Treating Caregivers Who Smoke at AFCH

Smoking Cessation Clinical Trial

Official title:

Treating Nicotine Addiction in Caregivers of Children at American Family Children's Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06051474
• Other study ID #: 2023-0727
• Secondary ID: SMPH\PEDIATRICS\
• Status: Recruiting
• Phase: Phase 4
• Start date: March 5, 2024
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: University of Wisconsin, Madison
• Contact: Brian Williams, MD
• Phone: 608-262-9364
• Email: bswillia[@]medicine.wisc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

• Complete a survey regarding smoking behavior and thoughts about quitting;

• Undergo a 20-minute counseling session; and,

• Use nicotine patches and mini-lozenges for 2 weeks

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized child will have a 'yes' response to the screening question, "Does anyone in your household smoke"

• Hospitalized child is expected to be admitted for >24 hours

• Caregiver is at least 18 years of age

• Participant self-identifies as the primary caregiver of the hospitalized child during the hospitalization

• Participant smokes =5 cigarettes per day

• Participant is willing and able to use NRT

• Participant is not currently pregnant, trying to get pregnant, or breastfeeding and willing to use acceptable birth control for duration of medication use

• Participant is willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

• Contraindication to NRT use (pregnancy, myocardial infarction in past 2 weeks)

• Previous reaction to the nicotine patch or mini-lozenge that prevented them from continuing to use it

• Current use of smoking cessation medications (any NRT, bupropion, varenicline)

• Caregiver's child is being cared for by study physician (Dr. Brian Williams)

• Need for an interpreter

Related Conditions & MeSH terms

• Smoking
• Smoking Cessation

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	American Family Children's Hospital	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	NRT use	Number of participants who use the NRT provided	2 weeks post-discharge
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.	2 weeks post-discharge
Secondary	Change in number of cigarettes smoked per day	Self-report by participants via survey	Baseline to 2 weeks post-discharge
Secondary	Number of times participant left child's bedside to smoke	Self-report by participant via survey	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.	Baseline to 2 weeks post-discharge
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.	Baseline to 2 weeks post-discharge