Smoking Cessation in Hospitalized Smokers

NCT ID: NCT01289275

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2014-07-31

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telephone Counseling

Up to 5 proactive counseling sessions

Group Type: EXPERIMENTAL

Telephone Counseling

Intervention Type: BEHAVIORAL

Up to 5 proactive counseling sessions from California Smokers' Helpline.

Brief Hospital Counseling

Intervention Type: BEHAVIORAL

All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.

Nicotine Patches

8 weeks of nicotine patches

Group Type: EXPERIMENTAL

Nicotine Patches

Intervention Type: DRUG

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.

Brief Hospital Counseling

Intervention Type: BEHAVIORAL

All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.

Telephone Counseling + Patches

5 proactive sessions, 8 weeks patches

Group Type: EXPERIMENTAL

Nicotine Patches

Intervention Type: DRUG

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.

Telephone Counseling

Intervention Type: BEHAVIORAL

Up to 5 proactive counseling sessions from California Smokers' Helpline.

Brief Hospital Counseling

Intervention Type: BEHAVIORAL

All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.

Brief hospital counseling

brief in hospital counseling, no proactive sessions or patches

Group Type: ACTIVE_COMPARATOR

Brief Hospital Counseling

Intervention Type: BEHAVIORAL

All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.

Interventions

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.

Intervention Type: DRUG

Telephone Counseling

Up to 5 proactive counseling sessions from California Smokers' Helpline.

Intervention Type: BEHAVIORAL

Brief Hospital Counseling

All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Hospital stay of less than 24 hours
• Inability to communicate orally
• Hypersensitivity to nicotine
• Pregnant
• Hospitalized for psychiatric treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Shu-Hong Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shu-Hong Zhu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

Scripps Mercy - Chula Vista

Chula Vista, California, United States

Univeristy of California, Davis

Davis, California, United States

UCSD - Thornton Hospital

La Jolla, California, United States

Scripps Mercy - San Diego Campus

San Diego, California, United States

UCSD Medical Center - Hillcrest

San Diego, California, United States

University of California, San Diego: California Smokers' Helpline

San Diego, California, United States

Countries

United States

References

Cummins SE, Gamst AC, Brandstein K, Seymann GB, Klonoff-Cohen H, Kirby CA, Tong EK, Chaplin E, Tedeschi GJ, Zhu SH. Helping Hospitalized Smokers: A Factorial RCT of Nicotine Patches and Counseling. Am J Prev Med. 2016 Oct;51(4):578-86. doi: 10.1016/j.amepre.2016.06.021.

Reference Type: DERIVED

PMID: 27647058 (View on PubMed)

Duffy SA, Cummins SE, Fellows JL, Harrington KF, Kirby C, Rogers E, Scheuermann TS, Tindle HA, Waltje AH; Consortium of Hospitals Advancing Research on Tobacco (CHART). Fidelity monitoring across the seven studies in the Consortium of Hospitals Advancing Research on Tobacco (CHART). Tob Induc Dis. 2015 Sep 3;13(1):29. doi: 10.1186/s12971-015-0056-5. eCollection 2015.

Reference Type: DERIVED

PMID: 26336372 (View on PubMed)

Cummins S, Zhu SH, Gamst A, Kirby C, Brandstein K, Klonoff-Cohen H, Chaplin E, Morris T, Seymann G, Lee J. Nicotine patches and quitline counseling to help hospitalized smokers stay quit: study protocol for a randomized controlled trial. Trials. 2012 Aug 1;13:128. doi: 10.1186/1745-6215-13-128.

Reference Type: DERIVED

PMID: 22853197 (View on PubMed)

Other Identifiers

5U01CA159533

Identifier Type: NIH

Identifier Source: secondary_id

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1U01CA159533-01

Identifier Type: NIH

Identifier Source: org_study_id

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