Tobacco Use CessationNCT03714191
Optimizing the Tobacco Cessation Clinical Decision Support Tool.
An observational study of Tobacco Use Cessation, run by NYU Langone Health at 1 site in United States.
Trial summary
The existing tobacco cessation best practice advisory (BPA) fires for providers (physicians, residents, fellows, midwives, nurse practitioners, physician assistants) during outpatient encounters when a patient is identified as a current tobacco user in the Social History section of their chart. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Patient Outcomes, Billing documentation and Regulatory
- How many people
- 54,417 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2018to 29 Feb 2020
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All providers of patients at NYU Langone Health (including NYU Winthrop) who are identified as currents smokers, as documented in the social history of their patient chart, and are eligible to receive the best practice advisory for tobacco cessation.
Who may be able to join
- All providers of patients at NYU Langone Health (including NYU Winthrop) who are identified as currents smokers, as documented in the social history of their patient chart, and are eligible to receive the best practice advisory for tobacco cessation.
Who cannot join
- non smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Using Rapid Cycle Randomized Controlled Trials to Study a Tobacco Cessation Best Practice Advisory.
The existing tobacco cessation best practice advisory (BPA) fires for providers (physicians, residents, fellows, midwives, nurse practitioners, physician assistants) during outpatient encounters when a patient is identified as a current tobacco user in the Social History section of their chart. The BPA was designed to help facilitate tobacco cessation interventions; it is part of the The Centers for Medicare \& Medicaid Services (CMS) Quality Payment Program (QPP). The purpose of the project is to optimize this BPA utilization and improve patient outcomes by comparing multiple versions of the tobacco cessation BPA.
- Conditions
- Tobacco Use Cessation
- Being tested
- Patient Outcomes, Billing documentation, Regulatory
- 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.
Patient OutcomesOther
The intervention includes different versions of the BPA design and message.
Billing documentationOther
The intervention includes different versions of the BPA design and message.
RegulatoryOther
The intervention includes different versions of the BPA design and message.
| Study group | Role | What they receive |
|---|---|---|
| Improved outcomes | Not described Receives: Other: Patient Outcomes | |
| Regulatory reminder | Not described Receives: Other: Regulatory | |
| Billing and documentation | Not described Receives: Other: Billing documentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alert acceptance rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start3 Oct 2018
- Primary completion24 May 2019
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 NYU Langone HealthThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54,417 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714191
- Sponsor's protocol ID
- QI-Tobacco Cessation
- Status last verified
- Jul 2021
- First submitted
- 4 Oct 2018
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Austrian J, Mendoza F, Szerencsy A, Fenelon L, Horwitz LI, Jones S, Kuznetsova M, Mann DM. Applying A/B Testing to Clinical Decision Support: Rapid Randomized Controlled Trials. J Med Internet Res. 2021 Apr 9;23(4):e16651. doi: 10.2196/16651.
PubMed 33835035
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Rapid Cycle Randomized Controlled Trials to Study a Tobacco Cessation Best Practice Advisory.
- ClinicalTrials.gov ID
- NCT03714191
- Acronym / sponsor ID
- QI-Tobacco Cessation
- Conditions
- Tobacco Use Cessation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54,417 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 24 May 2019 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 22 Oct 2018 (actual)
- 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.
The existing tobacco cessation best practice advisory (BPA) fires for providers (physicians, residents, fellows, midwives, nurse practitioners, physician assistants) during outpatient encounters when a patient is identified as a current tobacco user in the Social History section of their chart. The BPA was designed to help facilitate tobacco cessation interventions; it is part of the The Centers for Medicare \& Medicaid Services (CMS) Quality Payment Program (QPP). The purpose of the project is to optimize this BPA utilization and improve patient outcomes by comparing multiple versions of the tobacco cessation BPA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Improved outcomes | – | Other: Patient Outcomes |
| Regulatory reminder | – | Other: Regulatory |
| Billing and documentation | – | Other: Billing documentation |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All providers of patients at NYU Langone Health (including NYU Winthrop) who are identified as currents smokers, as documented in the social history of their patient chart, and are eligible to receive the best practice advisory for tobacco cessation.
Key inclusion criteria (1 listed)
- All providers of patients at NYU Langone Health (including NYU Winthrop) who are identified as currents smokers, as documented in the social history of their patient chart, and are eligible to receive the best practice advisory for tobacco cessation.
Key exclusion criteria (1 listed)
- non smokers
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 |
|---|---|---|
| Patient OutcomesThe intervention includes different versions of the BPA design and message. | Other | Improved outcomes |
| Billing documentationThe intervention includes different versions of the BPA design and message. | Other | Billing and documentation |
| RegulatoryThe intervention includes different versions of the BPA design and message. | Other | Regulatory reminder |
Primary outcome
Alert acceptance rate
Time frame: 1 year
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 21 Jul 2021.
- Derived from this study: PubMed 33835035Austrian J, Mendoza F, Szerencsy A, Fenelon L, Horwitz LI, Jones S, Kuznetsova M, Mann DM. Applying A/B Testing to Clinical Decision Support: Rapid Randomized Controlled Trials. J Med Internet Res. 2021 Apr 9;23(4):e16651. doi: 10.2196/16651.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Use Cessation, run by NYU Langone Health 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 1 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 21 Jul 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?
Alert acceptance rate (time frame: 1 year). 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 NCT03714191, which also lists 1 linked publication.
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 21 Jul 2021.