Enhancing Smoking Cessation of Low-Income Smokers in Managed Care

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Original Research

Enhancing Smoking Cessation of Low-Income Smokers in Managed Care

J Fam Pract. 2001 February;50(2):138-144

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References

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Methods

Recruitment of Participants

Participants were enrolled from January 19, 1998, to June 20, 1998, from 3 community heath center sites (Hackley, Baldwin, and Muskegon) in Michigan. Each practice site had the designation of a federally underserved site with the majority of care provided to very low-income patients. Each practice site had 5 to 7 providers with approximately 10,000 to 15,000 active patients on record. All participants were smokers older than 21 years with Medicaid managed care insurance. Participants were covered by 4 different managed care plans that agreed to allow the participation of their patients in the study. All participants had no medical contraindications to the use of transdermal nicotine, including pregnancy, and were willing to commit to quitting smoking within the next 30 days. Smokers were invited to participate in the study during their usual office visits and were offered 21-mg transdermal nicotine for 8 weeks as covered by Medicaid and determined appropriate by their providers.

Recruitment Rates

During the 6-month recruitment period, 501 smokers on Medicaid managed care were identified as eligible by office nurses and referred to participate in our study at the 3 practice sites. Of the referred group, 259 (52%) enrolled in our study and were randomized to either usual or relapse prevention care. A total of 233 (48% of the referred group) participated in our study. Participation was defined as receiving brief physician advice for the usual care group or brief physician advice and 1 telephonic-counseling session for the telephonic-counseling care group. These rates of enrollment were consistent across the 3 study sites. Participants were excluded from the final analysis if it was discovered after randomization that they did not have telephones. The informed consent process was approved by the institutional review board of Michigan State University. Figure 1 shows the recruitment and randomization flow.

Training of Providers and Staff

A total of 20 primary care physicians were trained to provide brief advice for smoking cessation consistent with the national guidelines.¹ Physician training consisted of a 2-hour update session on the guidelines, an overview of the study protocol, and role playing. Physicians received continuing medical education credit for participating. Ten nurses^3-4 per site and 10 telephone counselors were trained in computer-assisted relapse prevention. Nurse and telephone-counselor training consisted of 3 2-hour sessions on relapse prevention, computer skills, and individual case management. Nurses and counselors were encouraged to practice on case examples between training sessions. Their intervention skills were evaluated before they began counseling study participants. Quality assurance of counseling performance was performed through weekly audiotape review by research assistants. The computer program (“I’d Rather Cope than Smoke”⁹) provided a continuing record of counseling time and accuracy of data collection per nurse and counselor.

Study Design and Counseling Interventions

The participants who were assigned to the usual-care group participated in an intake session, received brief advice on smoking by their provider according to the guidelines,¹ were given a prescription for transdermal nicotine if medically appropriate, and had a follow-up scheduled for at least 1 visit (usually 7 to 30 days after the quit date) consistent with their medical condition. All participants also received “Clearing the Air” (National Cancer Institute publication no. 95-1647). The intake session lasted approximately 45 minutes. The intake was conducted by study staff (not the nurses providing telephone counseling) to prevent selection bias. Randomized assignment to either usual care or telephonic-counseling care groups occurred immediately after the intake session.

The participants assigned to the relapse prevention telephonic-counseling group received an intake session, usual care, a copy of “Clearing the Air,” a diary of coping responses the size of a cigarette pack, and 6 telephonic-counseling sessions. The sequence of follow-up sessions was determined according to the quit date: Session 1 was scheduled for 1 day after the quit date; session 2, 3 days; session 3, 7 days; session 4, 14 days; session 5, 30 days; and session 6, 60 days. Follow-up sessions lasted approximately 15 to 20 minutes. This sequence is consistent with previously reported studies by the authors⁹ and other investigators.^4,8 As previously reported, the computer software program, “I’d Rather Cope than Smoke,” was developed to assist in compliance with the relapse prevention protocol.⁹ All counseling sessions were done telephonically. Trained office nurses who used the software on laptop computers performed the first 3 treatment sessions. The intake and follow-up data of the first 3 sessions were electronically transferred to a computer network at Michigan State University where trained telephone counselors provided sessions 4 to 6.

Barriers to Maintaining Telephone Treatment