Effect of varying levels of disease management on smoking cessation: a randomized trial.
BACKGROUND
Cigarette smoking is a chronic, relapsing illness that is inadequately addressed in primary care practice.


OBJECTIVE
To compare cessation rates among smokers who receive pharmacotherapy alone or combined with either moderate- or high-intensity disease management that includes counseling and provider feedback.


METHODS
Randomized clinical trial from June 2004 to December 2007.


METHODS
50 rural primary care practices.


METHODS
750 persons who smoke more than 10 cigarettes per day.


METHODS
Pharmacotherapy alone (n = 250), pharmacotherapy supplemented with up to 2 counseling calls (moderate-intensity disease management) (n = 249), or pharmacotherapy supplemented with up to 6 counseling calls (high-intensity disease management) (n = 251). Interventions were offered every 6 months for 2 years. All participants were offered free pharmacotherapy. Moderate-intensity and high-intensity disease management recipients had postcounseling progress reports faxed to their physicians.


METHODS
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 who were blinded to treatment assignment conducted outcome assessments.


RESULTS
Pharmacotherapy utilization was similar 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%) participants requesting pharmacotherapy during the first, second, third, and fourth 6-month treatment cycles, respectively. Of participants who saw a physician during any given treatment cycle, 37.5% to 59.5% reported that they had discussed smoking cessation with their physician; this did not differ across the treatment groups. Abstinence rates increased throughout the study, and overall (0 to 24 months) analyses demonstrated higher abstinence among the high-intensity disease management group than the moderate-intensity disease management group (odds ratio [OR], 1.43 [95% CI, 1.00 to 2.03]) and among the combined disease management groups than the pharmacotherapy-alone group (OR, 1.47 [CI, 1.08 to 2.00]). Self-reported abstinence at 24 months was 68 of 244 (27.9%) and 56 of 238 (23.5%) participants in the high- and moderate-intensity disease management groups, respectively (OR, 1.33 [CI, 0.88 to 2.02]), and 56 of 244 (23.0%) participants in the pharmacotherapy-alone group (OR, 1.12 [CI, 0.78 to 1.61] for combined disease management vs. pharmacotherapy alone).


CONCLUSIONS
The effect of pharmacotherapy management cannot be separated from the provision of free pharmacotherapy, and cessation was validated in only 58% of self-reported quitters.


CONCLUSIONS
Smokers are willing to make repeated pharmacotherapy-assisted quit attempts, leading to progressively greater smoking abstinence. Although point-prevalence abstinence did not differ at 24 months, analyses that incorporated assessments across the full 24 months of treatment suggest that higher-intensity disease management is associated with increased abstinence.


BACKGROUND
National Cancer Institute.
Ellerbeck
Edward F
EF
Department of Preventive Medicine and Public Health, University of Kansas Medical Center, Kansas City, Kansas 66160, USA. eellerbe@kumc.edu
Mahnken
Jonathan D
JD
Cupertino
A Paula
AP
Cox
Lisa Sanderson
LS
Greiner
K Allen
KA
Mussulman
Laura M
LM
Nazir
Niaman
N
Shireman
Theresa I
TI
Resnicow
Kenneth
K
Ahluwalia
Jasjit S
JS
D000279:Administration, Cutaneous; D000328:Adult; D016642:Bupropion / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003376:Counseling; D019468:Disease Management; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage; D011320:Primary Health Care / Q000379:methods; D016037:Single-Blind Method; D016540:Smoking Cessation / Q000379:methods*; D012944:Social Support; D014029:Tobacco Use Disorder / Q000628:therapy*; D055815:Young Adult
D016642:Bupropion; D009538:Nicotine