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

Not Applicable

Completed

• Conditions: Tobacco Use Cessation; Second Hand Tobacco Smoke
• Interventions: Behavioral: Smoking Cessation Intervention Bundle

• Registration Number: NCT02281864
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-10-16
• Study First Submitted QC: 2014-10-30
• Study First Posted: 2014-11-04
• Study Start: 2014-12-10
• Primary Completion: 2019-06-01
• Study Completion: 2022-03-28
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Smoking Cessation Intervention Bundle	Smoking Cessation Intervention Bundle. The Investigator has developed an intervention that bundles the best evidence for tobacco dependence treatment, including the 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.

Primary Outcome Measures

Name	Time	Method
Demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels	12 months after patient hospitalization	Measured by child urine cotinine levels

Secondary Outcome Measures

Name	Time	Method
Child sick visits	12 months after patient hospitalization	Measured by data abstraction from medical record and data obtained from child's pediatrician
Increased parent report of having smoke free homes and cars	12 months after patient hospitalization	Measured by questionnaire
Increased parent quit rates	12 months after patient hospitalization	Measured by questionnaire and parent urine cotinine levels
Child exposure prevalence	12 months after patient hospitalization	Measured by questionnaire

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States