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

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation; Second Hand Tobacco Smoke
• Intervention / Treatment: Other: Control Group: Quitline; Behavioral: Smoking Cessation Intervention Bundle

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control Group: Quitline; Quitline referral. If the family is randomized to the control group, the research team will give the parent a brochure for the QuitLine	Other: Control Group: Quitline; Referral to the Quitline
Experimental: Intervention Group; 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.	Behavioral: Smoking Cessation Intervention Bundle; Receipt of the smoke cessation/reduction intervention bundle followed by referral to the Quitline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Karen M Wilson, MD, MPH, University of Colorado, Denver

Publications and helpful links

General Publications

• Holstein JA, O'Hara K, Moss A, Lowary M, Kerby G, Hovell M, Klein JD, Winickoff JP, Wilson K. Barriers and Motivators for Smoking Cessation Among Caregivers of Inpatient Pediatric Patients. Hosp Pediatr. 2022 Feb 1;12(2):220-228. doi: 10.1542/hpeds.2021-005984.
• Wilson KM, Torok MR, Wei B, Wang L, Lowary M, Blount BC. Marijuana and Tobacco Coexposure in Hospitalized Children. Pediatrics. 2018 Dec;142(6):e20180820. doi: 10.1542/peds.2018-0820.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2014
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): March 28, 2022

Study Registration Dates

• First Submitted: October 16, 2014
• First Submitted That Met QC Criteria: October 30, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): January 31, 2023
• Last Update Submitted That Met QC Criteria: January 30, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 14-0105.cc; R01CA181207-01A1 (U.S. NIH Grant/Contract)