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

Smoking Clinical Trial

— EHR Project  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358330
• Other study ID #: 2014-1041 EHR
• Secondary ID: A534252SMPH\MEDI
• Status: Completed
• Start date: February 2015
• Est. completion date: August 1, 2018

Study information

• Verified date: May 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28095
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Exclusion Criteria:

• Any clinic not meeting the above inclusion criteria

Related Conditions & MeSH terms

• Electronic Health Records
• Nicotine Dependence
• Smoking
• Tobacco Use Disorder
• Translational Research

Intervention

Other:
• EHR Enhanced Clinic Intervention
The clinics assigned to the experimental condition will have EHR enhancements introduced.

Locations

Country	Name	City	State
United States	University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment engagement rate among smokers at a clinic	Percentage of those smokers identified in a clinic who engage in smoking related treatment	12 months

External Links

•   University of Wisconsin Center for Tobacco Research and Intervention