Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| SMPH\PEDIATRICS\PED HOSP | Other Identifier | UW Madison | |
| Protocol Version 5/23/23 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to 1) see if a smoking cessation program is something that caregivers will use while their child is hospitalized, 2) see if caregivers think this program is something we should institute across the hospital, and 3) see if this program can help caregivers reduce their smoking.
Participants will:
All participants will receive a one-time visit with the study physician. This visit will consist of a brief counseling session. Counseling sessions will last approximately 20 minutes and cover the 3 objectives of 1) review participants' motivation for smoking and for quitting; 2) use the information on participants' motives to provide tailored education regarding a) benefits of quitting smoking to the caregiver and the child, b) strategies to reduce nicotine withdrawal symptoms/urges to smoke during the hospitalization, and c) benefits of smoke-free home and car rules; and, 3) review smoking cessation resources.
After the counseling session, participants will be provided a 2-week supply of nicotine patches and nicotine mini-lozenges, along with instructions for their use. The study physician will review how to use the medication, dosing, benefits of use, and potential side effects of use.
Within 24 hours of discharge, participants will be contacted to complete a post-intervention survey, which will assess nicotine replacement therapy (NRT) use during the hospitalization and likelihood that the participant would recommend program implementation in the hospital. Smoking behavior during the child's hospitalization will be examined, including assessments of 1) number of cigarettes smoked per day and 2) number of times participant left the child's bedside to smoke per day. Participant's self-efficacy and interest in quitting smoking will be assessed, using the same questions from the pre-intervention survey, to assess for changes after the intervention.
Participants will be contacted 2 weeks after discharge with a link to complete the follow-up survey to again assess current smoking status, use of NRT post-hospitalization, self-efficacy and interest in quitting smoking, establishment of smoke-free home and car rules, and interest in ongoing smoking cessation treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caregivers of hospitalized children | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Product | Drug | Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment in Study | Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll | Study recruitment, approximately 6 months |
| NRT Use | Number of participants who use the NRT provided | 2 weeks post-discharge, up to 4 weeks |
| Acceptability of Smoking Intervention | Self-report by participant via survey. Score ranges from 1-7, with 1 indicating would not recommend implementing cessation program and 7 indicating definitely recommend implementing program. | 2 weeks post-discharge, up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Cigarettes Smoked Per Day | Self-report by participants via survey | Baseline to 2 weeks post-discharge, up to 4 weeks |
| Change in Trips Outside | Self-report by participant via survey |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian Williams, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Family Children's Hospital | Madison | Wisconsin | 53792 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Caregivers of Hospitalized Children | Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Caregivers of Hospitalized Children | Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Enrollment in Study | Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll | The outcome measure looks at the number of people invited to enroll, which was 63, versus the number who enrolled; therefore, 63 were analyzed. | Posted | Number | percentage of people invited who enrolle | Study recruitment, approximately 6 months |
|
2 weeks
Not provided
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 | Caregivers of Hospitalized Children | Nicotine Replacement Product: Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 4mg, dosing depending on tobacco use per package insert). All participants will also receive a single smoking cessation counseling session with a physician. Surveys will be completed pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Williams | University of Wisconsin - Madison | 608-262-9364 | bswillia@medicine.wisc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2023 | Feb 5, 2026 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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
|
| From admission to discharge, up to 4 weeks |
| Change in Self-confidence in Quitting Smoking | Self-report by participant via survey. Score ranges from 1-7, with 1 indicating no confidence in ability to quit smoking and 7 indicating extreme confidence. | Baseline to 2 weeks post-discharge, up to 4 weeks |
| Change in Motivation to Quit Smoking | Self-report by participant via survey. Score ranges from 1-7, with 1 indicating no motivation to quit smoking and 7 indicating extreme motivation. | Baseline to 2 weeks post-discharge, up to 4 weeks |
| 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 | Number | participants |
|
| Relationship to child | Count of Participants | Participants |
|
| Highest level of education | Count of Participants | Participants |
|
| Reason for child's hospital admission | Count of Participants | Participants |
|
| Cigarettes smoked per day | Mean | Full Range | cigarettes per day |
|
| Time between waking and smoking first cigarette | Count of Participants | Participants |
|
| Confidence in quitting | Mean | Full Range | units on a scale |
|
| Motivation to quit | Mean | Full Range | units on a scale |
|
| Smoking in home | Count of Participants | Participants |
|
| Smoking in car | Count of Participants | Participants |
|
|
|
| Primary | NRT Use | Number of participants who use the NRT provided | Posted | Count of Participants | Participants | 2 weeks post-discharge, up to 4 weeks |
|
|
|
| Primary | Acceptability of Smoking Intervention | Self-report by participant via survey. Score ranges from 1-7, with 1 indicating would not recommend implementing cessation program and 7 indicating definitely recommend implementing program. | Posted | Mean | Full Range | score on a scale | 2 weeks post-discharge, up to 4 weeks |
|
|
|
| Secondary | Change in Number of Cigarettes Smoked Per Day | Self-report by participants via survey | Not all participants completed the survey | Posted | Mean | Full Range | cigarettes per day | Baseline to 2 weeks post-discharge, up to 4 weeks |
|
|
|
| Secondary | Change in Trips Outside | Self-report by participant via survey | Not all participants completed the survey | Posted | Mean | Standard Deviation | trips taken outside | From admission to discharge, up to 4 weeks |
|
|
|
| Secondary | Change in Self-confidence in Quitting Smoking | Self-report by participant via survey. Score ranges from 1-7, with 1 indicating no confidence in ability to quit smoking and 7 indicating extreme confidence. | Not all participants completed the survey. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 2 weeks post-discharge, up to 4 weeks |
|
|
|
| Secondary | Change in Motivation to Quit Smoking | Self-report by participant via survey. Score ranges from 1-7, with 1 indicating no motivation to quit smoking and 7 indicating extreme motivation. | Not all participants completed the survey | Posted | Mean | Standard Deviation | score on a scale | Baseline to 2 weeks post-discharge, up to 4 weeks |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 1 |
| 23 |
Not provided
Not provided
Not provided