Skip to main content
OpenTrials
Completed

NCT Number: NCT02281864

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tobacco Use Cessation Behavior Health Behavior Second Hand Tobacco Smoke

Age range

Up to 80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Smoking Cessation Intervention Bundle

Behavioral

Receipt of the smoke cessation/reduction intervention bundle followed by referral to the Quitline.

Control Group: Quitline

Other

Referral to the Quitline

Primary outcomes

  1. Demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels

    Time frame: 12 months after patient hospitalization

    Measured by child urine cotinine levels

Secondary outcomes

  1. Increased parent report of having smoke free homes and cars

    Time frame: 12 months after patient hospitalization

    Measured by questionnaire

  2. Increased parent quit rates

    Time frame: 12 months after patient hospitalization

    Measured by questionnaire and parent urine cotinine levels

  3. Child exposure prevalence

    Time frame: 12 months after patient hospitalization

    Measured by questionnaire

  4. Child sick visits

    Time frame: 12 months after patient hospitalization

    Measured by data abstraction from medical record and data obtained from child's pediatrician

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: INSPIRE

Important dates

Study start
2014
Primary completion
2019
Study completion
2022
First posted
Nov 4, 2014
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.