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Smoking Cessation in Hospitalized Smokers

University of California San Diego logo

University of California San Diego

Status and phase

Completed
Phase 4

Conditions

Smoking Cessation

Treatments

Drug: Nicotine Patches
Behavioral: Telephone Counseling
Behavioral: Brief Hospital Counseling

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01289275
5U01CA159533 (U.S. NIH Grant/Contract)
1U01CA159533-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,270 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

1,270 participants in 4 patient groups

Telephone Counseling
Experimental group
Description:
Up to 5 proactive counseling sessions
Treatment:
Behavioral: Telephone Counseling
Behavioral: Brief Hospital Counseling
Nicotine Patches
Experimental group
Description:
8 weeks of nicotine patches
Treatment:
Drug: Nicotine Patches
Behavioral: Brief Hospital Counseling
Telephone Counseling + Patches
Experimental group
Description:
5 proactive sessions, 8 weeks patches
Treatment:
Behavioral: Telephone Counseling
Drug: Nicotine Patches
Behavioral: Brief Hospital Counseling
Brief hospital counseling
Active Comparator group
Description:
brief in hospital counseling, no proactive sessions or patches
Treatment:
Behavioral: Brief Hospital Counseling

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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