Clinical trial NCT02735382: EHR-Based and Fax-Based Referral to a Tobacco Quitline: A Comparative Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Tobacco Smoking
Keywords: Translational Medical Research
Clinical Practice Guidelines
Electronic Health Records
Smoking
Tobacco
Quitline
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-04-12
Enrollment: 14930
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants Referred
timeFrame: Rates come from cumulative data collected over the course of 6 months.
Secondary outcomes:
measure: Number of Participants Meeting Criteria for Quality Referral
timeFrame: Rates come from cumulative data collected over the course of 6 months.
measure: Number of Participants Self-reporting Smoking Abstinence
timeFrame: 7-day point prevalence smoking outcomes at 4-months after participant registration with the WI Tobacco Quit Line.
measure: Change in Global Staff Satisfaction With the Referral Intervention
timeFrame: Satisfaction measures will be surveyed at baseline and at 6 months and reported as a single change score
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 Fiore, MD, MPH, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.