Smoking CessationNCT04107857
Electronic Health Record-Enabled Evidence-Based Smoking Cessation Quality Improvement Implementation Program
An observational study of Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The goal of this quality improvement program is to implement, evaluate, and sustain an evidence-based smoking cessation treatment program with a population-based approach so that all patients at the Siteman Cancer Center, Washington University, Barnes-Jewish Hospital, BJC Healthcare, and satellite locations receive… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- ELEVATE enhancement to electronic health record (EHR) to improve cessation counseling offer, ELEVATE enhancement to electronic health record (EHR) to improve smoking cessation medication offer and Data Driven Feedback reports
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2019to 2 Oct 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients 18 years of age or older
Who may be able to join
- -Patients seen at Siteman Cancer Center, Washington University, Barnes-Jewish Hospital, BJC Healthcare, or any of the satellite locations
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Electronic Health Record-Enabled Evidence-based Smoking Cessation Quality Improvement Program
The goal of this quality improvement program is to implement, evaluate, and sustain an evidence-based smoking cessation treatment program with a population-based approach so that all patients at the Siteman Cancer Center, Washington University, Barnes-Jewish Hospital, BJC Healthcare, and satellite locations receive assessment of smoking and all smokers receive treatment support.
- Conditions
- Smoking Cessation
- Being tested
- ELEVATE enhancement to electronic health record (EHR) to improve cessation counseling offer, ELEVATE enhancement to electronic health record (EHR) to improve smoking cessation medication offer, Data Driven Feedback reports
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELEVATE enhancement to electronic health record (EHR) to improve cessation counseling offerBehavioural
- Brief advise to quit smoking
- Referral to Missouri/Illinois Quitlines, Smokefree.TXT, or smokefree.gov
ELEVATE enhancement to electronic health record (EHR) to improve smoking cessation medication offerBehavioural
-Nicotine replacement therapy, varenicline, bupropion, or combination therapy (not provided by study)
Data Driven Feedback reportsBehavioural
-Feedback reports will be based on data
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation | * Patients enter the program through clinic appointments or community outreach programs.
* Patients will be given brief advice to quit smoking and referral options to receive evidence-based treatment through Missouri/Illinois Quitlines, Smokefree.TXT, or smokefree.gov dependent on the patient's preference for counseling
* Patient can also be prescribed smoking cessation pharmacotherapy Receives: Behavioral: ELEVATE enhancement to electronic health record (EHR) to improve cessation counseling offer; Behavioral: ELEVATE enhancement to electronic health record (EHR) to improve smoking cessation medication offer; Behavioral: Data Driven Feedback reports |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinic level percentage of patients receiving brief counseling
Measured: From 6 months pre-intervention through 6 months post-intervention
Clinic level percentage of smokers offered referral to additional counseling
Measured: From 6 months pre-intervention through 6 months post-intervention
Clinic level percentage of smokers offered medication
Measured: From 6 months pre-intervention through 6 months post-intervention
Secondary outcomes (6)
Clinic level percentage of patients receiving brief counseling
Measured: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
Clinic level percentage of smokers offered referral to additional counseling
Measured: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
Clinic level percentage of smokers offered medication
Measured: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
Clinic level percentage of smokers receiving smoking assessment
Measured: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
Clinic level percentage of smokers receiving cessation medication
Measured: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
Number of patients who have abstained from smoking
Measured: Estimated to be 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start2 Oct 2019
- Primary completion2 Apr 2020
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 1,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Li-Shiun Chen, M.D., ScD, MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107857
- Sponsor's protocol ID
- 89276
- Other IDs
- P30CA091842
- Status last verified
- Dec 2024
- First submitted
- 25 Sep 2019
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Health Record-Enabled Evidence-based Smoking Cessation Quality Improvement Program
- ClinicalTrials.gov ID
- NCT04107857
- Acronym / sponsor ID
- 89276
- Conditions
- Smoking Cessation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000,000 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institutes of Health (NIH)
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 27 Sep 2019 (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 goal of this quality improvement program is to implement, evaluate, and sustain an evidence-based smoking cessation treatment program with a population-based approach so that all patients at the Siteman Cancer Center, Washington University, Barnes-Jewish Hospital, BJC Healthcare, and satellite locations receive assessment of smoking and all smokers receive treatment support.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation | – | Behavioral: ELEVATE enhancement to electronic health record (EHR) to improve cessation counseling offer, Behavioral: ELEVATE enhancement to electronic health record (EHR) to improve smoking cessation medication offer, Behavioral: Data Driven Feedback reports* Patients enter the program through clinic appointments or community outreach programs. * Patients will be given brief advice to quit smoking and referral options to receive evidence-based treatment through Missouri/Illinois Quitlines, Smokefree.TXT, or smokefree.gov dependent on the patient's preference for counseling * Patient can also be prescribed smoking cessation pharmacotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age or older
Key inclusion criteria (1 listed)
- -Patients seen at Siteman Cancer Center, Washington University, Barnes-Jewish Hospital, BJC Healthcare, or any of the satellite locations
Key exclusion criteria (1 listed)
- -None
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 |
|---|---|---|
| ELEVATE enhancement to electronic health record (EHR) to improve cessation counseling offer* Brief advise to quit smoking * Referral to Missouri/Illinois Quitlines, Smokefree.TXT, or smokefree.gov | Behavioural | Smoking Cessation |
| ELEVATE enhancement to electronic health record (EHR) to improve smoking cessation medication offer-Nicotine replacement therapy, varenicline, bupropion, or combination therapy (not provided by study) | Behavioural | Smoking Cessation |
| Data Driven Feedback reports-Feedback reports will be based on data | Behavioural | Smoking Cessation |
Primary outcome
Clinic level percentage of patients receiving brief counseling
Time frame: From 6 months pre-intervention through 6 months post-intervention
Clinic level percentage of smokers offered referral to additional counseling
Time frame: From 6 months pre-intervention through 6 months post-intervention
Clinic level percentage of smokers offered medication
Time frame: From 6 months pre-intervention through 6 months post-intervention
6 secondary outcomes
Clinic level percentage of patients receiving brief counseling
Time frame: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
Clinic level percentage of smokers offered referral to additional counseling
Time frame: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
Clinic level percentage of smokers offered medication
Time frame: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
Clinic level percentage of smokers receiving smoking assessment
Time frame: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
Clinic level percentage of smokers receiving cessation medication
Time frame: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
Number of patients who have abstained from smoking
Time frame: Estimated to be 6 months post-intervention
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 20 Dec 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
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.
Li-Shiun Chen, M.D., ScD, MPH principal investigator
Washington University School of Medicine
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 Smoking Cessation, run by Washington University School of Medicine 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 20 Dec 2024. 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?
Clinic level percentage of patients receiving brief counseling (time frame: From 6 months pre-intervention through 6 months post-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2024.