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Smoking Cessation in Hospitalized Smokers

Phase 4
Completed
Conditions
Smoking Cessation
Interventions
Behavioral: Brief Hospital Counseling
Behavioral: Telephone Counseling
Registration Number
NCT01289275
Lead Sponsor
University of California, San Diego
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1270
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 & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Telephone Counseling + PatchesNicotine Patches5 proactive sessions, 8 weeks patches
Telephone CounselingBrief Hospital CounselingUp to 5 proactive counseling sessions
Telephone Counseling + PatchesBrief Hospital Counseling5 proactive sessions, 8 weeks patches
Telephone Counseling + PatchesTelephone Counseling5 proactive sessions, 8 weeks patches
Brief hospital counselingBrief Hospital Counselingbrief in hospital counseling, no proactive sessions or patches
Telephone CounselingTelephone CounselingUp to 5 proactive counseling sessions
Nicotine PatchesNicotine Patches8 weeks of nicotine patches
Nicotine PatchesBrief Hospital Counseling8 weeks of nicotine patches
Primary Outcome Measures
NameTimeMethod
Percentage of Participants With 30-day Abstinence6-months post enrollment

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.

Secondary Outcome Measures
NameTimeMethod
Self-reported Re-hospitalization6-months post enrollment
30-day Abstinence2-months post enrollment

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.

Percentage of Smokers Making a 24-hour Quit Attempt6-months post enrollment

Trial Locations

Locations (6)

Univeristy of California, Davis

🇺🇸

Davis, California, United States

UCSD Medical Center - Hillcrest

🇺🇸

San Diego, California, United States

UCSD - Thornton Hospital

🇺🇸

La Jolla, California, United States

Scripps Mercy - Chula Vista

🇺🇸

Chula Vista, California, United States

University of California, San Diego: California Smokers' Helpline

🇺🇸

San Diego, California, United States

Scripps Mercy - San Diego Campus

🇺🇸

San Diego, California, United States

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