Smoking Cessation in Hospitalized Smokers

• 30-day abstinence [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
  All participants will receive an assessment Interview 6-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone.
• 30-day abstinence [ Time Frame: 2-months post enrollment ] [ Designated as safety issue: No ]
  All participants will receive an assessment Interview 2-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone.

• 30-day abstinence [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
  All participants will receive two Assessment Interviews at 6- and 12-months after their initial contact with the Helpline. The interview will cover, as appropriate, tobacco use, use of quitting aids, pattern of quitting (including slips and relapse situations), and satisfaction with the services. The interview will be conducted over the telephone. Participants will receive a pre-contact letter 1 week before the evaluation interview with a non-contingent $2 bill incentive.
• 30-day abstinence [ Time Frame: 12-months post enrollment ] [ Designated as safety issue: No ]

• Percentage of smokers making a 24-hour quit attempt [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
• Continuous abstinence rates for those who made quit attempts [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
• Self-reported re-hospitalization [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]

• Percentage of smokers making a 24-hour quit attempt [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
• Continuous abstinence rates for those who made quit attempts [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
• Self-reported re-hospitalization [ Time Frame: 6-months post enrollment ] [ Designated as safety issue: No ]
• Percentage of smokers making a 24-hour quit attempt [ Time Frame: 12-months post enrollment ] [ Designated as safety issue: No ]
• Continuous abstinence rates for those who made quit attempts [ Time Frame: 12-months post enrollment ] [ Designated as safety issue: No ]
• Self-reported re-hospitalization [ Time Frame: 12-months post enrollment ] [ Designated as safety issue: No ]

When smokers are hospitalized they quit smoking, either voluntarily or involuntarily. Most of them, however, go back to smoking soon after discharge. This study will test an innovative approach which includes dispensing nicotine patches at discharge, providing proactive telephone counseling post discharge, or giving a combination of the two. The interventions are aimed at increasing the long term quit rate of these patients.

The specific aims of the study are to demonstrate the effects of two interventions, dispensing nicotine patches at discharge and providing proactive telephone counseling soon after discharge, on 12-month quit rates of hospitalized smokers in a 2 x 2 factorial design.

Most smokers in the U.S. actually do quit smoking when hospitalized, either voluntarily or involuntarily because of hospital's nonsmoking policy. However, the majority of them return to smoking soon after their discharge from the hospital. A hospital stay, therefore, is a "teachable moment" for these patients, a good opportunity to encourage them to lead a smoke-free life after they are discharged. Research, however, has found that brief counseling provided to smokers while they are hospitalized has limited effect. The scientific data clearly show that smokers should be identified at the hospital, provided counseling, and given intensive interventions with follow up extended to 1 month post discharge. Providing such clinical services to these patients will reduce their chance of relapse to smoking and the rate of re-hospitalization. In practice though, hospitals have had difficulty providing even basic bedside counseling with a subgroup of patients, not to mention a much longer follow up post-discharge with all patients.

The proposed study aims to demonstrate that state quitlines can help bridge the gap between the recommendations from existing scientific data and the current practice by hospitals. Quitlines deliver counseling services by telephone. This is convenient for patients because they do not have to go anywhere in order to receive the counseling. Moreover, telephone counseling can be delivered proactively by the counselor.

The potential impact of this study is that if this model is proven effective in a rigorous study design, then it is likely that state quitlines across the U.S. will adopt it and start working with hospitals that are interested in using such as system. If the new JCAHO requirements get adopted, there will be a strong incentive for the hospitals to work with partners like the quitlines that can help provide follow up counseling.

With the proposed project the investigators intend to establish a practical model that lends itself to broader dissemination, while testing the effectiveness of the interventions with the rigor of a randomized design.

• Drug: Nicotine Patches
  Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.
• Behavioral: Telephone Counseling
  Telephone counseling is conducted in the appropriate language (Spanish and English) by veteran counselors at the California Smokers' Helpline. The counseling protocol is similar to that used by the Helpline in previous efficacy studies. Counseling is proactive so after the smoker calls in subsequent calls are made by the counselor, a process that reduces attrition. The counseling group will receive proactive sessions initiated by quitline staff within 2 days of discharge, and a total of 6 individualized telephone counseling session that extend to two months post discharge. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors will use a structured protocol so that there will be a record for each counseling call. Quantitative information that will be available for analysis include: timing, length, and frequency of counseling calls.
• Behavioral: Brief Hospital Counseling
  All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.

• Experimental: Telephone Counseling
  Interventions:

  • Behavioral: Telephone Counseling
  • Behavioral: Brief Hospital Counseling
• Experimental: Nicotine Patches
  Interventions:

  • Drug: Nicotine Patches
  • Behavioral: Brief Hospital Counseling
• Experimental: Telephone Counseling and Nicotine Patches
  Interventions:

  • Drug: Nicotine Patches
  • Behavioral: Telephone Counseling
  • Behavioral: Brief Hospital Counseling
• Active Comparator: Brief hospital counseling
  Intervention: Behavioral: Brief Hospital Counseling

Inclusion Criteria:

• 18 years or older
• Smoke >=6 CPD
• English or Spanish speaking
• Valid phone number
• Valid address
• CA resident
• Gave consent to participate in study and evaluation

Exclusion Criteria:

• Hospital stay of less than 24 hours
• Terminal illness (prognosis less than 12 months)
• Inability to communicate orally
• Hypersensitivity to nicotine
• Pregnant
• Hospitalized for psychiatric treatment