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

Study Overview
=================
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.

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

Conditions
-----------------
Tobacco Use Cessation, Second Hand Tobacco Smoke

Intervention / Treatment
-----------------
* Behavioral: Smoking Cessation Intervention Bundle
* Other: Control Group: Quitline


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Group: Quitline<br>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<br>* Referral to the Quitline<br>|
| Experimental: Intervention Group<br>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<br>* Receipt of the smoke cessation/reduction intervention bundle followed by referral to the Quitline.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased parent report of having smoke free homes and cars | Measured by questionnaire | 12 months after patient hospitalization | 
| Increased parent quit rates | Measured by questionnaire and parent urine cotinine levels | 12 months after patient hospitalization | 
| Child exposure prevalence | Measured by questionnaire | 12 months after patient hospitalization | 
| Child sick visits | Measured by data abstraction from medical record and data obtained from child's pediatrician | 12 months after patient hospitalization |