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

NCT02358330 | Completed DMC

• 3 other identifiers: 2014-1041 EHRA534252SMPH\MEDICINE\TOBACCO RE
• Study Type: observational
• Target: 28,095
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking; Nicotine Dependence; Electronic Health Records; Translational Research

Outcome Measures

Primary Outcomes (1)

• Treatment engagement rate among smokers at a clinic

  Percentage of those smokers identified in a clinic who engage in smoking related treatment

  12 months

Study Arms (2)

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

Other: EHR Enhanced Clinic Intervention

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

Interventions

EHR Enhanced Clinic Intervention OTHER

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

EHR Enhanced Clinic Referral

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a multiple baseline design with the unit of analysis as the clinic. 20-28 clinics will be recruited.

You may qualify if:

• The clinics participating in the MBD experiment will be selected based on the following criteria:
• Size: clinics will be fairly large, including at least 4-6 clinicians, to ensure adequate recruitment for clinical trials connected with thye EHR recruitment.
• 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.
• 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).
• 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).
• 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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

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

Madison, Wisconsin, 53711, United States

Location

Related Links

• University of Wisconsin Center for Tobacco Research and Intervention

MeSH Terms

Conditions

Smoking; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael C Fiore, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 6, 2015
• Study Start: February 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

US (1)