Background
Cigarette smoking is a chronic, relapsing illness that is inadequately addressed in primary care practice.
Objective
To compare cessation rates among smokers receiving pharmacotherapy management alone or combined with either moderate- or high-intensity disease management that includes counseling and provider feedback.
Design
Randomized clinical trial from June 2004 to December 2007.
Setting
50 rural primary care practices.
Patients
750 patients smoking ≥ 10 cigarettes/day.
Intervention
Participants were randomized to one of three groups: pharmacotherapy management (n = 250); pharmacotherapy management supplemented with up to 2 counseling calls (moderate-intensity disease management (n = 249)); or pharmacotherapy management supplemented with up to 6 counseling calls (high-intensity disease management (n = 251)). Interventions were offered every six months for two years. All participants received offers of free pharmacotherapy; moderate-intensity and high-intensity disease management recipients had post-counseling progress reports faxed to their physicians. Participants and counselors were not blinded to treatment assignment.
Measurements
Self-reported point-prevalence smoking abstinence at 24 months (primary outcome) and overall (0 to 24 months) analyses of smoking abstinence, utilization of pharmacotherapy, and discussions about smoking with physicians (secondary outcomes). Research assistants, blinded to treatment assignment, conducted outcome assessments.
Results
Pharmacotherapy utilization was comparable across treatment groups, with 473 of 741 (63.8%), 302 of 739 (40.9%), 175 of 732 (23.9%), and 179 of 726 (24.7%) requesting pharmacotherapy during the 1st, 2nd, 3rd, and 4th 6-month cycles of treatment. Of participants that saw a physician during any given treatment cycle, 37.5 – 59.5% reported that they discussed smoking cessation with their physician, but this did not differ across the treatment groups. Abstinence rates increased throughout the 24-month study and overall (0 to 24 months) analyses demonstrated higher abstinence among recipients of high-intensity versus moderate-intensity disease management (OR, 1.43 [95% CI, 1.00 to 2.03]) and higher abstinence in the combined disease management groups compared to pharmacotherapy management alone (OR, 1.47 [95% CI, 1.08 to 2.00]). The primary outcome, self-reported abstinence at 24 months, was 68 of 244 (27.9%) and 56 of 238 (23.5%) in the high-intensity and moderate-intensity disease management groups, respectively (OR, 1.33 [95% CI, 0.88 to 2.02]) and 56 of 244 (23.0%) in the pharmacotherapy management group (OR, 1.12 [95% CI, 0.78 to 1.61] (combined disease management versus pharmacotherapy management alone)).
Limitations
The impact of pharmacotherapy management cannot be separated from the provision of free pharmacotherapy. Cessation was validated in only 58% of self-reported quitters.
Conclusion
Smokers are willing to make repeated pharmacotherapy-assisted quit attempts leading to progressively greater smoking abstinence. A...