Treating Caregivers Who Smoke at AFCH

University of Wisconsin, Madison (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: Nicotine Replacement Product
Phase 4

Detailed 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.

Study Design

Study Type:
Anticipated Enrollment :
50 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Treating Nicotine Addiction in Caregivers of Children at American Family Children's Hospital
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Caregivers of hospitalized children

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.

Outcome Measures

Primary Outcome Measures

  1. Enrollment in study [Study recruitment, approximately 6 months]

    Enrollment will be measured as a relation between the number of people invited to enroll versus the number who enroll

  2. NRT use [2 weeks post-discharge]

    Number of participants who use the NRT provided

  3. Acceptability of smoking intervention [2 weeks post-discharge]

    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.

Secondary Outcome Measures

  1. Change in number of cigarettes smoked per day [Baseline to 2 weeks post-discharge]

    Self-report by participants via survey

  2. Number of times participant left child's bedside to smoke [From admission to discharge, up to 4 weeks]

    Self-report by participant via survey

  3. Change in self-confidence in quitting smoking [Baseline to 2 weeks post-discharge]

    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.

  4. Change in motivation to quit smoking [Baseline to 2 weeks post-discharge]

    Self-report by participant via survey. Score ranges from 1-7, with 1 indicating no motivation to quit smoking and 7 indicating extreme motivation.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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

Contacts and Locations


Site City State Country Postal Code
1 American Family Children's Hospital Madison Wisconsin United States 53792

Sponsors and Collaborators

  • University of Wisconsin, Madison


  • Principal Investigator: Brian Williams, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
University of Wisconsin, Madison Identifier:
Other Study ID Numbers:
  • 2023-0727
  • Protocol Version 5/23/23
First Posted:
Sep 25, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2023