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

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ClinicalTrials.gov Identifier: NCT02281864
Recruitment Status : Recruiting
First Posted : November 4, 2014
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Second Hand Tobacco Smoke Behavioral: Smoking Cessation Intervention Bundle Other: Control Group: Quitline Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Interventions to Help Smoking Parents of Inpatients Reduce Exposure (INSPIRE)
Study Start Date : December 2014
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels [ Time Frame: 12 months after patient hospitalization ]
    Measured by child urine cotinine levels


Secondary Outcome Measures :
  1. Increased parent report of having smoke free homes and cars [ Time Frame: 12 months after patient hospitalization ]
    Measured by questionnaire

  2. Increased parent quit rates [ Time Frame: 12 months after patient hospitalization ]
    Measured by questionnaire and parent urine cotinine levels

  3. Child exposure prevalence [ Time Frame: 12 months after patient hospitalization ]
    Measured by questionnaire

  4. Child sick visits [ Time Frame: 12 months after patient hospitalization ]
    Measured by data abstraction from medical record and data obtained from child's pediatrician



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Ages Eligible for Study:   up to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281864


Contacts
Contact: Michelle Lowary, MS 720-777-8485 michelle.lowary@childrenscolorado.org
Contact: Gwendolyn Kerby, MD 720-777-6181 gwendolyn.kerby@childrenscolorado.org

Locations
United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Michelle Lowary, MS    720-777-8485    michelle.lowary@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Investigators
Principal Investigator: Karen M Wilson, MD, MPH University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02281864     History of Changes
Other Study ID Numbers: 14-0105
R01CA181207-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018