Clinical trial NCT02281864: Interventions to Help Smoking Parents of Inpatients Reduce Exposure (INSPIRE)
Official title: Interventions to Help Smoking Parents of Inpatients Reduce Exposure (INSPIRE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Second Hand Tobacco Smoke
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-11-04
Enrollment: 600
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels
timeFrame: 12 months after patient hospitalization
Secondary outcomes:
measure: Increased parent report of having smoke free homes and cars
timeFrame: 12 months after patient hospitalization
measure: Increased parent quit rates
timeFrame: 12 months after patient hospitalization
measure: Child exposure prevalence
timeFrame: 12 months after patient hospitalization
measure: Child sick visits
timeFrame: 12 months after patient hospitalization
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Karen M Wilson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.