Clinical trial NCT02358330: Project 1: Evaluating EHR-Based Health System Modifications for the Chronic Care of Smoking
Official title: Project 1: Evaluating EHR-Based Health System Modifications for the Chronic Care of Smoking
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Nicotine Dependence
Electronic Health Records
Translational Research
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 28095
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment engagement rate among smokers at a clinic
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael C Fiore, MD
role: PRINCIPAL_INVESTIGATOR
References: