EHR-Based and Fax-Based Referral to a Tobacco Quitline: A Comparative Study

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Smoking; Tobacco Use Cessation
• Intervention / Treatment: Behavioral: Tobacco quitline EHR referral; Behavioral: Tobacco quitline Fax referral

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.

• Study Type: Interventional
• Enrollment (Actual): 14930
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 57311-2027
      • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Clinic Eligibility:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EHR-based referral to quit line; Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication. Intervention: Behavioral: Tobacco quitline EHR referral	Behavioral: Tobacco quitline EHR referral; Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.
Active Comparator: Fax-based referral to quit line; Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication. Intervention: Behavioral: Tobacco quitline Fax referral	Behavioral: Tobacco quitline Fax referral; Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.
Experimental: EHR-based Clinic Staff; Clinics will use an EHR-based fully-electronic HIPAA-compliant tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication. Staff in these clinics will complete surveys to address Aim 4 of the study.	Behavioral: Tobacco quitline EHR referral; Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.
Active Comparator: Fax-based referral to quit line Clinic Staff; Clinics will use a paper fax tool to refer their adult patients who use tobacco to the telephone tobacco quitline for tobacco cessation counseling and medication. Staff in these clinics will complete surveys to address Aim 4 of the study.	Behavioral: Tobacco quitline Fax referral; Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Referred	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.	Rates come from cumulative data collected over the course of 6 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Meeting Criteria for Quality Referral	To evaluate the rates of quality referrals of tobacco users visiting primary care clinics to the tobacco quitline. Quality referrals are defined as ones that result in individuals who enroll in and receive tobacco quit line services.	Rates come from cumulative data collected over the course of 6 months.
Number of Participants Self-reporting Smoking Abstinence	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.	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	In order to assess clinician and staff satisfaction with the eReferral and paper-based referral systems, a single-item "The steps I need to take to address my patients' tobacco use are efficient and well designed" was administered to healthcare system clinical staff. The response format was 1 = Strongly disagree; 2 = Disagree; 3 = Mildly disagree; 4 = Feel neutral; 5 = Mildly agree; 6 = Agree; 7 = Strongly agree. Higher scores indicate greater satisfaction with the assigned intervention (EHR-based vs Fax-based referral systems). The item is not part of any existing validated scale and was created for purposes of the project; this item was selected from a larger set of items and determined to be the most appropriate measure of overall staff satisfaction.	Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michael Fiore, MD, MPH, MBA, University of Wisconsin, Madison

Publications and helpful links

General Publications

• Zehner ME, Kirsch JA, Adsit RT, Gorrilla A, Hayden K, Skora A, Rosenblum M, Baker TB, Fiore MC, McCarthy DE. Electronic health record closed-loop referral ("eReferral") to a state tobacco quitline: a retrospective case study of primary care implementation challenges and adaptations. Implement Sci Commun. 2022 Oct 8;3(1):107. doi: 10.1186/s43058-022-00357-4.
• Fiore M, Adsit R, Zehner M, McCarthy D, Lundsten S, Hartlaub P, Mahr T, Gorrilla A, Skora A, Baker T. An electronic health record-based interoperable eReferral system to enhance smoking Quitline treatment in primary care. J Am Med Inform Assoc. 2019 Aug 1;26(8-9):778-786. doi: 10.1093/jamia/ocz044. Erratum In: J Am Med Inform Assoc. 2019 Oct 1;26(10):1159.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Smoking; Quitline; Tobacco; Electronic Health Records; Clinical Practice Guidelines; Translational Medical Research
• Other Study ID Numbers: 2015-0844; 1R35CA197573-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No