Interventions to Help Smoking Parents of Inpatients Reduce Exposure (INSPIRE)

Tobacco Use Cessation Clinical Trial

— INSPIRE  

Official title:

Interventions to Help Smoking Parents of Inpatients Reduce Exposure (INSPIRE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02281864
• Other study ID #: 14-0105.cc
• Secondary ID: R01CA181207-01A1
• Status: Completed
• Phase: N/A
• Start date: December 10, 2014
• Est. completion date: March 28, 2022

Study information

• Verified date: January 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Children who are hospitalized are especially vulnerable to the effects of tobacco use and dependence among their caregivers, and they are more likely to be exposed than children who are not hospitalized. Hospitalization is an important teachable moment for health care providers to intervene with tobacco dependent parents, and help them reduce their child's exposure, potentially improving outcomes after hospitalization, and their future health. Understanding the best way to approach and intervene with these families will provide the investigator with the necessary information to create a sustainable intervention that can be disseminated to hospitals across the country that provide pediatric care, and to ultimately make a significant improvement in the health of children.

Description:

This study is a randomized controlled trial (RCT) to determine whether the proposed bundled intervention is superior to usual care in the pediatric inpatient setting can decrease children's secondhand smoke exposure, and encourage their parents to make smoke-free home rules and quit smoking, as measured by a validated survey and biomarkers.

We have developed an intervention that bundles the best evidence for tobacco dependence treatment, including the United States Public Health Service (USPHS) guidelines, and evidence from parent-specific interventions, to create a sustainable, transferrable intervention specific to using the inpatient stay to help parents quit smoking and reduce their children's exposure. The intervention bundle includes screening for exposure, assessing readiness to quit, providing at least one brief motivational interviewing session in the hospital, dispensing nicotine replacement therapy if appropriate, providing a smoking cessation/reduction starter kit and arranging for follow up after the child is discharged.

INSPIRE specific aims:

Aim 1: To assess the efficacy of the intervention in increasing parent report of having smoke-free homes and cars 6 and 12 months after hospitalization

Aim 2: To demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels 6 and 12 months post-hospitalization

Aim 3: To assess the efficacy of the intervention in increasing parent quit rates 6 and 12 months after hospitalization

Aim 4 (Exploratory): To use implementation process measures from the RE-AIM framework to assess the extent that our intervention results in hospital-wide systems change, including automatic screening for tobacco smoke exposure and delivery of tobacco control services.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 28, 2022
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• Families admitted to the inpatient units of Children's Hospital Colorado

• Families with children <17 years of age

• Families with at least one custodial parent smoker

Exclusion Criteria:

• Admitted in the hospital < 24 hours

• Families with children in foster care

• Families with unclear custody of the child (i.e. children admitted with non-accidental trauma)

Related Conditions & MeSH terms

• Second Hand Tobacco Smoke
• Tobacco Use Cessation

Intervention

Behavioral:
• Smoking Cessation Intervention Bundle
Receipt of the smoke cessation/reduction intervention bundle followed by referral to the Quitline.

Other:
• Control Group: Quitline
Referral to the Quitline

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels	Measured by child urine cotinine levels	12 months after patient hospitalization
Secondary	Increased parent report of having smoke free homes and cars	Measured by questionnaire	12 months after patient hospitalization
Secondary	Increased parent quit rates	Measured by questionnaire and parent urine cotinine levels	12 months after patient hospitalization
Secondary	Child exposure prevalence	Measured by questionnaire	12 months after patient hospitalization
Secondary	Child sick visits	Measured by data abstraction from medical record and data obtained from child's pediatrician	12 months after patient hospitalization