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

NCT ID: NCT02281864

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-10
• Study Completion Date: 2022-03-28

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.

Conditions

Tobacco Use Cessation; Second Hand Tobacco Smoke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Control Group: Quitline

Intervention Type: OTHER

Referral to the Quitline

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.

Group Type: EXPERIMENTAL

Smoking Cessation Intervention Bundle

Intervention Type: BEHAVIORAL

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

Interventions

Smoking Cessation Intervention Bundle

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

Intervention Type: BEHAVIORAL

Control Group: Quitline

Referral to the Quitline

Intervention Type: OTHER

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)

• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen M Wilson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35083490 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30455340 (View on PubMed)

Other Identifiers

R01CA181207-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-0105.cc

Identifier Type: -

Identifier Source: org_study_id