified. Personal patterns of relapse triggers and coping response were recorded.
Outcomes Measured
The main outcome measure was carbon monoxide verified smoke-free status at a telephone follow-up 90 days after the quit date in both usual and telephonic-counseling groups. Multiple attempts were made to contact participants, regardless of the level of participation at 3 months. Participants reporting 7-day smoke-free status at 3 months were invited to have carbon monoxide verification at the office and were paid $50 for their time.
The secondary outcome measures included physician, nurse, counselor, and participant compliance with protocols; provider and staff satisfaction with the program; and nicotine replacement use.
Statistics
Comparisons of study group characteristics were made using standard statistical measures. Categorical variables were tested using the chi-square test for contingency tables and the Student t test for continuous variables. Several continuous variables were categorized and analyzed by both methods.
The study denominator was based on intention-to-treat assignment as in randomized controlled trials20,21 for evaluation of pharmacotherapy for nicotine addiction. Participants who refused follow-up, failed to call back, gave incorrect contact numbers, or dropped out were counted as smokers.
Smoking quit rates at 90-day follow-ups were compared using the z score for equality of proportions. Adjustments were made in self-reported outcomes based on carbon monoxide verification rates.
Results
Demographic Comparison of Study Groups
A total of 238 smokers participated in the study (N=123 usual care group, and N=110 in the telephonic-counseling group) and patient demographics are reported in Table 2. The smoking characteristics of the study groups are provided in Table 3. Adjustments for participants without telephones did not induce any significant differences.
As shown in Table 4, the most common reasons for quitting by far were personal health reasons and health problems related to smoking. Very few participants reported advice from their physician as the reason to quit smoking. The groups were comparable and did not differ significantly in their reasons for quitting.
Smoke-Free Status
Of the 233 patients with telephones enrolled in the study, 80 (65%) in the usual care group and 74 (67%) in the telephonic-counseling group were successfully contacted. Of those contacted, 19 in the usual care group and 24 in the telephonic-counseling group reported that they were smoke free. However, smoke-free status was successfully confirmed using carbon monoxide (CO) monitoring in only 56% of patients claiming to be smoke free in the usual care group, while 95% of patients in the telephonic-counseling group had their smoke-free status confirmed. Thus, in the per-protocol analysis, smoke-free status was confirmed in 10 of 80 (12.5%) in the usual care group and 23 of 74 (31%) in the telephonic-counseling group (P=.004).
In the intention-to-treat analysis we assumed that all missing cases were smoke free and used denominators of 123 and 110 for the usual care and telephonic-counseling groups, respectively. In this intention-to-treat analysis, the rates of self-reported smoke-free status were 15% and 19% (P=ns). In the intention-to-treat analysis of CO-verified smoke-free status, patients in the telephonic-counseling group were more likely to be smoke free (8.1% vs 21%, P <.01).
Nicotine Replacement Use
Prescriptions for nicotine replacement were received by 91% of the usual care and 99% of the telephonic-counseling care participants. At follow-up evaluation, 73% of the usual care and 67% of telephonic-counseling care participants reported using at least an initial course of nicotine replacement. These proportions of use did not differ significantly between the study groups
Discussion
Smoking has been shown to be one of the most modifiable health risks significantly related to higher health care charges, even after controlling for age, sex, race, diabetes, and heart disease.22 Although indemnity plans have been largely unsupportive of services for smoking cessation counseling, managed care plans have shown considerable success at decreasing the prevalence of smoking by offering comprehensive smoking cessation services.23,24 In fact, offering full coverage of both behavioral and pharmacotherapy services results in a greater reduction in smoking prevalence than partial coverage.24 The studies mentioned on smoking cessation were conducted with participants who were employed and had commercial insurance coverage.