NCT04107857

Brief 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 assessment of smoking and all smokers receive treatment support.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

October 2, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2020

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2024

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

6 months

First QC Date

September 25, 2019

Last Update Submit

December 18, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Clinic level percentage of patients receiving brief counseling

    From 6 months pre-intervention through 6 months post-intervention

  • Clinic level percentage of smokers offered referral to additional counseling

    From 6 months pre-intervention through 6 months post-intervention

  • Clinic level percentage of smokers offered medication

    From 6 months pre-intervention through 6 months post-intervention

Secondary Outcomes (6)

  • Clinic level percentage of patients receiving brief counseling

    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

    Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention

  • Clinic level percentage of smokers offered medication

    Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention

  • Clinic level percentage of smokers receiving smoking assessment

    Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention

  • Clinic level percentage of smokers receiving cessation medication

    Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention

  • +1 more secondary outcomes

Study Arms (1)

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 offerBehavioral: ELEVATE enhancement to electronic health record (EHR) to improve smoking cessation medication offerBehavioral: Data Driven Feedback reports

Interventions

* Brief advise to quit smoking * Referral to Missouri/Illinois Quitlines, Smokefree.TXT, or smokefree.gov

Smoking Cessation

-Nicotine replacement therapy, varenicline, bupropion, or combination therapy (not provided by study)

Smoking Cessation

-Feedback reports will be based on data

Smoking Cessation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 18 years of age or older

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Li-Shiun Chen, M.D., ScD, MPH

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 27, 2019

Study Start

October 2, 2019

Primary Completion

April 2, 2020

Study Completion

October 2, 2024

Last Updated

December 20, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations