Electronic Health Record-Enabled Evidence-Based Smoking Cessation Quality Improvement Implementation Program

December 18, 2024 updated by: Washington University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years of age or older

Description

Inclusion Criteria:

-Patients seen at Siteman Cancer Center, Washington University, Barnes-Jewish Hospital, BJC Healthcare, or any of the satellite locations

Exclusion Criteria:

-None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: 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
Behavioral: 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)
Behavioral: Data Driven Feedback reports
-Feedback reports will be based on data

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Clinic level percentage of patients receiving brief counseling
Time Frame: From 6 months pre-intervention through 6 months post-intervention
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
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
From 6 months pre-intervention through 6 months post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
Estimated to be 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Li-Shiun Chen, M.D., ScD, MPH, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 89276
  • P30CA091842 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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