Smoking Cessation in Hospitalized Smokers

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Telephone Counseling; Behavioral: Brief Hospital Counseling; Drug: Nicotine Patches

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.

• Study Type: Interventional
• Enrollment (Actual): 1270
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91910
      • Scripps Mercy - Chula Vista
    • Davis, California, United States, 95616
      • Univeristy of California, Davis
    • La Jolla, California, United States, 92037
      • UCSD - Thornton Hospital
    • San Diego, California, United States, 92103
      • UCSD Medical Center - Hillcrest
    • San Diego, California, United States, 92103
      • Scripps Mercy - San Diego Campus
    • San Diego, California, United States, 92111
      • University of California, San Diego: California Smokers' Helpline

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telephone Counseling; Up to 5 proactive counseling sessions	Behavioral: Telephone Counseling; Up to 5 proactive counseling sessions from California Smokers' Helpline.; Behavioral: Brief Hospital Counseling; All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
Experimental: Nicotine Patches; 8 weeks of nicotine patches	Behavioral: Brief Hospital Counseling; All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.; 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.
Experimental: Telephone Counseling + Patches; 5 proactive sessions, 8 weeks patches	Behavioral: Telephone Counseling; Up to 5 proactive counseling sessions from California Smokers' Helpline.; Behavioral: Brief Hospital Counseling; All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.; 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.
Active Comparator: Brief hospital counseling; brief in hospital counseling, no proactive sessions or patches	Behavioral: Brief Hospital Counseling; All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With 30-day Abstinence	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. Intention to treat analysis.	6-months post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Smokers Making a 24-hour Quit Attempt		6-months post enrollment
Self-reported Re-hospitalization		6-months post enrollment
30-day Abstinence	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.	2-months post enrollment

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 31, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimate): February 3, 2011

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: smoking cessation; hospital; tobacco cessation; tobacco use disorder; self-help; telephone; smoking abstinence; disparity; cardiopulmonary diseases
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 1U01CA159533-01 (U.S. NIH Grant/Contract); 5U01CA159533 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO