Clinical trial NCT01289275
Conditions: Smoking Cessation
Keywords: tobacco cessation smoking cessation telephone self-help smoking abstinence tobacco use disorder hospital cardiopulmonary diseases disparity
Sponsor: University of California, San Diego
Start date: 2011-08-01; Completion date: 2014-07-01
Enrollment: 1270 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
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.

Detailed description:
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.

Arms: arm 1: Up to 5 proactive counseling sessions arm 2: 8 weeks of nicotine patches arm 3: 5 proactive sessions, 8 weeks patches arm 4: brief in hospital counseling, no proactive sessions or patches
Interventions: intervention 1: Nicotine Patches intervention 2: Telephone Counseling intervention 3: Brief Hospital Counseling
Intervention descriptions: intervention 1: 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. intervention 2: Up to 5 proactive counseling sessions from California Smokers' Helpline. intervention 3: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.

Protocol documents: