Post-discharge smoking intervention study methods

Date: 
11/01/2014

Rigotti, N.A., et al. “Sustained care intervention and post-discharge smoking cessation among hospitalized adults: A randomized clinical trial.” JAMA 2014; 312(7): 719-728. 

The lead author is from Massachusetts General Hospital in Boston.

The study was called The Helping Hand (Hospital-initiated Assistance for Nicotine Dependence) trial and was funded by the National Institutes of Health/National Heart Lung and Blood Institute. Eligible participants were current smokers who received smoking cessation counseling in the hospital, stated that they planned to try to quit smoking after discharge, and agreed to accept smoking cessation medication. Participants were randomly assigned to either a sustained care group or a standard care group.

Sustained care condition consisted of two components designed to reduce patient barriers to completing a full course of tobacco treatment after discharge. The first component was a 30-day supply of free tobacco cessation medication, provided at discharge and refillable twice for up to 90 days of treatment. The second component consisted of five automated outbound interactive voice response telephone calls at 2, 14, 30, 60 and 90 days after discharge. The calls provided advice and support messages that prompted smokers to stay committed to quitting, encouraged proper use and adherence to smoking cessation medication, offered medication refills, and triaged smokers to a return telephone call from a live counselor for additional support. The telephone script encouraged participants to request a callback from a counselor if they had low confidence in their ability to stay off cigarettes, had resumed smoking but still wanted to quit, needed a medication refill, had problems with the medication, or had stopped using any medication. Trained counselors made the return telephone calls.

Standard care condition was simply a program that provided smokers with a specific post-discharge medication recommendation and advice to call a free telephone quit line. 

The primary outcome was a 7-day tobacco abstinence, biochemically validated, 6 months after discharge. Abstinence was defined as the abstinence from any tobacco product including electronic cigarettes. Secondary outcome measures were self-reported 7-day point prevalence and continuous abstinence at 1, 3 and 6 months post-discharge. For self-reported abstinence at 6 months, patients were asked to provide a mailed saliva sample for assay of nicotine components. Those patients using nicotine replacement therapy had an in-person measurement of expired air carbon monoxide.

Post-discharge Intervention Study Results

A total of 397 patients consented to enroll and were randomly assigned to receive either sustained care (198) or standard care (199) after hospital discharge.

The mean age of participants was 53 years, 48% male, 81% non-Hispanic whites, and 51% had a high school education or less.

Tobacco cessation treatment in the hospital did not differ by group: 67% of participants used an in-hospital cessation medication, generally nicotine replacement therapy, to manage nicotine withdrawal symptoms.

Medication use

In both groups, the post-discharge medication was predominantly nicotine replacement therapy. Bupropion and varenicline were each used by 5.5% or less of participants, with no difference in use by study group. 

Participants in the sustained care group had a longer duration of medication use compared with the standard care group. In sustained care group, 61% of participants completed eight or more weeks of the 12-week treatment course, compared with 37% in the standard care group.

Abstinence rates after discharge by treatment groups

Biochemically validated 7-day abstinence at 6 months was higher with sustained care (26%) than with standard care (15%).

Self-reported continuous tobacco abstinence after hospital discharge was higher for sustained care than for standard care at each follow-up assessment: 1 month (46% vs 33%), 3 months (34% vs 24%), and 6 months (27% vs 16%).

Post-discharge Intervention Study Conclusions

This trial demonstrated a method to achieve long-term tobacco cessation among hospitalized cigarette smokers who received an inpatient tobacco dependence intervention and who expressed an interest in cessation treatment after discharge. The sustained care intervention model succeeded in improving the use of both counseling and pharmacotherapy by smokers after discharge, and it increased by71% the proportion of patients with biochemically confirmed tobacco abstinence 6 months after discharge.  According to the authors, tobacco abstinence for 6 months is a standard measure to indicate long-term smoking cessation. The uniqueness of the intervention was the use of interactive voice response technology to automate telephone calls, proving an efficient, low-cost way to maintain contact with smokers after hospital discharge.

The authors concluded that among hospitalized smokers who planned to quit, a post-discharge intervention that included automated telephone calls and free medication resulted in higher sustained smoking cessation rates than standard post-discharge advice to use smoking medication and counseling.  These findings suggest a low-cost approach to achieving sustained smoking cessation after a hospital stay.

Varenicline-Bupropion Study Methods

Rose, J.E.; Behm, F.M. “Combination treatment with varenicline and bupropion in an adaptive smoking cessation paradigm.” Am J Psychiatry, June 17, 2014. Doi: 10.1176/appi.ajp.2014.13050595. [Epub ahead of print]

The varenicline-bupropion study was conducted at Duke University Medical Center in Durham, North Caroline.

The study objective was to evaluate the usefulness of a combination of varenicline and bupropion for smokers who are not likely to succeed in quitting with nicotine patch treatment alone. The study specifically evaluated whether combination treatment with varenicline and bupropion is more efficacious than varenicline alone as a rescue treatment for nicotine patch non-responders. This study was funded by the National Institute on Drug Abuse.

After enrollment, participants were seen at the research facility weekly for two weeks before the quit date and at four sessions held 1 ,3, 7 and 11 weeks after the quit date. Smoking diaries and measures of expired-air CO were collected at each session. After the first week of pre-quit nicotine patch treatment, all patch non-responders were randomly assigned to receive varenicline along with either sustained-release bupropion tablets or placebo tablets.

Varenicline dosing was 0.5 mg once daily for days 1-3; 0.5 mg twice daily on days 4-7; and 1 mg twice daily through 12 weeks.

Bupropion dosing was 150 mg once daily for 3 days, then 150 mg twice daily through 12 weeks.

Primary outcome measure was continuous smoking abstinence at weeks 8-11 after the target quit date.

Varenicline-Bupropion Study Conclusions

There were 349 participants enrolled in the study: 222 were nicotine patch non-responders at week 1, and subsequently, were randomly assigned to the two treatment groups.

The primary outcome of 4-week smoking abstinence for weeks 8-11 showed a significant effect of combination treatment with varenicline and bupropion (39.8%) relative to varenicline plus placebo (25.9%).

When the effect of the combination was examined only in male smokers, who had abstinence rates of 50.9% compared to 19.6% of varenicline plus placebo.

In female smokers, there was no significant difference between treatment conditions. Abstinence rates were 29.3% for female patients receiving combination treatment and 30.6% for those receiving  varenicline plus placebo.

For participants in the high baseline cigarette consumption group (at least 20 cigarettes per day), abstinence rates were 41.8% for the combination and 23.9% for varenicline plus placebo.

For participants in the low baseline cigarette consumption group (less than 20 cigarettes per day), abstinence rates were 37.0% for the combination and 29.3% for varenicline plus placebo.

Similarly, for participants in the high baseline nicotine dependence groups (as determined by a standard test for dependence) abstinence rates were 44.4% for the combination and 18.6% for varenicline plus placebo. For participants in the low baseline nicotine dependence groups (as determined by a standard test for dependence) abstinence rates were 31.7% for the combination and 39.5% for varenicline plus placebo.

According to the authors, the results showed an overall benefit of adding bupropion treatment to varenicline for nicotine patch non-responders. Male smokers and those with high levels of nicotine dependence appeared to have a greater therapeutic response. For these smokers, the end-of-treatment abstinence rates among those in the combination drug group were more than double those of smokers in the varenicline-only group.

In contrast, no significant difference between the two treatments was observed in female smokers or those with lower levels of nicotine dependence.

According to the authors, based on the magnitude of enhancement in abstinence rate and an excellent safety and tolerability profile, the results of this study support the use of combination treatment with varenicline and bupropion for male smokers and highly dependent smokers who do not respond with sufficient smoking reduction during the first week of pre-quit nicotine patch.  

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