Effect of Varying Levels of Disease Management on Smoking Cessation

A Randomized Trial

  1. Edward F. Ellerbeck, MD, MPH;
  2. Jonathan D. Mahnken, PhD;
  3. A. Paula Cupertino, PhD;
  4. Lisa Sanderson Cox, PhD;
  5. K. Allen Greiner, MD, MPH;
  6. Laura M. Mussulman, MA, MPH;
  7. Niaman Nazir, MBBS, MPH;
  8. Theresa I. Shireman, PhD;
  9. Kenneth Resnicow, PhD; and
  10. Jasjit S. Ahluwalia, MD, MPH, MS
  1. From University of Kansas Medical Center, Kansas City, Kansas; University of Michigan, Ann Arbor, Michigan; and University of Minnesota Medical School, Minneapolis, Minnesota.

    Abstract

    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.

    Design: Randomized clinical trial from June 2004 to December 2007.

    Setting: 50 rural primary care practices.

    Participants: 750 persons who smoke more than 10 cigarettes per day.

    Intervention: 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.

    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 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).

    Limitation: 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.

    Conclusion: 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.

    Primary Funding Source: National Cancer Institute.

    Article and Author Information

    • Acknowledgment: The authors thank the research assistants and case managers for their support with the design and implementation of this study: Carla Berg, PhD; Genevieve Casey; Olivia Chang; Andrea Elyachar; Tresza Hutcheson; Shawn Jeffries, PhD; and Terri Tapp. They also thank Harry Lando, PhD, University of Minnesota School of Public Health, for his scientific contributions to the study concept and design.

    • Grant Support: From the National Cancer Institute (grant R01-101963). Study medication was provided by GlaxoSmithKline.

    • Potential Financial Conflicts of Interest: None disclosed.

    • Reproducible Research Statement: Study protocol, statistical code, and data set: Available (with institutional approval) from Dr. Ellerbeck (e-mail, eellerbe{at}kumc.edu).

    • Requests for Single Reprints: Edward F. Ellerbeck, MD, MPH, Department of Preventive Medicine and Public Health, University of Kansas Medical Center, MSN 1008, 3901 Rainbow Boulevard, Kansas City, KS 66160; e-mail, eellerbe{at}kumc.edu.

    • Current Author Addresses: Drs. Ellerbeck, Cupertino, Cox, Nazir, and Shireman and Ms. Mussulman: University of Kansas Medical Center, MSN 1008, 3901 Rainbow Boulevard, Kansas City, KS 66160.

    • Dr. Mahnken: University of Kansas Medical Center, MSN 1026, 3901 Rainbow Boulevard, Kansas City, KS 66160.

    • Dr. Greiner: University of Kansas Medical Center, MSN 4010, 3901 Rainbow Boulevard, Kansas City, KS 66160.

    • Dr. Resnicow: University of Michigan, 3867 SPH I, 109 South Observatory, Ann Arbor, MI 48109-2029.

    • Dr. Ahluwalia: University of Minnesota Medical School, Mayo Mail Code 806, 420 Delaware Street Southeast, Minneapolis, MN 55455.

    • Author Contributions: Conception and design: E.F. Ellerbeck, K.A. Greiner, L.M. Mussulman, T.I. Shireman, K. Resnicow, J.S. Ahluwalia.

    • Analysis and interpretation of the data: E.F. Ellerbeck, J.D. Mahnken, A.P. Cupertino, L.S. Cox, K.A. Greiner, N. Nazir, T.I. Shireman, K. Resnicow, J.S. Ahluwalia.

    • Drafting of the article: E.F. Ellerbeck, J.D. Mahnken, A.P. Cupertino, L.S. Cox, N. Nazir, T.I. Shireman.

    • Critical revision of the article for important intellectual content: E.F. Ellerbeck, J.D. Mahnken, A.P. Cupertino, L.S. Cox, K.A. Greiner, L.M. Mussulman, J.S. Ahluwalia.

    • Final approval of the article: E.F. Ellerbeck, J.D. Mahnken, A.P. Cupertino, L.S. Cox, K.A. Greiner, L.M. Mussulman, N. Nazir, T.I. Shireman, K. Resnicow, J.S. Ahluwalia.

    • Provision of study materials or patients: K.A. Greiner, L.M. Mussulman.

    • Statistical expertise: J.D. Mahnken, N. Nazir.

    • Obtaining of funding: E.F. Ellerbeck, K.A. Greiner, K. Resnicow, J.S. Ahluwalia.

    • Administrative, technical, or logistic support: K.A. Greiner, L.M. Mussulman.

    • Collection and assembly of data: E.F. Ellerbeck, K.A. Greiner, L.M. Mussulman, N. Nazir, T.I. Shireman.

    • ClinicalTrials.gov registration number: NCT00440115.

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    1. Ann Intern Med April 7, 2009 vol. 150 no. 7 437-446
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