Skip to content

Smoking Cessation in Hospitalized Smokers

Smoking Cessation in Hospitalized Smokers

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01289275
Enrollment
1270
Registered
2011-02-03
Start date
2011-08-31
Completion date
2014-07-31
Last updated
2020-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

tobacco cessation, smoking cessation, telephone, self-help, smoking abstinence, tobacco use disorder, hospital, cardiopulmonary diseases, disparity

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.

Interventions

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.

BEHAVIORALTelephone Counseling

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

BEHAVIORALBrief Hospital Counseling

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

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of California, San Diego
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With 30-day Abstinence6-months post enrollmentAll 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

MeasureTime frameDescription
Percentage of Smokers Making a 24-hour Quit Attempt6-months post enrollment
Self-reported Re-hospitalization6-months post enrollment
30-day Abstinence2-months post enrollmentAll 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.

Countries

United States

Participant flow

Recruitment details

Smokers hospitalized at participating healthcare systems UCSD, Scripps, and UC Davis) between August 2011 and November 2013.

Pre-assignment details

Inclusion criteria: adults, speak and read English or Spanish, smoked prior to hospitalization, cigarette consumption greater than 5 cigarettes per day.

Participants by arm

ArmCount
Telephone Counseling
Telephone Counseling: Proactive. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse. Counselors use a structured protocol so that there will be a record for each counseling call.
317
Nicotine Patches
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. Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
320
Telephone Counseling and Nicotine Patches
Nicotine Patches: 8 weeks of nicotine patches at discharge. Telephone Counseling: Proactive. Counseling includes a 30-40 minute pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) that are scheduled according to the probability of relapse.
317
Brief Hospital Counseling
Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
316
Total1,270

Baseline characteristics

CharacteristicTelephone CounselingTotalBrief Hospital CounselingTelephone Counseling and Nicotine PatchesNicotine Patches
Age, Continuous48.2 years
STANDARD_DEVIATION 13.2
49.9 years
STANDARD_DEVIATION 13.2
49.6 years
STANDARD_DEVIATION 13
49.1 years
STANDARD_DEVIATION 13
51.1 years
STANDARD_DEVIATION 13.5
Ethnicity (NIH/OMB)
Hispanic or Latino
74 Participants294 Participants75 Participants73 Participants72 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
243 Participants976 Participants241 Participants244 Participants248 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
2 Participants11 Participants1 Participants3 Participants5 Participants
Race (NIH/OMB)
Asian
9 Participants33 Participants6 Participants11 Participants7 Participants
Race (NIH/OMB)
Black or African American
49 Participants236 Participants66 Participants59 Participants62 Participants
Race (NIH/OMB)
More than one race
15 Participants46 Participants15 Participants8 Participants8 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
77 Participants298 Participants70 Participants76 Participants75 Participants
Race (NIH/OMB)
White
165 Participants646 Participants158 Participants160 Participants163 Participants
Region of Enrollment
United States
317 Participants1270 Participants316 Participants317 Participants320 Participants
Sex: Female, Male
Female
136 Participants550 Participants136 Participants144 Participants134 Participants
Sex: Female, Male
Male
181 Participants720 Participants180 Participants173 Participants186 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
8 / 31711 / 32015 / 3179 / 316
other
Total, other adverse events
0 / 3170 / 3200 / 3170 / 316
serious
Total, serious adverse events
69 / 31777 / 32076 / 31788 / 316

Outcome results

Primary

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.

Time frame: 6-months post enrollment

Population: all randomized subjects

ArmMeasureValue (NUMBER)
Telephone CounselingPercentage of Participants With 30-day Abstinence18.0 percentage of participants
Nicotine PatchesPercentage of Participants With 30-day Abstinence23.4 percentage of participants
Telephone Counseling and Nicotine PatchesPercentage of Participants With 30-day Abstinence22.1 percentage of participants
Brief Hospital CounselingPercentage of Participants With 30-day Abstinence18.7 percentage of participants
Secondary

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.

Time frame: 2-months post enrollment

Population: all randomized subjects

ArmMeasureValue (NUMBER)
Telephone Counseling30-day Abstinence19.6 percentage of participants
Nicotine Patches30-day Abstinence22.5 percentage of participants
Telephone Counseling and Nicotine Patches30-day Abstinence24.0 percentage of participants
Brief Hospital Counseling30-day Abstinence18.4 percentage of participants
Secondary

Percentage of Smokers Making a 24-hour Quit Attempt

Time frame: 6-months post enrollment

Population: all randomized subjects

ArmMeasureValue (NUMBER)
Telephone CounselingPercentage of Smokers Making a 24-hour Quit Attempt70.0 percentage of participants
Nicotine PatchesPercentage of Smokers Making a 24-hour Quit Attempt78.9 percentage of participants
Telephone Counseling and Nicotine PatchesPercentage of Smokers Making a 24-hour Quit Attempt77.6 percentage of participants
Brief Hospital CounselingPercentage of Smokers Making a 24-hour Quit Attempt69.7 percentage of participants
Secondary

Self-reported Re-hospitalization

Time frame: 6-months post enrollment

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Telephone CounselingSelf-reported Re-hospitalization45 Participants
Nicotine PatchesSelf-reported Re-hospitalization50 Participants
Telephone Counseling and Nicotine PatchesSelf-reported Re-hospitalization53 Participants
Brief Hospital CounselingSelf-reported Re-hospitalization51 Participants

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026