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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02281864
Acronym
INSPIRE
Enrollment
600
Registered
2014-11-04
Start date
2014-12-10
Completion date
2022-03-28
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Second Hand Tobacco Smoke, Tobacco Use Cessation

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.

Interventions

BEHAVIORALSmoking Cessation Intervention Bundle

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

OTHERControl Group: Quitline

Referral to the Quitline

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels12 months after patient hospitalizationMeasured by child urine cotinine levels

Secondary

MeasureTime frameDescription
Increased parent report of having smoke free homes and cars12 months after patient hospitalizationMeasured by questionnaire
Increased parent quit rates12 months after patient hospitalizationMeasured by questionnaire and parent urine cotinine levels
Child exposure prevalence12 months after patient hospitalizationMeasured by questionnaire
Child sick visits12 months after patient hospitalizationMeasured by data abstraction from medical record and data obtained from child's pediatrician

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026