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Clinical Trials/NCT02735382
NCT02735382
Completed
Not Applicable

Transforming the Treatment of Tobacco Use in Health Care: Seizing the Potential of the Electronic Health Record to Deliver Comprehensive Chronic Care Treatment for Smoking: Study 1: the EHR and Fax Referral Study

University of Wisconsin, Madison1 site in 1 country14,930 target enrollmentSeptember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tobacco Use Cessation
Sponsor
University of Wisconsin, Madison
Enrollment
14930
Locations
1
Primary Endpoint
Number of Participants Referred
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study is designed to assess whether completely electronic, HIPAA-compliant, EHR-based, closed-loop referrals for tobacco cessation from primary care clinics to a state telephone tobacco quitline service can increase the number/percentage of adult tobacco users receiving evidence-based tobacco dependence treatment when compared to paper-based fax referrals. This study also will survey clinic staff to evaluate satisfaction with the referral process.

Detailed Description

Aim 1: To evaluate the rates of referral of tobacco users visiting primary care clinics to the WTQL, comparing those who were referred via an EHR-based electronic referral system vs. those referred via a manual paper fax referral system. Analyses will address the change in rates of referrals from pre- to post-intervention and the trajectory of referral post-intervention and will reflect per clinic rates. Aim 2: To evaluate the rates of quality referrals of tobacco users visiting primary care clinics to the WTQL, comparing those who were referred via an EHR-based electronic referral system vs. those referred via a manual paper fax referral system (quality referrals are defined as ones that result in individuals who enroll in and receive WTQL counseling and/or medication treatment services). Analyses will address the change in referrals from pre- to post-intervention and will reflect per clinic rates. Aim 3: To examine variation in referral rates across clinics to test the hypothesis that the eReferral system will result in greater consistency in referral in addition to higher rates of referral. Qualitative methods will be used to understand the sources of variation. Aim 4: To assess clinician and staff satisfaction with the eReferral and paper fax referral systems via self-report questionnaires. Aim 5: To evaluate smoking abstinence rates of tobacco users who were referred to and accepted services from the WTQL, comparing those who were referred via an EHR-based referral system vs. those referred via a manual paper fax referral system.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
April 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The presence of discrete primary care clinical services within the clinic (defined as general internal medicine or family medicine clinical services);
  • At least three primary care clinician providers in the clinic (physicians or nurse practitioners/physician assistants who see patients independently of a physician);
  • A total primary care clinical volume of at least 60 patients each week;
  • An existing EHR requirement for staff to document tobacco use status including smoking status on all adult patients visiting the clinic at every visit;
  • A capacity to enumerate patient visit information including adult patients/month and adult tobacco users/month by clinician and by clinic;
  • A willingness to participate in the proposed research;
  • A lead physician or a clinic manager on site who agree to serve as a clinic champion for the project;
  • Prior use of the fax referral system to refer patients to the Wisconsin Tobacco Quit Line with use data available for the 12 months prior to study launch;
  • A willingness to accept random assignment to either of the two experimental conditions.

Exclusion Criteria

  • Those clinics not meeting the above criteria (e.g. too small, limited EHR capacity).
  • (Note: In this study, the clinics are the "subjects" under study. The patients that will be referred by the clinic to the Wisconsin Tobacco Quit Line will be least 18 years old and Cigarette smokers)

Outcomes

Primary Outcomes

Number of Participants Referred

Time Frame: Rates come from cumulative data collected over the course of 6 months.

EHR-based vs. Fax-based rates of referral of adult tobacco users visiting primary care clinics to the tobacco quitline. The rate of referral will be determined by the ratio of total referrals to total smokers identified in the clinic's EHR over a period of 6 months of study observation.

Secondary Outcomes

  • Number of Participants Meeting Criteria for Quality Referral(Rates come from cumulative data collected over the course of 6 months.)
  • Number of Participants Self-reporting Smoking Abstinence(7-day point prevalence smoking outcomes at 4-months after participant registration with the WI Tobacco Quit Line.)
  • Change in Global Staff Satisfaction With the Referral Intervention(Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score)

Study Sites (1)

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