NCT02281864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 10, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

4.5 years

First QC Date

October 16, 2014

Last Update Submit

January 30, 2023

Conditions

Tobacco Use CessationSecond Hand Tobacco Smoke

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Increased parent report of having smoke free homes and cars

    12 months after patient hospitalization

  • Increased parent quit rates

    12 months after patient hospitalization

  • Child exposure prevalence

    12 months after patient hospitalization

  • Child sick visits

    12 months after patient hospitalization

Study Arms (2)

Control Group: Quitline

OTHER

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

Intervention Group

EXPERIMENTAL

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

Interventions

Smoking Cessation Intervention BundleBEHAVIORAL

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

Intervention Group
Control Group: QuitlineOTHER

Referral to the Quitline

Control Group: Quitline

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

  • 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.

    PMID: 35083490DERIVED

  • 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.

    PMID: 30455340DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Karen M Wilson, MD, MPH

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2014

First Posted

November 4, 2014

Study Start

December 10, 2014

Primary Completion

June 1, 2019

Study Completion

March 28, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

US(1)