Smoking Cessation
Conditions
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.
Up to 5 proactive counseling sessions from California Smokers' Helpline.
All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With 30-day Abstinence | 6-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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Smokers Making a 24-hour Quit Attempt | 6-months post enrollment | — |
| Self-reported Re-hospitalization | 6-months post enrollment | — |
| 30-day Abstinence | 2-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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 1,270 |
Baseline characteristics
| Characteristic | Telephone Counseling | Total | Brief Hospital Counseling | Telephone Counseling and Nicotine Patches | Nicotine Patches |
|---|---|---|---|---|---|
| Age, Continuous | 48.2 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 Participants | 294 Participants | 75 Participants | 73 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 243 Participants | 976 Participants | 241 Participants | 244 Participants | 248 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 11 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 33 Participants | 6 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 236 Participants | 66 Participants | 59 Participants | 62 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 46 Participants | 15 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 77 Participants | 298 Participants | 70 Participants | 76 Participants | 75 Participants |
| Race (NIH/OMB) White | 165 Participants | 646 Participants | 158 Participants | 160 Participants | 163 Participants |
| Region of Enrollment United States | 317 Participants | 1270 Participants | 316 Participants | 317 Participants | 320 Participants |
| Sex: Female, Male Female | 136 Participants | 550 Participants | 136 Participants | 144 Participants | 134 Participants |
| Sex: Female, Male Male | 181 Participants | 720 Participants | 180 Participants | 173 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 317 | 11 / 320 | 15 / 317 | 9 / 316 |
| other Total, other adverse events | 0 / 317 | 0 / 320 | 0 / 317 | 0 / 316 |
| serious Total, serious adverse events | 69 / 317 | 77 / 320 | 76 / 317 | 88 / 316 |
Outcome results
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telephone Counseling | Percentage of Participants With 30-day Abstinence | 18.0 percentage of participants |
| Nicotine Patches | Percentage of Participants With 30-day Abstinence | 23.4 percentage of participants |
| Telephone Counseling and Nicotine Patches | Percentage of Participants With 30-day Abstinence | 22.1 percentage of participants |
| Brief Hospital Counseling | Percentage of Participants With 30-day Abstinence | 18.7 percentage of participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telephone Counseling | 30-day Abstinence | 19.6 percentage of participants |
| Nicotine Patches | 30-day Abstinence | 22.5 percentage of participants |
| Telephone Counseling and Nicotine Patches | 30-day Abstinence | 24.0 percentage of participants |
| Brief Hospital Counseling | 30-day Abstinence | 18.4 percentage of participants |
Percentage of Smokers Making a 24-hour Quit Attempt
Time frame: 6-months post enrollment
Population: all randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telephone Counseling | Percentage of Smokers Making a 24-hour Quit Attempt | 70.0 percentage of participants |
| Nicotine Patches | Percentage of Smokers Making a 24-hour Quit Attempt | 78.9 percentage of participants |
| Telephone Counseling and Nicotine Patches | Percentage of Smokers Making a 24-hour Quit Attempt | 77.6 percentage of participants |
| Brief Hospital Counseling | Percentage of Smokers Making a 24-hour Quit Attempt | 69.7 percentage of participants |
Self-reported Re-hospitalization
Time frame: 6-months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telephone Counseling | Self-reported Re-hospitalization | 45 Participants |
| Nicotine Patches | Self-reported Re-hospitalization | 50 Participants |
| Telephone Counseling and Nicotine Patches | Self-reported Re-hospitalization | 53 Participants |
| Brief Hospital Counseling | Self-reported Re-hospitalization | 51 Participants |