AsthmaNCT02489708
Pediatric Emergency Department Decision Support System to Reduce Secondhand Smoke
A study testing Cessation Counseling in people with Asthma and Smoking Cessation, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
This two phase study will develop and evaluate a Pediatric Emergency Department (PED) Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure intervention to caregivers who bring their child to the PED. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Asthma, Smoking Cessation
- What is being tested?
- Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2021
- 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 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Nurses who work at least 2 shifts per week
- Current smokers accompanying their 0-18 year old child to the Emergency Department or Urgent Care
Who cannot join
- Non English speaking families
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
This two phase study will develop and evaluate a Pediatric Emergency Department (PED) Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure intervention to caregivers who bring their child to the PED.
Read the detailed description
The study will be the first to develop and evaluate a Pediatric Emergency Department (PED) Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure intervention to caregivers who bring their child to the PED. The investigators will conduct a two-phased project to develop, refine, and integrate a Decision Support System into the current electronic medical record system. In Phase I, the investigators will develop a three-part DSS with prompts to: 1) ASK about child SHSe and caregiver smoking 2) Use a software program (REDCap) to ADVISE caregivers to reduce their child's SHSe via total smoking home and car bans and quitting smoking, and 3) ASSIST caregivers to quit by directly connecting them to their choice of free cessation resources (e.g., Quitline, txt2quit, smokefree.gov) during the PED visit. If the investigators discover that a teen participant is a smoker, the investigators will provide them with resources for the Quitline, tx2quit, and teen.smokefree.gov. The investigators will create reports to provide feedback to nurses on their SHSe counseling behaviors. Nurses will provide input on program content, functions, and design. In Phase II, the investigators will conduct a 3-month feasibility trial to test the results of implementing the DSS on changes in nurse SHSe-related behaviors, and child and caregiver outcomes.
- Conditions
- Asthma, Smoking Cessation
- Being tested
- Cessation Counseling
- Keywords
- Bronchiolitis, Cough, Ear Infection, Respiratory Infection, Wheezing, Clinical Decision Support Systems
- Medical subject headings
- Asthma, Smoking Cessation, Bronchiolitis, Cough, Otitis, Respiratory Tract Infections, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cessation CounselingBehavioural
Nurses will be trained to use Electronic Medical Record system to counsel families about second hand smoke exposure. Saliva samples will be obtained from 15 children at baseline and at follow-up to explore the effects of the nurse intervention.
| Study group | Role | What they receive |
|---|---|---|
| Cessation Counseling | Experimental | Nurses will be trained to use Electronic Medical Record system to counsel families about second hand smoke exposure. Saliva samples will be obtained from 15 children at baseline and at follow-up to explore the effects of the nurse intervention. Receives: Behavioral: Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Rate of Use of Decision Support System by Nurses
Measured: 3 months
Change in Amount of Second Hand Smoke Exposure in Children
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- E. Melinda Mahabee-Gittens, MD, MS, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489708
- Sponsor's protocol ID
- CINC 2014-5592
- Other IDs
- 1R21CA184337-01A1
- Status last verified
- Dec 2021
- First submitted
- 28 May 2015
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Mahabee-Gittens EM, Dexheimer JW, Gordon JS. Development of a Tobacco Cessation Clinical Decision Support System for Pediatric Emergency Nurses. Comput Inform Nurs. 2016 Dec;34(12):560-569. doi: 10.1097/CIN.0000000000000267.
PubMed 27379524Mahabee-Gittens EM, Dexheimer JW, Khoury JC, Miller JA, Gordon JS. Development and Testing of a Computerized Decision Support System to Facilitate Brief Tobacco Cessation Treatment in the Pediatric Emergency Department: Proposal and Protocol. JMIR Res Protoc. 2016 Apr 20;5(2):e64. doi: 10.2196/resprot.4453.
PubMed 27098215Mahabee-Gittens EM, Dexheimer JW, Tabangin M, Khoury JC, Merianos AL, Stone L, Meyers GT, Gordon JS. An Electronic Health Record-Based Strategy to Address Child Tobacco Smoke Exposure. Am J Prev Med. 2018 Jan;54(1):64-71. doi: 10.1016/j.amepre.2017.08.011.
PubMed 29102458
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Emergency Department Decision Support System to Reduce Secondhand Smoke
- ClinicalTrials.gov ID
- NCT02489708
- Acronym / sponsor ID
- CINC 2014-5592
- Conditions
- Asthma, Smoking Cessation
- Keywords
- Bronchiolitis, Cough, Ear Infection, Respiratory Infection, Wheezing, Clinical Decision Support Systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 3 Jul 2015 (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.
This two phase study will develop and evaluate a Pediatric Emergency Department (PED) Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure intervention to caregivers who bring their child to the PED.
Detailed description
The study will be the first to develop and evaluate a Pediatric Emergency Department (PED) Decision Support System (DSS)-Electronic Medical Records (EMR) System to facilitate the identification of smokers and the delivery of a Second Hand Smoke (SHSe) exposure intervention to caregivers who bring their child to the PED. The investigators will conduct a two-phased project to develop, refine, and integrate a Decision Support System into the current electronic medical record system. In Phase I, the investigators will develop a three-part DSS with prompts to: 1) ASK about child SHSe and caregiver smoking 2) Use a software program (REDCap) to ADVISE caregivers to reduce their child's SHSe via total smoking home and car bans and quitting smoking, and 3) ASSIST caregivers to quit by directly connecting them to their choice of free cessation resources (e.g., Quitline, txt2quit, smokefree.gov) during the PED visit. If the investigators discover that a teen participant is a smoker, the investigators will provide them with resources for the Quitline, tx2quit, and teen.smokefree.gov. The investigators will create reports to provide feedback to nurses on their SHSe counseling behaviors. Nurses will provide input on program content, functions, and design. In Phase II, the investigators will conduct a 3-month feasibility trial to test the results of implementing the DSS on changes in nurse SHSe-related behaviors, and child and caregiver outcomes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cessation Counseling | Experimental | Behavioral: Cessation CounselingNurses will be trained to use Electronic Medical Record system to counsel families about second hand smoke exposure. Saliva samples will be obtained from 15 children at baseline and at follow-up to explore the effects of the nurse intervention. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Nurses who work at least 2 shifts per week
- Current smokers accompanying their 0-18 year old child to the Emergency Department or Urgent Care
Key exclusion criteria (1 listed)
- Non English speaking families
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 |
|---|---|---|
| Cessation CounselingNurses will be trained to use Electronic Medical Record system to counsel families about second hand smoke exposure. Saliva samples will be obtained from 15 children at baseline and at follow-up to explore the effects of the nurse intervention. | Behavioural | Cessation Counseling |
Primary outcome
Change in Rate of Use of Decision Support System by Nurses
Time frame: 3 months
Change in Amount of Second Hand Smoke Exposure in Children
Time frame: 3 months
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 9 Dec 2021.
- Results publication: PubMed 27379524Mahabee-Gittens EM, Dexheimer JW, Gordon JS. Development of a Tobacco Cessation Clinical Decision Support System for Pediatric Emergency Nurses. Comput Inform Nurs. 2016 Dec;34(12):560-569. doi: 10.1097/CIN.0000000000000267.
- Results publication: PubMed 27098215Mahabee-Gittens EM, Dexheimer JW, Khoury JC, Miller JA, Gordon JS. Development and Testing of a Computerized Decision Support System to Facilitate Brief Tobacco Cessation Treatment in the Pediatric Emergency Department: Proposal and Protocol. JMIR Res Protoc. 2016 Apr 20;5(2):e64. doi: 10.2196/resprot.4453.
- Derived from this study: PubMed 29102458Mahabee-Gittens EM, Dexheimer JW, Tabangin M, Khoury JC, Merianos AL, Stone L, Meyers GT, Gordon JS. An Electronic Health Record-Based Strategy to Address Child Tobacco Smoke Exposure. Am J Prev Med. 2018 Jan;54(1):64-71. doi: 10.1016/j.amepre.2017.08.011.
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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.
E. Melinda Mahabee-Gittens, MD, MS principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cessation Counseling in people with Asthma and Smoking Cessation, run by Children's Hospital Medical Center, Cincinnati 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 2 inclusion and 1 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 9 Dec 2021. 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?
Change in Rate of Use of Decision Support System by Nurses (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT02489708, which also lists 3 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 9 Dec 2021.