Project 1: Evaluating EHR-Based Health System Modifications for the Chronic Care of Smoking

NCT ID: NCT02358330

Last Updated: 2020-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

28095 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Smoking is the leading preventable cause of cancer mortality in the US. Despite its profound health and economic costs, smoking treatment is infrequently provided in healthcare settings, and when provided, it is not sufficiently effective. To address this, this project will develop and evaluate more efficient electronic health record (EHR) methods to identify smokers and engage them in evidence-based treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Specifically, this Project will develop and test new EHR enhancements and associated healthcare practices that are designed to efficiently identify smokers and recruit them into a chronic care treatment for smoking (which will be developed and evaluated in Projects 2-4). The EHR enhancements will include: 1) smoker identification and documentation aids, 2) a "Smoker Registry" (which stores relevant data on smokers and facilitates tracking their smoking status over time), 3) a 1-click system to refer smokers to the chronic care treatment for smoking, 4) a closed-loop function to provide EHR feedback to clinicians on the outcomes of their referrals, and 5) communications resources to inform smokers of treatment options and to increase their recruitment into treatment. The effects of the EHR-based enhancements and the chronic care smoking treatment will be evaluated with a multiple baseline design involving 18 primary care clinics in three healthcare systems in Wisconsin; all participants for affiliated clinical research Projects will be recruited from these clinics. This highly innovative research will evaluate the impact of an integrated set of EHR enhancements-coupled with a chronic care approach to smoking treatment-on smoker identification, and smoking treatment referral and engagement. In addition, this research will explore factors that influence the use of EHR-based enhancements in clinics. In sum, this research will develop a set of EHR-based health system enhancements that increase both the adoption of chronic care treatment by healthcare systems and smokers' engagement in that treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Nicotine Dependence Electronic Health Records Translational Research

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EHR Enhanced Clinic Referral

A set of standard EHR modifications will be implemented in 18 clinics as part of the MBD (multiple baseline design) experiment.The key new EHR functions that will be implemented and tested are: 1) a modified "screen for smoking sta-tus" to enhance the identification and documentation of all smokers visiting targeted primary care clinics; 2) a "Smoker Registry" to track smokers, document their receipt of treatment services, and organize direct-to-consumer communications; 3) a 1-click referral system to evidence-based smoking treat-ment with UW-CTRI case managers; 4) a closed-loop feedback feature to communicate to the clinician the fate of a referral, documenting receipt of the referral and treatment engagement; and 5) EHR-based communication options to inform smokers of treatment resources

EHR Enhanced Clinic Intervention

Intervention Type OTHER

The clinics assigned to the experimental condition will have EHR enhancements introduced.

Standard care (control) clinics

10 control clinics will also be inducted into the study. These clinics will use existing EHR resources to identify smokers (e.g., the expanded vital signs) and to document their smoking status, and then use the standard paper fax-to-quit methods to refer patients to the Wisconsin Tobacco Quit Line

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EHR Enhanced Clinic Intervention

The clinics assigned to the experimental condition will have EHR enhancements introduced.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The clinics participating in the MBD experiment will be selected based on the following criteria:

1. Size: clinics will be fairly large, including at least 4-6 clinicians, to ensure adequate recruitment for clinical trials connected with thye EHR recruitment.
2. Location: clinics will be concentrated in Southcentral and Southeastern Wisconsin so that case managers from UW-CTRI Madison and Milwaukee research sites can provide services at multiple clinics.
3. Diversity: clinics from each of the two health systems will include both urban and rural locations, and at least one high- and one low-SES clinic (based on rates of Medicaid and uninsured patients).
4. Independence: clinics will not share staff or be physically adjacent to one another to combat bleeding of interventions across clinics (see 87 for the independence requirement for MBD).
5. All clinics will routinely collect the data that will serve as dependent variables in the MBD design (this will be universal among the three health system clinics).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael C Fiore, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.ctri.wisc.edu/

University of Wisconsin Center for Tobacco Research and Intervention

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A534252

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\MEDICINE\TOBACCO RE

Identifier Type: OTHER

Identifier Source: secondary_id

2014-1041 EHR

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Motivating Change in Aging Smokers
NCT05194917 COMPLETED NA
Mobile Contingency Management for Smoking Cessation
NCT04881630 ACTIVE_NOT_RECRUITING NA
Tobacco Use Treatment in Cancer Patients
NCT03482583 COMPLETED PHASE4
Rural COPD E-Visit Study
NCT06236347 ENROLLING_BY_INVITATION NA
Smoking Cessation E-Visit
NCT04316260 COMPLETED NA
Improving Quitline Support Study
NCT03538938 COMPLETED PHASE4