Tobacco Use CessationINSPIRENCT02281864
Interventions to Help Smoking Parents of Inpatients Reduce Exposure (INSPIRE)
A study testing Smoking Cessation Intervention Bundle in people with Tobacco Use Cessation and Second Hand Tobacco Smoke, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Tobacco Use Cessation, Second Hand Tobacco Smoke
- What is being tested?
- Smoking Cessation Intervention Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2014to 28 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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.
Read the 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
- Being tested
- Smoking Cessation Intervention Bundle, Control Group: Quitline
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation Intervention BundleBehavioural
Receipt of the smoke cessation/reduction intervention bundle followed by referral to the Quitline.
Control Group: QuitlineOther
Referral to the Quitline
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Smoking Cessation Intervention Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels
Measured by child urine cotinine levels
Measured: 12 months after patient hospitalization
Secondary outcomes (4)
Increased parent report of having smoke free homes and cars
Measured by questionnaire
Measured: 12 months after patient hospitalization
Increased parent quit rates
Measured by questionnaire and parent urine cotinine levels
Measured: 12 months after patient hospitalization
Child exposure prevalence
Measured by questionnaire
Measured: 12 months after patient hospitalization
Child sick visits
Measured by data abstraction from medical record and data obtained from child's pediatrician
Measured: 12 months after patient hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study start10 Dec 2014
- Primary completion1 Jun 2019
- Study completion28 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Karen M Wilson, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281864
- Sponsor's protocol ID
- 14-0105.cc
- Other IDs
- R01CA181207-01A1
- Acronym
- INSPIRE
- Status last verified
- Jan 2023
- First submitted
- 16 Oct 2014
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35083490Wilson 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.
PubMed 30455340
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Help Smoking Parents of Inpatients Reduce Exposure (INSPIRE)
- ClinicalTrials.gov ID
- NCT02281864
- Acronym / sponsor ID
- INSPIRE / 14-0105.cc
- Conditions
- Tobacco Use Cessation, Second Hand Tobacco Smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Dec 2014 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 28 Mar 2022 (actual)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Quitline | Other | Other: Control Group: QuitlineQuitline referral. If the family is randomized to the control group, the research team will give the parent a brochure for the QuitLine |
| Intervention Group | Experimental | Behavioral: Smoking Cessation Intervention BundleSmoking 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. |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Cessation Intervention BundleReceipt of the smoke cessation/reduction intervention bundle followed by referral to the Quitline. | Behavioural | Intervention Group |
| Control Group: QuitlineReferral to the Quitline | Other | Control Group: Quitline |
Primary outcome
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
4 secondary outcomes
Increased parent report of having smoke free homes and cars
Time frame: 12 months after patient hospitalization
Increased parent quit rates
Time frame: 12 months after patient hospitalization
Child exposure prevalence
Time frame: 12 months after patient hospitalization
Child sick visits
Time frame: 12 months after patient hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Derived from this study: PubMed 35083490Holstein 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.
- Derived from this study: PubMed 30455340Wilson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Wilson, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation Intervention Bundle in people with Tobacco Use Cessation and Second Hand Tobacco Smoke, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate whether children whose parents receive the intervention bundle have greater decreases in cotinine levels (time frame: 12 months after patient hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02281864, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.