Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5U01CA159533 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone Counseling | Experimental | Up to 5 proactive counseling sessions |
|
| Nicotine Patches | Experimental | 8 weeks of nicotine patches |
|
| Telephone Counseling + Patches | Experimental | 5 proactive sessions, 8 weeks patches |
|
| Brief hospital counseling | Active Comparator | brief in hospital counseling, no proactive sessions or patches |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Patches | Drug | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shu-Hong Zhu, Ph.D. | UCSD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Mercy - Chula Vista | Chula Vista | California | 91910 | United States | ||
| Univeristy of California, Davis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27647058 | Derived | 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. | |
| 26336372 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Inclusion criteria: adults, speak and read English or Spanish, smoked prior to hospitalization, cigarette consumption greater than 5 cigarettes per day.
Smokers hospitalized at participating healthcare systems UCSD, Scripps, and UC Davis) between August 2011 and November 2013.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | Brief Hospital Counseling | Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | years old at enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | all randomized subjects | Posted | Number | 95% Confidence Interval | percentage of participants | 6-months post enrollment |
|
Data were collected over 7 months, ending with the 7 month post-enrollment evaluation.
Rehospitalization was asked at the time of evaluation.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| rehospitalization | General disorders | Systematic Assessment | rehospitalization with yes/no. The reason for rehospitalization was not established so we cannot designate the organ system |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sharon Cummins, Ph.D. | UC San Diego, California Smokers' Helpline | 8583001046 | scummins@ucsd.edu |
Not provided
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D020340 | Tobacco Use Cessation |
| D014029 | Tobacco Use Disorder |
| D011660 | Pulmonary Heart Disease |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Telephone Counseling | Behavioral | Up to 5 proactive counseling sessions from California Smokers' Helpline. |
|
| Brief Hospital Counseling | Behavioral | All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices. |
|
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 |
| Davis |
| California |
| 95616 |
| United States |
| UCSD - Thornton Hospital | La Jolla | California | 92037 | United States |
| Scripps Mercy - San Diego Campus | San Diego | California | 92103 | United States |
| UCSD Medical Center - Hillcrest | San Diego | California | 92103 | United States |
| University of California, San Diego: California Smokers' Helpline | San Diego | California | 92111 | United States |
| 22853197 | Derived | 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. |
| 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. |
| BG002 | 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. |
| BG003 | Brief Hospital Counseling | Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices. |
| BG004 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | Brief Hospital Counseling | Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices. |
|
|
| Secondary | Percentage of Smokers Making a 24-hour Quit Attempt | all randomized subjects | Posted | Number | 95% Confidence Interval | percentage of participants | 6-months post enrollment |
|
|
|
| Secondary | Self-reported Re-hospitalization | Posted | Count of Participants | Participants | 6-months post enrollment |
|
|
|
| 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. | all randomized subjects | Posted | Number | 95% Confidence Interval | percentage of participants | 2-months post enrollment |
|
|
|
| 8 |
| 317 |
| 69 |
| 317 |
| 0 |
| 317 |
| EG001 | 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. | 11 | 320 | 77 | 320 | 0 | 320 |
| EG002 | 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. | 15 | 317 | 76 | 317 | 0 | 317 |
| EG003 | Brief Hospital Counseling | Brief Hospital Counseling: All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices. | 9 | 316 | 88 | 316 | 0 | 316 |
|
Not provided
Not provided
| D001523 |
| Mental Disorders |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |